FDA to audit medical devices for Y2K

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Better late then never I say.

http://dailynews.yahoo.com/headlines/hl/story.html?s=v/nm/19990526/hl/y7_1.html

WASHINGTON, May 26 (Reuters Health) -- To ensure that electronic medical devices will not malfunction in the year 2000 due to the Y2K computer ``bug,'' the Food and Drug Administration (FDA) is planning to audit the data of a sample of medical device manufacturers, FDA officials told a House hearing on Tuesday.

The agency is seeking funding to audit data of 60 manufacturers of ``high risk'' devices that could threaten patient health or safety if they malfunction on January 1, 2000, said William Hubbard, FDA Acting Deputy Commissioner for Policy in testimony before a joint hearing of the House Commerce Committee's subcommittee on Health and the Environment and Oversight and Investigations.

Previously, the FDA said it saw no need to verify the information on Y2K readiness provided by device makers, and officials said the agency lacked the resources to perform the checks in any case.

That stance was harshly attacked by the General Accounting Office (GAO), which said that some hospitals had tested devices posted on FDA's website as being Y2K ready, and found that they malfunctioned when dates were advanced to January 1, 2000.

``We continue to believe that organizations such as FDA can provide medical device users with a greater level of confidence that their equipment is Y2K compliant through independent reviews of manufacturers' compliance test results,'' testified Joel Willemssen, GAO's Y2K expert. Willemssen told the committee that FDA's proposed audit would satisfy his agency's concerns.

In his written testimony, however, the FDA's Hubbard continued to maintain that the potential medical device problem is not as serious as many have claimed.

``FDA believes that the information received to date confirmed our original expectation that the year 2000 problems with medical devices will not be significant or widespread if facilities take appropriate actions to address this issue,'' Hubbard said in his testimony.

``There will be specific problems that need correction; however, the current assessment is that they are much more likely to disrupt patient care rather than be of direct danger to patients.''

-- y2k dave (xsdaa111@hotmail.com), May 27, 1999

Answers

Too little, too late. They've been too busy attempting to curtail our right to take vitamins, etc.

-- Shelia (Shelia@active-stream.com), May 27, 1999.

I would like to know how a malfunctioning pacemaker is not of direct danger to the patients!

As for the vitamins comment, the folks in Food and Drug Administration (FDA) who deal with devices are separate from the drug/food supplements folks. They're part of FDA called the Bureau of Medical Devices and Diagnostic Procedures (BMDDP).

-- Wallflower (y2kwallflr@aol.com), May 28, 1999.


A malfunctioning pacemaker is of course a danger. But no pacemakers have clocks in them. Pacemakers are concerned with what is happening at the current time and have no use whatsoever for a calendar - they operate from heartbeat to heartbeat.

Your comment on pacemakers show that you really have no idea on what the Y2K problem is. Do your research!

-- Osco (oscarl@aol.com), May 28, 1999.


Not so Oscar. Newer pacemakers have a function where they can record abnormal heart rythyms into memory, then download them when tested, these DO require a date function.

-- kozak (kozak@formerusaf.guv), May 28, 1999.

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