VA and HHS Create Year 2000 Biomedical Equipment Clearinghouse

Washington, D.C. — The Departments of Veterans Affairs (VA) and Health and Human Services (HHS) are establishing an on-line database to provide health care providers and their patients with timely information about the potential impact of the Year 2000 date change on specific biomedical equipment.

“This clearinghouse will provide timely and easily obtainable information about medical devices that health care practitioners, medical treatment facilities and consumers may use and/or manage,” said VA Under Secretary for Health Dr. Kenneth W. Kizer.

Said HHS Deputy Secretary Kevin L. Thurm, “The clearinghouse is key to meeting government’s vital mission to provide much needed information and to help ensure patient health and safety.”

Under an interagency agreement, VA and HHS will establish the Federal Y2K Biomedical Clearinghouse as an on-line database on an Internet web site operated and maintained by the Food and Drug Administration (FDA). The web site address is http://www.fda.gov/cdrh/yr2000/year2000.html. Data included in the clearinghouse will be restricted to publicly releasable information provided directly by manufacturers to the members of the clearinghouse.

There are approximately 13,000 medical device manufacturers. The database will serve to identify which equipment is unaffected by the date change and which equipment have problems ranging from display of an incorrect date to device failure on Jan. 1, 2000.

The agreement calls for VA and HHS to serve as strategic partners of the clearinghouse, providing input and recommendation to technical partners FDA and the Veterans Health Administration, who are responsible for the design, development, implementation and maintenance of the clearinghouse.

Kizer and members of the National Patient Safety Partnership first called for the clearinghouse in a July 9 news conference. The partnership — a voluntary public-private group of health care organizations established to improve patient safety by reducing preventable adverse events and untoward outcomes of health care or health care related processes — held the news conference to increase consumer and manufacturer awareness of the need for appropriate measures to alleviate potential risks.

Over the past year, VA has led the way in identifying Year 2000 impact on biomedical equipment, having solicited data from 1,500 manufacturers of equipment used in VA health care facilities as many as four times and taking steps to ensure fixes are completed well before Jan. 1, 2000.

At the same time, FDA has operated a Year 2000 web site for biomedical equipment since March. So far, some 2,400 manufacturers have supplied Year 2000 information to the database.

“The new, expanded web site will be of immense benefit to our nation’s health care providers and consumers,” said acting FDA Commissioner Michael Friedman.