FDA turns up Y2K heat on medical device firms
FDA turns up Y2K heat on medical device firms
By DON LONG
Healthcare InfoTech Managing Editor
The Food and Drug Administration keeps turning up the heat on medical manufacturers suspected of failing to be Y2K-compliant.
Though the agency said at the beginning of the month that it was only planning to audit the manufacturing practices of selected medical device manufacturers, it now says that it could seize devices it believes will fail on Jan. 1, 2000.
Late last week, Kevin Thurm, deputy secretary of Health and Human Services, reported that the FDA believes as many as 200 medical device manufacturers have produced non-compliant products. He told members of the Senate Special Committee on the Year 2000 Technology Problem that the devices these companies make will not create serious problems, but "are more likely to disrupt" patient care.
Thurm repeated the agency’s pledge to create a list of the devices in this category. That list could be extremely long, however, since an official of the General Accounting Office (GAO; Washington) has reported that more than 4,000 devices could fail a Y2K test.
Thurm said that FDA remedial action could range from going public with its warning advisories to manufacturers to "mandatory recalls, or seizure of the non-compliant devices in extreme risk situations."
Whether the FDA will be able to carry out this threat and, if so, to what extent is fairly problematic. The agency has repeatedly said it does not have the resources to do much device testing, and even the proposed audit will require additional funding. Thus, following through on a large number of recalls or seizures would push the limits of the agency’s resources.
Thurm noted that the FDA also is awaiting the results of a survey of pharmaceutical companies regarding their Y2K compliance status. But he said that the agency "has processes in place to address product availability and has used these procedures to help get necessary products to patients."
Thurm also reported that, as of March 31, all of the Health Care Financing Administration’s (HCFA; Baltimore, MD) internal systems were certified as compliant. But he could not offer the same assurance for HCFA’s providers, such as physicians offices and skilled nursing facilities, and only 22% of Medicare HMOs are ready thus far.
While the FDA may be turning up the heat on the medical device industry, the U.S. Senate earlier this week attempted to turn down the Y2K heat on the high-tech industry in general.
On Tuesday, it approved a bill touted as an attempt to prevent frivolous liability lawsuits in the wake of Y2K failures. That legislation would give companies a 90-day period to fix computer problems before lawsuits can be filed, encourage mediation, make it harder to file class action lawsuits and cap punitive damages that small businesses must pay.
Senate approval of that action, however, does not ward off a threatened veto by President Bill Clinton, who has said the legislation would not protect consumers and small businesses with valid legal claims. Another problem is that the Senate bill needs to be reconciled with a different version of a bill recently passed by the House.
Many of these problems could happen more often in rural areas, according to Mark Stoodard, president of the Utah-based Rural Health Management Corp. In testimony before the Y2K committee, he said that hospitals in rural areas most often are the ones lacking the financial resources to correct Y2K problems.
"A patient thermometer isn’t too terribly expensive," he said, "but a CT [computed tomography] scanner is, and having to replace equipment of that magnitude can take a rural hospital’s entire capital budget for several years."
That observation was supported by the testimony of Anthony Vitullo, a Dallas attorney who said that a survey commissioned by his firm found that "one-third of all Texas hospitals already have encountered date-sensitive problems and that only 21% are fully compliant." He said, "There’s going to be a big problem with these Texas rural hospitals. They’re just not going to make it."
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