Y2K: FDA lists devices with high-risk potential
Date-sensitive items pose particular hazards
The Food and Drug Administration (FDA) has compiled a list of computer-controlled devices that would endanger patients should they fail because of date-related problems. The list of approximately 80 devices is subject to periodic updates. The agency notes that inclusion of a type of device on the list does not mean that all devices of this type are Y2K-noncompliant.
The FDA list includes the types of computer-controlled devices whose failure to function as designed or expected could cause immediate or serious health consequences. The three categories of items are:
1. used in the direct treatment of a patient where device failure could compromise the treatment or could injure the patient;
2. used in monitoring vital patient param- eters whose data are immediately necessary for effective treatment;
3. necessary to support or sustain life during treatment or care.
Here are a few examples of items from the list as it stood at press time:
• lung water monitor;
• portable oxygen generator;
• continuous ventilator;
• arrhythmia detector and alarm;
• pacemaker programmers;
• neonatal incubator.
The FDA has published the list both as a guide to health care facilities and for the agency’s use in identifying manufacturers who will be candidates for FDA oversight. The agency will ascertain whether the manufacturers have made available to users Y2K information on equipment status and remedial measures.
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