Thousands of health devices not Y2K-ready

The original Oct. 25 World Wide Web story should not have attributed any information to Thomas Shope, special assistant to the director at the Food and Drug Administration's Office of Science and Technology. The mistake occurred because the House Commerce Committee inadvertently posted on its Web site a statement by Joel Willemssen, director of the General Accounting Office's Civil Agencies Information Systems, Accounting and Management Division, under a link bearing Shope's name. The committee has since corrected its site.

The statement of Joel C. Willemssen as submitted for the record

The statement of William Hubbard, FDA's senior associate commissionerfor Policy, Planning and Legislation, as submitted for the record

The General Accounting Office last week warned members of a congressional subcommittee that tens of thousands of biomedical devices remain at risk for failure because of Year 2000 problems, and manufacturers and health care providers lack detailed information on critical life-support systems currently in use.

In a written statement submitted to the House Health and Environment Subcommittee, Joel Willemssen, director of GAO's Civil Agencies Information Systems, Accounting and Management Division, told lawmakers that GAO investigators identified 4,053 biomedical products from 214 manufacturers that are not Year 2000-compliant and therefore pose a risk to users.

Responsibility for the oversight and regulation of medical devices, including the impact of the Y2K problem, lies with the Food and Drug Administration, according to Willemssen. Since 1998, FDA has provided information collected from medical device and scientific and research instrument manufacturers through its Federal Y2K Biomedical Equipment Clearinghouse. However, the number of noncompliant devices identified by GAO is approximately four times the number reported by FDA through its clearinghouse, Willemssen said in a written statement.

Examples of noncompliant devices identified by GAO included heart ventricular assist devices, cardiopulmonary bypass consoles, heart defibrillators, fetal ultrasonic monitors, neonatal incubators and dozens of other critical health care devices. For at least 127 manufacturers of these devices, GAO was unable to determine the availability of Y2K solutions, according to Willemssen's statement.

Willemssen'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 hospitals and public-health institutions that were considered high-risk for Year 2000 failures. 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," Willemssen said in a prepared statement.

According to Willemssen, the FDA has identified 90 products that are controlled by computers and that could put patients at risk. "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," Willemssen's statement read.

However, GAO 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 problems but failed to identify its products, according to Willemssen's prepared remarks. Another manufacturer listed 65,000 different products on its World Wide Web site but did not offer users any way to find its high-risk medical devices.

Willemssen's prepared remarks also indicate 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 actively use 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," Willemssen wrote.

In a letter to FCW, Thomas Shope, special assistant to the director in the FDA's Office of Science and Technology, said the FDA has not come to the same conclusions regarding the response by manufacturers. "To the contrary, we think the industry has responded well to the Y2K issue and provided the needed information," Shope wrote. "A comprehensive statement by a manufacturer that all products had no date-related issues was adequate and sufficient information. Our public database, in fact, has been designed to accept and provide exactly that type of information from manufacturers of devices. There is no need to identify specific products in such a case, although FDA has encouraged device manufacturers to provide specific information about compliant products."

Shope also said the FDA database currently lists more than 7,000 devices as Y2K-compliant.According to Willemssen's prepared testimony, however, "it is not clear at this time how extensively health care providers are using this information to determine their Y2K readiness."

Vendors and users can get more information and search for the status of biomedical products by visiting FDA's Federal Y2K Biomedical Clearinghouse at www.fda.gov/cdrh/yr2000/year2000.html.