The Food and Drug Administration has begun a final tally of computer-controlled biomedical devices that are unable to compute the year 2000 and as a result could harm patients.
The FDA ultimately could exercise its authority to rid the healthcare market of flawed devices before year-end, said Kevin Thurm, HHS deputy secretary, in testimony last week before a special U.S. Senate panel.
A preliminary list of about 70 categories of "potentially high-risk devices" was expected to be ready today, a spokesman for Thurm said.
The FDA will identify the manufacturers of devices in each of the categories and determine by Oct. 1 whether manufacturers' plans to correct flaws or remove problem products from service are adequate to ensure public safety, Thurm said. Continuing problems could be deemed health hazards, leading to actions ranging from public advisories and voluntary recalls to mandatory recalls and, in extreme cases, seizures of devices, the HHS spokesman said.