FDA issues Y2K problem list
Recent surveys of health care organizations indicate that most think they will be ready for any potential problems related to the year 2000 (Y2K) computer bug. But according to the Food and Drug Administration (FDA), some biomedical equipment you may have may not work — or may not 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 Classified Devices, inserted in this issue) is very comprehensive, and the FDA notes that inclusion on the list doesn’t mean that the device has a problem, or if they are not Y2K non-compliant, that they might pose a risk to patients. For most home care agencies, the infusion and IV therapy equipment will be of the most concern. The FDA plans to use the list to audit manufacture claims of compliance and later issue a list of non-compliant devices.
The equipment 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; are used in the monitoring of vital patient parameters and whose data are immediately necessary for effective treatment; or is necessary to support or sustain life during treatment or patient care.
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 Premarket Approval application process or which 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.
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