A Medical Device Daily

The Department of Health and Human Services has named 15 individuals to the federal coordinating council that will guide the efforts of the soon-to-be-established comparative effectiveness research institute. The 15, who will collectively be referred to as the Institute of Medicine (IOM) Committee on Comparative Effectiveness Research Priorities (CCERP), will oversee the investment of roughly $1 billion, and HHS spokeswoman Jenny Backus is quoted in the statement as saying that the Obama administration "is committed to openness and transparency." Toward that end, the council "will host open meetings and a listening session as it begins its important work."

The statement notes that the listening session is scheduled for April 19, but the HHS press office told Medical Device Daily last Friday that there were no further details available.

As one might expect, the council includes Carolyn Clancy, MD, the director of the Agency for Healthcare Research and Quality. Representing the Centers for Medicare & Medicaid Services is Thomas Valuck, MD, a senior adviser in the Center for Medicare Management at CMS who was part of the team that set up the hospital pay-for-performance program.

Representing FDA on the CCERP is Jesse Goodman, MD, the director of the Center for Biologics Evaluation and Research (CBER). Goodman took the job at CBER in 2002 and was elected to serve at the Institute of Medicine (IOM) three years later. Also on the council is Elizabeth Nagel, MD, director of the National Heart, Lung and Blood Institute of the National Institutes of Health. However, there appear to be no consumers or industry representatives.

In a March 20 statement to the CCERP, which met Friday to receive input, Teresa Lee, vice president of payment and healthcare delivery policy for the Advanced Medical Technology Association (AdvaMed; Washington) urged IOM "to make public all of the meetings of the IOM Committee on Comparative Effectiveness Research Priorities in order to keep all stakeholders informed of the priority-setting process, and to enable their on-going input."

Lee also recommended that the committee "make its recommendations available for public comment before they are finalized in the report to Congress and the Secretary" so as to "enhance the credibility of the IOM Committee's recommendations." This, in turn, is enabled by giving the committee "input from patients, clinicians, health care providers, and manufacturers who have firsthand experience with how various topics would be relevant for clinical practice," Lee said.

Torti confidentiality memo leaked

FDA may be leakier than other federal government agencies, so acting FDA Commissioner Frank Torti, MD, decided recently to address the subject with the agency's employees. In a March 13 e-mail blast, Torti notes that while the agency "is committed to the principles of open government" as delineated in a White House memo dated Jan. 21, FDA must nonetheless "comply with its obligations to keep certain information confidential." The memo showed up in the Wall Street Journal, but source who leaked the memo is not named in the article.

Among the elements discussed in Torti's memo are trade secrets and confidential commercial information, but Torti also states that "the deliberative process privilege, which protects the pre-decisional advice, opinions and recommendations of agency employees," is also confidential information. Two other areas of concern in Torti's memo are attorney-client privilege and attorney-work product privilege, both of which have been the subject of memos coming out of the Department of Justice for the better part of this decade.

Needless to say, some object. The Wall Street Journal reported that FDA critic Steve Nissen, MD, of the Cleveland Clinic (Cleveland), is "a little stunned that FDA would send this memo out at this time," and speculated as to "what some of the people on the Hill think." However, FDA spokeswoman Judy Leon told WSJ the memo deals with "fairly obvious stuff."

Welch Allyn AED recall expanded

Welch Allyn (Skaneateles Falls, New York), has announced a recall of more than 14,000 automated external defibrillators manufactured between October 2002 and January 2007 after 39 reports of device malfunction.

Because of the small numbers of affected AED 10 and MRL JumpStart units, the company is recommending that owners of the units hold on to them until a replacement unit arrives. Welch plans to offer U.S. and Canadian customers either a no-cost replacement for "a like device" or a new AED 10 unit that would have a 5-year warranty, "at a significantly reduced cost." The March 11 announcement at the Welch web site states that "all international customers will be offered exchange AED 10 devices."

The statement notes that FDA's reports include "20 reported instances of low energy shock, eight of electromagnetic noise interference, and 11 of unexpected device shutdown."

FDA: say no to insulin pen sharing

FDA issued an alert last week to remind healthcare professionals not to use single-use insulin pen injector cartridges on more than one patient. According to the March 19 announcement, the agency knows of incidents at two hospitals in which insulin injection pen cartridges were used on multiple patients in more than 2,000 instances. Even though the needles were said to have been changed, FDA is concerned that the use of a cartridge on more than one patient runs a risk of disease transmission. However, the agency's statement does not comment on how widespread the practice may be.

Amy Egan, M.D., deputy director for safety at the division that deals with endocrinology products in the Center for Drug Evaluation and Research, said in the statement that the cartridges "are not designed, and are not safe, for one pen to be used by more than one patient even if needles are changed between patients due to the risk of transmitting blood-borne pathogens." Injection pen cartridges are not as prone as the traditional needle-and-syringe arrangement to drawback of patient fluids, but most such systems are not foolproof.

Patients at the two unnamed hospitals have been contacted and while some have been diagnosed with hepatitis C, it is unknown whether or how many of such diagnoses are related to cartridge sharing.

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