FDA publishes list of Y2K high-risk medical equipment
Do your facility’s critical devices check out?
Bracing for the effects of the Y2K computer bug on health care organizations, the Food and Drug Administration (FDA) has developed a list of types of computer-controlled, high-risk medical devices that could result in "potentially serious consequences for the patient" should they fail because of date-related problems.
The agency notes that just because a device type is included on the list doesn’t mean that all such devices are necessarily Y2K noncompliant. The FDA says it will use the list to identify devices and manufacturers that would present the most serious risks to patients if they experienced a Y2K-related failure.
The list includes three types of devices:
• those used in the direct treatment of a patient where device failure could compromise the treatment or could injure the patient;
• those used in the monitoring of vital patient parameters and whose data are immediately necessary for effective treatment;
• those necessary to support or sustain life during treatment or patient care.
The list does not include diagnostic devices the failure of which would not result in immediate harm to the patient, even though the diagnostic information they provide might be unavailable or incorrect.
The list below contains the potentially high-risk device types. 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.
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