HCFA: More work needed to avert Y2K problems
As the world marches toward the new millennium, questions still exist over whether the health care sector will be affected by the Y2K bug. A new report released in July by the General Accounting Office (GAO) looked at vital services, including health care, and concluded that work still needs to be done if Americans expect uninterrupted services.
As of the beginning of June, 4,142 biomedical companies have submitted data to the Department Health and Human Services (HHS) clearinghouse. About 61% of these manufacturers reported having products that do not employ dates and about 8% (311 manufacturers) reported having date-related problems such as an incorrect display of date/time. According to the Food and Drug Administration (FDA), the 311 manufacturers reported 897 products with date-related problems.
Despite the small percentage of manufacturers who reported problems, information about these problems have been difficult to obtain, the report said. "Not all compliance information was available on the clearinghouse because the clearinghouse referred the user to 427 manufacturers’ Web sites."
The GAO reviewed the Web sites and found a total of 35,446 products. Of these products, 18,466 were reported as not employing a date; 11,211 were reported as compliant; 4,445 were shown as noncompliant; and the compliance status of 1,324 was unknown.
The GAO has also criticized HHS for not independently verifying manufacturers’ compliance claims. HHS originally balked at the idea of reviewing manufacturers’ results, claiming the task would take too much time and would be too expensive. The GAO report said the FDA, a component agency of HHS, announced in May that it planned to develop a list of critical care/life support medical devices and the manufacturers of these devices. From this list, the FDA will select a sample of manufacturers for review, and hire a contractor to develop a program to assess manufacturers’ activities to identify and correct problems.
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