Congressional pressure prompts changes in FDA

April 8, 1992

Pressed to make rapid changes to show it is committed to enforcingsafe medical device practices, the Food and Drug Administrationhas named a new acting director for its device evaluation division. Acting director Alan Andersen, formerly head of science

Pressed to make rapid changes to show it is committed to enforcingsafe medical device practices, the Food and Drug Administrationhas named a new acting director for its device evaluation division.

Acting director Alan Andersen, formerly head of science andtechnology at the Center for Devices and Radiological Health,takes office this week. A search for a permanent chief has begun,said Monica Reveille, an FDA press liaison. Current director ofmedical device evaluation, Robert Sheridan, will move to an as-yetunnamed management position within the FDA.

The change was announced by CDRH director James Benson lastweek. In a memo, Benson said the move was spurred by "organizationalchanges" taking place within the FDA.

Sheridan's move might prove a positive one for manufacturers,according to Robin Wiley, legislative assistant for the NationalElectrical Manufacturers Association imaging division.

"If he is being moved to a higher post within the FDAit could be a good thing, particularly if he has more direct involvementin drafting regs for the Safe Medical Devices Act," she said.

But the FDA's Reveille said that although Sheridan will serveas a senior adviser to commissioner David Kessler, his role willbe strictly a management one.

"He won't be involved in drafting any regulations,"she said.

The announcement comes on the heels of intense scrutiny byCongress of the FDA's record for approving and inspecting medicaldevices. The agency has been called on the carpet for failingto enforce safe manufacturing practices. New director Andersenis expected to bring a scientific bent to the device evaluationprocess, emphasizing a need for increased clinical and evaluativedata on new products.

In addition to Sheridan's replacement, the FDA also announceda stringent new proposal aimed at increased accountability bymanufacturers. The proposal, unveiled by Kessler last week, requiresmanufacturers to track their devices from factory to patient.

The Safe Medical Devices Act of 1990, which took effect inNovember, already requires imaging centers, physicians, hospitalsand manufacturers to report device malfunctions. The new additionto the act requires manufacturers to stay in touch with how theirdevices are performing in the field--and in patients.

In case of malfunction or injury, manufacturers would be requiredto report patient name and device location to the FDA within threeworking days. Manufacturers would also be required to keep recordson each device in use and to conduct performance audits everysix months.

The proposal only applies to 35 so-called "critical"devices, Wiley said. Life support, life sustaining and implantabledevices are included; imaging-specific products are not.

"The scope is limited to nonimaging devices, and we don'thave any problems with it," she said. "We can't thinkof any justification the FDA would have to designate an imagingdevice, unless it subsequently uncovers a problem with a specificpiece of equipment."

The FDA's Reveille confirmed that imaging devices are not includedin the tracking proposal but would not rule out whether they willbe added in the future. Comments are being accepted on the proposal,which becomes effective May 28.

At the Health Industry Manufacturers Association, presidentAlan Magazine said the tracking proposal represents an expensiveburden. Based on FDA estimates, implementation would cost about$100 million by the end of 1992 and $3.7 billion over the next15 years, he said.

Additional concern among manufacturers exists over Congressionalthreats to increase the FDA's enforcement powers, Wiley said.A bill on Capitol Hill would give the agency expanded enforcementpriority in addition to that which it already wields.

"NEMA's position is: Let's get the Safe Medical DevicesAct up and running and then we can revisit the issue if need be,"she said. "Congressional efforts in that area may be premature."

Wiley added that the imaging industry has worked cooperativelywith Kessler for the past year in defining safe medical practices.

"We will continue to work with him as he moves towardimplementing a more rigid enforcement policy," she said.