KCER: Kidney Community Emergency Response Coalition

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

2011-08-30T11:18:00.000-04:00

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

2011-08-03T16:54:00.001-04:00

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)

2011-07-08T09:41:00.000-04:00

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

2011-05-13T12:38:00.000-04:00

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

2011-05-11T08:31:00.000-04:00

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

2011-05-04T09:39:00.001-04:00

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

2011-04-04T11:25:00.001-04:00

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

2011-04-04T11:22:00.000-04:00

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

2011-03-21T16:32:00.000-04:00

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

2011-03-21T16:26:00.001-04:00

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

2011-03-21T16:24:00.001-04:00

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

2011-03-03T14:33:00.000-05:00

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

2011-01-20T13:59:00.001-05:00

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

2011-01-07T12:47:00.000-05:00

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

2011-01-07T12:45:00.000-05:00

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

2011-01-07T12:22:00.006-05:00

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.

Recall Notice: Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results

2010-12-28T09:40:00.001-05:00

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: www.precisionoptiuminfo.com. Click here for more information.

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

2010-12-01T16:14:00.000-05:00

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

2010-11-15T11:33:00.000-05:00

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

2010-11-11T09:22:00.000-05:00

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

2010-10-29T18:41:00.002-04:00

On October 29, 2010 B. Braun Medical Inc. and the FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated trace amounts 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 recall instructions please, reference the Recall Notice contained in the following link. Click here for more information.

KCER Team Leader to Present at Upcoming ASN Renal Week Conference in Denver

2010-10-29T09:37:00.002-04:00

Kenneth Lempert M.D., M.S.P.H. and a team leader for the KCER Physician Placement and Assistance Response Team will be part of a panel of experts presenting on a topic entitled, “Nephrology in Natural Disasters: What to do with Acute Kidney and End Stage Renal Disease Patients During Disasters.” As part of this distinguished group, Dr. Lempert will lead a discussion focusing specifically on the Impact of Disasters on Dialysis Patients’ Health. For those interested in attending this session the date, time, and location are as follows:

Date – November 19th 2010

Time – 4:30 p.m. to 6:30 p.m. PT

Location – Denver Four Seasons 2/3

For more information click here.

Recall Notice: Excelsior Medical Identifies Potential Loss of Sterility and Leaking in 5ml Fill in 6cc Prefilled Saline Flush Syringes

2010-10-18T11:46:00.000-04:00

On October 15, 2010, Excelsior Medical issued a recall notice that several models of its Prefilled Saline Flush Syringes had the potential to leak and/or lose sterility. The recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Please note that using syringes that have a sterility issue could result in systemic infection, which may lead to serious injury and/or death. Should you be in possession of any of these syringes, please discontinue use immediately and return them to your point of purchase. 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: CareFusion Corp. Issues Recall of Alaris PC Units (Model 8015) Due to Potential For Delay or Interruption of Therapy

2010-10-18T11:43:00.000-04:00

On October 15, 2010, CareFusion Corporation issued a recall of its Alaris PC Units (Model 8015) manufactured between the time period of December 20, 2008 through September 8, 2009 and distributed from December 20, 2008 through June 28, 2010. The organization identified that under certain wireless network conditions, a communication error can occur which can lead to the freezing/interruption of the PC Unit screen and a subsequent delay in therapy. Should the communication error occur during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy which could lead to serious injury or death. Any users experiencing this problem should remove the device from service and contact the CareFusion Recall Center immediately at 888.562.6018 or via email at SupportCenter@carefusion.com. Corrective action will require a hardware update to all affected units. Please also note that CareFusion does not require that the devices be returned. Click here for more information.

Amgen Initiates Voluntary Nationwide Recall of Certain Lots of EPOGEN ® and PROCRIT ®

2010-09-28T09:13:00.000-04:00

Amgen announced September 24, 2010 that certain lots of EPOGEN(R) and PROCRIT(R) (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The recall is being conducted in cooperation with the United States Food and Drug Administration. Evaluations by Amgen and Centocor Ortho Biotech Products, L.P. found a low potential to impact patients who may have received the affected product. The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity. Adverse events related to EPOGEN should be reported to 1-800-77-AMGEN. Adverse events related to PROCRIT should be reported to 1-800-547-6446. Consumers with questions regarding this recall can contact Amgen at 1-800-77-AMGEN (open 24 hours per day, 7 days per week) or Centocor Ortho Biotech Products at 1-800-547-6446 (open 24 hours per day, 7 days per week). Click here for more information.

Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients

2010-09-17T13:06:00.003-04:00

The U.S Food and Drug Administration (FDA) is notifying healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrocholoride) oral tablets and oral solution. This change is being made to prevent potential valganciclovir overdosing in children with low body weight, low body surface area, and below normal serum creatinine. The revised dosing recommendations are being updated to include an upper limit on the calculated creatinine clearance using the modified Schwartz formula, which is used to calculate the pediatric dose of Valcyte. Valganciclovir is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children 4 months to 16 years of age who have undergone a kidney or heart transplant. Cytomegalovirus is a member of the herpes-type viruses that can cause disease in different parts of the body. Patients with weakened immune systems, such as organ transplant patients, are particularly susceptible to CMV infection and must take medications such as Valcyte to prevent the disease. Click here for more information.

BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class I Recall

2010-09-16T08:36:00.002-04:00

Westmed, Inc. is initiating a nationwide recall of 24,834 units of BagEasy Manual Resuscitation Devices. Select lots of the BagEasy Device have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which potentially could result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation. This recall is classified by the FDA as Class I. Consumers who have units from the identified lots of BagEasy manual resuscitation devices which are being recalled should stop using them and return the product to Westmed or their distributor. To obtain a full listing of the part numbers and lo-t numbers, visit the FDA website (www.fda.gov), or contact Westmed customer service at 1-800-975-7987. Westmed voluntarily recalled these products after learning of units disconnecting at user facilities. The FDA has been apprised of this action. Westmed has become aware of potential for disconnection at the patient port retention during assembly of the BagEasy manual resuscitation device after receiving reports from three separate facilities regarding unit disconnecting during setup or use. The healthcare providers obtained another unit and continued with setup or treatment. The BagEasy manual resuscitation device was distributed to other medical device distribution companies as well as directly to hospitals and other treatment facilities. It can be identified by product labeling that contains part and lot numbers. Westmed is notifying its distributors and customers by certified mail and direct contact by sales representatives and is arranging for return of all recalled products. For more information, visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226014.htm.

Fresenius Urgent Recall for AC Power Cords

2010-09-10T10:04:00.003-04:00

Fresenius Medical Care is initiating a recall for certain Fresenius devices that may have a defective plug, which is part of an AC power cord manufactured by Electri-Cord manufacturing company. This alert is being issued in response to a FDA Alert regarding customer reports of sparking, charring and fires of similarly designed AC power cords in non-dialysis products manufactured by other companies. Fresenius is advising all customers to assess whether their devices have the affected Electri-Cord AC power cords and inspect the cord plugs for evidence of damage (charring, discoloration of the plastic, broken or loose prongs). The potential risks from power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires, which may be exacerbated in an oxygen rich environment. Depending on the device, therapy, and environment, these failures may lead to potential serious injury or death. Fresenius Medical Care NA has not received any reports of serious patient harm related to the situation. Visit www.fmcna.com or www.fda.gov for more information.

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

2010-08-17T06:21:00.001-04:00

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

2010-08-13T07:37:00.004-04:00

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.

DHS Launches "See Something, Say Something" Campaign

2010-07-06T07:13:00.000-04:00

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?

2010-06-28T11:55:00.000-04:00

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/

Federal Government Shows Modest Progress in Disaster Planning for Children

2010-05-14T07:05:00.001-04:00

FOR IMMEDIATE RELEASE

May 13, 2010

www.childrenanddisasters.acf.hhs.gov

Federal Government Shows Modest Progress in Disaster Planning for Children

The National Commission on Children and Disasters has delivered a report to the White House and Congressional leaders that revealed only modest progress of federal agencies in implementing recommendations designed to ensure better protections of children during major domestic disasters.

The new report (www.childrenanddisasters.acf.hhs.gov) measured the response of six federal agencies to an earlier commission report released in late 2009 that identified several shortcomings in disaster preparedness, response and recovery.

The Commission found signs of progress in the design of safer emergency sheltering environments for children. However, the report also showed federal agencies made limited progress in pediatric disaster medical care and training, disaster mental health research, and the need to encourage states and child care providers to improve their disaster preparedness plans.

“Hurricane Season is just around the corner. Kids are the most vulnerable Americans during disasters. To protect children, much more needs to be done, and it needs to be done now,” said Mark Shriver, Chairperson of the Commission.

Disasters are especially traumatic and disruptive for children. Following a catastrophic event like a hurricane, earthquake or flood, it is essential for schools and child care centers to have plans for evacuation and reunification with families. Shelters need to have age-appropriate supplies, like formula, diapers and cribs. All settings must have a plan for children with disabilities.

The Progress Report urges the Obama Administration and Congress to take bold and swift action to prepare and respond to the unique needs of children in disasters. The Commission calls for the White House to develop a National Strategy for Children and Disasters to command better integration, coordination and outcomes from federal agencies and state, Tribal, local, and non-governmental partners. Congress must provide adequate resources to support first responders, hospitals and a national disaster human services case management program to meet the recovery needs of children and families.

The National Commission on Children and Disasters is an independent, bipartisan Commission established to examine and assess the needs of children in the preparation for, response to, and recovery from all hazards. The next Commission report is due to the President and Congress in October 2010.

###

The Nashville Flood of 2010

2010-05-10T08:58:00.001-04:00

Health and Safety Information

The Metro Health Department is currently out of tetanus vaccine, but expects 2,400 doses to arrive at the Lentz Public Health Center by 12 p.m. today. Vaccines will then be available at the Lentz clinic, and doses will also be sent to the following locations:

Lentz Public Health Center (615) 340-5616
311 23rd Avenue North, Nashville, TN 37203

East Clinic (615) 862-7916
1015 East Trinity Lane, Nashville, TN 37216

Woodbine Clinic (615) 862-7940
224 Oriel Avenue, Nashville, TN 37210

Flood waters may contain sewage and other hazardous substances – there is some risk of disease from eating or drinking anything contaminated with flood water.
If you have any open cuts or sores that will be exposed to flood water, keep them as clean as possible by washing well with soap to control infection. If a wound develops redness, swelling, or drainage, seek immediate medical attention.
Do not allow children to play in flood water areas, wash children's hands frequently (always before meals), and do not allow children to play with flood-water contaminated toys that have not been disinfected. You can disinfect toys using a solution of one cup of bleach in 5 gallons of water.
If you smell the odor of natural gas in your home (similar to rotten eggs) do not turn appliances on or off, and do not use your home phone. Leave the premises immediately and call Piedmont Natural Gas from a neighbor’s home or your cell phone. Do not try to turn off your natural gas service on your own.
Piedmont Natural Gas Safety Bulletin
If you see a downed power line wires, assume it is live and report the emergency to 911.
Be sure to turn off all power to flooded areas in your home containing electrical wires or appliances.

Oil Spill Notice to Dialysis and Transplant Providers

2010-05-01T11:09:00.001-04:00

Dear Southern Louisiana Dialysis / Transplant Providers:

(Medical Directors, Nurse Managers, & Facility Administrators)

This email to provide available information and resources in regards to the Oil Spill in the Gulf of Mexico. Louisiana state officials are stressing that there is “no risk to water systems” at present. Having said that, all dialysis providers should continue to monitor your dialysis and water systems as per your routine. Please note that any disruption in normal water supply and/or maintenance issues (pressure) requires vigilance with regards to water for dialysis services. Pay extra attention to your water tests and cultures.

Be cognizant that your patients may have questions and/or concerns and your staffs should be ready to answer them accordingly. For those of you that work with peritoneal dialysis (PD) and home hemodialysis (HD) patients, please remind them to stay vigilant about their monitoring, as well. Share the air quality information listed below (e.g., odor) with your staffs and patients. The Network will continue to monitor communications from Louisiana state officials and provide updates as necessary.

Louisiana Response Information: In response to the oil leaking in the Gulf of Mexico and out of an abundance of caution, state agencies are on alert to ensure that we work to protect Louisiana’s coastline and natural resources in the event that oil reaches our shores. The state took immediate steps this week to protect our wildlife and fisheries by requesting the placement of protective barriers, called “booms” around areas of our coastline. Leaders of our affected agencies, who deal with the coast and our natural habitat, are in constant contact with the federal officials, including the United States Coast Guard. Working together, we will respond to any threat to our shores. The federal government has launched an informational website about the response to the oil leak. It is online at www.deepwaterhorizonresponse.com

Statement by Louisiana Department of Health and Hospitals / Louisiana Department of Environmental Quality Regarding Petroleum Odor in Onshore Communities:

The Louisiana Department of Health and Hospitals and the Louisiana Department of Environmental Quality are reporting that residents of coastal areas of southeast Louisiana, including New Orleans, may be detecting an odor possibly resulting from the oil spill approaching the Louisiana coast. DHH and DEQ have requested continuous air quality testing and monitoring from the EPA, and DEQ will be assisting the EPA by increasing the frequency of air sampling at its Kenner and Chalmette monitors. These samples will receive expedited turnaround by EPA labs. If it is determined that air quality issues exist, DEQ and DHH will communicate these issues immediately to local authorities or take any other action deemed appropriate to protect public health and safety.

Some people may be sensitive to any change in air quality, which could cause symptoms, such as nausea, vomiting, or headaches. If you have these symptoms, you should consider staying indoors, ventilating your home with air conditioning and avoiding strenuous outdoor activity. If these symptoms do not improve, you should then consider contacting your primary care physician or other health care provider for medical advice. If you have pre-existing medical conditions, such as asthma or other respiratory illness, you should consider communicating with your physician if you feel symptomatic.

Additional Resources:

· Environmental Protection Agency (EPA): http://www.epa.gov/safewater/index.html

· USGS public water utility information: http://water.usgs.gov/owq/FAQ.htm

· Louisiana Emergency Management Agency: http://emergency.la.gov/

Hurricane Forecasts

2010-04-07T13:38:00.001-04:00

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

2010-03-30T07:14:00.001-04:00

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

2010-03-24T11:29:00.001-04:00

FLOOD SAFETY: No matter what time of year it is, there is always a risk for flooding. There are many states being impacted by floods. Be sure to listen to your local news and weather for safety information specific to your area. For more information, visit the following sites:

Class I Recall: Baxter's HomeChoice Peritoneal Dialysis Cycler

2010-03-03T15:16:00.001-05:00

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

2010-03-03T10:18:00.001-05:00

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.

RECALL: OneTouch SureStep Test Strips (LifeScan)

2010-03-01T09:49:00.000-05:00

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.

Disaster Preparedness Award: Call for Nominations

2010-02-19T10:42:00.002-05:00

The Kidney Community Emergency Response Coalition (KCER) invites you to nominate an individual or organization that has provided outstanding leadership and service to the renal community in disaster preparedness and response. Please download the Disaster Preparedness Award nomination form and submit your entry today!

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

2010-02-17T09:43:00.001-05:00

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

International Renal Community Coordinates Disaster Response to Earthquake in Haiti

2010-02-12T15:34:00.002-05:00

TAMPA – A magnitude 7.0 earthquake struck outside Port-au-Prince, Haiti on January 12, 2010. Disasters can severely limit the availability of chronic dialysis treatments for individuals living with end stage renal disease (ESRD), or kidney failure. The situation in Haiti was additionally compounded by the scarcity of dialysis before the earthquake. Following the catastrophic damage, healthcare providers were limited in providing lifesaving chronic or acute dialysis treatments.

In response, the American Society of Nephrology (ASN) initiated a task force consisting of partners from the ASN Acute Kidney Injury (AKI) and Dialysis Advisory Groups, the International Society of Nephrology, the Kidney Community Emergency Response (KCER) Coalition and the Florida ESRD Network, the National Kidney Foundation, the Sociedad Latino-Americana de Nefrologia e Hipertension, dialysis providers, industry leaders, and the U.S. Departments of State and Health and Human Services.

The KCER Coalition assisted in coordinating daily teleconferences and disseminating critical information to response agencies on the ground in Haiti and the Dominican Republic. This collaboration provided a timely and effective humanitarian response to Haitian earthquake victims. Due to being pinned under collapsed buildings, individuals who survive earthquakes and are pulled from rubble may develop rhabdomyolysis, or crush syndrome. Crush syndrome can lead to acute kidney failure or death if not quickly identified and treated. According to the Centers for Disease Control & Prevention (CDC), crush syndrome occurs in 2-15% of earthquake victims. Half of the victims of crush syndrome will experience acute renal failure and half of those patients will need dialysis.

KCER will use this experience to develop best practices and outreach efforts to educate the U.S. renal community on how similar disasters could impact the provision of dialysis care. The response to Haiti and the impact of acute kidney injury will be topics of interest at this year’s KCER Summit. Held annually since the devastating impact of Hurricane Katrina, the Summit enables the renal community to stay abreast of current issues in disasters and provides a collaborative environment to advance the readiness of the renal community. This meeting is free and open to the public. The 2010 KCER Summit will be held from 1:00 to 5:00 p.m. on Tuesday, April 13 in Orlando, Florida. This meeting is being held in conjunction with the National Kidney Foundation Spring Clinical Meetings.

The Florida End Stage Renal Disease Network (Network 7) provides administrative support for the volunteer-driven KCER Coalition.

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This material was prepared by FMQAI, the End Stage Renal Disease Network for Florida (Network 7), under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy.

The Kidney Community Emergency Response (KCER) Coalition provides technical assistance to ESRD Networks, Medicare organizations, and other groups to ensure timely and efficient emergency preparedness, response, and recovery for the kidney community. KCER strives to provide resources to save lives, improve outcomes, empower patients and families, educate healthcare workers, build partnerships with stakeholders, promote awareness in the community, and support the ESRD Network Program.

KCER Response to the Earthquake in Haiti

2010-02-09T14:39:00.000-05:00

Since the catastrophic earthquake outside of Port-au-Prince on January 12, KCER has been working with the international renal community to provide coordination and support. This collaboration includes the American Society of Nephrology, the Latin American Society of Nephrology, and the International Society of Nephrology.

KCER volunteers and strategic planners include dozens of kidney-related companies, associations, and organizations who were able to contribute money, supplies, and volunteers to assist in the Haiti relief.

Originally formed in response to the devastating 2004 and 2005 hurricane seasons, KCER is a volunteer-based coalition of healthcare providers, government representatives, hospitals, patients, patient-centered organizations, and renal professional associations. KCER activities include patient education and staff training on disaster preparedness; promoting awareness to the emergency management community; and supporting the End Stage Renal Disease (ESRD) Network Program.

The KCER Coalition provides technical assistance to facilitate comprehensive, timely, and accurate information dissemination to the renal community and disaster response agencies. KCER provided situation reports, maps, and daily conference call coordination.

Responding to the needs in Haiti strengthens KCER's ability to respond to disasters in the U.S. impacting ESRD providers and patients. This crisis will raise awareness of the critical needs of kidney patients during a disaster. Following the earthquake, dialysis units were destroyed and patients were unable to receive regular dialysis treatments. This situation is compounded by acute kidney injuries from "crush syndrome" which may also require dialysis treatment.

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. 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 http://american.redcross.org is working with its partners to assist those affected by this disaster. To contribute, please visit the Red Cross online. The U.S. Government urges citizens to not self-deploy to the area. KCER encourages healthcare workers to join their local Medical Reserve Corps.

RECALL: Edwards Lifesciences Aquarius Hemodialysis System

2010-01-29T07:36:00.000-05:00

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

2010-01-25T07:57:00.001-05:00

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

2010-01-22T08:25:00.001-05:00

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.

2010-01-17T10:39:00.000-05:00

For information about disaster relief in Haiti, please visit

www.usaid.gov
www.state.gov
www.reliefweb.int
ICRC Family Links
Translated Haitian Creole Health Information
www.doctorswithoutborders.org
http://new.paho.org/disasters/

To donate goods or to volunteer:http://cidi.org/reg_offr.htm

For missing U.S. citizen family members: http://www.state.gov/p/wha/ci/ha/earthquake/index.htm

If you are a U.S. dialysis facility who is treating a victim of the earthquake in Haiti, please contact your local ESRD Network.

American Society of Nephrology Responds to Dialysis Needs in Haiti

2010-01-16T18:42:00.001-05:00

ASN encourages individuals and organizations interested in contributing financial support to donate directly to entities specifically dedicated to providing disaster relief to Haiti, such as the William J. Clinton Foundation (http://www.clintonfoundation.org/haitiearthquake/) or the American Red Cross (www.redcross.org).

A comprehensive list of organizations collecting funds for this disaster is provided by InterAction through its website at http://www.interaction.org/crisis-list/earthquake-haiti.

Through its Acute Kidney Injury (AKI) and Dialysis Advisory Groups, ASN is monitoring the situation in Haiti. ASN has also established contact with other kidney-related organizations, including the International Society of Nephrology, the Kidney Community Emergency Response (KCER) Coalition and the Florida ESRD Network, the National Kidney Foundation, the Sociedad Latino-Americana de Nefrologia e Hipertension, dialysis providers, and industry as well as the US Departments of State and Health and Human Services.

For further information about this disaster, please visit the Department of State's Agency for International Development at http://www.usaid.gov/locations/latin_america_caribbean/country/haiti/eq/. In addition, ASN will continue to provide updated reports.

Catastrophic Earthquake Strikes Haiti

2010-01-13T10:26:00.002-05:00

A 7.0 magnitude earthquake occurred 10 miles southwest of Port-au-Prince, Haiti on January 12, 2010; at 4:53 p.m. EST. The earthquake occurred at a depth of 6.2 miles. A Tsunami Watch was issued for Haiti, Cuba, Bahamas, and the Dominican Republic on January 12, 2010 at 5:03 p.m. EST, but was subsequently cancelled at 6:45 p.m. EST (1 hour and 42 minutes later).

USGS is reporting numerous aftershocks ranging from 4.2 to 5.9 magnitudes, and media is reporting unconfirmed fatalities, injuries, and extensive damages. Under the U.S. Department of State Office of Foreign Disaster Assistance (OFDA), US&R task forces from Fairfax County, VA and Los Angeles County, CA will deploy to Haiti to provide search and rescue assistance. (NWS; NOAA; USGS)

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

2010-01-08T07:48:00.001-05:00

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?

2010 KCER Summit

2009-12-18T09:57:00.002-05:00

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

2009-12-16T13:56:00.000-05:00

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!

2009-12-07T12:23:00.001-05:00

This New Year’s Eve, nearly 50 percent of Americans will make at least one resolution as they look toward 2010. KCER 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.

KCER 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.

KCER Newsletter: winter weather checklist

2009-11-19T07:04:00.001-05:00

This month's issue of "Welcome to Disasterville" focuses on winter weather. Be sure to check it out at http://www.kcercoalition.com/newsletter.htm

KCER Summit: Save the date!

2009-11-18T07:53:00.002-05:00

Our next annual in-person meeting will be held on April 13, 2010. Please make plans to join us in Orlando, Florida for this event. The KCER Summit brings together KCER Coalition volunteers, members from the renal community, and disaster officials to showcase Coalition accomplishments and to discuss new ways to help kidney patients and providers become better prepared for disasters.

Accusure Insulin Syringes Qualitest Pharmaceuticals - Recall

2009-10-28T07:15:00.000-04:00

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

2009-10-19T08:27:00.000-04:00

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

2009-10-12T07:51:00.001-04:00

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

2009-10-05T08:13:00.000-04:00

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.

2009-10-02T07:21:00.001-04:00

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

2009-09-24T10:41:00.001-04:00

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

2009-09-21T09:35:00.000-04:00

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

2009-09-16T13:51:00.001-04:00

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

2009-09-08T09:15:00.000-04:00

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

2009-08-27T09:28:00.000-04:00

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!

2009-08-25T12:58:00.001-04:00

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.

PATIENT EDUCATION WEEK

2009-08-17T14:46:00.000-04:00

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!

2009-08-17T10:18:00.005-04:00

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?

Surviving the Storm - A Success!

2009-08-07T10:18:00.002-04:00

Thank you to everyone for making "Surviving the Storm: Disasters and Dialysis" a success. Our speakers included representatives from the Medical Reserve Corps and the National Weather Service. There were more than 75 registered attendees, including dialysis providers, industry leaders, government officials, and ESRD Networks.

For those who could not attend the meeting, please review the presentations and handouts posted at http://www.kcercoalition.com/cpp.htm.

Disasterville - Volume 5, August 2009

2009-07-20T11:41:00.007-04:00

The new issue of "WELCOME TO DISASTERVILLE" has been posted to the KCER website.

September is National Preparedness Month.

Ready is a national public service campaign sponsored by the U.S. Federal Emergency Management Agency in partnership with The Advertising Council. The Campaign educates and empowers Americans to prepare for, and respond to emergencies, including natural disasters and potential terrorist attacks.

The Campaign’s goal is to get Americans involved and ultimately increase our nation’s level of preparedness. Emergencies can range from inconvenient to devastating. But taking some simple preparedness steps in advance can minimize their impact your life.

Being Ready includes: getting an Emergency Supply Kit; making a Family Emergency Plan; being Informed about emergencies and their appropriate responses; and getting Involved in community efforts

Read the newest copy of Disasterville for a list of conferences and meetings where you can stop by the KCER exhibit for more information.

Win Big With Quality!

2009-07-02T13:08:00.002-04:00

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.

SURVIVING THE STORM: DISASTERS & DIALYSIS

2009-06-22T15:09:00.000-04:00

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.

MEDICAL RESERVE CORPS: Volunteers building strong, healthy, and prepared communities.

2009-06-19T12:13:00.000-04:00

The MRC was founded after President Bush’s 2002 State of the Union Address, in which he asked all Americans to volunteer in support of their country. It is a partner program with Citizen Corps, a national network of volunteers dedicated to ensuring hometown security. The mission of the Medical Reserve Corps (MRC) is to improve the health and safety of communities across the country by organizing and utilizing public health, medical and other volunteers.

MRC volunteers include medical and public health professionals such as physicians, nurses, pharmacists, dentists, veterinarians, and epidemiologists. Many community members—interpreters, chaplains, office workers, legal advisors, and others—can fill key support positions.

MRC volunteers also strengthen the overall health of Americans by participating in general public health initiatives such as flu vaccination clinics and diabetes detection programs. MRC volunteers can choose to support communities in need nationwide.

For more information, visit www.medicalreservecorps.gov

Ready.gov: Hurricanes

2009-06-16T14:15:00.001-04:00

http://www.ready.gov/america/beinformed/hurricanes.html

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:

OSHA Fact Sheet: Respirators versus surgical masks

2009-06-08T10:02:00.001-04:00

The KCER Pandemic Team has posted a new resource to their web page.

"OSHA FACT SHEET. Respiratory Infection Control: Respirators versus surgical masks."

You can access this important information at the KCER Pandemic Team's page at www.kcercoalition.com/pandemic.htm

Pandemic Flu: Lessons From the Frontlines

2009-06-05T09:21:00.001-04:00

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 CPR/AED/First Aid

2009-06-04T13:07:00.002-04:00

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.

Welcome to Disasterville - June 2009

2009-05-26T14:41:00.000-04:00

June 1 marks the beginning of the Atlantic Hurricane Season. Check out the newest issue of "Welcome to Disasterville," KCER's monthly newsletter.

http://www.kcercoalition.com/newsletter.htm

Hurricane Preparedness Week

2009-05-22T10:40:00.004-04:00

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

2009-05-10T09:37:00.001-04:00

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: Hepatits B Vaccine Shortages

2009-05-06T09:38:00.001-04:00

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

2009-05-06T09:36:00.000-04:00

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 Kidney Patients and Providers

2009-05-05T09:16:00.002-04:00

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

2009-05-01T15:11:00.001-04:00

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.

State H1N1 (swine flu) hotline numbers posted to the KCER Website

2009-05-01T07:58:00.003-04:00

The KCER Coalition posted state general information hotline numbers for H1N1 flu (swine flu). Please visit www.kcercoalition.com.

Do you have a pandemic influenza plan? KCER, Swine Flu, and You.

2009-04-30T09:25:00.004-04:00

The CMS Conditions for Coverage (link) require that all dialysis facilities have a plan for emergencies - including pandemic influenza. The KCER Pandemic Preparedness Response Team has developed resources for dialysis facilities and patients to create and support facility emergency plans. These tools are free and available on www.kcercoalition.com.

Even if your state does not have any cases of swine flu, it is critical to monitor local media and government agencies, and follow the CDC guidelines for "What You Can Do to Stay Healthy." Facilities should read theInterim Guidance for Clinicians & Public Health Professionals at http://cdc.gov/swineflu/guidance/ and maintain contact with their local ESRD Network for information specific to the area.

Each state follows different policies and procedures in the reporting and testing of suspected cases. Check to see if your state department of health has a swine flu hotline for general information.

Facilities should educate their staff and patients on swine flu and what they can do to stay healthy. The CDC recommends:

Stay informed. The CDC website will be updated regularly as information becomes available.

Influenza is thought to spread mainly person-to-person through coughing or sneezing of infected people.

Take everyday actions to stay healthy.

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, especially after you cough or sneeze. Alcohol-based hands cleaners are also effective.
Avoid touching your eyes, nose or mouth. Germs spread that way.Stay home if you get sick. CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.

Follow public health advice regarding school closures, avoiding crowds and other social distancing measures.

Develop a family emergency plan as a precaution. This should include storing a supply of food, medicines, facemasks, alcohol-based hand rubs and other essential supplies.

Call 1-800-CDC-INFO for more information.

Visit www.ready.gov for more information on developing a family plan.

ATTENTION!!! "Surviving the Storm: Disasters & Dialysis" POSTPONED DUE TO EMERGENCY RESPONSE

2009-04-29T11:38:00.002-04:00

The Kidney Community Emergency Response Coalition (KCER) has decided to postpone SURVIVING THE STORM: DISASTERS AND DIALYSIS scheduled for Monday, May 4 in Dallas, Texas; and the KCER Strategic Planning Committee Meeting (May 5, Dallas, Texas) due the ongoing swine flu outbreaks.

We apologize for the incovnenience. Please stay tuned to www.kcercoalition.com for more information about the meeting. All registered participants will be notified of rescheduling plans. Thank you for your support of the KCER Coalition!

Swine Flu: 91 cases, 1 death confirmed by the CDC

2009-04-29T11:36:00.000-04:00

There are everyday actions people can take to stay healthy.

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, especially after you cough or sneeze. Alcohol-based hands cleaners are also effective.
Avoid touching your eyes, nose or mouth. Germs spread that way.

Try to avoid close contact with sick people.

Influenza is thought to spread mainly person-to-person through coughing or sneezing of infected people.
If you get sick, CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.

WORLD HEALTH ORGANIZATION Swine influenza - update 4

28 April 2009--The situation continues to evolve rapidly. As of 19:15 GMT, 28 April 2009, seven countries have officially reported cases of swine influenza A/H1N1 infection. The United States Government has reported 64 laboratory confirmed human cases, with no deaths. Mexico has reported 26 confirmed human cases of infection including seven deaths.
The following countries have reported laboratory confirmed cases with no deaths - Canada (6), New Zealand (3), the United Kingdom (2), Israel (2) and Spain (2).

Further information on the situation will be available on the WHO website on a regular basis.
WHO advises no restriction of regular travel or closure of borders. It is considered prudent for people who are ill to delay international travel and for people developing symptoms following international travel to seek medical attention, in line with guidance from national authorities.

There is also no risk of infection from this virus from consumption of well-cooked pork and pork products. Individuals are advised to wash hands thoroughly with soap and water on a regular basis and should seek medical attention if they develop any symptoms of influenza-like illness.
Related links

Disasterville Volume 2 - May 2009

2009-04-28T10:05:00.000-04:00

Welcome to Disasterville, Volume 2 (May 2009)
KCER Newsletter

We are pleased to present our new monthly KCER newsletter, Welcome to Disasterville! You can download a copy from our website at www.kcercoalition.com/newsletter.htm

KCER Pandemic Team Monitors U.S. Swine Flu Outbreak

2009-04-27T09:55:00.001-04:00

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

2009-04-16T08:11:00.001-04:00

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 activated

2009-04-14T09:43:00.001-04:00

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

2009-04-07T08:29:00.001-04:00

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!

2009-03-31T08:07:00.004-04:00

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/

Flooding in North Dakota and Minnesota - Presidential Disaster Declaration

2009-03-26T07:07:00.004-04:00

As a consequence of severe storms and flooding in the State of North Dakota, on this date and after consultation with public health officials as necessary, I, Charles E. Johnson, Acting Secretary of the U.S. Department of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby determine that a public health emergency exists and has existed since March 13, 2009, in the State of North Dakota. http://dhhs.gov/

In response to flooding in North Dakota, the CDC has updated their website with critical flood safety information. Please visit the site here: http://emergency.cdc.gov/disasters/floods/index.asp

Additionally, on March 24, 2009 the president signed FEMA-1829-DR for the State of North Dakota as a result of severe storms and flooding during the period of March 13 and continuing. Approval was granted for Public Assistance for 34 counties and 2 Native American reservations, for emergency protective measures (Cat B) including direct Federal assistance. Visit http://www.fema.gov/news/event.fema?id=11268

Introducing... Disasterville

2009-03-25T10:05:00.004-04:00

* NEW*

Welcome to Disasterville, Volume 1 (April 2009)
KCER Newsletter

We are pleased to present our new monthly KCER newsletter, Welcome to Disasterville! You can download a copy from our website at www.kcercoalition.com/newsletter.htm