The Council on Renal Nutrition of New England (CRNNE) will be hosting a fall conference.

Wednesday, November 2, 2011
Hoagland-Pingus Conference Center
22 Maple Avenue
Shrewsbury, MA

To register, review the adgenda and get direction, click here. For more information, contact Lynda Parke, Corresponding Secretary, CRNNE.

Preparing patients for emergencies is an important responsibility that empowers and saves lives. To encourage and facilitate this essential practice, the Kidney Community Emergency Response (KCER) Coalition has designated September 19-26, 2011 as National Emergency Preparedness Education Week for Kidney Patients. Coinciding with National Preparedness Month, which runs throughout the month of September, National Preparedness Education Week is an opportunity to prioritize patient safety, while helping to meet the key CMS Condition for Coverage stating, “facilities must provide appropriate training and orientation in emergency preparedness to patients”. 

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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 2011 Coalition Member. See list ofover 5,700 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 FDA has 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.

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Special Open Door Forum on August 4, 2011: CMS Proposed Rulemaking for Payment Years 2013/14 QIP

CMS has released more proposed performance measures to be used in 2013/14, which has important implications for withholding Medicare payments to dialysis providers.  The details are listed in the Federal Register, dated July 8, 2011.  Public comments are accepted until August 30, 2011.

Click here to read the notice from CMS.

There is an Open Door Forum call on this topic set for August 4, 2011

Dialysis patients are vulnerable to Healthcare Associated Infections (HAI) because they have multiple and frequent exposure to healthcare environment that exposes them to infections and they also require a method of vascular access such as central line catheter that put them at risk of acquiring infections. Dialysis facilities also are vulnerable to spread of infections because patients are treated in small places, there is more body fluid than any other out-patient setting, and high number of opportunities for infections / hour of patient care. Due to these facility and patient level risk factors, many infections occur at dialysis facilities each year. The Centers for Disease Control and Prevention (CDC) recommends tracking infection rates and germ types with CDC's National Healthcare Safety Network (NHSN) to learn where and why infections are happening, target actions to stop them, and track progress. Network of New England was awarded a project on HAI by the Department of Health, State of Connecticut under Emerging Infections Program (EIP). Under this project, surveillance of HAI will be performed using CDC's National Healthcare Safety Network (NHSN) module. In Particular Network of
New England will:

• Train and assist dialysis facilities to enroll in NHSN
• Train and assist with interpretation of NHSN surveillance definitions
• Train on how to enter data into the NHSN Dialysis Event (DE) module

Network of New England will also document specific provider techniques and infection control practices aimed to lower the risk of infection based on best practices recommended in authoritative guidelines including but not limited to those prepared by the CDC.

On July 1, 2011 the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would add new measures such as "whether the facility reports certain dialysis-related infections to the CDC" for the ESRD quality incentive program. The proposal, if finalized, would be effective for dialysis treatments furnished on or after January 1, 2012. Joining hands with Network of New England now will help dialysis facilities to be ready for 2013 pay for performance period. 

Click here for more information about the proposed Quality Incentive Program.

The Network of New England is asking dialysis facilities to volunteer to participate in the Network project.   This is the moment to act and seize the opportunity to track your facility's infections using a national standard tool, NHSN.

*Increased Risk of Post-transplant Lymphoproliferative Disorder (PTLD), predominantly involving the Central Nervous System (CNS), and Progressive Multifocal Leukoencephalopathy (PML)

Bristol-Myers Squibb informed healthcare professionals about the REMS that is required for Nulojix to ensure that the benefits of Nulojix outweigh the risks of PTLD and PML, both of which can be fatal. Patients treated with Nulojix are at an increased risk for developing PTLD, predominantly involving the CNS. PML has been reported in patients receiving Nulojix at higher than recommended doses as part of an immunosuppressant regimen.

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FDA Safety Announcement: Erythropoiesis-Stimulating Agents in CKD -Modified Dosing Recommendations

The FDA is working to inform healthcare professionals that new modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney disease (CKD) have been approved in order to improve the safe use of these drugs. The FDA made these new recommendations because of data showing increased risks of cardiovascular events with ESAs in this patient population. The new dosing recommendations are based on clinical trials showing that using ESAs to target a hemoglobin level of greater than 11 g/dL in patients with CKD provides no additional benefit than lower target levels, and increases the risk of experiencing serious adverse cardiovascular events, such as heart attack or stroke.

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Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. 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.

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The FDA has 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.

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Bristol-Myers Squibb has 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.

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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.

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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.

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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.

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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.

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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.

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RECALL: Fresenius Medical Care - CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the Blood Volume Monitor

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.

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The Triad Group has 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 products could put at-risk patients at risk of developing life-threatening infections.

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This device has been identified for recall due to a design defect that can lead to unintended “fracture and peeling” of the bond and/or detachment of the distal end of the scoring element.  Continued use of recalled devices may lead to retained device fragments or significant arterial injury which may lead to death or the need for surgical intervention.  The recall targets 17,682 units distributed between 9/2007 and 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.

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A dialysis patient’s survival depends on proper functioning of their vascular access, also known as their lifeline.  The Atlas of Dialysis Vascular Access, available on the Fistula First website will help educate the entire patient care team on keeping the dialysis patient’s lifeline functioning. 

The Atlas, developed by Tushar Vachharajani, MD, FACP, FASN, Dialysis Access Group of Wake Forest University School of Medicine, Winston-Salem, North Carolina, highlights the basic anatomy of the most frequently used vascular access sites and identifies associated problems.  The Atlas is a photo-based teaching guide for all individuals involved in the use, management and preservation of vascular access.  The Atlas, reviewed and enthusiastically endorsed by the FFBI Clinical Practice workgroup, contains images collected from patients who have endured the problems and have graciously consented to be photographed.

Clich here to view the Atlas of Dialysis Vascular Access presentation. It can also be found on the FFBI website at www.fistulafirst.org under What’s New.

On December 29, 2010 CMS published the final rule for the Dialysis Quality Incentive Program (QIP). Adjustments to payment for services under the QIP will be applied January 1, 2012.

Click here to read the Medicare Fact Sheet.