American Regent has issued a voluntary recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50 mL Single Dose Vials because some vials may contain particulates.  Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.  American Regent is undertaking this recall in consideration of the potential for safety issues if any of the following lots of product are administered to patients.

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The FDA and Abbott Diabetes Care are working to notify 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. Strips that have either been exposed to warm weather or prolonged storage may have a higher likelihood of providing a false result. 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. Both scenarios pose risks to health.

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When the 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.   The particles can potentially enter a patient's body and lead to serious adverse health consequences, such as pulmonary embolism, stroke, or heart attack.  These issues could result in serious injury or death.

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FDA notified healthcare professionals of the class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700.  These units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.

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WalkMed Infusion LLC 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. If the pump door is not closed and latched per the instructions for use located on the side of the pump and in the operator manual, the pump door open alarm may not alert the user to this condition. It is then possible for the pump mechanism not to be engaged and a gravity feed flow condition to exist if the pump operator has not checked tube set for flow prior to starting the pump. This could result in over infusion of medication.

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B. Braun Medical Inc. and 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 a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010

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Routine internal testing conducted on this product found that some of these syringes may leak and lose sterility. This recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Exposure to syringes with a sterility issue could result in systemic infection, which may lead to serious injury and/or death.

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ISSUE: Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions.

If the communication error occurs 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. This could lead to serious injury and/or death. These devices were manufactured from December 20, 2008 through September 8, 2009 and distributed from December 20, 2008 through June 28, 2010.

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Health Literacy Month, celebrated each October, is a time when health literacy advocates around the world promote the importance of understandable health information. This month is a time for all health literacy advocates to let the world know why health literacy matters.

To learn more about Health Literacy Month, go to www.healthliteracymonth.org, email Helen Osborne at helen@healthliteracy.com or call 508-653-1199.

Amgen announced 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.

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The FDA is notifying healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride) oral tablets and oral solution. The FDA has determined that adding an upper limit of 150 mL/min/1.73 m2 to the creatinine clearance calculated using the Schwartz formula for the determination of pediatric doses can help prevent the potential for Valcyte overdosing in children with low body weight, low body surface area, and below normal serum creatinine.

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Westmed, Inc., Tucson, AZ, is initiating a nationwide recall of 24,384 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 a Class I Recall.

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 the full listing of part numbers and lot numbers, visit the FDA website (www.fda.gov), or contact Westmed customer service at 1-800-975-7987.

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Medicare Rights Center

There are important changes to enrollment periods for the 2011 plan year and future plan years, according to Medicare Advantage and Prescription Drug Plan enrollment guidance released by the Centers for Medicare & Medicaid Services (CMS) at the end of August. 

One significant change is the elimination in 2011 of the Open Enrollment Period (OEP), which in previous years began on January 1. Beginning in 2011, there will be a new Medicare Advantage Disenrollment Period (MADP) from January 1 to February 14 of each year. During the MADP, people may disenroll from a Medicare private health plan, also known as a Medicare Advantage plan, to Original Medicare. However, individuals are not permitted to switch to another private health plan, or from Original Medicare to a private health plan. People who disenroll from private health plans during the MADP will also be able to enroll in a stand-alone prescription drug plan.

For the 2011 plan year, the Annual Election Period for Medicare private health plans and the Annual Coordinated Election Period for Part D prescription drug plans, sometimes referred to as the Fall Open Enrollment Period, will run from November 15, 2010 to December 31, 2010. While this is the same timeframe as in previous years, beginning next year the fall election periods will take place earlier, from October 15, 2011 to December 7, 2011.

The guidance implements provisions in the Affordable Care Act (ACA).

View a timeline of Medicare enrollment periods
Read the Medicare Advantage enrollment guidance
Read the prescription drug plan enrollment guidance

Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.

Device Users: 2008K, 2008K2, 2008K@home, 2008H and Granuflo I Mixer

Fresenius Medical Care North America Customer Service (1-800-227-2572)

Fresenius Medical Care is initiating this 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 cores 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. 

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September is National Preparedness Month (NPM). NPM, sponsored by the Ready Campaign in partnership with Citizen Corps and the Ad Council, is held each September and is designed to encourage Americans to take simple steps to prepare for emergencies in their homes, businesses, and communities. NPM is sponsored by the U.S. Department of Homeland Security's (DHS) Ready Campaign. ESRD Network of New England is a proud NPM 2010 Coalition Member. See list ofover 4,000 members here.

To learn more about what you can do in your facility and at home, visit the Ready website. For tools and resources specific to dialysis, check out Network of New England's emergency preparedness webpage.

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.

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Pandemic (H1N1) 2009 briefing note 23

The world is now in the post-pandemic period. Based on knowledge about past pandemics, the H1N1 (2009) virus is expected to continue to circulate as a seasonal virus for some years to come. While the level of concern is now greatly diminished, vigilance on the part of national health authorities remains important. Such vigilance is especially critical in the immediate post-pandemic period, when the behaviour of the H1N1 (2009) virus as a seasonal virus cannot be reliably predicted.

For example, it is likely that the virus will continue to disproportionately affect a younger age group, at least in the immediate post-pandemic period. Groups identified during the pandemic as at higher risk of severe or fatal illness will probably remain at heightened risk, though the number of such cases could diminish. In addition, a small proportion of people infected during the pandemic developed a severe form of primary viral pneumonia that is not commonly seen during seasonal epidemics and is especially difficult to treat. It is not known whether this pattern will continue during the post-pandemic period, further emphasizing the need for vigilance.

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ESRD Prospective Payment System

The new Prospective Payment System (PPS) for dialysis out patient facilities becomes effective January 1, 2011. The statutory requirement implements a case-mix adjusted bundled payment system. Please note the final rule is 923 pages! The link is http://edocket.access.gpo.gov/2010/pdf/2010-18466.pdf

Today, CMS also issued a proposal rule to establish a new Quality Incentive Program (QIP) to use quarterly measures to determine a performance score, which will be linked to Medicare payment. The ESRD Quality Improvement Program Proposed Rule has a comment period ending September 24, 2010.

Read the Press Release here.

"Dialysis Dining on the Go” is a new publication that is a dialysis patient's guide for fast food, casual dining, and convenience foods specific to individual restaurants and companies. “Dialysis Dining on the Go" was created to allow for greater freedom and confidence in making appropriate food choices while eating out. Selections are described throughout using traffic signals- "Go" (green), "Caution" (yellow), and "Stop" (red). GO choices include foods lower in sodium and higher in protein; CAUTION choices include foods higher in phosphorus and sodium; and STOP choices include foods higher in potassium and sodium. Other instructional tips showcased throughout the guidebook include: A word from the authors, When I don't know what to choose at a restaurant, Better fluid control tips, Salad bar recommendations, Dessert recommendations, How to read a food label, Pizza & Chinese foods, and more!

Ordering Information:

• By E-mail only. E-mail addresses as follows: alleycat2001rd@yahoo.com OR cynthiag42@hotmail.com
• Book cost is $9.95 per book plus shipping and handling. Approximate shipping costs $3.00 per book.
•  Credit Card payment accepted via Pay Pal.
• For quantities ordered of 250 or more, there will be a $2.00 discount per book, excluding shipping charges.

CMS recently launched a new Dialysis Survey & Certification Web Page!

The Survey and Certification Program certifies ESRD facilities for inclusion in the Medicare Program by validating that the care and services of each facility meet specified safety and quality standards, called "Conditions for Coverage." The Survey and Certification Program provides initial certification of each dialysis facility and ongoing monitoring to ensure that these facilities continue to meet these basic requirements.

The new web page provides basic information related to survey and certification of dialysis facilities for ESRD surveyors and dialysis providers. It includes links to applicable laws and regulations, and provides resources to support and assess compliance with Federal regulations.

The FFBI Speakers Bureau includes experts in the field of vascular access that are available to make presentations at local, regional, and/or national meetings. Speakers represent nephrologists, nurses, vascular access surgeons, primary care providers, vascular access coordinators, etc. who are able to travel the US and abroad. “I think the FFBI Speakers Bureau is a terrific way to help disseminate the successful approaches and techniques that have enabled nephrologists, surgeons and dialysis centers to move the fistula prevalence rate so dramatically in the US over the past few years” says Michael Lilly, MD, FFBI Surgical Clinical Consultant.

Some topics of expertise include:
• Fistula First
• Cannulation Training
• Vascular Access Physical Exam
• Team Development
• Needle Fear, Body Image, Patient Perspective
• Vascular Access Construction, Maintenance and Maturation
• Buttonhole Cannulation for Patients and Staff
• Interventional Nephrology
• Coding and Reimbursement for Vascular Access
• Primary Care Recognition and Treatment of Chronic Kidney Disease

To see a complete list of topics and speakers available visit the Fistula First website at http://www.fistulafirst.org/AboutFistulaFirst/SpeakersBureau.aspx.

The month of April is National Donate Life Month, a time designated nationally to help raise awareness about the critical need for organ, eye, tissue, marrow and blood donors and inspire people to register their decision to donate life. Every day in April, people across the U.S. make a special effort to celebrate the tremendous generosity of those who have saved lives by becoming donors and to encourage more Americans to follow their fine example.

To find out more information on how to become a registered donor, go to www.donatelife.net.

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 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 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.

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The U.S. Food and Drug Administration (FDA) has learned that DNA from porcine circovirus
type 1 (PCV1), a virus not known to cause disease in humans, is present in the Rotarix vaccine. All
available evidence indicates that there has been no increased risk to patients who have received this
vaccine. PCV1 is not known to cause any disease in animals or humans; therefore, it has not been
routinely tested for in vaccine development. Rotarix has been extensively studied, before and after
approval, and found to have an excellent safety record (i.e., no unusual adverse events). However, FDA
is recommending that healthcare practitioners temporarily suspend usage of the Rotarix vaccine for
rotavirus immunization in the United States while the agency learns more about the detection of
components of the virus found in the vaccine.

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Almost 400,000 Americans have kidney disease requiring dialysis treatments. Many more have the disease and don’t even know it. The 2010 campaign will focus on Diabetes, the leading cause of Chronic Kidney Disease. World Kidney Day (WKD) is a global health awareness campaign focusing on the importance of our kidneys and reducing the frequency and impact of kidney disease and its associated health problems worldwide.

Together, we can stop this disease from claiming so many lives. For more information about kidney disease, visit www.kidney.org or World Kidney Day, visit www.worldkidneyday.org

PSAW (March 7-13, 2010) is a national education and awareness-building campaign for improving patient safety at the local level. Healthcare organizations across the country are encouraged to plan events to promote patient safety within their own organizations. Educational activities are centered on educating patients on how to become involved in their own health care, as well as working to build partnerships with their patient community.

For mor information, and useful tools and resources, go to: http://www.npsf.org/hp/psaw/

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.

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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.

For more information, including patient videos & education and provider tools & resources, visit: http://www.nkdep.nih.gov/kidneymonth/

NKDEP is an initiative of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), U.S. Department of Health & Human Services (DHHS).

The American Association of Kidney Patients (AAKP) is pleased to announce the date and location of the 2010 Annual Convention in sunny Tampa, FL, September 2 - 4, 2010.

AAKP created its Annual Convention to provide kidney disease patients, as well as their friends and family members with the opportunity to discuss their concerns and share their experiences while learning about important issues affecting their health care. In addition to exciting social events, it is the largest national convention where kidney patients can interact on a person-to-person basis with fellow patients and health care professionals. During this three-day event, attendees participate in educational topics for those with chronic kidney disease (CKD) to long-term dialysis and transplant recipients. Participants also learn about various treatments for each stage.

For more information, visit http://www.aakp.org/events/convention/2010/

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

The National Kidney Foundation 2010 Spring Clinical Meetings will be taking place in Orlando, Florida from April 13 - 17, 2010.

SCM 10 presents a unique opportunity for busy renal health care providers to learn new developments related to all aspects of nephrology. It is designed for kidney doctors in the private sector and academia, fellows and residents with a special interest in kidney disease, general internists, pharmacists, physician assistants, nurse practitioners, nurses and technicians, social workers, and renal and clinical dietitians.

To register, simply visit http://www.kidney.org/news/meetings/clinical/index.cfm

Effective July 1, 2010, the Medicare (dialysis) in-facility claims billing submission will require the reporting of KT/V, vascular access type and infection. The URR will no longer be required. The hemoglobin lab value will continue to be reported.

To view the CMS Pub 100-04 Medicare Claims Processing notice addresing these changes, click here.

These sounds can teach hemodialysis patients and healthcare providers what to listen for when monitoring AV fistulas and AV grafts. Physical examinations should be performed at each dialysis treatment, using a stethoscope to assure the vascular access has blood flow.

Dr. Vachharajani uses the audio clips in the initial training for patient care technicians and nurses, as well as during a refresher course for all dialysis staff members. His patients are encouraged to perform a daily physical examination of their dialysis access and these sounds are used to teach them the difference between a normal and abnormal bruit. Dr. Vachharajani says, “I use these sounds to teach my fellows the nitty-gritty of nephrology practice,” and “these sounds are included in a one-day course for charge nurses.”

To listen to the bruit audio clips visit the FFBI website at www.fistulafirst.org under What’s New.

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.

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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.

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OSHA's "Respirator Safety" video demonstrates how to correctly put on and take off common types of respirators, such as N95s. "The Difference between Respirators and Surgical Masks" video explains how they prevent exposure to infectious diseases.

"Respirators play an important role in protecting many workers from exposure to chemical and biological hazards in the workplace," says Assistant Secretary of Labor for OSHA David Michaels. "At a time when pandemic influenza has highlighted the risk to healthcare workers, these videos will prepare and protect workers from the very illnesses they are responsible for treating."

The videos also explain how workers can perform a user seal check to test whether a respirator is worn properly and will provide the expected level of protection. Viewers may watch both English and Spanish versions by visiting OSHA's Respiratory Protection page or the Department of Labor's YouTube site.

According to OSHA's respiratory protection standard 29 CFR 1910.134, respirators must be used as part of a comprehensive respiratory protection plan.

http://www.osha.gov/SLTC/respiratoryprotection/index.html#trainingvideos
http://www.youtube.com/usdepartmentoflabor

Baxter recently sent an Urgent Device Correction letter to peritoneal dialysis clinician to help reduce or eliminate overfill, also referred to as Increased Intraperitonal Volume (IIPV), associated with HomeChoice/HomeChoice PRO cyclers. IIPV can result in serious injury or death from conditions including, but not limited to, hydrothorax, heart failure, pulmonary edema or pericardial effusion. Baxter has received complaints of IIPV, which resulted from patient use errors and/or prescription errors.

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Start off the New Year with some answers to your CROWNWeb-related questions!

What is independent facilities’ perspective of the CROWNWeb system?

What is the latest on the Batch Data Submission process?

How are facilities using the CROWNWeb system in the REAL WORLD?

Join other renal community stakeholders, CMS and the Renal – Requirements, Communications and Training team (RCT) as we present the latest information related to the CROWNWeb system via a six-part WebEx series.

These sessions will be held the last Thursday of each month, January 28, 2010 - June 24, 2010; and will provide a means for the community to share thoughts regarding each topic.

Larry Emerson, President of the National Renal Administrators Association (NRAA), will kick-off this six-part WebEx series by discussing independent facilities’ overall perspective of the CROWNWeb system.

Register for these WebEx sessions today! http://www.projectcrownweb.org/crown/presentations.php

January 26, 2010
1:00 p.m. - 2:00 p.m. EST

Registration Form

Teleconference: 1-888-273-3658
Access Code: 4745702

Speaker: Karen Robbins, MS, RN, CNN - Educator Hartford Hospital Dialysis & Transplant Programs

Program Objectives:

• Discuss how a QAPI will help improve process & clinical care
• Expand your current knowledge base in improving QAPI programs
• Disscuss practical approaches to establishing a QAPI program

Please follow these instructions to join the event:

1) Click on or go to https://ifmcevents.webex.com
2) Locate your event
3) Click on the Join Now link to the right of the event or click on the name of the event
4) Enter your name and email address
5) Enter the Event Password: Network1
6) Click on Join
7) Dial the teleconference number. The number is 1-888-273-3658.

Please join us 15 minutes prior to the presentation to ensure the automatic system set-up has been properly established.

If you have any questions or problems accessing the meeting, please call the IFMC WebEx Helpline at 515-440-8555.

For information about participating in this WebEx, please call 203-387-9332 or email Peggy Lynch.