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12/22/1999

We're Y2K Ready, Says FDA

Cheryl A. Thompson

The Food and Drug Administration (FDA) announced last week it remains confident that pharmaceutical supplies and manufacturing are prepared to enter the new year without disruption and that no serious problems with medical devices are expected to result from Y2K problems.

Through its work this past year with a special alliance of pharmaceutical manufacturers, FDA reported that drug supplies are above normal levels. Patients concerned about their supplies of medications can be given the brochure "Preparing for the Year 2000 as it Relates to My Pharmaceutical Needs," available for downloading from http://www.fda.gov/cder/y2k/y2ka.pdf

FDA's Center for Devices and Radiological Health (CDRH) determined that most medical devices do not use computers and will not be greatly affected by Y2K computer glitches. Of those devices that are computerized, very few could be affected in a way that might be risky to patients, CDER said. Computer systems that contain patient records and other important data should also be assessed. 

Information from device manufacturers regarding the Y2K status of their products can also be found at FDA's Federal Y2K Biomedical Equipment Clearinghouse on the CDRH Web site, http://www.fda.gov/cdrh/yr2000/year2000.html. News about problems with computer-controlled medical devices can also be found at the site. To subscribe to the electronic mailing list that CDRH will use to distribute notices of unexpected Y2K-related problems with medical devices, send the message "subscribe dev-alert" to fdalists@archie.fda.gov

The FDA Emergency Operations Center, reachable at 301-443-1240 or 888-INFO-FDA, will have extra staff working during the initial days of the new year to deal quickly with any reported problems. This 24-hour center regularly receives emergency reports of food illness, medical device problems, and adverse drug effects. The online MedWatch application will not be available from December 23, 1999, through January 5, 2000. 

All deaths related to medical devices must be reported to FDA and the manufacturer. The agency said it wants reports of any date-related problem with a medical device, regardless of the consequence to the patient. 

FDA advised all health care facilities to have a contingency plan ready for the new year. For help in making such a plan, FDA suggested the following resources: 

After December 31, manufacturers can continue to sell medical devices with minor Y2K problems. FDA said buyers should ascertain that the devices are Y2K compliant. If not Y2K compliant, the devices should have labeling that prominently discloses the existence of the Y2K-related problem and explains how to safely use the device. 

The Department of Health and Human Services also reported last week that HCFA does not consider any state's Medicaid program to be at high risk of Y2K-related failure. Also, all Medicare managed care organizations have certified to HCFA that their computer programs will be Y2K-ready by the end of the year. 

Y2K Update–December 1999