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COMPUTING

FDA: Y2K readiness for hundreds of medical devices unknown

May 27, 1999
Web posted at: 3:58 p.m. EDT (1958 GMT)

by Orlando de Bruce

From...
Federal Computer Week

y2k graphic

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(IDG) -- Food and Drug Administration officials told House subcommittees that more than 300 medical manufacturers have equipment on the market that could experience failures from Year 2000 computer problems.

William Hubbard, acting deputy commissioner for policy at the FDA, and Thomas Shope, the FDA's special assistant to the director, testified during a joint hearing of the House's Health and Environment and Oversight and Investigations subcommittees.

Hubbard and Shope said more than 800 medical devices produced by the manufacturers are date-sensitive or embedded with chips and could malfunction because the chips cannot properly process dates after 2000. About 2,000 manufacturers sell medical devices that are date-sensitive. About 200 manufacturers have yet to contact the FDA about whether the medical devices they make are Year 2000-compliant.

Joel Willemssen, director of the Civil Agencies Information Systems Accounting and Information Management Division of the General Accounting Office, 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.

FDA officials say manufacturers are working with the agency to bring equipment up to compliance and are confident that they will have the devices operational by Jan. 1, 2000. Shope and Hubbard said FDA will use its World Wide Web site, www.fda.gov, to inform providers that the equipment must be compliant.

Willemssen said the FDA needs to be more aggressive when notifying providers about flawed equipment. Willemssen said some providers do not realize that 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," Willemssen said.


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