Y2K information notice

[Gary Purdy <GWP1@nrc.gov>]

On December 17, 1999 the US NRC issued INFORMATION NOTICE 99-32:  THE EFFECT OF THE YEAR 2000 ISSUE ON MEDICAL LICENSEES.  Excerpts of the text are provided below

 
Discussion:

NRC is concerned with the effect that the Y2K computer problem may have on medical licensees.  In particular we are concerned with treatment planning systems used in brachytherapy and teletherapy procedures.  The Y2K problem may cause treatment planning systems to operate in an incorrect manner.  For example, the treatment planning system may incorrectly calculate the activity of the source(s) used in brachytherapy or teletherapy procedure.  This could cause an incorrect treatment time to be calculated and lead to a patient receiving an overdose or an underdose of radiation.  Additionally, some dose calibrators have been found not to be Y2K Compliant by the manufacturer.  

Addressees should contact their treatment planning system and dose calibrator vendors to determine if their systems are Y2K Ready.  Further, addressees should verify that their treatment planning systems and dose calibrators are Y2K Ready. The Y2K status of some medical equipment may be found at the U.S. Food and Drug Administration (FDA) website <http://www.fda.gov/cdrh/yr2000/year2000.html> or manufacture's website.  In some cases, manufacturers have upgrades available to correct the Y2K problems for these systems, but licensees need to act to determine whether their systems have Y2K problems and obtain the upgrades.

After the transition to the year 2000, your systems should be tested for proper operation before treating a patient.  

FDA also has developed the MedWatch Reporting Database.  FDA's MedWatch reporting requirements are stated below:

Mandatory Reports: Any device-related death or serious injury in your facility, you are required to report deaths to FDA and the manufacturer and injuries to the manufacturer only. Please report these problems through procedures established by your facility; identify the report as a Y2K problem.

Voluntary Reports:  Any date-related problem that did not cause death or injury but caused unexpected performance, for example, a malfunction that could cause death or serious injury if the problem recurred. We encourage you to report any contradiction between your device findings and those findings claimed by the manufacturer. Please identify your report as a Y2K problem.

  How to Report:  By telephone to 1-800-FDA-1088 
                     By FAX, use Form 3500 to 1-800-FDA-0178 
                     By Mail, use Form 3500, to 
                        MedWatch
                        Food and Drug Administration, HF-2
                        5600 Fishers Lane
                        Rockville, MD 20857-9787
                     Electronically at: <http://www.fda.gov/medwatch/index.html>

Have a Happy New Year!!
Gary Purdy
Health Physicist
US NRC
gwp1@nrc.gov 

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