
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: SATURDAY, March 28, 1992                   TAG: 9203280073
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-7   EDITION: METRO 
SOURCE: Los Angeles Times
DATELINE: WASHINGTON                                LENGTH: Medium

IMPLANTED-DEVICE RECORDS REQUIRED

The Food and Drug Administration said Friday it plans to require makers 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 Kessler, FDA commissioner.

The proposed regulations would apply to 35 types of major medical devices, such as heart valves and silicone breast implants.

The rules are mandated by the Safe Medical Devices Act of 1990 and would take effect after a 60-day public comment period. They 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, 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 valves, which has been blamed for several hundred deaths.

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 days.

The regulations would apply only to devices implanted after the rules go into effect.

by CNB