NN&I - August 2010

National August 2010 Nephrology News & Issues 9Subscribe to our free eNewsletter at www.nephronline.com The U.S. Food and Drug Administration said it has required Baxter Healthcare Corp. to take specific steps to carry out the April recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination. Baxter is responsible for recalling as many as 200,000 CVIP currently in use in the United States. Under the FDA's requirements, Baxter will also provide a transition guide to assist custom -ers affected by the recall. The guide will include a list of FDA-cleared or approved pump alternatives, sugges -tions to help minimize disruption and patient risk during the transition peri -The Mayo Clinic in Rochester, Minn., is the best hospital in the country to get kidney disease care, according to the U.S. News & World Reports' annual ranking of the best hospitals. More than 1,600 hospitals are listed in the ranking for treating kidney disor -ders. All are experienced in treating difficult casesa hospital is listed only if at least 148 inpatients that needed a high level of expertise in this specialty were treated there in 2006, 2007, and 2008, or if surveyed specialists recommended the hospital for such patients. Mayo was also ranked at the top of the list for diabetes care. Behind Mayo, Johns Hopkins Hospital in Baltimore ranked second, followed by the Cleveland (Ohio) Clinic and New York-Presbyterian University Hospital of Columbia/Cornell University. Massachusetts General Hospital in Boston rounded out the top five. od, and detailed information on the refund, replacement, and lease termi-nation programs. The FDA is requiring Baxter to con-tinue to provide batteries, spare parts, and service for the affected pumps dur -ing the transition period for customers who submit a Certificate of Medical Necessity to Baxter. The certificate, provided by Baxter, asks for informa-tion such as the number of CVIP cur -rently in use, serial numbers, and the anticipated date that the CVIP will be removed from use. After receiving the completed certificate, Baxter will con -tinue service for 24 months or until the customer has transitioned to another pump.FDA issues requirements for Baxter Healthcare infusion pump recall Mayo Clinic tops ranked hospitals for kidney carepresident of the RPA from 1993-1994, during which time he worked on the MCP bundle of services. He retired in October 2006. "The RPA should never forget that people like Jimmy--dedicated compassionate, hard work-ing clinicians--[drove] some of the best and most important public policy initiatives of (this) relatively young orga-nization during his tenure on the Board of Directors and presidency," wrote fellow nephrologist Allen Nissenson in the May issue of RPA News. Results from a survey completed by \037 attendees at major nephrology confer -ences last year suggest that dialysis machine manufacturers need to focus on improving automation of patient monitoring during treatment. Gambro, which conducted the sur -vey "Dialysis Opinions- Facilitating dialysis delivery," presented the results during a symposium at the 47th ERA-EDTA Congress in Munich in June. The majority of the respondents expressed a need for dialysis equip- ment that is able to take over treat- ment parameters that can be automat-ically controlled to reach the targeted dose at the end of the session, such as a Kt/V or Kt value; or blood vol-ume changes that can be controlled through biofeedback to better pre -serve hemodynamic stability. The respondents also expressed a desire to let the dialysis machine con- trol the entire process of blood purifi-cation, hemodynamics, and physiol-ogy through advanced biofeedback technology and to allow more patients to perform self-care dialysis, Gambro noted in its presentation. The Dialysis Opinion surveys have been conducted annually at major nephrology and dialysis congresses since 1992. Responses to this ques-tionnaire totaled 3,590 nephrology professionals.The Centers for Medicare & Medicaid Services has issued a proposed rule that would reduce preventive services for Medicare beneficiaries by 6.1% on or after Jan. 1. The proposed rule would implement provisions in the Patient Protection and Affordable Care Act of 2010 that would seek to "eliminate out-of-pocket costs for beneficiaries for most preventive services, including the new annual wellness visit," CMS said. This visit augments the benefits of the Initial Preventive Physical Examination (IPPE) with an annual wellness visit. CMS will accept comments on the proposed rule until Aug. 24 and will respond to them in a final rule to be issued on or about Nov. 1. CMS proposes a 6.1% cut in services National_08_10[5].indd 9 7/16/10 1:28:35 PM