[Congressional Record Volume 144, Number 146 (Wednesday, October 14, 1998)]
[Senate]
[Page S12582]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




             MEDICAL DEVICE MANUFACTURER YEAR 200 RESPONSE

  Mr. GRAMS. Mr. President, about two weeks ago, a list of medical 
device companies was printed in the Congressional Record which 
indicated they were non-responsive to The Food and Drug 
Administration's request for Year 200 compliance status.
  As Chairman of the Senate Medical Technology Caucus, I believe it is 
important my colleagues have the latest on manufacturers which have 
been responsive to the FDA's request for information on the Year 2000 
compliance status of their products Companies were asked by the FDA to 
indicate in their response the following:
  The medical devices marketed and have sold are not Year 2000 
vulnerable; medical devices marketed and sold are all year 2000 
compliant; the manufacturer is providing specific information regarding 
those products which are not compliant or their assessment is currently 
incomplete; or the manufacturer is working on an assessment and will 
post the results.
  Mr. President, there are many sectors of our economy which still need 
to address the potential for problems in the year 2000, but I am 
pleased that a vast majority of medical device companies in the United 
States have responded to the FDA on year 2000 compliance status and 
deserve to be recognized for having done so.
  I would like to mention specifically thirteen companies mistakenly 
listed in the Congressional Record as being unresponsive to the FDA's 
request. These manufacturers have responded to the FDA's request for 
Year 2000 compliance status: Apothecary Incorporated, Augustine Medical 
Incorporated, Braemar Corporation, Dantec Medical Incorporated, 
Diametrics Medical Incorporated, Keomed Incorporated, Medtronic PS 
Medical Medtronic Bio-medicus, Medtronic Neurological, Prime Ideas 
Incorporated, Puritan Bennett Corporation, Timm Research Company, and 
Williams Sound Corporation.
  Mr. President, while this list only represents companies based in 
Minnesota, the FDA has compiled a much larger listing of companies 
which are or have addressed year 2000 issues on their website located 
at www.fda.gov.

 ____________________