Introduction to the Y2K Clearinghouse

Introduction to the Y2K Clearinghouse

The Federal Y2K Biomedical Equipment Clearinghouse (Y2K Clearinghouse) has been established to provide information regarding the status or impact on product performance of the "Year 2000 Date Problem" for medical devices and scientific laboratory equipment (biomedical equipment). The information provided here, or the linked sites maintained by manufacturers, have been provided by the manufacturer of the product in response to the January 21, 1998, request from the Deputy Secretary of the Department of Health and Human Services.

Additionally, Y2K compliant product information has been provided by manufacturers in response to the March 29, 1999, request from the Acting Director of the Center for Devices and Radiological Health.

This information was requested on behalf of the Federal departments that purchase and use such products and that need to know whether such products are affected to plan remedial actions. Inclusion of information in the Y2K Clearinghouse indicates that the manufacturer has certified to the Food and Drug Administration that the data is complete and accurate. The Food and Drug Administration, however, cannot and does not make any independent assurances or guarantees as to the accuracy or completeness of this data.

The information is listed by manufacturer reporting the information and by product and model number. The solutions which the manufacturer has identified to be provided to mitigate the problems, including when assessments will be completed for products whose compliance status assessment is currently incomplete are indicated.

Data is posted to the Y2K Clearinghouse as it is received from the manufacturer. Because submission of data is voluntary, data is provided for those manufacturers who have reported. Abscence of any data for a manufacturer indicates that the manufacturer has not reponded. Abscence of data for a particular product for a manufacturer who has responded should be interpreted as an indication of compliance for all of the responding manufacturer's products which are not listed. Of course, there can be no assurance of the compliance status of any manufacturer who does not respond. For manufacturers whose assessments are incomplete, the data posted will be updated when additional information is received from the manufacturer.

Individuals or organizations with questions regarding the status of specific products should contact the manufacturer via the contact points listed. The Food and Drug Administration will not, in general, have information regarding specific products beyond that listed here. In addition, the FDA has not tested or evaluated the Year 2000 compliance status of products listed or not listed in the Y2K Clearinghouse.