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Official downplays prospects of device seizures
The federal Food and Drug Administration (FDA) in Rockville, MD, may be using a contractor to review manufacturers’ year 2000 (Y2K) test results, but don’t expect it to begin seizing problematic medical devices.
On May 25, 1999, the FDA’s acting deputy commissioner for policy testified that the FDA plans to hire a contractor to conduct an on-site review of manufacturers’ test results supporting their compliance certifications for a sample of critical devices. This was a reversal of earlier statements made by the FDA, stating it didn’t have the resources to conduct such reviews.
A few weeks later, Kevin Thurm, deputy secretary of the Department of Health and Human Services in Washington, DC, told members of the Senate Special Committee on the Year 2000 Technology Problem that the FDA might "issue public warnings or suggest voluntary recalls" of devices that the agency believes will malfunction on Jan. 1, 2000, and might even seize dangerous devices in "extreme cases."
The threshold for a seizure is high, however, says Tom Shope, special assistant to the director of the office of science and technology at the FDA. "[Thurm] was enumerating the list of authorities that FDA has to operate under. If there is a device that presents an unreasonable risk to public health, the FDA can seize it. [But] we don’t know of many products that by virtue of the Y2K problem will present that kind of risk to patients." More likely, the FDA would encourage the manufacturer to do a voluntary recall, he adds.
Through the audits, the FDA is attempting to develop some additional assurance that the manufacturers are following the kind of procedures that would indicate that they have assessed the devices correctly, Shope says. The audits are a voluntary activity with the manufacturer; the FDA will publicize overall results of the audits, but company-by-company results will remain confidential.
In addition to the audits, the FDA has published a list of potentially high-risk computer-controlled medical devices that have the potential for the most serious consequences for the patient should they fail because of date-related problems. (See list, at right.)
If the FDA finds products that have Y2K-compliance problems, it plans to take action, Shope says. "We would expect the manufacturer to take the appropriate steps to notify customers, and if needed, the FDA would certainly publicize the issue as well."
The possible recall or even seizure of medical devices puts additional pressure on the vendors and hospitals that haven’t completed a significant amount of compliance testing, says David Hall, senior consultant at ACS Technology Solutions in Oak Brook, IL.
Some have no idea if they have problems
"I’m still finding medical centers and some equipment vendors that haven’t done much to figure out whether they have a [Y2K] problem," he says. If the FDA announces a problem with a certain medical device, they are under the gun to make sure the one they have works.
At this time, however, the FDA says it has found no indications that the manufacturers haven’t done a good job of assessing their products, Shope says. "We don’t know of any verifiable incidences that manufacturers have not identified problem products appropriately."
(Editor’s note: The FDA offers a Federal Year 2000 Biomedical Equipment Clearinghouse database that provides the general public, government agencies, and the health care and research communities information on the Y2K-compliance status of biomedical equipment. The database can be found on the Internet at www.fda.gov/cdrh/yr2000/ year2000.html.
For more Y2K-compliance information, the General Accounting Office in Washington, DC, also recommends that providers check manufacturers’ Web sites, although the quality of the data varies significantly from site to site.)