Information Notice 1999-32, Effect of Year 2000 Issue on Medical Licensees
| ML993480416 | |
| Person / Time | |
|---|---|
| Issue date: | 12/17/1999 |
| From: | Cool D NRC/NMSS/IMNS |
| To: | |
| Cool D | |
| References | |
| IN-99-032 | |
| Download: ML993480416 (10) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555 December 17, 1999 NRC INFORMATION NOTICE 99-32: THE EFFECT OF THE YEAR 2000 ISSUE ON
MEDICAL LICENSEES
Addressees
All U.S. Nuclear Regulatory Commission medical licensees.
Purpose
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to remind all
addressees of the potential problems their computer systems and software may encounter as a
result of the change to the year 2000. It is expected that recipients will review this information
for applicability to their facilities and consider actions, as appropriate, to avoid potential
problems. However, suggestions contained in this information notice are not new NRC
requirements; therefore, no specific action nor written response is required.
Description of Circumstances
The Year 2000 (Y2K) problem pertains to the potential inability of computers to correctly
recognize dates beyond December 31,1999. This problem results from computer hardware
and/or software that uses two-digit fields to represent the year. These systems may misread the
year 2000 and cause the systems to fail, generate faulty data, or act in an incorrect manner.
The Y2K problem has the potential to interfere with the proper operation of any computer
system, hardware that is microprocessor-based (embedded software), software, or database.
As discussed in this Information Notice (IN), "Y2K Ready" is defined as a computer system or
application that has been determined to be suitable for continued use into the year 2000, even
though the computer system or application is not Y2K Compliant. A Y2K Readiness Program is
a plan for a facility to become Y2K Ready. "Y2K Compliant" is defined as a computer system or
application that accurately processes date/time data (including, but not limited to, calculating, comparing, and sequencing) from, into, and between the years 1999 and 2000, and beyond, including leap-year calculations.
The Y2K problem is urgent because it has a fixed, non-negotiable deadline that is quickly
approaching. This matter requires priority attention because of the limited time remaining to
assess the magnitude of the problem, assess its associated risks, and implement programs that
will achieve a satisfactory resolution of the Y2K problem.
ML993480416 J ---. 2
IN 99-32 December 17, 1999 Existing reporting requirements under 10 CFR Part 21 provide for notification to NRC of
deficiencies, non-conformances, and failures, such as the Y2K problem in safety-related
systems
Examples of systems that may be affected by the Y2K problem include:
- Treatment planning systems
- Dose calibrators
- Embedded systems
- Decay programs
- Interlocks
- Radiation monitoring systems
- Dosimeters, dosimetry programs, and readers
° Communication systems
° Surveillance and maintenance tracking systems
To alert licensees and certificate holders to the Y2K problem, NRC issued several INs:
- IN 96-70, "Year 2000 Effect on Computer System Software," on December 24, 1996;
- IN 97-61, "U.S. Department of Health and Human Services Letter, to Medical Device
Manufacturers, on the Year 2000 Problem," on August 6, 1997;
- IN 98-30, "Effect of The Year 2000 Computer Problem on NRC Licensees and Certificate
Holders," on August 12, 1998;
0 IN 99-18, "Update on NRC's Year 2000 Activities for Materials Licensees and Fuel Cycle
Licensees and Certificate Holders," on June 14, 1999; and
0 IN 99-20, "Contingency Planning for the Year 2000 Computer Problem," on
June 25, 1999.
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
IN 99-32 December 17, 1999 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.
The list below contains the FDA's potentially high-risk device types that could be subject to Y2K
problems. The list includes the section number in Title 21 of the U.S. Code of Federal
Regulations where the generic device type is described. While all of the generic device types
listed below are not subject to NRC jurisdiction, licensees should consider FDA's guidance that
these radiation or radionuclide systems are potentially at risk for a Y2K problem.
892.5050* MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM*
892.5300* MEDICAL NEUTRON RADIATION THERAPY SYSTEM*
892.5700* REMOTE CONTROLLED RAE" ONUCLIDE-APPLICATOR SYSTEM*
892.5750* RADIONUCLIDE RADIATION 1-HERAPY SYSTEM*
892.5900* X-RAY RADIATION THERAPY SYSTEM*
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-1 088 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>
IN 99-32 December 17, 1999
- The device classifications specified above, flagged with an asterisk, include radiation treatment
planning systems that are accessories to these device types.
For additional Y2K information, visit our website at
<http://www.nrc.gov/NRCfY2K/Y2KNMSS.html>. The site contains updates of NRC's Y2K
activities and provides useful links for additional Y2K information.
This information notice requires no specific action or written response. If you have any
questions about the information in this notice, please contact the technical contact listed below
or the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safet'
and Safeguards
Contact: Gary Purdy, NMSS
(301) 415-7897 E-mail: gwpl@nrc.gov
Attachments:
1. Selected Year 2000 Web Sites
2. List of Recently Issued NMSS Information Notices
3. List of Recently Issued NRC Information Notices
Attachment 1 IN 98-32 December 17, 1998 SELECTED YEAR 2000 WEBSITES
1. The American Hospital Association conducted a survey of hospital Year 2000 (Y2K)
readiness status. The results of the survey can found at the American Hospital
Association's website. <http://www.aha.org/y2k>
2. The American Medical Association website has Y2K information for the medical
community. <http://www.ama-assn.org/not-mo/y2k/index.htm>
3. The Federal Communications Commission website provides information regarding the
effects of Y2K on the communications and broadcasting industry.
<http://www.fcc. gov/year2000/>
4. The Food and Drug Administration has placed reports of Y2K-compliant and
non-compliant medical devices on its website. The reports are organized by
manufacturer. <http://www.fda.gov/cdrh/yr2000/year2ooo.html>
5. The General Accounting Office has placed Y2K reports on assessment, testing, and
contingency planning on its website. <http://www.gao.gov/y2kr.htm>
6. The Health Care Financing Administration has placed Y2K information for health care
claim repayments for Medicare, Medicaid, and Child Health Insurance Programs on its
website. The site also includes the Y2K status of health care facilities, Y2K activities, and
Y2K help for health care facilities. <http://www.hcfa.gov>
7. The Institution of Electrical Engineers Y2K website provides information on embedded
systems. The site explains the use of Y2K risk management techniques.
8. The intraVision website provides links to Oncology/Radiology commercial sites.
<http://www.intravsn.com/vendors.shtml>
9. The International Atomic Energy Agency website provides Y2K information for nuclear
safety, waste management, medical facilities, and safeguards/physical protection.
<http://www.iaea. org/worldatom/program/y2k>
10. The National Institute of Standards and Technology (NIST) Y2K webpage includes Y2K
test programs for small businesses, free software, Y2K standards, Y2K compliance and
testing, Y2K hotlines, and Y2K slide shows. <http://www.nist.gov/y2k> At the NIST
website for small businesses, "The Conversion 2000: Y2K JumpStart Kit" for jump-starting
a Y2K project is available. Also, action planning, assessment, and remediation project
planning workshops are available. <http://y2khelp.nist.gov>
Attachment 1 IN 99-32 December 17, 1999 11. The North American Electric Reliability Council website provides information and guidance
on the effect of the Year 2000 problem on the electricity supply for North America.
12. The U.S. Nuclear Regulatory Commission (NRC) website provides the status and findings
of NRC's Y2K program which includes nuclear power plant audits, Information Notices, Generic Letters, and Y2K links. <http://www.nrc.gov/NRC/NEWS/year2000.html>
13. The President's Council on Year 2000 Conversion website has information regarding Y2K
and the Federal government's efforts to prepare its computer systems, links to information
on Y2K compliance for critical sectors of the economy, and other Y2K resources. In
addition, the Council has established a Y2K consumer information line at
1-888-USA-4-Y2K, which provides free Y2K information to the public. <http://y2k.gov>
14. The Radiation and Health Physics website provides links to radiation detection device
manufacturers and dosimetry companies.
<http://www.sph.umich.edu/group/eih/UMSCHPS/commercial/>
15. The Rx2000 website is devoted to Y2K medical issues. The site has a pay section and a
free section. Information found in the free section includes a provider preparedness model
and comparator, Rx2000 list server and discussion forum, health care Y2K articles and
publications, Rx2000 downloadable presentations, links, and health care Y2K self-help
materials. <http://www.rx2000.org>
16. The Small Business Administration website provides Y2K help for small businesses. The
site includes Y2K materials, Y2K activities, and links to other sites.
<http://www.sba govly2k>
17. The United Kingdom Year 2000 website provides Y2K Information on software
compliance. The reports are organized by manufacturer.
<http://www.open.gov. uk/bug2000.htm>
18. The Department of Veterans Affairs (VA) website provides Y2K information and
contingency planning for hospitals and the status of VA Y2K efforts. <http://www.va.gov>
Except for its own website, the U.S. Nuclear Regulatory Commission makes no claims regarding
the accuracy of the information provided at these websites. The list of sites is provided for use
by addressees as a possible source of Y2K information.
Attachment 2 IN 99-32 December 17, 1999 LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
Information Date of
Notice No. Subject Issuance Issued to
99-31 Operational Controls to Guard 11/17/99 All NRC licensed fuel cycle
Against Inadvertent Nuclear conversion, enrichment and
Critically fabrication facilities
99-30 Failure of Double Contingency 11/8/99 All fuel cycle licensees and
Based on Administrative certificates performing laboratory
Controls Involving Laboratory analysis to determine uranium
Sampling and Spectroscopic content, in support of
Analysis of Wet Uranium administrative criticality safety
Waste controls
99-29 Authorized Contents of Spent 10/28/99 All power reactor licensees and
Fuel Casks spent fuel storage licensees and
applicants
99-28 Recall of Star Brand Fire 9/30/99 All holders of licenses for nuclear
Protection Sprinkler Heads power, research and test
reactors, and fuel cycle facilities
99-27 Malfunction of Source 9/2/99 All medical licensees authorized
Retraction Mechanism in to conduct teletherapy treatments
Cobalt-60 Teletherapy
Treatment Units
99-26 Safety and Economic 8/24/99 All Distributors and/or
Consequences of Misleading Manufacturers of Generally
Marketing Information Licensed Products
99-24 Broad-Scope Licensees' 7/12/99 All medical licensees' of broad
Responsibilities for Reviewing scope and master materials
and Approving Unregistered licensees
Sealed Sources and Devices
99-23 Safety Concerns Related to 7/6/99 All U. S. NRC medical licensees
Related Control Unit Failures of authorized to use brachytherapy
the Nucletron Classic Model sources in Nucletron Classic
High-Dose-Rate Remote Model high-dose-rate remote
Afterloading Brachytherapy afterloaders
Devices
Attachment 3 IN 99-32 December 17, 1999 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
Information Date of
Notice No. Subject Issuance Issued to
99-31 Operational Controls to Guard 11/17/99 All NRC licensed fuel cycle
Against Inadvertent Nuclear conversion, enrichment and
Criticality fabrication facilities
99-30 Failure of Double Contingency 11/8/99 All fuel cycle licensees and
Based on Administrative certificates performing laboratory
Controls Involving Laboratory analysis to determine uranium
Sampling and Spectroscopic content, in support of
Analysis of Wet Uranium administrative criticality safety
Waste controls
99-29 Authorized Contents of Spent 10/28/99 All power reactor licensees and
Fuel Casks spent fuel storage licensees and
applicants
99-01, Rev. 1 Degradation of Prestressing 10/7/99 All holders of operating licensees
Tendon Systems in for nuclear power reactors
Prestressed Concrete
Constrainments
99-28 Recall of Star Brand Fire 9/30/99 All holders of licenses for nuclear
Protection Sprinkler Heads power, research and test
reactors, and fuel cycle facilities
99-27 Malfunction of Source 9/2/99 All medical licensees authorized
Retraction Mechanism in to conduct teletherapy treatments
Cobalt-60 Teletherapy
Treatment Units
99-26 Safety and Economic 8/24/99 All Distributors and/or
Consequences of Misleading Manufacturers of Generally
Marketing Information Licensed Products
99-25 Year 2000 Contingency 8/10/99 All holders of OLs for nuclear
Planning Activities power plants and fuel cycle
facilities
OL = Operating License
CP = Construction Permit
IN 99-32 December 17, 1999
- The device classifications specified above, flagged with an asterisk, include radiation treatment
planning systems that are accessories to these device types.
For additional Y2K information, visit our website at
<http://www.nrc.gov/NRC/Y2K/Y2KNMSS.html>. The site contains updates of NRC's Y2K
activities and provides useful links for additional Y2K information.
This information notice requires no specific action or written response. If you have any
questions about the information in this notice, please contact the technical contact listed below
or the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Contact: Gary Purdy, NMSS
(301) 415-7897 E-mail: gwpl@nrc.gov
Attachments:
1. Selected Year 2000 Web Sites
2. List of Recently Issued NMSS Information Notices
3. List of Recently Issued NRC Information Notices
DOCUMENT NAME: G:\Purdy\99-32.in
To receive a copy of this document, indicate in the box:
"("'= Co win att/encl "F" = Cony w/attencl "N" = No cony *See previous concurrence
OFC Section B/MSlBT E MSI IMNS
NAME GPurdy/LL JHickey DCool
DATE 12/16/1999 12/ /1999 12/ /1999
OFFICIAL RECORD COPY
IN 99-XX
December XX, 1999 For additional Y2K information, visit our website at
<http://www.nrc.gov/NRC/Y2KrY2KNMSS.html>. The site contains updates of NRC's Y2K
activities and provides useful links for additional Y2K information.
This information notice requires no specific action or written response. If you have any
questions about the information in this notice, please contact the technical contact listed below
or the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Contact: Gary Purdy, NMSS
(301) 415-7897 E-mail: gwpl@nrc.gov
Attachments:
1. Selected Year 2000 Web Sites
2. List of Recently Issued NMSS Information Notices
3. List of Recently Issued NRC Informationh Notices
DOCUMENT NAME: G:\Purdy\last Y2K IN.wpd
To receive a copy of this document, indicate in the box:
"C"= Copy w/o attlencl. "E"= Copy w/attlencl."N' = No copy *See previous concurrence
OFC Section B/MSIB MSIB INS m
NAME GPurdy/LL JHick, "y-*_
DATE 12/9/1999 12/ Jý /1999 12/t/ /1999 UI-I-IIAL I-UIKU k;UI-Y - Prootea Dy: l//l*/f a-_ /uispatcnea Dy:_