Florida Kidney Disaster Coalition

Recall Notice: H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing

2011-08-30T11:13:00.000-04:00

On August 27, 2011, H & P Industries and the FDA issued a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased. It is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting System. Click here for more information.

Recall Notice: Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall

2011-08-03T16:46:00.002-04:00

On August 3, 2011, the FDA notified healthcare professionals of a Class I recall of certain Arrow NextStep Antegrade Chronic Hemodialysis Catheters, due to reports of breakage and/or separation of the stylet. These products were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina, and Tennessee. Listed below are the affected product and lot numbers which were manufactured between April 14, 2011 and May 9, 2011.

Product Number Lot Number

CS-15192-IXM RV1034909
CS-15232-IXM RV1034911
CS-15272-IXM RV1034912
CS-15312-IXM RV1034913
CS-15422-IX RV1034914
CS-15502-IX RV1034915

The Arrow NextStep Antegrade Catheter is indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis. Chronic hemodialysis catheters are typically placed into a large vein in the patient's neck. Customers should check their stock, cease use and distribution, and quarantine all affected product. See the Recall Notice for additional information. For questions regarding this recall, contact Arrow International Inc. Customer Service at 1-(800)-233-3187. Click here for more information.

FDA Notice: Nulojix (belatacept) – Risk Evaluation and Mitigation Strategy (REMS)

2011-07-08T09:38:00.000-04:00

On July 7, 2011, Bristol-Myers Squibb (BMS) informed healthcare professionals about the REMS that is required for Nulojix to ensure that the benefits of Nulojix outweigh the risks of Post-transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML), both of which can be fatal. Patients treated with Nulojix are at an increased risk for developing PTLD, predominantly involving the Central Nervous System. PML has been reported in patients receiving Nulojix at higher than recommended doses as part of an immunosuppressant regimen. It is recommended that healthcare providers verify the patient’s Epstein-Barr virus status before initiating therapy with Nulojix. BMS established the ENLiST Registry to further evaluate the safety profile of Nulojix. BMS encourages provider participation in the ENLiST Registry. Click here for more information.

Recall Notice: Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall - Software Defect May Cancel Shock

2011-05-13T12:41:00.000-04:00

On May 10, 2011, Defibtech, LLC a manufacturer of Automated External Defibrillators (AEDs) issued a recall of its Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. The company warned that AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient. AEDs are used on victims of sudden cardiac arrest when the patient is unconscious, unresponsive, and not breathing. To address this issue, Defibtech will provide customers with a free software upgrade. Because the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Full instructions and recommendations are being mailed to affected customers. Defibtech is responsible for contacting all end users unless a distributor has agreed to contact their accounts directly regarding this field correction. Questions regarding this recall may be directed to Al Raebuck, Customer Service Manager, Defibtech at techsupport@defibtech.com, 1-877-453-4507 or 1-203-453-4507. Click here for more information.

Recall Notice: Weck Hem-o-Lok Ligating Clips: Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy

2011-05-11T08:26:00.000-04:00

On May 6, 2011, The FDA notified health care providers that Weck Hem-o-Lok Ligating Clips should not be used for the ligation of the renal artery during a laparoscopic living-donor nephrectomy because of serious risks to the donor. There is the potential for the clips to become dislodged, which can lead to uncontrolled bleeding, additional surgery, or death of the donor. In 2006, the manufacturer added this contraindication to the Instructions for Use after receiving 15 reports of 12 injuries and three deaths which occurred between 2001 and 2005. Since the contraindication issued in 2006, there have been three more kidney deaths, all associated with the contraindicated use. The Weck Hem-o-Lok Ligating Clip is a V-shaped clip made from a non-absorbable material that comes in various sizes. It is used to permanently close bleeding vessels or tissue structures. See the FDA safety communication for a listing of affected model numbers, and recommendations for healthcare providers, hospital staff, and patients. Click here for more information.

Recall Notice: Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency

2011-05-04T09:44:00.001-04:00

On May 3, 2011, Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets. Company product testing indicated that a tablet in this lot had a higher potency than anticipated. The affected lot number in the U.S. is 9H49374A with an expiration date of September 30, 2012. Any decrease of active ingredient in the mediation may increase the risk of clots which could lead to heart attack or stroke, and alternatively, if there is too much active ingredient, there is an increased risk of bleeding. It is recommended that patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affect lot and if so, should consult their physician for additional medical advice. For further information related to this recall contact: Stericycle, Inc. at (866) 918-8739. Click here for more information.

Recall Notice: Roche ACCU-CHEK FlexLink Plus Infusion Set: Class I Recall - Potential for Under-Delivery of Insulin

2011-04-04T11:37:00.001-04:00

A Class I Recall has been issued for Roche ACCU-CHEK FlexLink Plus Infusion Sets. There is the potential for under-delivery of insulin due to a tube (cannula) which may become kinked or bent when inserting the ACCU-CHEK FlexLink Plus infusion set. If gone unnoticed, this can result in the under-delivery or no delivery of insulin. This can lead to elevated blood glucose levels (hyperglycemia). Hyperglycemia can lead to many serious health complications including death. Of important note, this recall only applies to the ACCU-CHEK FlexLink Plus infusion sets that were launched in November 2010. ACCU-CHEK Ultraflex, other Accu-Chek infusion sets or insulin pumps are not affected by this recall and can be continued as directed by a physician or other qualified healthcare provider. Roche requests that its consumers stop using the ACCU-CHEK FlexLink Plus infusion sets and return the unused products. Patients are encouraged to contact their health care providers or caregivers to determine if changes to their therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set. Click here for more information.

Recall Notice: Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A, D

2011-04-04T11:32:00.000-04:00

Tested Samples of Soladek Vitamin Solution have been found to contain elevated levels of vitamin A and vitamin D that were many times the recommended daily allowance for these vitamins. The intake of excessively high levels of these vitamins poses a risk to human health. Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma. Soladek Vitamin Solution is marketed with claims that the product treats "hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy." The product is sold in a box labeled in Spanish and containing a vial of the solution. Those in possession of Soladek should stop using the product immediately. Any consumers who have been using Soladek and are experiencing any of the above symptoms should see a doctor immediately. Click here for more information.

Recall Notice: H & P Industries Povidine Iodine Prep Pads: Recall - Potential Microbial Contamination

2011-03-21T16:39:00.001-04:00

Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources

On March 18, 2011, H&P Industries, Inc. initiated a voluntary recall of ALL LOTS of Povidine Prep Pads manufactured by their company, but which are privately labeled for many accounts. Recent testing has shown of Elizabethkingia meningoseptica on the pads. Use of contaminated Povidine Prep Pads could lead to life threatening infections, especially in at risk populations, including neonates, immune suppressed pateints, and surgical patients. Providine Iodine Prep Pads are used to prevent infection in minor cuts, scrapes, and burns, and are labeled as an antiseptic for preparation of the skin prior to surgery. The pads were distributed nationwide to healthcare customers ans are packaged in individual packets in a box of 100 packets Healthcare organizations should contat H&P Industries at (262) 538-2900 to arrange a return. Any consumer in possession of these pads should not use the product.

Click here for more information.

Recall Notice: American Regent Injectable Products: Recall - Visible Particulates in Products

2011-03-21T16:38:00.000-04:00

On March 18, 2010, American Regent, Inc. initiated a recall of certain injectable products manufactured by the company which have the potential for glass to flake from the product vial into the injection solution. The recalled products include:

[03/16/2011 - Press Release3, Dexamethasone Sodium Phosphate - American Regent]
[03/15/2011 - Press Release4, Bacteriostatic Sodium Chloride - American Regent]
[03/15/2011 - Press Release5, Concentrated Sodium Chloride - American Regent]
[02/04/2011 - Press Release6, Sodium Thiosulfate - American Regent]
[02/03/2011 - Press Release7, Potassium Phosphates - American Regent]

Previous, related product alerts:

[12/24/2010 - Dexamethasone Sodium Phosphate Injection8]
[12/29/2010 - Sodium Bicarbonate Injection9]

Glass delamination (separation) can occur with high pH solutions. Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics, and other healthcare facilities should not use recalled American Regent products. Recalled products should be immediately quarantines for return. Refer to the highlighted Press Releases above for specific lot numbers recalled.
Click here for more information.

Recall Notice: B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall - Hardware May Become Unresponsive

2011-03-03T14:37:00.000-05:00

On February 1, 2011, B. Braun Medical Inc. and the FDA issued a Class 1 Recall of its Outlook 400ES Safety Infusion System, Model# 621-400ES. Infusions systems upgraded with the Motorola compact flash hardware and supporting software, when used in a network environment that utilizes Temporal Key Integrity Protocol (TKIP) authentication, can potentially induce a memory leak that can cause the Management Processor to become non-responsive. This causes normal operation to stop, which is signaled by an audible backup alarm indicating that the pump is not delivering the medicine. It is encouraged that customers deactivate the wireless communication on their pumps and return them to the manufacturer. Any questions can be directed to B. Braun Medical Inc. at (972) 245-2243. Click here for more information.

Recall Notice: Fresenius Medical Care - CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors

2011-01-20T13:56:00.000-05:00

On January 14, 2011, Fresenius Medical Care North America announced a voluntary recall notice of CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors (Part Numbers 03-2695-9 and 03-2795-7) for use with the Blood Volume Monitor (BVM), due to reports of arterial line kinks. These kinks may manifest as arterial pressure alarms or be mistaken as access problems. There is also the potential for kinking to cause hemolysis can result in serious injury or death. The recall includes the following part numbers and lot numbers which were sold in the U.S. and Canada.

Part Number: 03-2695-9
Lot Numbers: 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102,10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180

Part Number: 03-2795-7
Lot Numbers: 09JR01174, 09JR01229, 09NR01139, 10KR01801

Customers who have the affected lots of CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the BVM which are being recalled should discontinue their use immediately and return product to Fresenius Medical Care. Clinic Managers, Unit Administrators and/or distributors with questions may contact Fresenius Medical Care Customer Service Team at 1-800-323-5188 in USA (7am-6pm CST, 5 days per week, with after-hours emergency support) and 1-888-709-4411 in Canada.

In addition, it is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting System. Click here for more information.

Recall Notice: Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

2011-01-07T12:52:00.000-05:00

On January 7, 2011, The Triad Group issued a recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. The recall pertains to all such products marked as either STERILE or non-sterile. The recall was initiated over concerns of possible product contamination with Bacillus cereus. Continued use of affected product could put at-risk patients at risk of developing life-threatening infections.
Recalled lots were distributed nationwide to retail pharmacies and sold in individual packets and in boxes containing 100 packets. The affected alcohol prep pads, alcohol swabs, and alcohol swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin. If a consumer has any of these types of products in their possession listing "Triad Group" as the manufacturer, they should not use the product and should return it to the place of purchase for a full refund. Click here for more information.

Recall Notice: AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall

2011-01-07T12:51:00.000-05:00

On January 5, 2011, AngioScore Inc. issued a recall of certain AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platforms manufactured by the company. The recall affects 17,682 units distributed from 09/2007 to 11/2010, including the following model part (REF) numbers and includes all sizes and lot codes for each model listed: 2076-4020, 2076-5020, 2076-6020, 2092-6020, 2105-6020. The devices are being recalled due to a design defect which can cause unintended fracture and peeling, resulting in fraying of the bond and/or detachment of the distal end of the scoring element. AngioScore Inc. is advising customer to immediately discontinue use of any recalled product. Not doing so may lead to retained device fragments or arterial injury that could lead to the need for surgical intervention or death. Click here for more information.

Recall Notice: American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50mL Single Dose Vials Due t

2011-01-07T12:49:00.000-05:00

On December 23, 2010, American Regent issued a voluntary recall of its Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50 mL Single Dose Vials due to the possibility of vials containing particulate matter. If use is not discontinued, potential adverse health events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. For this reason, American Regent is undertaking this recall in consideration of the potential for safety issues if any unapproved product is administered to patients. To access recalled product lot numbers, expiration dates, and additional instruction please, reference the Recall Notice in the following link. Click here for more information.

2010-12-28T09:44:00.000-05:00

Recall Notice: Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results
(including Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, ReliOn Ultima)
On December 22, 2010, The FDA and Abbott Diabetes Care issued a recall notification to healthcare professionals and patients regarding the recall of 359 different lots of glucose test strips marketed under the following brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima. The issue relates to the insufficient absorption of blood into the test strip. Test strips included in the recall may give falsely low blood glucose results, which can lead patients to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading. The recalled test strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The test strips, which were manufactured between January and May 2010, are sold both in retail and online settings directly to consumers, but are also used in health care facilities. Patients with diabetes should be aware of this problem and take steps to prevent it from affecting their health. Customers can check if they have tests trips from the recalled lots by visiting Abbott’s website to look up their product lot number: http://www.precisionoptiuminfo.com/. Click here for more information.

Recall Notice: B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter Bag

2010-12-01T16:19:00.000-05:00

On November 30, 2010, B Braun Medical Inc. issued a reiteration of a prior June 28, 2010 recall on use of its addEASE Binary Connectors. The organization identified that when an addEASE Binary Connector is inserted into a partial additive bag (PAB) stopper, fragments of the stopper may enter the bag, resulting in a small amount of visible particles in the solution. These particles can potentially enter a patient’s body and lead to serious injury and/or death. It is recommended that anyone currently using this product discontinue doing so immediately. Click here for more information.

Recall Notice: Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

2010-11-15T11:44:00.001-05:00

On November 15, 2010, the FDA and Sigma International Gerneral Medical Apparatus, LLC reiterated an earlier recall notice from September 15, 2010 regarding Sigma Spectrum Infusion Pump Model 35700. The recall includes pumps that have serial numbers from 706497 to 724065. The recall was issued because these units may fail suddenly, causing inaccurate flow conditons during use, ranging from back flow to over-infusion, including free flow. Also, of concern in that the pump does not issue and alarm when this occurs which could result in the serious injury of death of the user.

Should you be in possession of a recalled pump, Sigma is requiring the return of the devices. For questions and return information please, contact the company at 1-866-482-2893, Monday through Friday, 8 AM though 5 PM (Eastern Time). Click here for more information.

Recall Notice: Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem

2010-11-11T09:28:00.000-05:00

On October 8, 2010, WalkMed Infusion LLC. and the FDA notified healthcare professionals of a nationwide recall of the Triton Pole Mount Infusion Pump, serial numbers 001 through 500 and serial numbers TR1401 through TR 2559, manufactured and sold before June 2010. The issue stems from a problem with the latch alarm on the pump door which if gone unnoticed could potentially lead to an over infusion of medication to the patient. It is requested that consumers who have Triton Pole Mount Infusion Pumps which are being recalled should return the pump to the manufacturer. Click here for more information.

Recall Notice: Heparin Sodium (B. Braun): Recall - Trace Contaminant

2010-10-29T18:55:00.002-04:00

On October 29, 2010, B. Braun Medical Inc. and the FDA notified healthcare professional of a nationwide recall of certain lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010. Should you be in possession of this product discontinue use immediately. To identify product lot numbers, expiration dates, and further recall instructions, please reference the Recall Notice contained in the following link. Click here for more information.

FDA Proposes Withdrawal of Low Blood Pressure Drug: Companies failed to provide evidence of clinical benefit of midodrine hydrochloride

2010-08-17T06:20:00.000-04:00

The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.

The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.

To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities.

Orthostatic hypotension is a condition in which patients are unable to maintain blood pressure in the upright position and, therefore, become dizzy or faint when they stand up.

Generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories. According to a database used by the FDA, about 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009.

Access the FDA information at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222580.htm

Disasters, crush syndrome, and acute kidney injury to be featured at Renal Week 2010: Denver, CO

2010-08-13T07:43:00.000-04:00

In a terrorist attack, crush injury and crush syndrome may result from structural collapse after a bombing or explosion. Crush injury is defined as compression of extremities or other parts of the body that causes muscle swelling and/or neurological disturbances in the affected areas of the body. Typically affected areas of the body include lower extremities (74%), upper extremities (10%), and trunk (9%). Crush syndrome is localized crush injury with systemic manifestations. These systemic effects are caused by a traumatic rhabdomyolysis (muscle breakdown) and the release of potentially toxic muscle cell components and electrolytes into the circulatory system. Crush syndrome can cause local tissue injury, organ dysfunction, and metabolic abnormalities, including acidosis, hyperkalemia, and hypocalcemia.

Previous experience with earthquakes that caused major structural damage has demonstrated that the incidence of crush syndrome is 2-15% with approximately 50% of those with crush syndrome developing acute renal failure and over 50% needing fasciotomy. Of those with renal failure, 50% need dialysis.

-Centers for Disease Control and Prevention
http://www.bt.cdc.gov/masscasualties/blastinjury-crush.asp

Nephrology in Natural Disasters: What to Do with Acute Kidney Injury and End-stage Renal Disease Patients during Disasters
November 19, 2010 | 04:30 PM - 06:30 PM
Presented by the American Society of Nephrology – Renal Week 2010
Denver, Colorado

Session Description
This topic serves to educate physicians living in at-risk areas about how to respond to a natural disaster, prepare a dialysis unit, assess nephrology needs (e.g., continue chronic dialysis for existing patients, need for acute dialysis for acute kidney injury patients), how to respond appropriately to minimize renal injury, how to manage crush victims following disasters, and complications. The International Society of Nephrology (ISN) has spearheaded these efforts with the Renal Disaster Relief Task Force. ASN recently developed its own task force. The merging of experience may be of great value to the physicians from many countries who attend the Renal Week.

Session Objectives
Upon completion of this session, the participant will be able to: be better equipped to develop algorithms for: 1) evacuation; 2) recognizing and forming support networks; and 3) treatment plan for renal patients.

Moderators
Jeffrey B. Kopp, MD, FASN
Ricardo Correa-Rotter, MD

Lectures
Nephrology Experience in Natural Disasters
04:30 PM - 05:00 PM

Impact of Disasters on Dialysis Patients' Health
05:00 PM - 05:30 PM
Kenneth D. Lempert, MD

Haiti Earthquake from a Nephrology Point of View
05:30 PM - 06:00 PM
Didier Portilla, MD

Recommendations for the Management of Crush Victims Following Mass Disasters
06:00 PM - 06:30 PM
Raymond C. Vanholder, MD, PhD

Please see the registration information at http://www.asn-online.org/education_and_meetings/renal_week/2010/program-session-details.aspx?sess_id=36

NOAA Still Expects Active Atlantic Hurricane Season; La Niña Develops

2010-08-06T14:57:00.001-04:00

The Atlantic Basin remains on track for an active hurricane season, according to the scheduled seasonal outlook update issued today by NOAA’s Climate Prediction Center, a division of the National Weather Service. With the season’s peak just around the corner – late August through October – the need for preparedness plans is essential.

NOAA also announced today that, as predicted last spring, La Niña has formed in the tropical Pacific Ocean. This favors lower wind shear over the Atlantic Basin, allowing storm clouds to grow and organize. Other climate factors pointing to an active hurricane season are warmer-than-average water in the tropical Atlantic and Caribbean, and the tropical multi-decadal signal, which since 1995 has brought favorable ocean and atmospheric conditions in unison, leading to more active seasons.

“August heralds the start of the most active phase of the Atlantic hurricane season and with the meteorological factors in place, now is the time for everyone living in hurricane prone areas to be prepared,” said Jane Lubchenco, Ph.D., under secretary of commerce for oceans and atmosphere and NOAA administrator.

Across the entire Atlantic Basin for the whole season – June 1 to November 30 – NOAA’s updated outlook is projecting, with a 70 percent probability, a total of (including Alex, Bonnie and Colin):

14 to 20 Named Storms (top winds of 39 mph or higher), including:
8 to 12 Hurricanes (top winds of 74 mph or higher), of which:
4 to 6 could be Major Hurricanes (Category 3, 4 or 5; winds of at least 111 mph)

These ranges are still indicative of an active season, compared to the average of 11 named storms, six hurricanes and two major hurricanes; however, the upper bounds of the ranges have been lowered from the initial outlook in late May, which reflected the possibility of even more early season activity.

“All indications are for considerable activity during the next several months,” said Gerry Bell, Ph.D., lead seasonal hurricane forecaster at NOAA’s Climate Prediction Center. “As we’ve seen in past years, storms can come on quickly during the peak months of the season. There remains a high likelihood that the season could be very active, with the potential of being one of the more active on record.”

Be prepared for the hurricane season with important information available online at hurricanes.gov/prepare and at FEMA’s ready.gov.

NOAA’s mission is to understand and predict changes in the Earth's environment, from the depths of the ocean to the surface of the sun, and to conserve and manage our coastal and marine resources. Visit us on Facebook.

Tropical Depression 3

2010-07-22T11:32:00.000-04:00

11am Eastern Time

A TROPICAL STORM WARNING HAS BEEN ISSUED FOR THE FLORIDA EAST COAST FROM GOLDEN BEACH SOUTHWARD INCLUDING THE ENTIRE FLORIDA KEYS AND FLORIDA BAY...AND ALONG THE WEST COAST OF FLORIDA NORTHWARD TO BONITA BEACH.


A TROPICAL STORM WATCH HAS BEEN ISSUED FOR THE EAST COAST OF FLORIDA
FROM NORTH OF GOLDEN BEACH TO JUPITER INLET INCLUDING LAKE
OKEECHOBEE.

SUMMARY OF WATCHES AND WARNINGS IN EFFECT...

A TROPICAL STORM WARNING IS IN EFFECT FOR...
* FOR THE FLORIDA EAST COAST FROM GOLDEN BEACH SOUTHWARD INCLUDING THE ENTIRE FLORIDA KEYS AND FLORIDA BAY...AND ALONG THE WEST COAST OF FLORIDA NORTHWARD TO BONITA BEACH

A TROPICAL STORM WATCH IN IN EFFECT FOR...
* THE EAST COAST OF FLORIDA NORTH OF GOLDEN BEACH TO JUPITER INLET INCLUDING LAKE OKEECHOBEE

A TROPICAL STORM WARNING MEANS THAT TROPICAL STORM CONDITIONS ARE EXPECTED SOMEWHERE WITHIN THE WARNING AREA WITHIN 36 HOURS.

A TROPICAL STORM WATCH MEANS THAT TROPICAL STORM CONDITIONS ARE POSSIBLE WITHIN THE WATCH AREA...GENERALLY WITHIN 48 HOURS.

FOR STORM INFORMATION SPECIFIC TO YOUR AREA IN THE UNITED STATES...INCLUDING POSSIBLE INLAND WATCHES AND WARNINGS...PLEASE MONITOR PRODUCTS ISSUED BY YOUR LOCAL NATIONAL WEATHER SERVICE FORECAST OFFICE. FOR STORM INFORMATION SPECIFIC TO YOUR AREA OUTSIDE UNITED STATES...PLEASE MONITOR PRODUCTS ISSUED BY YOUR NATIONAL METEOROLOGICAL SERVICE.

DHS Launches "See Something, Say Something" Campaign

2010-07-06T07:14:00.000-04:00

Department of Homeland Secretary’s (DHS) Janet Napolitano launched the first phase of DHS' nationwide "See Something, Say Something" campaign and announced a new national information-sharing partnership with Amtrak as part of the Department's Nationwide Suspicious Activity Reporting (SAR) Initiative during a whistlestop train tour—highlighting the public's role in keeping our country safe and the Obama administration's commitment to bolstering surface transportation security.

"Implementing a national suspicious activity reporting partnership with Amtrak and expanding the 'See Something, Say Something' campaign strengthens our ability to guard against terrorism and crime," said Secretary Napolitano. "These initiatives enable us to provide frontline security personnel with the latest information and intelligence to recognize behaviors and indicators associated with new and evolving threats."

In the coming months, DHS will expand the "See Something, Say Something" campaign nationally with public education materials, advertisements and other outreach tools to continue engaging travelers, businesses, community organizations, and public and private sector employees to remain vigilant and play an active role in keeping our country safe.

In support of DHS’s “See Something, Say Something” Campaign, FEMA’s Individual and Community Preparedness Division has partnered with the International Association of Chiefs of Police (IACP) to research how to improve the public’s response to suspicious activity. FEMA and IACP plan to present on the research findings and recommendations at the IACP Annual Conference in late October.

Gulf of Mexico Oil Spill: is my drinking water safe?

2010-06-28T11:56:00.001-04:00

Drinking Water

Is my drinking water safe?

Is my water safe to drink?
The oil spill is not currently expected to affect drinking water. The closest drinking water intake in use in Southeastern Louisiana on the Mississippi River is 49 miles upstream from the mouth of the river. The oil is not expect to migrate that far upstream. If you have any concerns about your water, contact your water utility.

Will my private well be impacted by the oil spill?
No. The oil sheen is not expected to impact domestic wells.

How will I know if my water isn't safe to drink?
Your water supplier must notify you by newspaper, mail, radio, TV, or hand-delivery if your water doesn't meet EPA or state standards or if there is a waterborne disease emergency. The notice will describe any precautions you need to take, such as boiling your water. Follow the advice of your water supplier if you ever receive such a notice.

My water tastes or smells different. What should I do?
If you have any concerns about your water, you should contact your water supplier. The oil spill is not expected to affect drinking water. If your water supply does not meet EPA or state standards your water supplier must notify you by newspaper, mail, radio, TV, or hand-delivery.

Deepwater Horizon Response Unified Command (BP Gulf oil spill response)

http://www.deepwaterhorizonresponse.com/

Hurricane Forecasts

2010-04-07T13:33:00.002-04:00

Colorado State University meteorologists are continuing to foresee above-average activity for the 2010 Atlantic hurricane season. There are eight hurricanes predicted for the Atlantic Hurricane Season, with four major hurricanes (Category 3 or higher).

For more information on Dr. Klotzbach and Dr. Gray's forecast, visit: http://tropical.atmos.colostate.edu/forecasts/2010/april2010/apr2010.pdf

For more information on the National Hurricane Center's changes and updates to this year's hurricane forecasts, visit: http://www.nhc.noaa.gov/pdf/nhc_new_2010.pdf

Safety Announcement From FDA - High-Dose Zocor and Increased Risk of Muscle Injury

2010-03-30T07:15:00.001-04:00

FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor* (simvastatin) and increased risk of muscle injury

[3-19-2010] Based on review of data from a large clinical trial and data from other sources, the U.S. Food and Drug Administration (FDA) is informing the public about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class.

The clinical trial data being reviewed is from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. The agency is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury (see Data Summary below).

The muscle injury, also called myopathy, is a known side effect with all statin medications. Patients with myopathy generally have muscle pain, tenderness or weakness, and an elevation of a muscle enzyme in the blood (creatine kinase). The higher the dose of statin used, the greater the risk of developing myopathy. The risk of myopathy is also increased when simvastatin, especially at the higher doses, is used with certain drugs (see Simvastatin Dose Limitations below).

The most serious form of myopathy is called rhabdomyolysis. It occurs when a protein (myoglobin) is released as muscle fibers break down. Myoglobin can damage the kidneys. Patients with rhabdomyolysis may have dark or red urine and fatigue, in addition to their muscle symptoms. Damage to the kidneys from rhabdomyolysis can be so severe that patients may develop kidney failure, which can be fatal.

Known risk factors for developing rhabdomyolysis include age (> 65 years), low thyroid hormone levels (hypothyroidism), and poor kidney function. Myopathy and rhabdomyolysis are listed as possible side effects in the simvastatin and other statin drug labels.

Healthcare professionals should:

· Understand that rhabdomyolysis is a rare adverse event reported with all statins.

· Be aware of the potential increased risk of muscle injury with the 80 mg dose of simvastatin compared to lower doses of simvastatin and possibly other statin drugs.

· Follow the recommendations in the simvastatin label regarding drugs that may increase the risk for muscle injury when used with simvastatin (see Simvastatin Dose Limitations below).

Patients should:

· Not stop taking simvastatin unless told to by their healthcare professional.

· Talk to their healthcare professional about any questions they have about the use of simvastatin.

· Call their healthcare professional if they experience any of the following: muscle pain, tenderness or weakness, urine that is dark or red-colored, or unexplained tiredness.

This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete.

*Simvastatin is sold as a single-ingredient generic medication and as the brand-name, Zocor. It is also sold in combination with ezetimibe as Vytorin; and niacin as Simcor.

Additional Information for Patients

Patients currently using 80 mg simvastatin should:

· Know that rhabdomyolysis is a rare side effect reported with all statin medications.

· Not stop taking simvastatin unless told to by their healthcare professional.

· Review their medical history and current medications with their healthcare professional to determine if they should continue using simvastatin.

· Talk to their healthcare professional about any questions or concerns they have about simvastatin.

· Call their healthcare professional if they have muscle pain, tenderness or weakness, dark or red colored urine, or unexplained tiredness.

· Report any side effects with simvastatin to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box.

Additional Information for Healthcare Professionals

FDA recommends that healthcare professionals should:

· Understand that rhabdomyolysis is a rare adverse event reported with all statins.

· Be aware of the potential increased risk of muscle injury with the 80 mg dose of simvastatin compared to lower doses of simvastatin and possibly other statin drugs.

· Review patients' medical history and medications to determine if simvastatin is clinically appropriate.

· Discuss with patients the benefits and risks, including the risk of myopathy and rhabdomyolysis, of simvastatin therapy.

· Be aware of potential drug-drug interactions with simvastatin.

· Report any adverse events associated with the use of simvastatin to FDA's MedWatch program using the information in the "Contact Us" box at the bottom of the page.

Data Summary

FDA's review of the SEARCH trial is part of the agency's continuing effort to evaluate the risk of muscle injury with simvastatin; this review includes evaluating data from clinical trials, observational studies, and adverse event reports, as well as data on prescription use of simvastatin.

The SEARCH trial evaluated over 6.7 years the number of major cardiovascular events (heart attack, revascularization, and cardiovascular death) in 6031 patients taking 80 mg of simvastatin compared to 6033 patients taking 20 mg of simvastatin. All patients in the study had previously had a heart attack.

Preliminary SEARCH trial results revealed that more patients in the simvastatin 80 mg group developed myopathy compared to patients in the simvastatin 20 mg group (52 [0.9%] cases compared to 1 case [0.2%]). Further, FDA's preliminary analyses of the primary data suggest that 11 (0.02%) of the patients in the simvastatin 80 mg group developed rhabdomyolysis compared to no patients in the simvastatin 20 mg group.

In 2008, the agency alerted the public about an increased risk of developing rhabdomyolysis when doses greater than 20 mg of simvastatin are given with amiodarone. The agency also included information about this drug interaction in its Summer 2008 issue of the FDA Drug Safety Newsletter¹ and in its November 2008 Patient Safety News broadcast².

In March 2010, FDA approved a labeling revision for simvastatin based on interim results from an ongoing clinical trial – the Heart Protection Study 2 (HPS2). The revised label states that patients of Chinese descent should not receive simvastatin 80 mg with cholesterol-modifying doses of niacin-containing products. Further, the revised label recommends caution when such patients are treated with simvastatin 40 mg or less in combination with cholesterol-modifying doses of niacin-containing products. The interim HPS2 results showed that the incidence of myopathy was higher in patients of Chinese descent (0.43%) compared with patients not of Chinese descent (0.03%) taking 40 mg simvastatin plus cholesterol-modifying doses (≥1 g/day) of a niacin-containing product. It is not known if the increased risk for myopathy observed in these patients applies to other patients of Asian descent.

Moreover, FDA has requested that the sponsor of simvastatin change the product labeling to instruct healthcare professionals to avoid prescribing simvastatin doses greater than 40 mg daily when patients are taking the medication diltiazem, due to an increased risk for myopathy.

A 2010 review of prescription drug use data conducted by FDA found that, despite dose limitations and drug-drug interaction precautions included in the simvastatin drug label, patients are continuing to be prescribed higher doses of simvastatin with other medications that are known to increase the risk for rhabdomyolysis (see Simvastatin Dose Limitations below).

It is important for healthcare professionals to consider the potential risks and known benefits of simvastatin compared to other cholesterol-lowering therapies when deciding to use simvastatin. Healthcare professionals should also carefully review patients' medications for potential drug-drug interactions before prescribing or dispensing simvastatin.

This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete.

Ongoing Safety Review of High-dose Zocor (simvastatin) and Increased Risk of Muscle Injury http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm204882.htm

2010-03-03T15:21:00.001-05:00

FDA Classifies Baxter's January HomeChoice Peritoneal Dialysis Cycler Field Corrective Action as a Class I Recall

Baxter is Deploying Revised Labeling, Training and Upcoming Software Revisions to Further Assist Clinicians and Patients

DEERFIELD, Ill., March 2, 2010 – Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter’s recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. This action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of this device. Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with this issue.

About IIPV

IIPV may result in serious injury or death from conditions such as: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function and pericardial effusion. Children and non-verbal patients may be at increased risk because of their smaller size and/or inability to communicate. Increased monitoring of these patients is recommended. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.

Patients and caregivers should watch for the potential signs of IIPV. These include: difficulty breathing; vomiting or spitting up; a child complaining of a “funny feeling” in the abdomen; a child crying during therapy without other apparent reasons; difficulties feeding; feeling full, bloated, or overfilled after treatment; abdominal pain or discomfort; expanded or tense abdomen; localized swelling around the genital area (labia, scrotum) or groin region, belly button, the tunnel tract of the peritoneal dialysis catheter or the PD catheter exit site; leakage of fluid from the PD catheter exit site; and unexpected increase in blood pressure.

If patients or caregivers notice any of these symptoms, they should stop the device, initiate manual drain, and contact their healthcare provider immediately. Additional information that will be relevant in assessing patients for IIPV includes: careful monitoring of pre- and post-treatment weight; evaluating vital signs including heart rate and blood pressure; review of the recorded ultrafiltration from the device; and development of symptoms of respiratory distress or increased effort in breathing. For patients in a clinic, hospital, or critical care setting, clinicians should consider increased monitoring. This would include evaluating oxygen saturation and evidence of abdominal tenseness.

Baxter is continuing to investigate the causes, fixes, and mitigations associated with IIPV and use of the HomeChoice device. Current mitigations under development and implementation include changes to device labeling and software, which are intended to address issues such as prescription and patient errors, including bypassing alarms. Patients will receive new Patient At-Home Guides, which contain expanded information about IIPV, the symptoms, warnings and cautions, and how to address IIPV, should it occur. Baxter has also developed and is validating a software modification to address this issue and plans to submit a 510(k) to the FDA midyear. The software update will include additional user interface messages and alarms, and change default settings and allowable ranges to reduce risk of excessive accumulation of fluid in the peritoneal cavity.

HomeChoice systems are intended for automatic control of dialysis solutions exchange in the treatment of adult and pediatric renal failure patients undergoing peritoneal dialysis. The recall notice does not require the physical return of HomeChoice units and patients may continue using them. Affected model numbers include: 5C4471, 5C4471R, 5C8310, 5C8310R, 5C4474, 5C4474R, R5C8320, R5C8320R, T5C4441, T5C4441R, T5C8300, T5C8300R, 5C4474D and 5C4474DR. It is important that clinicians rev the prescription settings for devices to help reduce prescription errors and weigh the risks and benefits of continued use of this device by their patients.

Baxter sent recall notices to clinicians and patients informing them of this action and identifying steps that are intended to reduce the harm associated with IIPV. These January 2010 letters contain more detailed information about device usage and are available at www.baxter.com. Customers or patients with questions regarding this notice may contact Baxter 24 hours a day, seven days a week at 1-800-553-6898. Any adverse reactions experienced with the use of this product, and/or quality problems, should be reported to Baxter’s Renal business at 1-888-736-2543, prompt 3, and the FDA's MedWatch Program at 1-800-FDA-1088 or www.fda.gov/MedWatch/report.htm .

“We are committed to providing peritoneal dialysis patients with the safest and most effective therapy possible,” said Bruce McGillivray, president of Baxter’s Renal business. “We stand ready to support our patients and the nephrology community as we develop and implement measures intended to reduce the occurrence of IIPV.” The company does not expect the corrections required to address the IIPV issue to be financially material.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the company’s HomeChoice systems, including expectations with respect to the cost of addressing the IIPV issue identified in this release. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: future actions of regulatory bodies and other governmental authorities, including the FDA and foreign counterparts that could substantially affect the nature or timing of the company’s actions; additional product development steps, including software development; product quality or patient safety issues; and the other factors identified in the company’s most recent filing on Form 10-K and other SEC filings, all of which are available on the company’s web site. The company does not undertake to update its forward-looking statements.

March is National Kidney Month!

2010-03-03T10:17:00.000-05:00

http://www.nkdep.nih.gov/kidneymonth/

Kidneys filter your blood. They remove wastes and extra water. When the kidneys are diseased, they stop doing these jobs and wastes build up, damaging the body. If not treated, kidney disease can lead to kidney failure. But you can prevent kidney failure.

Early kidney disease has no symptoms. Most people don't know something is wrong until their kidneys are about to fail. The only way to tell if you have kidney disease is to get tested. Simple blood and urine tests are used to detect kidney disease.

OneTouch SureStep Test Strips (LifeScan): Recall

2010-03-01T09:50:00.001-05:00

LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL. If patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death. The eight lots of consumer OneTouch SureStep Test Strips being recalled are identified in the firm's press release. Lot numbers are located on the outer carton and test strip vial. LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010. It is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher. Read the complete MedWatch 2010 Safety summary, including a link to the firm's press release.

Drug Safety Communication : Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp

2010-02-17T09:46:00.001-05:00

FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving an ESA. Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer.

Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program. FDA is requiring a REMS because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions.

Patients with chronic kidney failure (includes patients on dialysis and those not on dialysis) using ESAs should:

Know that the use of ESAs can increase the risk for stroke, heart attack, heart failure, blood clots, and death.
Read the Medication Guide to understand the benefits and risks of using an ESA.
Get blood tests while using ESAs. The test results may help guide the course of therapy and lower the risks of using these drugs. Patients' healthcare professionals should make them aware of how often to have blood tests.
Talk with their healthcare professional about any questions they have about the risks and benefits of using ESAs.

Read the complete MedWatch 2010 Safety summary including links to the Drug Safety Communication and current Prescribing Information for these products, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200391.htm

RECALL: Edwards Lifesciences Aquarius Hemodialysis System

2010-01-29T07:37:00.001-05:00

FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.

The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius.

The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.

The company received reports of clinically significant fluid imbalance.

When a certain level of fluid imbalance is detected the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. By repeatedly overriding the balance alarm without solving the issue, such as a closed clamp or kinked line, it is possible to remove too much fluid from or replace too much fluid to the patient.

In extreme cases, this could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death. Public Contact: Baxter International, Inc. is the U.S. distributor of the Aquarius.

For questions regarding the Aquarius, contact the Baxter Clinical Help Line at 1-888-736-2543.

Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes

2010-01-25T07:56:00.001-05:00

Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump).

These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection.

Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.

This recall includes all product codes and lot numbers with expiration dates before 2011-11 (Nov 1, 2011). The firm voluntarily recalled the products after learning of the possibility of needle detachment.

FDA has been apprised of this action. No injuries have been reported to date.

Product was distributed nationwide, including Puerto Rico.

Company is notifying its distributors and customers by Fax and Email and is arranging for return of all recalled products.

Consumers with questions may contact the company at 305.599.7174 x249.

Helping Haiti

2010-01-22T08:26:00.001-05:00

President Bill Clinton and President George W. Bush have established the Clinton Bush Haiti Fund for donations for the relief and support of Haiti.

The American Red Cross is working with its partners to assist those affected by this disaster. To contribute, please visit the RedCross online.

Health professionals wishing to go to Haiti, individuals, organizations, and companies wishing to make monetary contributions, or donate medical supplies or equipment, should register and indicate what resources they have at http://www.cidi.org.

For more ways to help, visit the Center for International Disaster Information (CIDI) site.

Preparing for Disasters makes Renal & Urology News' "Top 10" List

2010-01-08T07:46:00.002-05:00

http://www.renalandurologynews.com/dialysis-chains-prepare-for-disaster/article/123903/

Dialysis Chains Prepare for Disaster

For most patients with end-stage renal disease, dialysis centers provide crucial, even lifesaving, treatment. But are dialysis facilities prepared for emergencies?

KCER Summit

2009-12-18T09:58:00.001-05:00

Non-Safety-Related Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine in Pre-Filled Syringes

2009-12-16T13:57:00.001-05:00

December 15, 2009, 9:00 AM ET

Why are some lots of pediatric H1N1 vaccine manufactured by Sanofi Pasteur in pre-filled syringes being recalled from the market?

As part of its quality assurance program, the manufacturer, Sanofi Pasteur, performs routine, ongoing stability testing of its influenza A (H1N1) vaccine after the vaccine has been shipped to providers. Stability testing means measuring the strength (also called potency) of a vaccine over time. It is performed because sometimes the strength of a vaccine can go down over time. On December 7, Sanofi Pasteur notified CDC and FDA that the potency in one batch (called a “lot”) of pediatric syringes that had been distributed was later found to have dropped below a pre-specified limit. As a result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had been distributed also had an antigen content that, while properly filled at the time of manufacturing, was later measured to be below pre-specified limits. This means that doses from these four vaccine lots no longer meet the manufacturer’s specifications for potency. Sanofi Pasteur will send providers directions for returning any unused vaccine from these lots.

What does potency mean for the H1N1 vaccine?

Potency (or strength) is determined by the measurement of the concentration of the active ingredient (also called antigen) in the H1N1 vaccine.

Are there any concerns about safety of vaccines from these lots?

No. There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety.

Should infants and children who received vaccines from these lots be revaccinated?

No. The vaccine potency is only slightly below the “specified” range. The vaccine in these lots is still expected to be effective in stimulating a protective response despite this slight reduction in the concentration of antigen. There is no need to re-administer a dose to those who received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.

What action(s) should parents of children who have received vaccine from the recalled lots take?

Parents of children who received vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series if not already completed.

What are the lot numbers affected by this recall?

Vaccine doses with the following lot numbers are included in the recall:

0.25 ml pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):
UT023DA
UT028DA
UT028CB

0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):
UT030CA

How many doses of the pediatric H1N1 vaccine are affected by this recall?

Approximately 800,000 doses of vaccine in these lots were distributed to providers.

Is the potency issue related to this recall isolated to just the pediatric H1N1 vaccine for 6-35 month olds?

The potency problem described here is specific to the four lots of Sanofi Pasteur’s pediatric H1N1 vaccine in 0.25 mL pre-filled syringes. Sanofi Pasteur is investigating what caused the problem. The same vaccine packaged in other dosing forms, such as pre-filled syringes for older children adults, and multi-dose vials, continues to meet specifications. This recall does not affect H1N1 vaccine produced by other manufacturers.

Were these lots of vaccine shipped after failing a required test?

No. The lots being recalled passed all quality controls and met all specifications before they were shipped.

All vaccines are routinely tested for purity, potency and safety prior to release. The four lots of vaccine met all required specifications at the time of release and shipment to distribution centers. The vaccine provided in multi-dose vials and the single-dose, 0.5 mL pre-filled syringes for persons 36 months and older continues to meet all specifications.

What is being done to notify providers who received vaccine from the affected lots?

Sanofi Pasteur will send a notification to providers who received doses from any of the four lots of vaccine so that they can return any unused vaccine.

Where were the affected lots of vaccine distributed?

Vaccine from these four lots was distributed throughout the United States.

For U.S. children 6-35 months old, what other options are available currently for vaccination against H1N1 influenza?

For children 6 months of age and older, vaccine is available in multidose vials. The vaccine in multidose vials has not experienced this drop in potency and meets all standards of safety, purity and potency. As with all multidose vials of vaccines, these multidose vials contain a preservative (thimerosal) to prevent potential contamination after the vial is opened. The standard dose for this preparation in the 6-35 month age group is the same as for the pre-filled syringes, 0.25 mL. For healthy children at least 2 years of age, the nasal spray (live, attenuated influenza vaccine) is also an option. This vaccine is produced in single-units that do not contain thimerosal.

Resolve to be ready!

2009-12-07T12:28:00.000-05:00

This New Year’s Eve, nearly 50 percent of Americans will make at least one resolution as they look toward 2010. FKDC wants to encourage the renal community to make preparing for an emergency a resolution that is both important and easy to keep.

1. Create a family emergency plan. Your family may not be together when an emergency happens, so it is important to plan in advance: how you will contact one another; how you will get back together; and what you will do in different situations. You can download a family emergency plan template from by visiting http://www.ready.gov/america/makeaplan/index.html

2. Put together an emergency supply kit. You may need to survive on your own after an emergency. This means having your own food, water, and other supplies in sufficient quantity to last for at least three days. Local officials and relief workers will be on the scene after a disaster, but they cannot reach everyone immediately. You could get help in hours, or it might take days. In addition, basic services such as electricity, gas, water, sewage treatment, and telephones may be cut off for days, or even a week or longer. To find a complete checklist of the supplies your household may need in the event of an emergency, visit http://www.ready.gov/america/getakit/index.html

3. Be informed about the different types of emergencies that can happen in your area and their appropriate responses. Learn about the hazards that may strike your community, the risks you face from these hazards, and your community’s plans for warning and evacuation. You can obtain this information by visiting http://www.ready.gov/america/beinformed/index.html

4. Get involved in emergency preparedness. Visit www.CitizenCorps.gov to find local Citizen Corps Councils, USAonWatch (Neighborhood Watch) groups, Community Emergency Response Teams (CERT), Fire Corps programs, Volunteers in Police Service (VIPS) programs, and Medical Reserve Corps (MRC) units. Ask them what you can do to prepare and train yourself and your community for disasters and how to get involved locally.

Contact local chapters of the American Red Cross and National Voluntary Organizations Active in Disaster for local disaster preparedness and response service opportunities.

If you are interested in starting a local emergency preparedness initiative in your neighborhood or community, visit http://serve.gov/toolkits/disaster/index.asp to download a toolkit that will walk you through the steps to start a project.

FKDC encourages you to use these tools to make a New Year’s resolution that will bring you and your loved ones peace of mind.

Wishing you a happy and safe New Year, and remember, Resolve to Be Ready in 2010.

2009-11-19T07:05:00.002-05:00

In Florida, we don't have to worry about cold weather very often. Just for that reason, it's important to be prepared for severe winter weather. You might not have the necessary supplies on hand in case of severe cold.

Heating Checklist

Have at least one of the following heat sources in case the power goes out:
*Fireplace with plenty of dry firewood or gas log fireplace
*Portable space heaters or kerosene heaters

Check with your local fire department to make sure that kerosene heaters are legal in your area.

Never place a space heater on top of furniture or near water.

Use electric space heaters with
*automatic shut-off switches and
*nonglowing elements.

Keep heat sources at least 3 feet away from furniture and drapes.

Never leave children unattended near a space heater.

Have the following safety equipment:
*Chemical fire extinguisher
*Smoke alarm in working order (Check once a month and change batteries once a year.)
*Carbon monoxide detector

Never use an electric generator indoors, inside the garage, or near the air intake of your home because of the risk of carbon monoxide poisoning:
*Do not use the generator or appliances if they are wet.
*Do not store gasoline indoors where the fumes could ignite.
*Use individual heavy-duty, outdoor-rated cords to plug in other appliances.

Cooking and Lighting Checklist

* Never use charcoal grills or portable gas camp stove indoors—the fumes are deadly.
* Use battery-powered flashlights or lanterns.
* Avoid using candles.
* Never leave lit candles alone.

Accusure Insulin Syringes Qualitest Pharmaceuticals - Recall

2009-10-28T07:16:00.001-04:00

Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe. Click here for more information.

Dexferrum (iron dextran injection) - Labeling Change

2009-10-19T08:29:00.001-04:00

American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. Fatal reactions have followed the test dose of iron dextran injection, even in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration. For more information, visit FDA Medwatch and American Regent.

Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators

2009-10-12T07:50:00.001-04:00

Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR).

The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: http://www.unomedical.com/?pageid=H3160.

Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers. Customers with questions are urged to contact Unomedical at 1-800-634-6003.

Philips Issues Worldwide Recall of Select Heartstart Fr2+ Automated External Defibrillators

2009-10-05T08:15:00.001-04:00

September 28, 2009 - Seattle - Philips announced today that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May, 2007 and January, 2008 are included in the voluntary recall.

The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy.

Philips has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during routine self tests, not during emergency use of the AED. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated, although Philips has received no reports of injury associated with this chip failure.

The AEDs affected by this recall have been distributed globally to fire departments, emergency medical services, hospitals, and other organizations. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs by sending notification letters to distributors and users. In addition, the company has set up a page on the Philips Web site with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is. The Web page is www.philips.com/FR2PlusAction.

Philips has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Customers who have questions about the recall or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.

Any adverse events experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

2009-10-02T07:30:00.001-04:00

New USP Standards for Heparin Products Will Result in Decreased Potency Adjustments may be needed to achieve desired anticoagulant effect in some patients.

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

FDA Alert to Health Care Professionals

USP Heparin Information

Information for Consumers: What You Should Know about Changes to Heparin

National Resource Center on Advancing Emergency Preparedness for Culturally Diverse Communities

2009-09-24T10:34:00.002-04:00

http://www.diversitypreparedness.org/

The National Resource Center on Advancing Emergency Preparedness for Culturally Diverse Communities, developed by the Drexel University School of Public Health’s Center for Health Equality, with support from the HHS Office of Minority Health.

This website provides information on preparedness in a variety of languages, including: Albanian, Amharic, Arabic, Armenian, Bengali, Bosnian, Brazilian, Burmese, Chamorro, Chinese, Chinese Simplified, Chinese Traditional, Chuukese, Croatian, Dutch, English, Ethiopian, Farsi, French, German, Haitian Creole, Hindi, Hmong, Italian, Japanese, Khmer/Cambodian, Kirundi, Korean, Kurdish, Laotian, Marshallese, Mien, Oromo, Persian, Polish, Portuguese, Russian, Samoan, Serbian, Sinhalese, Somali, Spanish, Sri Lanka, Swahili, Tagalog, Thai, Tongan, Turkish, Ukrainian, Urdu, Vietnamese, and Yupik.

International Clean Hands Week is Sept. 20-26, 2009

2009-09-21T09:36:00.001-04:00

The Clean Hands Coalition (CHC) reminds healthcare professionals that International Clean Hands Week is Sept. 20-26, 2009. The Clean Hands Coalition is a unified alliance of public and private partners working together to create and support coordinated, sustained initiatives to significantly improve health and save lives through hand hygiene. The CHC is facilitated by the Centers for Disease Control and Prevention (CDC) For more information and ideas on how to celebrate this week by raising hand hygiene awareness, go to http://www.cleanhandscoalition.org/nchw.htm

Recall: LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)

2009-09-16T13:49:00.001-04:00

Audience: Emergency medical personnel, consumers

[Posted 09/16/2009] FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy.

The AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.

Physio-Control called their customers from August 18-19, 2009 with a follow-up email message on August 20, 2009. The company sent replacements on August 19, 2009.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178].

[09/16/2009 - Recall Notice - FDA]

FDA ALERT: MYFORTIC

2009-09-08T09:16:00.001-04:00

Myfortic (mycophenolic acid)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals

Novartis and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information.

PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of Myfortic therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.

Read the complete MedWatch Safety summmary at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181306.htm

Levemir Insulin (Novo Nordisk):Stolen vials still may be on market

2009-08-27T09:23:00.000-04:00

FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.

Read the complete MedWatch 2009 Safety summary including a link to the FDA News release and the original June 13,2009 alerts at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166359.htm

Join us for the next Coffee House Conversations™ telephone call!

2009-08-25T12:59:00.001-04:00

To empower and educate individuals affected by chronic kidney disease (CKD), transplantation and donation, the National Kidney Foundation’s People Like Us hosts monthly Coffee House Conversations™ telephone calls. On these free, interactive telephone calls, you will hear from experts, and be given an opportunity to ask them questions.

Dial in to the toll free number and enter the password below for all Coffee House Conversations™ telephone series calls.

Call-In Number: 888-603-9220
Password: KIDNEY

The next call is:

Get Ready for an Emergency
Tuesday, September 15
7:00 p.m. - 8:30 p.m. ET
call in: 1.888.603.9220
Pass code: KIDNEY

*Space is limited! You can register online now, call 1-888-JOIN-NKF (888-564-6653) or fill out this registration form (PDF* download).

Send an e-mail to coffeehouse@kidney.org for more information or to submit questions about upcoming calls.

2009-08-25T09:36:00.001-04:00

August 24, 2009

Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]

Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals. Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes. The syringes in these lots have been found to have needles which can detach from the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection. Consumers who have any recalled Accusure Insulin Syringes (31 G –Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1) should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. The lot number can be found on the white paper backing of each individual syringe. These recalled products were distributed from January 2007 through June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico). This information is posted here.

August 13, 2009

GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology

Audience: Diabetes healthcare professionals, hospital risk managers, patients. FDA notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.

GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.

2009-08-17T14:49:00.001-04:00

National Emergency Preparedness Education Week For Kidney Patients
September 13-19, 2009

The week of September 13-19, 2009 has been designated as the time for education and emergency preparedness for all patients requiring renal replacement therapy. All dialysis and transplant facilities across the United States will prepare each patient for the unexpected.

KCER READY!

2009-08-17T14:48:00.001-04:00

In honor of National Preparedness Month, we are very pleased to introduce KCER READY!

KCER READY! is a self assessment to help dialysis facilities and ESRD organizations promote a higher level of disaster preparedness for their staff and patients. We invite you to take a short quiz to evaluate your level of preparedness. Some of these questions are based on the national Readiness Quotient and others are based on the ESRD Conditions for Coverage regarding emergency preparedness. Are you KCER READY?

Swine flu now is so common, state labs limit testing

2009-07-28T14:18:00.000-04:00

http://www.tampabay.com/news/health/article1022338.ece

By Richard Martin, Times Staff Writer
Posted: Jul 27, 2009 07:01 PM

Swine flu has become so widespread that public health officials in Florida and elsewhere have stopped mass testing for the virus.

Florida's state labs now test for the H1N1 virus only in patients with life-threatening illnesses or those who live near suspected outbreaks in settings such as summer camps, schools, nursing homes and jails. Florida's labs began the new practice on July 13; other states have made similar changes.

When the virus first emerged in April, the Centers for Disease Control and Prevention had recommended testing for all suspected cases of swine flu.

Now that the flu is established as a pandemic, the public health emphasis has changed from tracing the disease's progression to containing it.

Here's what the latest developments in the swine flu epidemic mean for you:

Why the change?

One of the main reasons for widespread testing when swine flu first emerged was to determine whether the virus could be stopped. Health officials now know it can't, said Dr. Patricia Ryder, director of the disease control division of the Pinellas County Health Department.

The virus has spread to every state and U.S. territory, and is spreading rapidly in nearly every country around the world.

So the role of the state labs has shifted to identifying the severity of the illness and preventing outbreaks in group settings.

But what if I have another kind of flu? Shouldn't I be tested?

Of patients who have tested positive for flu this summer, 98 percent have been found to have swine flu, said Dr. Richard S. Hopkins, acting state epidemiologist.

But if you really want a test, private doctors still can send samples to private labs.

Has this new testing policy changed how doctors treat patients with flu symptoms?

No. Doctors continue to prescribe antiviral drugs such as Tamiflu for patients with flu symptoms who also have underlying conditions such as asthma, obesity, heart and lung disease and pregnancy that put them in high-risk categories.

For most people with flu symptoms who are otherwise healthy, doctors do not prescribe antiviral drugs; rather, they tell those patients to stay home, rest, isolate themselves and drink fluids. This is to preserve the antivirals for those who need them most. The CDC also says that the drugs have little benefit for low-risk patients.

With less testing, how will we know how many people actually have swine flu?

Even with widespread testing, it has been impossible to know how many people have contracted the virus, because for most people, the symptoms are mild.

In the U.S., for example, the CDC has reported more than 40,000 swine flu cases, but officials estimate that more than 1 million people have or have had the virus.

Both the World Health Organization and CDC have announced that they would stop tracking and reporting the number of confirmed swine flu cases.

If there's no testing, how can I know to avoid places where people have the flu?

There never has been a requirement to publicly announce flu cases. Your best defense remains personal hygiene measures.

How do I protect myself and my family?

• Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.

• Wash your hands often with soap and water, or use alcohol-based hand cleaners, especially after you cough or sneeze.

• Avoid touching your eyes, nose or mouth.

• Avoid contact with those who have respiratory symptoms.

• Stay home if you are sick for seven days after your symptoms begin or until you have been symptom-free for 24 hours, whichever is longer.

What's the latest on the swine flu vaccine?

Vaccine development remains a top priority. The CDC has said that up to 40 percent of Americans could get swine flu this year and next, and several hundred-thousand could die unless a vaccine campaign is successful.

U.S. government and health officials are currently recruiting people for swine flu vaccine testing, with a goal of having one approved and ready for distribution in October.

Richard Martin can be reached at rmartin@sptimes.com or (727) 893-8330.

[Last modified: Jul 28, 2009 06:37 AM]

Win Big With Quality!

2009-07-02T13:12:00.001-04:00

FMQAI: The Florida ESRD Network is pleased to announce its 2009 Annual Forum at the Renaissance Tampa Hotel International Plaza from November 15-17, 2009. The 2009 Annual Forum will provide you with excellent opportunities to share best practices and meet with the leaders in the renal community. Please join the Network, while we focus on the CMS goals of protecting patient safety, enhancing ongoing quality improvement, and improving patients’ experience of dialysis care.

2009-06-22T15:10:00.001-04:00

SURVIVING THE STORM:
DISASTERS AND DIALYSIS
August 3, 2009 - Dallas, Texas

RESCHEDULED!

SURVIVING THE STORM: DISASTERS AND DIALYSIS is a forum to ensure effective preparedness and efficient response to disasters impacting kidney dialysis and transplant patients and facilities.

This conference will focus on special requirements of dialysis and transplant patients, inclusion of the ESRD population in emergency and disaster plans, applying national emergency management principles to dialysis/transplant, disaster education to advance the quality of care, and weather service resources available to the kidney community.

This meeting is free and open to the public but you must register to attend. Please complete and return the registration form.

Surviving the Storm: Disasters and Dialysis
Monday, August 3, 2009
8:00 a.m. - 4:00 p.m.
Adolphus Hotel
Dallas, Texas

This agenda is tentative as of June 22, 2009. A finalized agenda will be posted soon. Please contact Sherilyn Burris, sburris@nw7.esrd.net if you have questions about this meeting or would like to exhibit your company/organization.

Hotel Reservations

A limited number of rooms at the Adolphus Hotel have been set aside for all attendees at a government rate of $115.00. To make your reservations, please contact Kolina Ford at (813) 383-1530 xt3884 or kford@nw7.esrd.net. Room reservations must be made by Monday, July 20, 2009 to receive this discounted rate.

SPOTLIGHT: LIGHTNING SAFETY

2009-06-19T12:12:00.000-04:00

There were 756 deaths from lightning from 1990-2003.

PLAN in advance your evacuation and safety measures. When you first see lightning or hear thunder, activate your emergency plan. Now is the time to go to a building or a vehicle. Lightning often precedes rain, so don't wait for the rain to begin before suspending activities.

IF OUTDOORS...Avoid water. Avoid the high ground. Avoid open spaces. Avoid all metal objects including electric wires, fences, machinery, motors, power tools, etc. Unsafe places include underneath canopies, small picnic or rain shelters, or near trees. Where possible, find shelter in a substantial building or in a fully enclosed metal vehicle such as a car, truck or a van with the windows completely shut. If lightning is striking nearby when you are outside, you should: Crouch down. Put feet together. Place hands over ears to minimize hearing damage from thunder. Avoid proximity (minimum of 15 ft.) to other people.

IF INDOORS... Avoid water. Stay away from doors and windows. Do not use the telephone. Take off head sets. Turn off, unplug, and stay away from appliances, computers, power tools, & TV sets. Lightning may strike exterior electric and phone lines, inducing shocks to inside equipment.

SUSPEND ACTIVITIES for 30 minutes after the last observed lightning or thunder.

INJURED PERSONS do not carry an electrical charge and can be handled safely. Apply First Aid procedures to a lightning victim if you are qualified to do so. Call 911 or send for help immediately.

Ready.gov: Hurricanes

2009-06-16T14:17:00.000-04:00

Hurricanes are severe tropical storms that form in the southern Atlantic Ocean, Caribbean Sea, Gulf of Mexico and in the eastern Pacific Ocean. Scientists can now predict hurricanes, but people who live in coastal communities should plan what they will do if they are told to evacuate.

Step 1: Get A Kit / "To-Go Bag"

Get an Emergency Supply Kit,which includes items like non-perishable food, water, a battery-powered or hand-crank radio, extra flashlights and batteries. You may want to prepare a portable kit and keep it in your car. This kit should include:
- Copies of prescription medications and medical supplies;
- Bedding and clothing, including sleeping bags and pillows;
- Bottled water, a battery-operated radio and extra batteries, a first aid kit, a flashlight;
- Copies of important documents: driver’s license, Social Security card, proof of residence, insurance policies, wills, deeds, birth and marriage certificates, tax records, etc.

Make sure you have a “to-go bag” ready in case you need to evacuate, include:
- Water and non-perishable food;
- Battery operated radio and batteries so you can get important information from local officials;
- First aid kit;
- Flashlight;
- Maps
- Important documents such as proof residence, pictures of your family including pets, insurance policies, and tax records;
- Comfortable clothing and blankets;
- Unique family needs such as prescription medications, pet supplies, infant supplies or any other unique need your family may have;

Step 2: Make a Plan

Prepare your family

Make a Family Emergency Plan. Your family may not be together when disaster strikes, so it is important to know how you will contact one another, how you will get back together and what you will do in case of an emergency
Plan places where your family will meet, both within and outside of your immediate neighborhood.
It may be easier to make a long-distance phone call than to call across town, so an out-of-town contact may be in a better position to communicate among separated family members.
You may also want to inquire about emergency plans at places where your family spends time: work, daycare and school. If no plans exist, consider volunteering to help create one.
Plan to Evacuate
- Identify ahead of time where your family will meet, both within and outside of your immediate neighborhood.
- Identify several places you could go in an emergency, a friend's home in another town, a motel or public shelter.
- If you do not have a car, plan alternate means of evacuating.
- If you have a car, keep a half tank of gas in it at all times in case you need to evacuate.
- Take your Emergency Supply Kit.
- Take your pets with you, but understand that only service animals may be permitted in public shelters. Plan how you will care for your pets in an emergency.
Take a Community Emergency Response Team (CERT) class from your local Citizen Corps chapter. Keep your training current.

Step 3: Be Informed

Familiarize yourself with the terms that are used to identify a hurricane.

A hurricane watch means a hurricane is possible in your area. Be prepared to evacuate. Monitor local radio and television news outlets or listen to NOAA Weather Radio for the latest developments.
A hurricane warning is when a hurricane is expected in your area. If local authorities advise you to evacuate, leave immediately.
Hurricanes are classified into five categories based on their wind speed, central pressure, and damage potential. Category Three and higher hurricanes are considered major hurricanes, though Categories One and Two are still extremely dangerous and warrant your full attention.

**Saffir-Simpson Hurricane Scale**
Scale Number (Category)	Sustained Winds (MPH)	Damage	Storm Surge
1	74-95	Minimal: Unanchored mobile homes, vegetation and signs.	4-5 feet
2	96-110	Moderate: All mobile homes, roofs, small crafts, flooding.	6-8 feet
3	111-130	Extensive: Small buildings, low-lying roads cut off.	9-12 feet
4	131-155	Extreme: Roofs destroyed, trees down, roads cut off, mobile homes destroyed. Beach homes flooded.	13-18 feet
5	More than 155	Catastrophic: Most buildings destroyed. Vegetation destroyed. Major roads cut off. Homes flooded.	Greater than 18 feet

Hurricanes can produce widespread torrential rains. Floods are the deadly and destructive result. Slow moving storms and tropical storms moving into mountainous regions tend to produce especially heavy rain. Excessive rain can trigger landslides or mud slides, especially in mountainous regions. Flash flooding can occur due to intense rainfall. Flooding on rivers and streams may persist for several days or more after the storm. Learn more about preparing your home or business for a possible flood by reviewing the Floods page.

Prepare Your Home

Cover all of your home's windows with pre-cut ply wood or hurricane shutters to protect your windows from high winds.
Plan to bring in all outdoor furniture, decorations, garbage cans and anything else that is not tied down.
Keep all trees and shrubs well trimmed so they are more wind resistant.
Secure your home by closing shutters, and securing outdoor objects or bringing them inside.
Turn off utilities as instructed. Otherwise, turn the refrigerator thermostat to its coldest setting and keep its doors closed.
Turn off propane tanks.
Ensure a supply of water for sanitary purposes such as cleaning and flushing toilets. Fill the bathtub and other large containers with water.

Prepare Your Business

Plan to stay in business, talk to your employees, and protect your investment.

Carefully assess how your company functions, both internally and externally, to determine which staff, materials, procedures and equipment are absolutely necessary to keep the business operating.
Identify operations critical to survival and recovery.
Plan what you will do if your building, plant or store is not accessible.
- Consider if you can run the business from a different location or from your home.
- Develop relationships with other companies to use their facilities in case a disaster makes your location unusable.
Learn about programs, services, and resources at U.S. Small Business Administration.

Listen to Local Officials
Learn about the emergency plans that have been established in your area by your state and local government. In any emergency, always listen to the instructions given by local emergency management officials.

Federal and National Resources

Find additional information on how to plan and prepare for a hurricane by visiting the following resources:

Pandemic Flu: Lessons From the Frontlines

2009-06-05T09:24:00.000-04:00

http://healthyamericans.org/reports/?reportid=64

Trust for America's Health (TFAH), the Center for Biosecurity, and the Robert Wood Johnson Foundation (RWJF) analyze the initial response to the H1N1 outbreak, Pandemic Flu: Lessons From the Frontlines, which found that U.S. officials executed strong coordination and communication and an ability to adapt to changing circumstances, but it also how quickly the nation's core public health capacity would be overwhelmed if an outbreak were more severe or widespread.

The Pandemic Flu: Lessons From the Frontlines report reviews 10 early lessons learned from the response to the H1N1 (swine) flu outbreak, 10 ongoing core vulnerabilities in U.S. pandemic flu preparedness, and case studies of challenges communities around the country faced when responding to the outbreak. The 10 early lessons learned from the 2009 H1N1 outbreak in the report were that:

Investments in pandemic planning and stockpiling antiviral medications paid off;
Public health departments did not have enough resources to carry out plans;
Response plans must be adaptable and science-driven;
Providing clear, straightforward information to the public was essential for allaying fears and building trust;
School closings have major ramifications for students, parents and employers;
Sick leave and policies for limiting mass gatherings were also problematic;
Even with a mild outbreak, the health care delivery system was overwhelmed;
Communication between the public health system and health providers was not well coordinated;
WHO pandemic alert phases caused confusion; and
International coordination was more complicated than expected.

The report also identifies some surprises encountered during the H1N1 outbreak, including that much of the world's pandemic planning had revolved around the potential threat of the H5N1 (bird) flu virus, which had been circulating in Asia and elsewhere for nearly a decade. It also reveals that planners anticipated there would be six weeks of lead time between the time a novel flu virus was identified and its spread to the United States.

In addition, according to the analysis in Pandemic Flu: Lessons From the Frontlines, there are a number of systemic gaps in the nation's ability to respond to a pandemic flu outbreak. To further strengthen U.S. preparedness, the following 10 core areas must be addressed:

Maintaining the Strategic National Stockpile - making sure enough antiviral medications, vaccinations, and equipment are available to protect Americans, which includes replenishing the stockpile when medications and supplies are used;
Vaccine development and production - enhancing the biomedical research and development abilities of the United States to rapidly develop and produce a vaccine;
Vaccinating all Americans - ensuring that all Americans would be able to be inoculated in a short period of time;
Planning and Coordination - improving coordination among federal, state, and local governments and the private sector preparedness and planning activities on an ongoing basis, including taking into account how the nature of flu threats change over time;
School closings, sick leave, and community mitigation strategies - improving strategies to limit the spread of disease ensuring all working Americans have sick leave benefits and that communities are prepared to limit public gatherings and close schools as necessary;
Global coordination - building trust, technologies, and policies internationally to encourage science-based, consistent decision making across borders during an outbreak;
Resources - providing enough funding for the on-the-ground response, which is currently under funded and overextended;
Workforce - stopping layoffs at state and local health departments and recruiting the next generation of public health professionals;
Surge capacity - improving the ability for health providers to manage a massive influx of patients; and
Caring for the uninsured and underinsured - ensuring that all Americans will receive care during an emergency, which limits the spread of the contagious disease to others, and making sure hospitals and health care providers are compensated for providing care.

Free registration for First Aid and CPR with AED

2009-06-04T13:10:00.001-04:00

In support of National Safety Month, the National Safety Council is offering free registration for "First Aid and CPR with AED."

Free Online Training (through June 7)

"First Aid and CPR with AED" can make the difference between life and death. Every year 1.1 million people in the U.S. have a heart attack and about half of them die. Many could have been saved if help came faster.

Registration is free through June 7 at www.nscfirstaid.com/nationalCPRweek.

Register as a "new student" and create your own login ID and password. Free registration is only until June 7. Once registered, you have 45 days to complete the course.

Hurricane Preparedness Week

2009-05-22T10:47:00.000-04:00

Atlantic Hurricane Season begins June 1. Hurricane Preparedness Week is May 24-30. Each day of the week focuses on a different aspect of hurricane preparedness. Visit http://www.nhc.noaa.gov/HAW2/english/intro.shtm

ATLANTIC BASIN SEASONAL HURRICANE FORECAST FOR 2009
Forecast Parameter and 1950-2000 Climatology (in parentheses) Issue Date 9 April 2009

Named Storms: 12
Named Storm Days: 55
Hurricanes: 6
Hurricane Days: 25
Intense Hurricanes: 2
Intense Hurricane Days: 5

PROBABILITIES FOR AT LEAST ONE MAJOR (CATEGORY 3-4-5) HURRICANE LANDFALL ON EACH OF THE FOLLOWING COASTAL AREAS:

Entire U.S. coastline - 54% (average for last century is 52%)
U.S. East Coast Including Peninsula Florida - 32% (average for last century is 31%)
Gulf Coast from the Florida Panhandle westward to Brownsville - 31% (average for last century is 30%)
Average major hurricane landfall risk in the Caribbean

2009-05-10T09:35:00.000-04:00

Interim Additional Guidance for Infection Control for Care of Patients with Confirmed, Probable, or Suspected Novel Influenza A (H1N1) Virus Infection in Outpatient Hemodialysis Settings

May 8, 2009 3:30 PM ET

These recommendations supplement the Centers for Disease Control and Prevention's Interim Guidance for Infection Control for Care of Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection in a Healthcare Setting. This information is provided to clarify novel influenza A (H1N1) virus infection control recommendations that are specific to outpatient hemodialysis centers. This information complements, but does not replace the general infection control recommendations for novel influenza A (H1N1).

Hemodialysis patients meeting criteria for isolation precautions for novel H1N1 influenza (confirmed, probable, or suspected novel H1N1 infection – see guidance on case definition) may be dialyzed in outpatient dialysis centers if they would not normally be referred to a higher level of care based on their symptomatology. Patients should be triaged at or prior to arrival at the facility and symptomatic patients with febrile respiratory illness (defined as fever [greater than 37.8° Celsius] plus one or more of the following: rhinorrhea or nasal congestion; sore throat; cough) should be segregated from other patients as soon as possible.
Patients should wear a surgical mask and be placed in a separate room (if available) for dialysis with the door closed. Hepatitis B isolation rooms used to dialyze hepatitis B surface antigen positive patients should not be used for these patients unless: 1) the patient with suspected or confirmed novel H1N1 influenza virus is hepatitis B surface antigen positive or 2) the facility has no hepatitis B surface antigen positive patients who would require treatment in the isolation room.
If a separate room is not available, the patient should wear a surgical mask and should be treated at a corner or end-of-row station, away from the main flow of traffic if available. The patient should be separated by at least 6 feet from the nearest patient stations (in all directions). If a facility has more than one patient meeting criteria for novel H1N1 influenza isolation precautions, consideration should be given to cohorting these patients and the staff caring for them together in the unit and/or on the same shift.
Contact and Standard Precautions with eye protection (goggles or face shield) should be used by healthcare personnel when coming within 6 feet of patients meeting criteria for novel H1N1 influenza isolation precautions. This includes the use of a N95 respirator, nonsterile gloves and gown. Respirators, gowns and gloves should be removed and discarded and hand hygiene, with soap and water or alcohol based hand sanitizer, performed prior to leaving the dialysis station.
As with all hemodialysis patients, all supplies taken to the station should be reserved for that patient alone and either discarded after use or cleaned and disinfected prior to use by another patient (information available at the MMWR report: Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients).
Equipment such as chairside computers used for medical charting, should be utilized for that patient alone during the treatment of that patient and appropriately cleaned and disinfected before use for another patient
Environmental surfaces should also be cleaned and disinfected in accordance with standard facility protocols after the patient has vacated the station and before setting up the machine and arrival of a new patient into that station
Precautions should be kept in place for 7 days after the onset of the patient's symptoms or at least 24 hours after symptoms have resolved, whichever is longer.

CDC: Hepatitis B Vaccine Shortage

2009-05-06T09:39:00.000-04:00

http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm

In December 2008, Merck communicated with CDC that it expected to deplete available adult and dialysis formulations of their hepatitis B vaccine, Recombivax HB® in the first quarter of 2009. Once depleted, these formulations will be unavailable for the remainder of 2009. Supply of GSK's Adult hepatitis B vaccine (Adult Engerix-B®) and Adult hepatitis A/hepatitis B combination vaccine (Twinrix®) is sufficient to meet demand for routine adult usage of this vaccine as well as CDC's ongoing High Risk Adult Hepatitis B Initiative.

FDA: Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump

2009-05-06T09:34:00.000-04:00

Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump

Audience: Diabetes healthcare professionals, patients

Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the “up” and/or “down” buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. Users may contact ACCU-CHEK Spirit hotline noted in the Press Release for a replacement pump or for any other questions regarding this potential defect.

Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Spirit

Pandemic Preparedness for Dialysis Patients and Providers

2009-05-05T09:26:00.000-04:00

Over the past few years, the KCER Coalition's Pandemic Preparedness Response Team has worked diligently developing information and resources for pandemic planning for the kidney community. Their webpage (www.kcercoalition.com/pandemic.htm) is filled with free resources to help patients prepare themselves and to assist dialysis facilities in developing their pandemic plans.

Some documents of interest are:

PANDEMIC PREPAREDNESS: MOST IMPORTANT THINGS TO KNOW

PANDEMIC FLU PLANNING CHECKLIST FOR INDIVIDUALS WITH CHRONIC KIDNEY DISEASE AND THEIR FAMILIES

RECOMMENDATIONS FOR DEVELOPING A DIALYSIS FACILITY PANDEMIC PLANNING CHECKLIST

Patient Education!

2009-05-01T15:05:00.001-04:00

Part of the CMS Conditions for Coverage require dialysis facilities to provide patient education on emergencies - including pandemic influenza. There are many resources available to promote patient education in your dialysis facility.

http://cdc.gov/h1n1flu/ The CDC is a clearinghouse for everything you need to know about swine flu (H1N1).

http://www.pandemicflu.gov/ One-stop access to U.S. Government swine, avian and pandemic flu information.

http://www.ready.gov/ "Ready's" pandemic influenza information

http://www.kcercoalition.com/ The KCER Coalition provides free educational resources, as well as useful links for swine flu.

H1N1 Flu (swine flu) - Florida

2009-05-01T07:52:00.000-04:00

All Florida ESRD patients and providers should continue to monitor the CDC website for updated information regarding influenza and healthcare settings. All Florida residents should listen to their local media (television, radio, internet) for information specific to your area. Click here to find your local health department.

The Miami Herald reported three suspected cases in Florida. While there are still no confirmed cases, it is critical to remember the CMS Conditions for Coverage require all ESRD facilities have a plan for dealing with emergencies, including pandemic influenza.

Florida Wildfire Update

2009-04-28T10:01:00.001-04:00

Florida - Deep Fire Update, - Broward & Collier Counties

Florida EOC is at activation Level III (monitoring). The Deep Fire has burned approximately 24,000 acres within Big Cypress National Preserve. The fire is 30% contained. No structures or facilities have been impacted, and there has been no request for Federal assistance. Crews continue burnout operations as a suppression strategy, while monitoring for and extinguishing spot fires. Because these operations are expected to impact visibility, Interstate 75 will remain closed until at least mid-day on Tuesday, and will reopen pending more favorable conditions. State Road 29 will remain closed until further notice. Big Cypress National Preserve has enacted some recreational access closures.

KCER Pandemic Team Monitors U.S. Swine Flu Outbreak

2009-04-27T09:50:00.000-04:00

The Kidney Community Emergency Response (KCER) Coalition's Pandemic Preparedness Team is actively monitoring the U.S. swine flu outbreak. KCER has distributed information to the ESRD Networks and is avaliable for technical assistance. Please visit www.kcercoalition.com for pandemic preparedness information and resources for the kidney community.

FDA Recalls Zoll AED Plus Defibrillator, Digoxin

2009-04-16T08:14:00.001-04:00

ZOLL AED Plus Defibrillator

Audience: Emergency medical personnel
[Posted 04/09/2009] ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device. Please visit http://www.fda.gov/cdrh/recalls/recall-021209b.html and http://www.zollaedplusbatteryhelp.com/

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

Audience: Pharmacists, cardiology healthcare professionals, consumers
[Posted 04/01/2009] Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase. Please visit http://www.fda.gov/oc/po/firmrecalls/caraco03_09.html

Florida flooding update, state emergency hotline activation

2009-04-14T09:42:00.000-04:00

U.S. Highway 90 at the Suwannee River bridge (Madison and Suwannee County line) has closed to all traffic due to high water and flood conditions.

U.S. 90 Closed At The Suwannee River - Detour Route: http://www.floridadisaster.org/eoc/PressReleases2008/90%20Closure.pdf

The State Emergency Operations Center (SEOC) in Tallahassee has activated to a Level 1, or full activation, in response to the flooding conditions in the Panhandle and Big Bend regions of the state.

The Florida Emergency Information Line (FEIL) is now operational from 7 a.m. to 7 p.m. daily to provide residents information on current events and safety measures. The number for residents to call is:
800-342-3557

2009-04-07T08:25:00.000-04:00

State of Florida - State Emergency Response Team
FOR IMMEDIATE RELEASE
CONTACT: ESF-14 Public Information

April 6, 2009
(850) 921-0217

STATE OF FLORIDA PREPARES FOR NORTH FLORIDA ROAD CLOSURES DUE TO FLOOD CONDITIONS ALONG THE SUWANNEE RIVER

TALLAHASSEE - State transportation, law enforcement and emergency management officials are preparing for the flooding of major roads in North Florida along the Suwannee River due to recent heavy rains in the region.

According to the Southeast River Forecast Center in Atlanta, the high levels of the Suwannee River could force the closure of U.S. 90 at the Suwannee River (Madison and Suwannee County line) as early as Wednesday.

If river water levels continue to rise, Interstate 10 (I-10) at the Suwannee River Bridge could also face closure as early as Thursday.

As a safety precaution, motorists are asked to delay or avoid travel through the impacted area until the conditions improve. Many smaller roads along the Suwannee River will be impacted as well over the
weekend.

To assist travelers, the state of Florida is coordinating response efforts with the state of Georgia to develop alternative routes through the region.

All motorists are advised to monitor their local media outlets for the latest information on weather conditions and possible road closures.

For real-time information on traffic conditions call 511 or visit www.FL511.com before getting on the road.

For additional information please visit www.FloridaDisaster.org

All students, teachers and parents can find educational information and free downloadable materials at: www.KidsGetAPlan.com

And for the latest daily situation and flash reports go to: www.YouTube.com/FloridaSERT

Flood alerts - Turn Around, Don't Drown

2009-03-31T08:26:00.003-04:00

The southeast region of the United States is expecting moderate to major flooding. The National Weather Service is issuing watches and warning for flooding in the Gulf Region. Residents should monitor their local weather service office.

Resources are also available from:

Southeast River Forecast Center http://www.srh.noaa.gov/alr/index.shtml
Significant River Flood Outlook http://www.hpc.ncep.noaa.gov/nationalfloodoutlook/index.htm l
Advanced Hydrologic Prediction Service http://www.weather.gov/ahps/

Flood alerts - Turn Around, Don't Drown

2009-03-31T08:26:00.001-04:00

Southeast River Forecast Center (http://www.srh.noaa.gov/alr/index.shtml
Significant River Flood Outlook (http://www.hpc.ncep.noaa.gov/nationalfloodoutlook/index.html
Advanced Hydrologic Prediction Service (http://www.weather.gov/ahps/

Flood Safety Awareness Week! March 15-21.

2009-03-17T10:44:00.000-04:00

http://www.floodsmart.gov/floodsmart/pages/landing_pages/landing_noaa.jsp?WT.mc_id=FEMA_NOAA

Floodwaters can be swift, powerful and, at times, deadly. However, advanced planning can help protect lives and minimize property losses due to flooding. With the spring thaw approaching, NOAA's National Weather Service and FEMA are partnering to observe the fifth annual Flood Safety Awareness Week, March 16-20, 2009.

The National Weather Service, along with FEMA's FloodSmart program, has launched a new Web page (www.floodsmart.gov/floodsmart/pages/landing_pages/landing_noaa.jsp?
WT.mc_id=FEMA_NOAA) that shows the effects and cost of flooding to millions of people in the United States. The site also provides essential information on what to know and do before, during and after a flood, and a variety of safety tips and online tools, including one that lets them see whether their homes and businesses are threatened at various flood stages.

"Floods claim nearly 100 lives and cost billions in property damage in the United States annually," said Jack Hayes, director of NOAA's National Weather Service. "Spring is peak flood season in many parts of the country, but floods can happen anywhere, at any time of the year. Many lives could be saved by following some simple and essential flood safety tips."

"Knowing what you can do to protect against the impact of flooding is critical in keeping your family, home and financial well-being secure," said Ed Connor, acting federal insurance administrator for FEMA's Mitigation Directorate. "Purchasing flood insurance is one important step you can take now. Many residents incorrectly believe that homeowners insurance covers the costs of flooding, but in fact, only a flood policy can." (Excerpt from www.noaanews.noaa.gov/stories2009/20090313_floodsafety.html)

FDA Notice: Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter recalled

2009-03-12T13:52:00.000-04:00

FDA notified healthcare professionals of a Class 1 Recall of model numbers Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163. These products were manufactured and distributed from February, 1997 through December, 2008. The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.

Read the MedWatch 2009 safety summary, including a link to the Recall Notice, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#Colleague

The importance of patient identification cards

2009-03-12T13:49:00.000-04:00

In mid-November 2008, the Kidney Community Emergency Response (KCER) Coalition mailed out lavender-colored patient identification cards to all dialysis facilities. The purpose of these cards is to assist in identifying a dialysis patient to emergency management, special needs shelter staff, and law enforcement that the individual needs access to treatment. Additionally, these cards provide a space for the local ESRD Network patient hotline, and other spaces for critical emergency information.

For more about the lavender patient cards or to print more cards, please visit http://www.kcercoalition.com/lavender.htm

FDA Notice: CellCept

2009-02-13T08:36:00.001-05:00

As directed, the Kidney Community Emergency Response (KCER) Coalition is providing this alert notice. Please share this information with your organization’s stakeholders, ESRD Network (facilities, patients), your State Agency contacts, and your staff. These notices will also be posted on the KCER website, http://www.kcercoalition.com/alerts.htm. Thank you!

CellCept (mycophenolate mofetil)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals
FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis.

Read the complete MedWatch 2009 Safety summary including links to the Dear Healthcare Professional and Dear Pharmacist letters, the new Medication Guide and the current Prescribing Information, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#CellCept

CDC lanches SNAPS: Snap Shots of State Population Data

2009-01-08T10:12:00.000-05:00

http://emergency.cdc.gov/snaps/

SNAPS provides local-level community profile information nationwide. It can be browsed by county and state and searched by zip code. SNAPS serves as a valuable tool when responding to public health emergency events at the state, Tribal, and local levels. It provides a "snap shot" of key variables for consideration in guiding and tailoring health education and communication efforts to ensure diverse audiences receive critical public health messages that are accessible, understandable, and timely.

SNAPS data is derived from the 2000 US Census and several 2003 CDC databases. For more information, see Credits.

FDA Alert: Innohep (12/31/08)

2009-01-03T12:52:00.000-05:00

Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to Innohep when treating these patients for deep vein thrombosis with or without pulmonary embolism.

Read the complete MedWatch 2008 Safety summary, including a link to the Dear Healthcare Professional letter and the December 2 FDA Ongoing Safety Review, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep

Be aware of carbon monoxide poisoning

2008-12-30T09:32:00.000-05:00

Winter months are the peak danger season for carbon monoxide poisoning. Review this information from the CDC.

Carbon monoxide (CO) is an odorless, colorless gas that can cause sudden illness and death if inhaled.

Carbon monoxide is found in combustion fumes, such as those produced by small gasoline engines, stoves, generators, lanterns, and gas ranges, or by burning charcoal and wood. CO from these sources can build up in enclosed or partially enclosed spaces. People and animals in these spaces can be poisoned and can die from breathing CO.

Exposure to CO can cause loss of consciousness and death. The most common symptoms of CO poisoning are headache, dizziness, weakness, nausea, vomiting, chest pain, and confusion. People who are sleeping or who have been drinking alcohol can die from CO poisoning before ever having symptoms.

Important CO Poisoning Prevention Tips

Never use a gas range or oven to heat a home.
Never use a charcoal grill, hibachi, lantern, or portable camping stove inside a home, tent, or camper.
Never run a generator, pressure washer, or any gasoline-powered engine inside a basement, garage, or other enclosed structure, even if the doors or windows are open, unless the equipment is professionally installed and vented. Keep vents and flues free of debris, especially if winds are high. Flying debris can block ventilation lines.
Never run a motor vehicle, generator, pressure washer, or any gasoline-powered engine outside an open window, door, or vent where exhaust can vent into an enclosed area.
Never leave the motor running in a vehicle parked in an enclosed or partially enclosed space, such as a garage.
If conditions are too hot or too cold, seek shelter with friends or at a community shelter.
If CO poisoning is suspected, consult a health care professional right away.

ftp://ftp.cdc.gov/pub/epr/disasters/hurricanes/video/high/CarbonMonoxideCarbonMonoxide.rmvb

NOW’S THE TIME: THE READY CAMPAIGN ENCOURAGES AMERICANS TO RESOLVE TO BE READY IN 2009

2008-12-15T08:26:00.000-05:00

WASHINGTON, D.C. — With the new year approaching, the U.S. Department of Homeland Security’s (DHS) Ready Campaign is reminding Americans to Resolve to be Ready in 2009. Resolve to be Ready is a nationwide effort designed to encourage individuals, families, businesses and communities to take action and prepare for emergencies in the new year.

“Individual planning is the cornerstone of emergency preparedness,” said Homeland Security Secretary Michael Chertoff. “Since establishing this department and Ready, we have come a long way in raising the baseline of preparedness in this country, but we still have a long way to go. As 2009 approaches, I urge all Americans to consider the importance – and real value – of being prepared for all hazards.”

Being Ready for emergencies can be an easy new year’s resolution to keep by following the Ready Campaign’s three simple steps: 1) Get an emergency supply kit; 2) Make a family emergency plan; and 3) Be informed about the types of emergencies that can happen in your area and their appropriate responses.

By taking these three steps – in particular having an emergency supply kit both at home and in the car – Americans will be prepared for winter mainstays like power outages and icy roads. Each of these kits should include basic necessities such as water, food and first aid supplies to help you survive if you are without power or become stranded in your vehicle. Complete checklists for each kit are available at www.ready.gov.

This year, the Ready Campaign is employing new media strategies to promote emergency preparedness. By using Twitter, a social networking tool, Ready hopes to not only reach new audiences, but also to open the lines of communication with the public, ensuring emergency preparedness is top of mind year-round. Twitter users can stay up-to-date on the latest Ready activities by following their username, “ReadydotGov,” on Twitter.

By making the decision to Resolve to be Ready in 2009 and following the simple preparedness steps in advance, Americans will minimize the impact of emergencies on themselves, their family and their businesses. By visiting www.ready.gov or calling 1-800-BE-READY, individuals can access free materials that will help them make and keep a new year’s resolution that will bring their families peace of mind.

February 2008 marked the Ready Campaign's fifth year at the Department of Homeland Security. Launched in 2003 in partnership with The Advertising Council, Ready is designed to educate and empower Americans to prepare for and respond to emergencies, including natural disasters and potential terrorist attacks. It has proven to be one of the most successful campaigns in Ad Council's more than 65-year history. Since its launch, the campaign has generated more than $756.5 million in donated media support. Individuals interested in more information about family, business and community preparedness can visit www.ready.gov.

Report Finds Economic Crisis Hurting U.S. Preparedness for Health Emergencies

2008-12-11T07:32:00.000-05:00

Trust for America’s Health (TFAH) today released the sixth annual Ready or Not? Protecting the Public’s Health from Disease, Disasters, and Bioterrorism report, which finds that progress made to better protect the country from disease outbreaks, natural disasters, and bioterrorism is now at risk, due to budget cuts and the economic crisis. In addition, the report concludes that major gaps remain in many critical areas of preparedness, including surge capacity, rapid disease detection, and food safety. In addition to assessing state and federal progress on indicators of emergency preparedness, the report offers specific recommendations to Congress, including restoring funding for health emergency preparedness, incorporating preparedness into healthcare reform, and enhancing research and development of technology and countermeasures.

Below is the national press release. The full report and a video release are also available on our website at http://healthyamericans.org/reports/bioterror08/. A playback of the audio press conference detailing highlights of the report will also be available this afternoon on the website.

Report Finds Economic Crisis Hurting U.S. Preparedness for Health Emergencies; More Than Half of States Score 7 or Lower Out of 10 in Readiness Rankings

Media contacts: Liz Richardson (202) 223-9870 x 21 or lrichardson@tfah.org or Laura Segal (202) 223-9870 x 27 or lsegal@tfah.org

WASHINGTON, DC, December 9, 2008 – Trust for America’s Health (TFAH) and the Robert Wood Johnson Foundation (RWJF) today released the sixth annual Ready or Not? Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism report, which finds that progress made to better protect the country from disease outbreaks, natural disasters, and bioterrorism is now at risk, due to budget cuts and the economic crisis. In addition, the report concludes that major gaps remain in many critical areas of preparedness, including surge capacity, rapid disease detection, and food safety.

The report contains state-by-state health preparedness scores based on 10 key indicators to assess health emergency preparedness capabilities. More than half of states and D.C. achieved a score of seven or less out of 10 key indicators. Louisiana, New Hampshire, North Carolina, Virginia, and Wisconsin scored the highest with 10 out of 10. Arizona, Connecticut, Florida, Maryland, Montana, and Nebraska tied for the lowest score with five out of 10.

Over the past six years, the Ready or Not? report has documented steady progress toward improved public health preparedness. This year however, TFAH found that cuts in federal funding for state and local preparedness since 2005, coupled with the cuts states are making to their budgets in response to the economic crisis, put that progress at risk.

“The economic crisis could result in a serious rollback of the progress we’ve made since September 11, 2001 and Hurricane Katrina to better prepare the nation for emergencies,” said Jeff Levi, PhD, Executive Director of TFAH. “The 25 percent cut in federal support to protect Americans from diseases, disasters, and bioterrorism is already hurting state response capabilities. The cuts to state budgets in the next few years could lead to a disaster for the nation’s disaster preparedness.”

Some serious 2008 health emergencies include a Salmonella outbreak in jalapeño and Serrano peppers that sickened 1,442 people in 43 states, the largest beef recall in history in February, Hurricanes Gustav and Ike, severe flooding in the Midwest, major wildfires in California in June and November, and a ricin scare in Las Vegas.

Among the key findings:

Budget Cuts: Federal funding for state and local preparedness has been cut more than 25 percent from fiscal year (FY) 2005, and states are no longer receiving any supplemental funding for pandemic flu preparedness, despite increased responsibilities.

In addition to the federal decreases, 11 states and D.C. cut their public health budgets in the past year. In the coming year, according to the Center on Budget and Policy and Priorities, 33 states are facing shortfalls in their 2009 budgets and 16 states are already projecting shortfalls to their 2010 budgets.

Rapid Disease Detection: Since September 11, 2001, the country has made significant progress in improving disease detection capabilities, but major gaps still remain.

Only six states do not have a disease surveillance system compatible with the U.S. Centers for Disease Control and Prevention’s (CDC) National Electronic Disease Surveillance System.
Twenty-four states and D.C. lack the capacity to deliver and receive lab specimens, such as suspected bioterror agents or new disease outbreak samples, on a 24/7 basis.
Only three state public health laboratories are not able to meet the expectations of their state’s pandemic flu plans.

Food Safety: America’s food safety system has not been fundamentally modernized in more than 100 years.

Twenty states and D.C. did not meet or exceed the national average rate for being able to identify the pathogens responsible for foodborne disease outbreaks in their states.

Surge Capacity: Many states do not have mechanisms in place to support and protect the community assistance that is often required during a major emergency.

Twenty-six states do not have laws that reduce or limit liability for businesses and non-profit organizations that help during a public health emergency.
Only eight states do not have laws that limit or reduce liability exposure for health care workers who volunteer during a public health emergency.
Seventeen states do not have State Medical Reserve Corps Coordinators.

Vaccine and Medication Supplies and Distribution: Ensuring the public can quickly and safely receive medications during a major health emergency is one of the most serious challenges facing public health officials.

Sixteen states have purchased less than half of their share of federally-subsidized antivirals to use during a pandemic flu outbreak.

Every state now has an adequate plan for distributing emergency vaccines, antidotes, and medical supplies from the Strategic National Stockpile, according to the CDC. In 2005, only seven states had adequate plans. The CDC changed to a different grading system in 2007. However, questions still remain about the contents of the federal stockpile.

“States are being asked to do more with less, jeopardizing our safety, security, and health,” said Risa Lavizzo-Mourey, M.D., M.B.A., president and CEO of the Robert Wood Johnson Foundation. “We all have a stake in strengthening America's public health system, because it is our first line of defense against health emergencies.”

The report also offers a series of recommendations for improving preparedness, including:

Restoring Full Funding. At a minimum, federal, state, and local funding for public health emergency preparedness capabilities should be restored to FY 2005 levels.

Strengthening Leadership and Accountability. The next administration must clarify the public health emergency preparedness roles and responsibilities at the U.S. Department of Health and Human Services and U.S. Department of Homeland Security.

Enhancing Surge Capacity and the Public Health Workforce. Federal, state, and local governments and health care providers must better address altered standards of care, alternative care sites, legal concerns to protect community assistance, and surge workforce issues.

Modernizing Technology and Equipment. Communications and surveillance systems and laboratories need increased resources for modernization.

Improving Community Engagement. Additional measures must be taken to engage communities in emergency planning and to improve protections for at-risk communities.

Incorporating Preparedness into Health Care Reform and Creating an Emergency Health Benefit. This is needed to contain the spread of disease by providing care to the uninsured and underinsured Americans during major disasters and disease outbreaks.

Score Summary:

For the state-by-state scoring, states received one point for achieving an indicator or zero points if they did not achieve the indicator. Zero is the lowest possible overall score, 10 is the highest. The data for the indicators are from publicly available sources or were provided from public officials. More information on each indicator is available in the full report on TFAH’s Web site at www.healthyamericans.org and RWJF’s Web site at www.rwjf.org. The report was supported by a grant from RWJF.

10 out of 10: Louisiana, New Hampshire, North Carolina, Virginia, Wisconsin
9 out of 10: Alabama, Indiana, Michigan, Pennsylvania, South Carolina, Tennessee, Vermont,
8 out of 10: Arkansas, Delaware, Georgia, Hawaii, Iowa, Minnesota, North Dakota, Ohio, South Dakota, Washington
7 out of 10: California, Colorado, D.C. Illinois, Kentucky, Missouri, New Jersey, New Mexico, New York, Oklahoma, Oregon, Rhode Island, Utah, West Virginia, Wyoming
6 out of 10: Alaska, Idaho, Kansas, Maine, Massachusetts, Mississippi, Nevada, Texas
5 out of 10: Arizona, Connecticut, Florida, Maryland, Nebraska, Montana

Trust for America’s Health is a non-profit, non-partisan organization dedicated to saving lives by protecting the health of every community and working to make disease prevention a national priority. www.healthyamericans.org

The Robert Wood Johnson Foundation focuses on the pressing health and health care issues facing our country. As the nation’s largest philanthropy devoted exclusively to improving the health and health care of all Americans, the Foundation works with a diverse group of organizations and individuals to identify solutions and achieve comprehensive, meaningful and timely change. For more than 35 years the Foundation has brought experience, commitment, and a rigorous, balanced approach to the problems that affect the health and health care of those it serves. Helping Americans lead healthier lives and get the care they need—the Foundation expects to make a difference in our lifetime. For more information, visit www.rwjf.org.

National Special Needs Population Registry - Beta Test Underway

2008-12-10T07:56:00.001-05:00

National Special Needs Population Registry - Beta Test Underway

Center for Disaster Risk Policy at Florida State University is currently Beta Testing a new National Special Needs Population Registry in three southeastern states.

The registry’s design allows for registration of all individuals with special needs as defined by FEMA’s Planning Guide for Special Needs Populations

Designed to allow local disaster planning and response agencies to provide the highest level of assistance to special needs individuals through the latest in web based applications, the registry will allow users, at a minimum, to assign individuals to shelter locations and transportation routes, to generate route pickup maps for the transportation disadvantaged and to generate numerous (over 200) types of reports on the data contained within the registry.

For additional information please visit the following web site: http://www.spinreg.org

National Influenza Vaccination Week

2008-12-09T14:50:00.001-05:00

December 8 – 14, 2008 is National Influenza Vaccination Week.

The Centers for Disease Control and Prevention (CDC) has announced the week of December 8-14, 2008, as National Influenza Vaccination Week. This week-long event is designed to raise awareness of the importance of continuing influenza (flu) vaccination, as well as foster greater use of flu vaccine in December, January, and beyond. Since flu activity typically does not peak until February or later, December and January still provide good opportunities to offer flu shots. This year, Thursday, December 11th, is designated as Seniors' Vaccination Day. The Centers for Medicare & Medicaid Services (CMS) needs your help to ensure that people with Medicare get their flu shots. Please use this week long event as an opportunity to place greater emphasis on flu prevention. If you have Medicare patients who have not yet received their annual flu shots, we ask that you encourage these patients to protect themselves from the seasonal flu and serious complications arising from the flu virus by recommending that they take advantage of the flu shot benefit covered by Medicare. And remember, health care professionals and their staff are also at risk for contracting and spreading the flu virus, so don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot -- Not the Flu!

NOTE: - Influenza vaccine plus its administration are covered Part B benefits. Influenza vaccine is NOT a Part D covered drug.

For More Information
Health care professionals and their staff can learn more about Medicare’s coverage of the flu vaccine and other Medicare Part B covered vaccines and related provider education resources created by CMS, by reviewing Special Edition MLN Matters article SE0838 located at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0838.pdf on the CMS website.

For more information about National Influenza Vaccination Week, please visit the Centers for Disease Control and Prevention’s website, http://www.cdc.gov/flu/nivw/

CrownWEB is Nearly Here

2008-12-04T11:34:00.000-05:00

The following announcement is being mailed and faxed to Administrators of all dialysis facilities in Florida. If you are not the correct person to receive this email, we ask that you forward it to the correct individual(s).

CROWNWeb is Nearly Here

The implementation date for the electronic data submission required by the new Conditions for Coverage is just around the corner. CROWNWeb is the application designated by CMS to meet this requirement.

How Do I Get Access to CROWNWeb?

Every facility (whether they are an independent, a regional chain or part of a large dialysis organization) will need to identify their Security Administrator and Backup Security Administrator for CROWNWeb. This will be the person responsible for assigning roles and scope within the CROWNWeb application for other users at your facility. To designate your facility’s Security Administrator you need to fill out the CROWNWeb Authentication Service (CAS) Account Form. This is an online form available at https://www.qualitynet.org/crown/registration_form.pdf. The form must be either TYPED directly into the online form and printed; or printed as a blank form and TYPED on a typewriter. No hand written forms can be accepted. The printed form must then be signed by both the person designated as the Security Administrator and their manager and notarized. The original notarized form, not a fax or copy, should be sent to the Network office no later than December 15. If your facility does not designate a Security Administrator, your facility will not be able to submit data electronically to CMS and will unable to comply with new Conditions for Coverage for electronic data submission.

NOTE: The CAS form requires signatures from three different people. Do NOT sign as your own manager and neither you nor your manager may notarize the form.
Important Date to Remember:

12/15/2008
DEADLINE for submitting Notarized CAS form for CROWNWeb access

This date applies to VISION users also.

FDA: Innohep (tinzaparin sodium injection)

2008-12-03T08:47:00.001-05:00

Innohep (tinzaparin sodium injection)

FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.

In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.

Read the complete MedWatch 2008 Safety summary, including a link to the FDA Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep

Medicare Publishes New Information on Quality of Care at Dialysis Facilities

2008-11-21T13:20:00.000-05:00

Medicare Publishes New Information on Quality of Care at Dialysis Facilities

Changes to Web Site Will Help Consumers Compare Care and Make
Informed Health Care Choices

The Centers for Medicare & Medicaid Services (CMS) today announced important additions to the Dialysis Facility Compare consumer Web site (http://www.medicare.gov/dialysis) that will give consumers even better insight into the quality of care provided by their local dialysis patient facilities.

The improvements include two new quality measures that demonstrate how well dialysis patients are treated for anemia (low red blood cell count) as well as updated information that will help patients better understand survival rates by facility.

To view the entire Press Release, please see: http://www.cms.hhs.gov/apps/media/press_releases.asp

Notice: ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)

2008-11-20T15:04:00.001-05:00

The kidney community uses a variety of products and resources to ensure the health and safety of patients and healthcare professionals. The United States Food and Drug Administration (FDA) issues alerts and notifications when these products and resources are unsafe or being recalled.

As directed by CMS, the KCER Coalition issues notices on FDA recalls via email and this website for the kidney community. To join the email list, please email sburris@nw7.esrd.net.

November 6, 2008

ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)

Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html

FKDC Supports Fire Prevention Week

2008-09-29T13:09:00.000-04:00

From October 5-11, 2008, fire safety advocates will spread the word to their communities that, with a little extra caution, preventing the leading causes of home fires – cooking, heating, electrical and smoking-materials – is within their power.

Did you know...?

Cooking fires are the number one cause of home fires and home fire injuries.
Heating fires are the second-leading cause of home fires.
The majority of home fires start in the kitchen.
Older adults are at the highest risk of death or injury from smoking-material (cigarettes, cigars) fires even though they are less likely to smoke than younger adults.
January and December were the peak months for home fires and home fire deaths.
Working smoke alarms cut the risk of dying in reported home structure fires in half.

For more fire facts and for information on how YOU can prevent home fires, log on to the National Fire Prevention Association at http://www.nfpa.org/

FKDC anuncia los recursos del desastre en español.

2008-09-24T11:52:00.000-04:00

FKDC anuncia los recursos del desastre en español.

Las necesidades y capacidades de cada persona son únicas, pero cada persona puede adoptar medidas importantes para prepararse para todo tipo de emergencias e implementar planes.

Ancianos: http://www.listo.gov/america/getakit/seniors.html
Para personas discapacitadas: http://www.listo.gov/america/getakit/disabled.html
Cruz Roja Americana: http://www.cruzrojaamericana.org/index.asp
Anuncios de servicio público sobre desastres naturales: http://www.bt.cdc.gov/disasters/psa/es/

FKDC Supports National Preparedness Month

2008-09-16T11:41:00.000-04:00

The Florida Kidney Disaster Coalition (FKDC) supports September as National Preparedness Month. On our website, you'll find resources to help educate staff and patients on the critical need to prepare for emergencies.

http://www.fkdc.org/NPMR.htm

Disaster Recovery Centers open for Florida residents impacted by Fay

2008-09-02T11:53:00.000-04:00

Community Relations teams and Disaster Recovery Centers (DRCs) will still be assisting individuals, households and businesses affected by Tropical Storm Fay in Brevard, Hendry, Okeechobee, St. Lucie and Volusia counties.

The DRCs will operate daily from 8 a.m. to 6 p.m. They are located at:

Brevard County:

Agricultural Center
3695 Lake Drive
Cocoa 32926

Near Lamplighter Village
503 N. John Rodes Blvd.
Melbourne 32901

Grant Street Community Center
2547 Grant St.
Melbourne 32934

Hendry County:

Labelle Rodeo Grounds
100 Rodeo St.
Labelle 33935

Okeechobee County:

[Across from County Courthouse]
304 N.W. 2nd St.
Okeechobee 34972

St. Lucie County:

St. Lucie Logistics Center
3855 S. U.S. Highway 1
Fort Pierce 34982

Volusia County:

Wal-Mart parking lot
2400 Veterans Memorial Parkway
Orange City 32763

The DRCs are staffed with Federal Emergency Management Agency (FEMA), State Emergency Response Team (SERT) disaster recovery specialists and representatives from voluntary agencies. They are ready to help survivors through the process of applying for disaster assistance.

Applicants should register by calling FEMA's toll-free line at 800-621-FEMA (3362). Those with a speech or hearing impairment may call TTY number at 800-462-7585. Multilingual operators are available. The toll-free telephone numbers will operate 7 a.m. to midnight daily until further notice. Application for disaster assistance can also be made by registering online at www.fema.gov or at a Disaster Recovery Center.

Once registered, FEMA disaster recovery specialists can check an individual's case, answer questions about their claim, or request information FEMA needs to process their claim. Recovery specialists can also supply contacts for other programs that may be able to help.

In addition, Community Relations teams visiting the declared disaster counties will provide information about disaster registration to businesses, homeowners and renters who suffered uninsured damages and losses due to Tropical Storm Fay.

FEMA coordinates the federal government's role in preparing for, preventing, mitigating the effects of, responding to, and recovering from all domestic disasters, whether natural or man-made, including acts of terror.

FEMA Declares Florida Counties Eligible for Disaster Assistance

2008-08-28T15:26:00.000-04:00

FEMA DECLARES SOME COUNTIES ELIGIBLE FOR DISASTER ASSISTANCE
Brevard Hendry Okeechobee St. Lucie Volusia

Disaster assistance is money or direct assistance to individuals, families and businesses in an area whose property has been damaged or destroyed and whose losses are not covered by insurance. It is meant to help you with critical expenses that cannot be covered in other ways. This assistance is not intended to restore your damaged property to its condition before the disaster.

While some housing assistance funds are available through our Individuals and Households Program, most disaster assistance from the Federal government is in the form of loans administered by the Small Business Administration.

First and foremost, to qualify for assistance, your losses must have occurred in an area covered by a disaster declaration.

Secondly, if you have insurance, you must file a claim with your insurance company.

Two types of disaster assistance, "Housing Needs" and "Other than Housing Needs", are available to individuals, families and businesses in an area whose property has been damaged or destroyed and whose losses are not covered by insurance.

Whether applying online OR over the phone, you should have a pen and paper and the following information ready:

Your Social Security number.
Current and pre-disaster address.
A telephone number where you can be contacted.
Insurance information.
Total household annual income
A routing and account number from your bank (only necessary if you want to have disaster assistance funds transferred directly into your bank account)
Lookup your bank routing number.
A description of your losses that were caused by the disaster.

Residents and business owners in the declared areas are encouraged to contact the FEMA Tele-registration Line at:

1-800-621-FEMA (3362)
Speech or hearing disabilities call TTY 1-800-462-7585

VISIT WWW.FEMA.GOV FOR MORE INFORMATION

President Declares Major Disaster for Florida

2008-08-25T08:16:00.000-04:00

President Declares Major Disaster for Florida
Release Date: August 24, 2008Release Number: HQ-08-168

WASHINGTON, D.C. -- The head of the U.S. Department of Homeland Security's Federal Emergency Management Agency (FEMA) today announced that federal disaster aid has been made available for Florida to supplement state and local recovery efforts in the area struck by Tropical Storm Fay beginning on August 18, 2008, and continuing.

FEMA Administrator David Paulison said federal funding is available to state and eligible local governments and certain private nonprofit organizations on a cost-sharing basis for emergency work and the repair or replacement of facilities damaged by Tropical Storm Fay in the counties of Brevard, Monroe, Okeechobee, and St. Lucie.

Federal funding is also available on a cost-sharing basis for hazard mitigation measures statewide.

Paulison named Thomas P. Davies the federal coordinating officer for federal recovery operations in the affected area. Davies said additional designations may be made at a later date if requested by the state and warranted by the results of further damage assessments.

FEMA coordinates the federal government's role in preparing for, preventing, mitigating the effects of, responding to, and recovering from all domestic disasters, whether natural or man-made, including acts of terror.

Tropical Storm Fay

2008-08-21T10:18:00.000-04:00

As of 9:00 a.m. (Eastern Time) Thursday morning, the center of Tropical Storm Fay was located in the east central Florida coastal waters, approximately 20 miles east of Daytona Beach. Maximum sustained winds remain near 60 mph. Fay has been nearly stationary during the past few hours but is expected to begin a slow west-northwest motion towards the east central and northeast Florida coast line during the morning hours. Sustained tropical storm force winds will spread along coastal areas of northeast and east central Florida through Thursday morning.

Rain bands along the south side of Fay’s circulation will continue to produce flooding over the saturated soils of east central Florida. Locations south of Brevard County could experience storm totals near 30 inches of rain. Flood watches remain in effect for central and northeast Florida. A flash flood warning is in effect for Brevard County until 12:00 pm Thursday. A flashflood warning means that flooding is imminent or occurring. Take immediate actions to protect life and property.

Travel is not recommended anywhere in east central Florida tonight. A tropical storm warning is in effect for Fort Pierce northward to Altamaha Sound, Georgia. A tropical storm warning means that tropical storm conditions are expected within the next 24 hours. An inland tropical storm warning is in effect for interior section of east central and northeast Florida. This means that tropical storm conditions are expected within the next 24 hours.

Even if you are not in the path of the storm, it is a good opportunity to review and practice your disaster plans. This includes educating your patients and helping them to develop their disaster plan. Patients should be informed where to go, what to do and who to contact. The following are key areas to address in preparing patients:

The Network has made available patient ID cards. Encourage your patients to use them. Additional copies can be downloaded from the FMQAI website at http://www.fmqai.com/ESRD/pdf/Emergency%20Hurricane%20Cards.pdf
If an evacuation order is issued, patients should be given a copy of their treatment orders, medications, instructions on their emergency diet, a list of Florida dialysis facilities and facility emergency contact information. (Please do not distribute the phone numbers marked for “Staff Use Only” to patients.)
If the patient is evacuating, ask where they plan to go and for an out of area contact number.
Peritoneal dialysis patients and home hemodialysis patients should be contacted and prepared with ample supplies and information on how to contact their supplier.

Due to the current weather situation, please remain aware of updated advisories. The following are useful links that may benefit you as well as your patients:

Link to local EOC
http://www.floridadisaster.org/County_EM/county_list.htm

Link to Emergency Guide for People on Dialysis
http://www.medicare.gov/Publications/Pubs/pdf/10150.pdf

Link to Emergency Preparedness Guide for Dialysis Facilities
http://www.fmqai.com/ESRD/pdf/CMSDisasterPlanningGuide.pdf

Following the storm, please contact the Network to advise of your facility’s status and if you are in need of assistance. Also, please notify the Network if you are unable to locate one of your patients, as well as if you are assisting another facility by dialyzing one of their patients. Thank you for your ongoing attention to the safety of your patients.

Network Office – 813-383-1530

CMS Draft Interpretive Guidelines Published

2008-08-15T11:13:00.001-04:00

The Centers for Medicare & Medicaid Services (CMS) has posted the “draft” interpretive guidance that will guide the survey process for the new ESRD Conditions for Coverage.

The document includes the regulatory language that was published as a final rule for the ESRD program in the Federal Register on April 15, 2008, as well as regulatory text that was incorporated by reference in that final rule.

Comments and rationale pertaining to the “draft” Interpretive Guidelines can be submitted to the CMS mailbox at ESRDSurvey@cms.hhs.gov no later than 5:00 p.m. Eastern time on August 18, 2008. A template to submit comments and rationale is included in the guideline document.

You can locate the “draft” Interpretive Guideline document on the FMQAI website at http://www.fmqai.com/ESRD/.

Coping with disasters

2008-08-04T11:10:00.000-04:00

Disasters can have a far-reaching impact on victims and responders. But you don’t have to be a disaster victim to experience the anxiety and stress. Disasters can cause widespread physical damage, but they can also cause emotional damage.

A disaster can make you sad, angry, confused, or scared. These emotions are very common. But sometimes, these emotions can last a long time or keep you from doing daily activities. You should be able to recognize the warning signs that you or your loved ones are experiencing difficulty.

Sometimes anniversaries of disasters can trigger anxiety. There are many organizations that can help you cope with disasters. If you are a dialysis or transplant patient, talk to your social worker about your feelings.

There are many resources on the Internet where you can find help. Here are just a few:

Lightning Safety Week!

2008-06-23T08:31:00.000-04:00

When Thunder Roars, Go Indoors!
Lightning Safety Week: June 22-28, 2008

Florida is the Lightning Capitol of the U.S., leading the nation in lightning deaths. Lightning kills an average of nine Floridians each year, more than any other weather hazard, and injures an additional 37 people.

Most people who are struck by lightning are not killed, but they are left badly bruised and burned. The force of being hit by lightning can literally blow off people's shoes, shred their clothes and throw them violently through the air. It not only hits you hard, but at 50,000 degrees, it also burns right through you, leaving you with disfiguring scars and internal damage.
Lightning survivors often have pain, loss of memory and other bad effects that sometimes last a lifetime.

A darkening cloud is often the first sign that lightning may strike. As soon as you see lightning or hear thunder, you are immediately at risk. By playing another inning or waiting even a few minutes to see if the storm is getting closer, you could be risking your life.

Go immediately inside a house or other enclosed structure to stay safe. No place outdoors is safe! Covered vehicles are fairly safe locations, but remember to keep your hands and feet away from the side of the car and away from the dashboard, steering wheel and windows.

People that have been struck by lightning do not carry an electrical charge. If you and the victim are in a safe area, it is safe and recommended to perform life saving first aid. You will not “get shocked” by touching the victim.

How far away is lightning from you? Use the FLASH to BANG method:

When you see the FLASH
Count the number of seconds to the BANG of thunder,
Divide this number by 5,
And this gives you the MILES the lighting is away from you.

It is recommended that if the thunder arrives within 30 seconds or less from your location, you should seek shelter. Wait thirty minutes after the last thunder before going outside.

http://www.lightningsafety.noaa.gov/