Information for Healthcare Facilities

Archived Information for Healthcare Facilities

February 23, 2000 - 10:00am EST - Update Regarding the 2000 Leap Year Transition Based on worldwide experience, FDA was not aware of any deaths or serious injuries resulting from the Y2K problem and medical devices during the rollover into the Year 2000. Every facet of the healthcare sector contributed to this outstanding outcome. With the approach of February 29, you should have been be prepared for the possibility of date-related problems associated with the leap year rollover. Because date-related problems could have occuedr on or after February 29, 2000, we reminded you to review your contingency plans and heighten your level of vigilance for possible problems during this time. You could check the Y2K (including leap year) status of computer-controlled devices by consulting FDA's Federal Y2K Biomedical Equipment Clearinghouse (Y2K Clearinghouse) at http://www.fda.gov/cdrh/yr2000/year2000.html. In addition, the Rx2000 Solutions Institute listed products with reported leap year problems on their web site at http://www.rx2000.org. Status of Federal Y2K Biomedical Equipment Clearinghouse The Y2K Clearinghouse is a database established to provide healthcare facilities and device users with information on the Y2K compliance status of biomedical equipment. The Clearinghouse contains information or manufacturer web-site links for Y2K non-compliant products, and information on specific product models that are Y2K compliant. After February 29, 2000, we will continue to make the Y2K Clearinghouse available on the World Wide Web; however, we will no longer update the information contained there. The existing links to manufacturer's web sites, which have been provided to FDA, will continue to be listed, but some device manufacturers may in the future remove Y2K product status information from their linked web sites. If Y2K information for a specific product is not available through the Y2K Clearinghouse, users should contact the device manufacturer directly.
Center for Devices and Radiological Health (CDRH)

	Computer-Controlled Potentially High-Risk Medical Devices (PHRD)
	Equipment Search
	FDA Medical Device Malfunction Advisory
	FDA Public Health Notifications
	FDA Talk Papers
	Frequently Asked Questions
	Guidance Documents
	Introduction to the Y2K Clearinghouse
	Press Releases
	User Facility Reporting Bulletin - Summer 1999
	Y2K and FDA - Preparing for the New Millennium "FDA Consumer Magazine", November-December 1999
	Y2K Meeting the Challenge - Year 2000 and Medical Devices
	Y2K Readiness Survey of Manufacturers of Essential Medical Supplies
	Zipped Copy of the Y2K Clearinghouse Database





Center for Drug Evaluation and Research (CDER)

	CDER Y2K Information



Health Care Financing Administration (HCFA)

	Y2K Home Page
	Y2K Preparations