Medical Device Daily Washington Editor

FDA reported that Cordis (Miami Lakes, Florida) has joined the recall brigade with the class I recall of the Dura Star RX and Fire Star RX balloon catheters. The Jan. 14 announcement indicated that the recall affected only lots that were manufactured in Mexico between February and December 2007 and distributed between March 26 and this past Jan. 8. The total number of balloon catheters was in the range of 132,000.

According to the FDA announcement, the balloons could deflate slowly or not at all, which could block the blood vessel. This can result in damage to the heart and require a surgical procedure to address. According to the Dow Jones news service, there have been no fatalities associated with the device to date, and Christopher Allman, a Cordis spokesman said the recall was not unlikely to have a material financial impact. The Dura Star and the Fire Star are not used to deploy the company’s flagship Cypher drug-eluting stent.

The firm is not certain as to the underlying cause of the problem with the balloon catheters. “That’s what we’re looking into right now,” Allman told Medical Device Daily. However, he could offer no timetable for completion of the root cause investigation, but added that Cordis has suspended manufacture of the two units pending the outcome of the investigation.

OIG seeks tips on nursing facility compliance

Compliance is an issue for more than just FDA-regulated industries, so members of the nursing facility industry probably were not shocked to discover that the Office of Inspector General (OIG) at the Department of Health and Human Services is considering a rewrite of the compliance program guidelines for their establishments. OIG is looking for input from industry on the question, and respondents have until Feb. 25 to make known their views.

The Jan. 24 entry in the Federal Register notes that the first such guidance was published in 2000 and that “the subsequent years of enforcement and compliance activity in the industry has allowed OIG to address more fully the various risk areas in nursing home compliance.”

The notice states that such guidances address “how providers can establish internal controls and implement monitoring procedures to identify, correct and prevent potentially fraudulent conduct.” OIG is looking for ideas on how to prevent and deal with “false claim submissions, quality of care concerns, kickbacks and accurate reporting of data to Medicare and Medicaid,” and indicated that it would appreciate “empirical data supporting any suggestions.”

OIG also expressed a preference for ideas “submitted in a format that addresses the topics outlined…rather than in the form of a comprehensive draft guidance that mirrors previous” guidances.

NIH seeking more outside ideas for research

In a move reminiscent of large corporations seeking to reinvent themselves in the Age of the Quick Response, the National Institutes of Health has come forward with a strategic plan to encourage outside-the-box thinking. A key part of the plan will be research prompted by the work and thinking of independent investigators.

Dubbed the Investing in Discovery initiative, the plan “will guide the Institute’s decision-making over the next five years” in terms of which areas of biomedical research that NIH wants to foster.

Jeremy Berg, PhD, the director of the National Institute of General Medical Sciences (NIGMS) at NIH, said in the statement that the plan, administered by NIGMS “articulates our core principles and shows how we will make strategic investments to maximize the benefits of the public funds entrusted to us.”

The range of fields expected to be bolstered by the effort include, according to the statement, cell biology, biophysics, genetics, and bioinformatics. Other areas of interest include computational biology and a select group of clinical and behavioral sciences.

The statement notes that “[c]entral to the plan is a commitment to investigator-initiated research, mostly research project grants known as R01s, as the main focus of the NIGMS portfolio.” The agency is not put off by efforts with uncertain outcomes, either. The statement noted that “NIGMS will make special efforts to encourage and support exceptionally innovative proposals that have the potential for significant impact, even if they carry more than the usual element of risk.”

Allegations that NIH was becoming more intractable in making research grants surfaced last year, with statistics indicating that only one in five research grant applications made it through the application process in FY06.

The rate of approval five fiscal years earlier has widely been reported to be around almost one in three (32.1%). However, a search of the grant database at NIH indicates that the agency awarded grants to 9,098 in FY01 vs. 9,128 in FY06. The total dollar value of grants in 2001 was $3.03 billion, whereas the same figure for 2006 was about $3.36 billion, an increase of roughly 10%.