Y2K: Device Manufacturers Not as Ready as they Claimed
The General Accounting Office's Joel Willemssen yesterday told the Senate Special Committee on the Year 2000 Problem that his agency had turned up 4,445 medical devices that were not Y2K- compliant, "nearly five times greater than" the number manufacturers reported to the FDA. Willemssen said the majority "of the problems with equipment ... involved incorrect date readings that would not directly threaten patient health," but that devices "could pose a risk" if used for certain purposes, such as blood sugar levels calculations (Landers, Dallas Morning News, 6/11). He added that his agency has developed a list of about 70 "computer controlled potentially high-risk devices," including a "ventilator, infusion pump, glucose test system and fetal cardiac monitor and radiation therapy simulation system." HHS Deputy Secretary Kevin Thurm told the committee, co-chaired by Sens. Christopher Dodd (D-CT) and Robert Bennett (R-UT), 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."
90 Day Limit
In related news, the Senate is expected to vote Tuesday on a measure giving companies 90 days to fix computer problems before consumers may file Y2K-related suits, among other restrictions (Abrams, AP/Boston Globe, 6/11).
Also testifying before the Y2K committee, Utah-based Rural Health Management Corp. President Mark Stoddard said that financially strapped hospitals, especially those in rural areas, have few resources to devote to the Y2K problem. He said, "A patient thermometer isn't too terribly expensive, but a CT scanner is, and having to replace equipment of that magnitude can take a rural hospital's entire capital budget for several years." Bennett said he would introduce a bill to provide $50 million in funding to help rural hospitals reach compliance. And from the Lone Star State, Dallas attorney Anthony Vitullo testified on a survey commissioned by his law firm that found "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." Texas Hospital Association spokesperson Amanda Engler countered, "Some of the rural hospitals are pretty far along, and some started later. They're all focused on fixing their mission-critical, life-and-death issues first. Everyone's prepared for irritating, minor problems" (Morning News, 6/11).