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