FDA releases list of high-risk medical devices
Inclusion depends on assessment of patient risk
To more sharply focus its efforts on the possible impact of the year 2000 (Y2K) date problem on medical devices, the federal Food and Drug Administration (FDA) in Rockville, MD, has developed a list of types of computer-controlled, potentially high-risk medical devices that have the potential for the most serious consequences for patients should they fail because of date-related problems. (For more information about the FDA’s Y2K activities, see cover story.)
Inclusion of a type of device on this list does not mean that all devices of this type have a date-related problem (are Y2K-noncompliant) or, if they are Y2K-noncompliant, that they necessarily pose a significant risk to patients.
Rather, this list includes those types of devices that could pose a risk to patients if the date-related failure affects the function or operation of the device. The FDA will use this list to identify those devices (and manufacturers) that would present the most serious risks to patients if they experienced a Y2K-related failure. This will help the agency focus attention on the devices that could present the highest levels of risk.
These potentially high-risk devices are those that are:
• used in the direct treatment of a patient where device failure could compromise the treatment or could injure the patient;
• used in the monitoring of vital patient parameters and contain data that are immediately necessary for effective treatment;
• necessary to support or sustain life during treatment or patient care.
The list does not include diagnostic devices which failures would not result in immediate harm to the patient, even though the diagnostic information they provide might be unavailable or incorrect. However, a few diagnostic devices have been included, if the results of calculations or other information processing by the device would not be readily apparent to the user, and a Y2K failure of the device could reasonably lead to serious adverse health consequences before being detected by the user.
This list should not be considered definitive of all high-risk devices. It may change as the FDA receives comments on the types of devices included in the list.
Device list
Where the generic device type has been classified by FDA, the list includes the section number in Title 21 of the Code of Federal Regulations where the device type is described. For those devices cleared for market through the Premarket Approval application process or which have not yet been classified, no classification regulation number is given.
Classified devices
(Classification regulation number followed by classification name)
• 862.1345 glucose test system
• 862.2140 centrifugal chemistry analyzer for clinical use
• 862.2150 continuous flow sequential multiple chemistry analyzer for clinical use
• 862.2160 discrete photometric chemistry analyzer for clinical use
• 862.2170 micro chemistry analyzer for clinical use
• 868.1150 indwelling blood carbon dioxide partial pressure (pco2) analyzer
• 868.1200 indwelling blood oxygen partial pressure (Po2) analyzer
• 868.1730 oxygen-uptake computer
• 868.2375 breathing frequency monitor
• 868.2450 lung water monitor
• 868.5160 gas machine for anesthesia or analgesia
• 868.5330 breathing gas mixer
• 868.5400 electroanesthesia apparatus
• 868.5440 portable oxygen generator
• 868.5470 hyperbaric chamber
• 868.5610 membrane lung (for long-term pulmonary support)
• 868.5830 autotransfusion apparatus
• 868.5880 anesthetic vaporizer
• 868.5895 continuous ventilator
• 868.5925 powered emergency ventilator
• 868.5935 external negative pressure ventilator
• 868.5955 intermittent mandatory ventilation attachment
• 870.1025 arrhythmia detector and alarm
• 870.1750 external programmable pacemaker pulse generator
• 870.3535 intra-aortic balloon and control system
• 870.3545 ventricular bypass (assist) device
• 870.3600 external pacemaker pulse generator
• 870.3610 implantable pacemaker pulse generator
• 870.3700 pacemaker programmers
• 870.4220 cardiopulmonary bypass heart-lung machine console
• 870.4320 cardiopulmonary bypass pulsatile flow generator
• 870.4330 cardiopulmonary bypass on-line blood gas monitor
• 870.4360 nonroller-type cardiopulmonary bypass blood pump
• 870.4370 roller type cardiopulmonary bypass blood pump
• 870.4380 cardiopulmonary bypass pump speed control
• 870.5225 external counter-pulsating device
• 870.5300 dc-defibrillator low energy (including paddles)
• 876.5270 implanted electrical urinary continence device
• 876.5630 peritoneal dialysis system and accessories
• 876.5820 hemodialysis systems and accessories
• 876.5860 high permeability hemodialysis system
• 876.5870 sorbent hemoperfusion system
• 876.5880 isolated kidney perfusion and transport system and accessories
• 880.5130 infant radiant warmer
• 880.5400 neonatal incubator
• 880.5410 neonatal transport incubator
• 880.5725 infusion pump
• 882.5820 implanted cerebellar stimulator
• 882.5830 implanted diaphragmatic/phrenic nerve stimulator
• 882.5840 implanted intracerebral/subcortical stimulator for pain relief
• 882.5850 implanted spinal cord stimulator for bladder evacuation
• 882.5860 implanted neuromuscular stimulator
• 882.5870 implanted peripheral nerve stimulator for pain relief
• 882.5880 implanted spinal cord stimulator for pain relief
• 884.1700 hysteroscopic insufflator
• 884.1730 laparoscopic insufflator
• 884.2660 fetal ultrasonic monitor and accessories
The following device classifications include radiation treatment planning systems that are accessories to these device types:
• 892.5050 medical charged-particle radiation therapy system
• 892.5300 medical neutron radiation therapy system
• 892.5700 remote controlled radionuclide-applicator system
• 892.5750 radionuclide radiation therapy system
• 892.5900 X-ray radiation therapy system
The following include post-medical device amendments Class III devices and devices not yet classified:
• ventilator, high frequency
• cardioconverter, implantable
• defibrillator, automatic implantable cardioverter
• defibrillator, implantable, dual chamber
• pulse-generator, dual chamber, implantable
• pulse-generator, program module
• pulse-generator, single chamber, sensor driven, implantable
• pulse-generator, single chamber
• system, pacing, temporary, acute, internal atrial defibrillation
• automated blood cell and plasma separator for therapeutic purposes
• lipoprotein, low density, removal
• separator for therapeutic purposes, membrane automated blood cell/plasma
• pump, drug administration, closed loop
• pump, infusion, implanted, programmable
• kit, test, alpha-fetoprotein for neural tube defects
• stimulator, cortical, implanted (for pain)
• stimulator, electrical, implanted, for parkinsonian tremor
• stimulator, sacral nerve, implanted
• stimulator, spinal-cord, totally implanted for pain relief
• stimulator, subcortical, implanted for epilepsy
• device, thermal ablation, endometrial
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