Medical Device Follow-Up Rule Planned : Health: FDA seeks to require makers of the products to track patients so they can be notified of defects or side effects.

The Food and Drug Administration said Friday it plans to require manufacturers of high-risk medical devices to track new patients closely so they can be notified of any product defects or serious side effects.

“Identifying and following patients who receive these devices is critical, so that the patients can be notified promptly of any problems,” said Dr. David A. Kessler, FDA commissioner.

The proposed regulations would apply to 35 types of major medical devices--such as heart valves and silicone breast implants--now being made by more than 370 companies.

The rules are mandated by the Safe Medical Devices Act of 1990 and are exempt from the Bush Administration’s highly publicized moratorium on new regulations.

The proposed FDA rules, which would take effect after a 60-day public comment period, pertain to permanent implants, such as heart valves and aneurysm clips, as well as to external but life-sustaining devices, such as breathing monitors, infusion pumps, respirators and defibrillators.

The regulations will “allow registries (of patients) to be created,” Kessler said, calling the action “an important first step.”

Referring to the controversy over leaking breast implants, which are suspected of causing serious medical problems, including autoimmune diseases, Kessler said: “We don’t even know right now how many patients have these devices.”

Silicone gel breast implants have been on the market for three decades, but Kessler recently moved to restrict their use amid growing health concerns for the estimated 1 million recipients.

The FDA and Pfizer Inc., manufacturer of the fracture-prone Bjork-Shiley heart valve, also have come under criticism for their inability to locate quickly the tens of thousands of recipients of the valve, which has been blamed for several hundred deaths.

A tracking mechanism, Kessler said Friday, “will help FDA protect the public by providing the information necessary to quickly remove dangerous and defective devices from the market.”

The proposed regulations would require a manufacturer to collect and maintain patient information during the life of its device and to audit such data every six months.

Each manufacturer also would be required to design a system to ensure its ability to trace, identify and report to the FDA every patient’s name and address within three working days.

The regulations would apply only to devices implanted after the rules become effective, they said.

The proposed rules were issued just days after the FDA was criticized by the General Accounting Office for being lax in regulating medical devices. But Kessler and Linda Suydam, special assistant to the deputy commissioner for operations, said the regulations had been in the works for a long time.