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FDA ANNOUNCES MEDICAL DEVICE TRACKING REQUIREMENTS

 WASHINGTON, Aug. 31 /PRNewswire/ -- The Food and Drug Administration (FDA) today announced a new rule to protect patients with critical medical implants and life-supporting devices if malfunctions arise.
 The action requires manufacturers of 17 implants and five devices to keep track of patients who receive them so they can be contacted if problems develop that would threaten patient health or life.
 The rule affects critical implants such as heart valves and pacemakers and life-supporting devices used at home such as breathing monitors, ventilators and defibrillators.
 The new requirement was mandated by the Safe Medical Devices Act of 1990, which requires tracking of medical devices whose failure could have serious consequences.
 "We need a system that will allow us to communicate quickly and effectively critical information about the safety and efficacy of implants and devices," said FDA Commissioner David A. Kessler, M.D. "Tracking will help save lives by making it possible to get in touch quickly with people who have faulty devices."
 Manufacturers will be required to have systems to track their products from the manufacturer through the distribution chain to the patient so that, if necessary, they can provide FDA with the names of patients and locations of devices within 10 working days. The tracking system will have to be maintained for the useful life of the device, with the data and function of the system audited periodically.
 No specific method tracking is required. Manufacturers can use different methods to ensure collection of information from patients or health care facilities, as long as the methods are adequate. More than one means of data collection may be necessary to ensure effective tracking.
 Medical devices to be tracked are:
 -- vascular graft implants
 -- ventricular bypass devices
 -- implantable pacemaker pulse generators
 -- cardiovascular permanent pacemaker electrodes
 -- annuloplasty rings
 -- replacement heart valves
 -- automatic implantable cardioverter/defibrillators
 -- tracheal implants
 -- implanted cerebellar stimulators
 -- implanted diaphragmatic/phrenic nerve stimulators
 -- implantable infusion pumps
 -- breathing frequency monitors
 -- continuous ventilators
 -- DC-defibrillators and paddles
 -- silicone inflatable breast implants
 -- silicone gel-filled breast implants
 -- silicone gel-filled testicular implants
 -- silicone gel-filled chin implants
 -- silicone gel-filled angel chik reflux valves
 -- electromechanical infusion pumps
 -- jaw implants
 -- inflatable penile implants
 Other devices will be subject to tracking in the future, as necessary to protect the public health.
 The new requirement was published as a final regulation Aug. 16 in the Federal Register; it took effect Aug. 29.
 FDA is one of eight Public Health Service agencies within HHS.
 -0- 8/31/93
 /NOTE TO EDITORS: Attention TV broadcasters: please use open caption for the hearing impaired./
 /CONTACT: Sharon Snider of the Food and Drug Administration, 301-443-3285 or, home, 301-622-0977/


CO: Food and Drug Administration ST: District of Columbia IN: MTC SU: EXE

DC-KD -- DC006 -- 7419 08/31/93 10:19 EDT
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Publication:PR Newswire
Date:Aug 31, 1993
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