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What about your critical medical devices?
Recent surveys of hospitals and medical groups indicate that most think they will be ready for any potential problems related to the year 2000 (Y2K) computer bug. One recent poll by the American Medical Group Association of Alexandria, VA, found that more than 95% of its respondents have discussed Y2K; more than 90% had a strategy for dealing with potential problems associated with Y2K; and 86% had a contingency plan in development.
But according to the Food and Drug Admini-stration (FDA), some biomedical equipment you may have might not work — or work correctly — come Jan. 1.
To help the medical community deal with the problem, the FDA has developed a list of types of computer-controlled, potentially high-risk medical devices that have the potential for the most serious consequences for the patient should they fail because of date-related problems.
The list (see p. 92) is very comprehensive, and the FDA notes that inclusion on the list doesn’t mean that the device has a problem, or are not Y2K-compliant, that they pose a risk to patients. The administration plans to use the list to audit manufacturer claims of compliance and later issue a list of non-compliant devices.
The equipment included in this list includes items 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 whose data are immediately necessary for effective treatment;
• are necessary to support or sustain life during treatment or patient care.
The list does not include diagnostic devices whose failure 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 if a Y2K failure of the device could reasonably lead to serious adverse health consequences before being detected by the user.
The list below contains the potentially high-risk device types. 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. For those devices cleared for market through the pre-market approval application process or have not yet been classified, no classification regulation number is given.
The Web site also includes links to the Federal Y2K Biomedical Equipment Clearinghouse Search — www.fda.gov/scripts/cdrh/year2000/y2k_ search.cfm — to 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.