FDA issues list of medical devices facing Y2K risk
Several devices listed are found in ICUs
The U.S. Food and Drug Administration (FDA) has issued a list of potentially high-risk computer-controlled medical devices used in hospitals that pose the most serious consequences for patients if they should fail due to year 2000 (Y2K) date-related problems.
The list includes many devices commonly used in critical care units for patient monitoring or to support or sustain life during treatment, the Rockville, MD-based FDA stated. The more than 100 devices listed by the FDA include oxygen uptake computers, breathing frequency monitors, arrhythmia detectors and alarms, intra-aortic balloon control systems, and neonatal incubators.
In a statement, the FDA noted that the absence of any device on the list doesn’t necessarily mean that the device is immune to Y2K-associated failures. Conversely, inclusion on the list doesn’t mean that all devices of that type will have a date-related problem or that they pose a significant patient risk.
However, the list excludes diagnostic devices that would pose immediate harm to patients in a Y2K failure. The agency says it produced the list to serve as a guide for hospitals in making proper Y2K assessments.
The agency says it is also working with device manufacturers "to provide increased assurance that product’s Y2K status has been carefully assessed and that upgrades have been developed and tested" in compliance with regulations.
However, the FDA recently stated that it could not review the compliance levels of all manufacturers’ devices, and plans to review only a representative sample of devices currently in use.
The device list comes in the aftermath of a congressional report criticizing the lack of Y2K readiness by the health care industry and warned of "significant potential for harm" to patients.
For months, nursing leaders have urged that nurses, including unit managers, play an active role in assessing the Y2K-compliance readiness of their unit’s equipment.
"Don’t put yourself in the position of being the one held responsible by the hospital if and when something goes wrong," warns Sally Raphel, RN, MS, director of nursing practice for the American Nurses Association in Washington, DC.
ICUs are particularly at risk of Y2K complications due to patients’ severity of illnesses and the technical complexity of their life-sustaining devices.
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