US FDA/CDRH: Year 2000 Home Page

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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Report A Y2K Problem

See Reports of Y2K Problems

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Introduction

The "Y2K problem" concerned computers, computer chips and software that may not properly recognize or process dates after December 31, 1999. In addition there were certain other specific dates that may have been troublesome (such as February 29, 2000).

Some medical devices and scientific research instruments have computers, computer chips or software integrated into them. The vast majority of medical devices functioned without any potential health or operational problem after December 31, 1999. Some may have had a minor problem, such as displaying an incorrect indication for the year (for example, 00 instead of 2000), and these likely did not significantly affect a patient’s health. A very small number of medical devices encounterd a real problem because of the switch to the new millennium, unless they were corrected prior to being used after December 31, 1999.

This web site provided information and guidance to medical device manufacturers, healthcare providers, researchers, and the public. The site included a searchable list of biomedical equipment and their Y2K compliance status. "Compliance", in this case, means that the device will function 100% as intended, in that the date change will not adversely affect the device’s operation. The database allowed you to search for any specific item of biomedical equipment, and determine its compliance status, and the effect of a "non-compliance".