FDA: Thousands of health devices not Y2K-ready

The Food and Drug Administration's top science and technology adviser last week warned members of a congressional subcommittee that tens of thousands of biomedical devices remain at risk of failure because of Year 2000 problems, and manufacturers and health care providers lack detailed information on critical life-support systems currently in use.

Testifying before the House Health and Environment Subcommittee, Thomas Shope, special assistant to the director in the FDA's Office of Science and Technology, told lawmakers that the FDA identified 4,053 biomedical products from 214 manufacturers that are not Year 2000-compliant and are considered potentially high-risk devices. Included on the FDA's list were heart ventricular assist devices, cardiopulmonary bypass consoles, heart defibrillators, fetal ultrasonic monitors, neonatal incubators and dozens of other critical health care devices.

Shope's testimony comes just weeks after an internal Pentagon study uncovered that the Defense Department sold or donated hundreds of thousands of medical devices to various hospitals and public-health institutions that were considered at high-risk of Year 2000 failures [FCW, Oct. 4].

Date miscalculations caused by Year 2000 glitches that take place in either external or internal systems supporting these devices could cause failures ranging from "the more benign, such as incorrect formatting of a printout...to the most serious—incorrect operation of equipment with the potential to decrease patient safety," Shope said in a prepared statement.

The FDA study identified 90 products that are controlled by computers and pose a potentially high-risk to patients. "These medical devices are characterized by their potential for immediate and serious adverse health consequences for a patient if they fail to function as designed or expected, including a failure to initiate or continue operation," Shope said.

However, the FDA also concluded that the manufacturers of these devices are not providing the health care community enough information on the Year 2000 status of their products. One manufacturer reported that its products had no Year 2000-related issues but failed to identify its products, Shope said. Another manufacturer listed 65,000 different products on its World Wide Web site but did not offer users any way to find the high-risk medical devices.

Shope also told the committee that many health care providers nationwide are not aware of the FDA's online Year 2000 clearinghouse, which provides up-to-date Year 2000 status information on thousands of devices. A survey by the American Medical Association of its 7,000 members indicated that only 17 percent of respondents were actively using the FDA clearinghouse site. In addition, less than one-half of all the nursing homes, physicians and home health agencies surveyed by the FDA said they were aware of the online database.

"Although compliance information on biomedical equipment is available through FDA's clearinghouse, the Y2K readiness status of equipment at health care providers' offices is not known because a significant number of providers did not respond to the surveys," Shope said.

Vendors and users can get more information and search search for the statusof various biomedical products by visiting FDA's Federal Y2K BiomedicalClearinghouse on the Web at www.fda.gov/cdrh/yr2000/year2000.html