NEWS
08/31/1993

<TITLE>FDA Announces New Rule to protect Patients with Critical Medical Implants</TITLE>
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P93-36                               Food and Drug Administration
FOR IMMEDIATE RELEASE                Sharon Snider (301) 443-3285

     The Food and Drug Administration 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." 
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                                        Page 2, P93-36, Tracking
     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 of 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
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                                        Page 3, P93-36, Tracking
          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. 
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