Baffling Y2K impact assessement by FDA?

greenspun.com : LUSENET : TimeBomb 2000 (Y2000) : One Thread

A July 23 statement by Michael A. Friedman, M.D., Chairman of the FDA, (http://www.hhs.gov/progorg/asl/testify/t980723b.txt) states

"Embedded Software

Computer software frequently is embedded as a "component" of devices, i.e., software contained on a microchip to control device operation. Examples of such common, important devices are: pacemakers, infusion pumps and ventilators. The majority of these products would not be impacted by the Year 2000 problem since almost none of them require knowledge of the current date to operate safely and effectively. For example, pacemakers do not use the current date in their operation."

Summarizing whether medical devices will pose Y2K problems...

"In reviewing the data received from the manufacturers so far, we see no indications that there will be significant problems which will place patients at risk, assuming the solutions being developed and offered by manufacturers are implemented."

Yet he then goes on to admit

"Of course, we can not make assurances about manufacturers who have not reported product status to us. We believe that the data received to date confirm our original expectations that the Year 2000 problems with medical devices are not significant or widespread problems, although there will be specific problems which need correction. With only a 10 percent response rate, however, it is not possible to draw definitive conclusions at this point."

Seems like Friedman has dismissed the embedded systems problem in medical devices based on a VERY limited amount of data. The medical research community does not draw such sweeping conclusions in the research area based on such sparce data (10% response rate).

Brian

-- Brian Smith (besmith@mail.arc.nasa.gov), August 24, 1998

Answers

Taken from the Boca Raton Business Journal 8/24/98:

" Cross Country Staffing and Rosebud Solutions announced the formation of a strategic alliance to address the initial stages of efforts by health care providers to avoid a Year 2000 crisis." " According to a Gartner Group survey, more than 80 percent of hospitals are still in the initial stages of assessing the impact of the Y2K problem on their information systems."

OUCH!!!! The initial stages!!!!!!!

-- John Callon (jcallon@gate.et), August 24, 1998.


Senator Bennett commented in a July 29th Senate Hearing (taped off CSPAN) that a witness had come forth from a hospital...witness had y2k compliance letter in hand on equipment being tested...equipment not only failed, but had to be scrapped-this was life sustaining hospital equipment...Bennett stated that if someone had been hooked up to this unit on 1/1/2000, that person would have died.

-- K. Golden (kgolden@solar.standford.edu), August 24, 1998.

I work in the health care arena. We updated our information system within the last year to deal with this problem. However, we still must rely on federal agencies to conduct our business (Medicare, Medicaid, IHS...). I don't work in IS but I am more aware of the y2k than our current IS Manager and I don't know if anyone has even started thinking about the imbedded systems problem. However, I think hospitals in general are going to be more vulnerable in the business services area than in the patient care area (but more vital).

If our system is any indication of the outlook for the health care industry, I would not want to be admitted to an ER come 12/31/99 and I certainly wouldn't be planning my vasectomy at that time either.

-- bhayes (bkhayes@intellex.com), August 25, 1998.


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