FDA: medical devices still at risk for Y2K

Food and Drug Administration officials last week told House subcommittees that more than 300 medical manufacturers have equipment on the market that could experience failures from Year 2000 computer problems, and another 200 manufacturers have yet to report if their equipment is Year 2000-compliant.

William Hubbard, acting deputy commissioner for policy at the FDA, and Thomas Shope, the FDA's special assistant to the director, said at a joint subcommittee hearing that more than 800 medical devices produced by the manufacturers are date-sensitive or have embedded chips that could malfunction because the chips cannot properly process dates after 2000.

About 2,000 manufacturers sell medical devices that are date-sensitive, Hubbard and Shope told the House's Health and Environment and Oversight and Investigations subcommittees.

About 200 manufacturers have yet to contact the FDA about whether the medical devices they make are Year 2000-compliant. Hubbard said it is possible that the 200 manufacturers did not respond to the FDA's letters because they have either gone out of business or are based in another country. Hubbard said the FDA will conduct an investigation to determine whether the 200 even need to respond. "We're not giving up on those 200," Hubbard said.

Joel Willemssen, director of the Civil Agencies Information Systems Accounting and Information Management Division of the General Accounting Office, encouraged the FDA to publicize the list of the 200 manufacturers that have not responded to alert providers who may use equipment from those companies.

Willemssen warned House members that the number of high-risk medical devices will increase because some manufacturers have more than one piece of equipment that could fail.

The impact of Year 2000 failures in medical equipment such as imaging and ultrasound devices could be deadly. Willemssen recommended that the FDA conduct independent testing and validation to ensure health care providers that equipment is safe.

Williamssen said some hospital officials have said they have received high-risk equipment from manufacturers that was marked Year 2000-compliant but still malfunctioned.

"FDA should look at outside resources to help them test the high-risk equipment to make certain that it is in fact Year 2000-compliant," he said.

FDA officials said most manufacturers are working with the agency to make equipment compliant and are confident that they will have the devices operational by Jan. 1, 2000.

Shope and Hubbard said the FDA will use its World Wide Web site, www.fda.gov, to inform health care providers that the equipment must be compliant.

Willemssen said the FDA needs to be more aggressive when notifying health care providers about flawed equipment because some do not realize that the FDA is posting the information on its Web site. "We need to make it clear to the public what we know and what we don't know, to reduce potential panic," he said.

Based on a GAO suggestion to conduct an independent certification, Hubbard said the FDA plans to test 60 high-risk pieces of equipment to assess if manufacturers are doing a thorough job.

"We have a high confidence level that there is not a problem, but that's not to say perhaps we can't do more," Hubbard said. "GAO says take it a step further and go into the firms and do an audit."

Rep. Sherrod Brown (D-Ohio) said Congress will look into providing the FDA with more funding for its Year 2000 efforts.


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