Dodd Faults Firms' Year 2000 Reports
By Stephen Barr
In a stern rebuke to manufacturers of medical devices, Sen. Christopher J. Dodd (D-Conn.) yesterday disclosed the names of companies that have not said whether their products are free of Year 2000 computer defects.
Dodd, who serves on a special Senate committee assessing potential threats caused by the so-called millennium bug, said the medical device industry has an "unacceptable" low response rate to letters sent by the Food and Drug Administration seeking Year 2000 data.
Because of the slow response, Dodd said he would submit a list of manufacturers that have not replied to the FDA for publication in the Congressional Record "for all Americans to see. . . . It is also my hope that this will serve as a wake-up call to other industries."
Some lawmakers and Clinton administration officials have expressed concern over the last few months about the lack of information from companies about the risks they face because of the computer problem, known as Y2K. At a July Senate hearing, Dodd and Sen. Robert F. Bennett (R-Utah) expressed frustration with the slow pace of notification to patients, doctors and hospitals on what types of medical devices might malfunction on Jan. 1, 2000.
There have been no predictions that patients will die because of the Y2K glitch, but some federal officials fear some devices, such as heart monitors and blood pumps, might not work as intended and pose a hazard to patient care.
The problem stems from the use in many computer systems of a two-digit dating system that assumes that 1 and 9 are the first two digits of the year. Without specialized reprogramming, the systems will recognize "00" not as 2000 but 1900, a glitch that could cause computer shutdowns or produce erroneous data.
Yesterday, Dodd said the FDA had identified 1,935 manufacturers of medical devices that might be vulnerable to Y2K problems but that only 755 had responded to a June FDA letter seeking information. This initial response rate "was indeed irresponsible," he said.
Dodd's lengthy list of companies included medical product firms in virtually every state and in some foreign countries.
But industry officials said the response rate is improving. More recent figures show 962 companies have responded to the FDA request for information -- a doubling of the number responding since the July hearing held by Bennett and Dodd.
Alan H. Magazine, the president of the Health Industry Manufacturers Association (HIMA), said Dodd's statements reflected "a genuine concern for patient safety, which we share. We think tremendous progress is being made toward getting companies to comply with FDA's requests."
Many companies do not release data until they complete all of their product assessments, while others have found it difficult to track down data because of corporate mergers, HIMA said.
"We also suspect it is taking time for company information to get onto the FDA list, so there may well be a backlog," Magazine said.
Dodd's scolding of the industry came on the same day the Veterans Affairs Department and the Health and Human Services Administration announced they will jointly establish an online database to provide doctors, hospitals and patients with timely Y2K information on biomedical equipment.
The new Federal Y2K Biomedical Clearinghouse, operated by the FDA, can be found at this Web address:
Data posted on the Internet site will be restricted to publicly releasable information provided directly by manufacturers, the VA said.
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