January 13, 1999

Dear Biomedical Equipment Manufacturer:

I am writing to alert you that we are planning to expand the product information located at the FDA-operated Year 2000 web site, and to ask for your continuing cooperation in this effort. We are making these changes as a result of feedback from biomedical equipment users regarding the utility of this site, now formally known as the Federal Y2K Biomedical Equipment Clearinghouse. As you may know from my previous correspondence, this site is intended to provide users with comprehensive and up-to-date information on products which may have Year 2000 compliance problems. Last year, manufacturers of biomedical equipment responded readily on our calls for assessment of and reports on problem products. This has produced what we believe to be an excellent starting point for biomedical equipment users in assessing their inventory.

During early 1999, we will be expanding the Y2K Clearinghouse in two basic areas:

1. Year 2000 Non-Compliant Products

   To better meet the need for detailed product information requested by biomedical equipment users, manufacturers will be asked to provide more detailed identification of non-compliant products, as well as more detailed descriptions of how products will operate as a result of their uncorrected date problem.

2. Year 2000 Compliant Products

   Many biomedical equipment users have told us that they need specific information on all compliant products located at one data site to meet their need to affirmatively inventory their compliant equipment. Accordingly, we will be asking manufacturers to submit lists of their specific product models that are Year 2000 compliant. In order for us to provide this information at one site, we are requesting that compliant product information be furnished to the Y2K Clearinghouse even if the manufacturer maintains this information on another web site.

Presently, we are working with our contractor to develop display specifications for the web site and a uniform data submission method. By late February 1999, you will receive a follow-up letter detailing the additional product status information we would like you to submit for all electronic products that are Year 2000 compliant. Those who have not yet responded to our previous requests, or have previously reported Year 2000 non-compliant products, will receive an additional letter detailing the product and date-related problem information needed to upgrade the web site for non-compliant products.

I urge you to work with us on this project. Your participation can help assure that users of your products have the information they need for the safe delivery of patient care as we approach the year 2000.

Back to Year 2000 Home Page

(Uploaded January 13, 1999)