FDA's device center is establishing a senior-level team of agency staffers and outside experts to lead an effort to revitalize the postmarket device safety program, the agency announced Jan. 19.

The group, called the "senior matrix execution team," is charged with setting priorities and overseeing implementation of a wide-ranging, four-point plan.

Its first meeting was Jan. 20, and a report is expected within four months identifying "where we can have the greatest impact...in order to make the program function better," Center for Devices & Radiological Health CDH Director Dan Schultz said in an interview. "The recommendations of this group will carry a lot of weight," Schultz noted.

The team will consist of senior representatives of each office within CDRH, the chief operating officer of FDA's Office of Regulatory Affairs Steve Niedelman, independent consultant Elizabeth Jacobson - a former CDRH deputy director and former AdvaMed executive - and Johns Hopkins University cardiologist Jeff Brinker.

Four-Point Plan Is Grounded In Collaboration

As part of the new "¹ Medical Device Postmarket Transformation Initiative," the team - and CDRH as a whole - will work to develop a "culture of collaboration" on postmarket safety among parties both within and outside FDA; to produce "world class" data sources and systems; to enhance risk/benefit communication efforts; and to improve enforcement strategies.

The initiative offers few ideas that have not already been discussed; however, it attempts to provide an initial roadmap for comprehensive change. Schultz has previously suggested that CDRH might be interested in applying user fee funds, currently reserved mostly for premarket review activities, to postmarket surveillance under a revised MDUFMA law (² Also see "Device Center Director Schultz Floats User Fees For Postmarket Efforts" - Medtech Insight, 24 October, 2005., p. 7).

However, he indicated Jan. 19 that the center plans to reallocate its resources rather than request major funding increases to finance the long-term postmarket plans. He believes that by increasing collaboration throughout the center and putting "things together in ways we have not before," the center will be able to make improvements in a cost-efficient way.

The proposal follows an intensive internal review of the current CDRH postmarket framework that began in the second half of 2005.

That reassessment was partly a response to outside pressure in the wake of a string of cardiac rhythm management device recalls by Guidant last summer.

The mainstream press and members of Congress, among others, have expressed concern about the agency's and industry's handling of safety information related to the recalled products.

The new initiative may in part be an effort to render unnecessary any potential attempts by Congress to impose new postmarket surveillance mandates on FDA.

Information Technology Upgrades Key To New Plan

As a companion to the new recommendations, the center provided a 77-page ³ report detailing the findings of its internal analysis of postmarket systems. The report notes significant difficulties in CDRH's ability to identify, assess, and respond to postmarket problems.

The report particularly focuses on issues of cross-center communication and the need to better integrate data collected from various sources.

Current information - from sources including adverse event reporting, manufacturing facility inspections and postmarket condition-of-approval clinical studies - "may be adequate for a specific purpose, but not always viewed in the aggregate," thus making it difficult to recognize and act on troublesome patterns, the report explains.

The center will renew efforts to significantly upgrade its IT and electronic reporting capabilities. A first generation electronic system aimed at increasing the efficiency of the current system of adverse event reporting under the Medical Device Reporting regulation is close to completion, according Schultz.

However, the long-term goal would involve a system that would allow staff to "data mine" all available postmarket information, not just MDR reports.

Improving Incoming Data And Outgoing Messages

The center also acknowledges substantial problems with the quality of data it receives due to the under-reporting of adverse events by device users and the difficulty in identifying precisely what devices are involved in a particular event and how, specifically, the devices were associated with the event.

Under the new initiative, the agency will push for a "standardized and globally accepted nomenclature for devices, and mechanisms and incentives for device users to include this information in healthcare records," the report says.

"There is no question that the future of medical device regulation is going to involve a system of unique product identifiers," Schultz said.

The center also plans to come up with a more routine method of searching healthcare literature and media reports to unearth adverse event data and to get the most out of routine information it receives from companies in annual reports on PMA-approved products.

Further, CDRH will continue to explore partnerships with other HHS departments and state governments to access population-based healthcare data. The center says it is already examining the potential postmarket surveillance utility of Medicare data for endovascular repair of abdominal aortic aneurysms.

The agency is less clear about what the future might hold in the realm of public health response. It notes, however, the need to better coordinate enforcement actions such as recalls with timely and accurate public announcements.

In addition, a recent Federal Register ⁴ notice suggests that the center plans to conduct a survey of healthcare practitioners regarding their preferences for the format and timing of public health notifications, one of CDRH's tools for alerting the public to device safety problems. CDRH has recently used public health notifications to provide updated adverse event information on Guidant's July Class I recalls of its Prizm 2 and Contak Renewal implantable cardioverter defibrillators.

The center also continues to work with AdvaMed and a Heart Rhythm Society task force to improve firms' communications to healthcare practitioners and patients about device performance, as a follow-up to a September 2005 public meeting organized by HRS.

FDA Unveils Medical Device “Postmarket Transformation”

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