Y2K Update
FDA releases Y2K list of critical medical devices
Pay special attention to these items before Jan. 1
The Food and Drug Administration (FDA) recently published a list of computer-controlled medical devices that have the potential for the most serious consequences for patients should they fail because of year 2000 (Y2K) date-related problems. The FDA notes that if a device is included on its list, that does not necessarily mean the device has a problem or poses more than a potential risk. Equipment on the list is:
• 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 whose data are immediately necessary for effective treatment;
• necessary to support or sustain life during treatment or patient care.
The FDA’s list does not include more than a few diagnostic devices because their failure would not result in immediate harm. However, the diagnostic information they provide might be unavailable or incorrect in the case of Y2K noncompliance. The few diagnostic devices that have been included would display information whose inaccuracy 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.
Where the generic device type has been classified by the FDA, the list includes the section number in Title 21 of the Code of Federal Regulations where the device type is described. That information can be found at the FDA Web site (www.fda. gov/cdrh/yr2000/classification.html). That site also includes links to the Federal Y2K Biomedical Equipment Clearinghouse Search (www.fda.gov/ scripts/cdrh/year2000/y2k_search.cfm), where you can determine the compliance status of medical devices as reported by the manufacturers. An additional link is provided to the Manufacturer Registration Database (www.fda.gov/scripts/ cdrh/cfdocs/cfrl/registra/search.cfm), which contains names and addresses of manufacturers who have registered with the FDA.
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
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