Information Notice 1999-32, Effect of Year 2000 Issue on Medical Licensees
| ML993480416 | |
| Person / Time | |
|---|---|
| Issue date: | 12/17/1999 |
| From: | Cool D A NRC/NMSS/IMNS |
| To: | |
| Cool D A | |
| 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
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.
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.
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.
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.
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.
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.
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 Critically
Failure of Double Contingency
Based on Administrative
Controls Involving
Laboratory
Sampling and Spectroscopic
Analysis of Wet Uranium Waste Authorized
Contents of Spent Fuel Casks Recall of Star Brand Fire Protection
Sprinkler
Heads Malfunction
of Source Retraction
Mechanism
in Cobalt-60
Teletherapy
Treatment
Units Safety and Economic Consequences
of Misleading
Marketing
Information
Broad-Scope
Licensees'
Responsibilities
for Reviewing
and Approving
Unregistered
Sealed Sources and Devices Safety Concerns Related to Related Control Unit Failures of the Nucletron
Classic Model High-Dose-Rate
Remote Afterloading
Devices 11/8/99 10/28/99 9/30/99 9/2/99 8/24/99 7/12/99 7/6/99 conversion, enrichment
and fabrication
facilities
All fuel cycle licensees
and certificates
performing
laboratory
analysis to determine
uranium content, in support of administrative
criticality
safety controls All power reactor licensees
and spent fuel storage licensees
and applicants
All holders of licenses for nuclear power, research and test reactors, and fuel cycle facilities
All medical licensees
authorized
to conduct teletherapy
treatments
All Distributors
and/or Manufacturers
of Generally
Licensed Products All medical licensees'
of broad scope and master materials
licensees
All U. S. NRC medical licensees
authorized
to use brachytherapy
sources in Nucletron
Classic Model high-dose-rate
remote afterloaders
99-30 99-29 99-28 99-27 99-26 99-24 99-23 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 99-30 99-29 99-01, Rev. 1 99-28 99-27 99-26 99-25 Against Inadvertent
Nuclear Criticality
Failure of Double Contingency
Based on Administrative
Controls Involving
Laboratory
Sampling and Spectroscopic
Analysis of Wet Uranium Waste Authorized
Contents of Spent Fuel Casks Degradation
of Prestressing
Tendon Systems in Prestressed
Concrete Constrainments
Recall of Star Brand Fire Protection
Sprinkler
Heads Malfunction
of Source Retraction
Mechanism
in Cobalt-60
Teletherapy
Treatment
Units Safety and Economic Consequences
of Misleading
Marketing
Information
Year 2000 Contingency
Planning Activities
11/8/99 10/28/99 10/7/99 9/30/99 9/2/99 8/24/99 8/10/99 conversion, enrichment
and fabrication
facilities
All fuel cycle licensees
and certificates
performing
laboratory
analysis to determine
uranium content, in support of administrative
criticality
safety controls All power reactor licensees
and spent fuel storage licensees
and applicants
All holders of operating
licensees
for nuclear power reactors All holders of licenses for nuclear power, research and test reactors, and fuel cycle facilities
All medical licensees
authorized
to conduct teletherapy
treatments
All Distributors
and/or Manufacturers
of Generally
Licensed Products All holders of OLs for nuclear 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 OFFICIAL RECORD COPY*See previous concurrence
OFC Section B/MSlBT E MSI IMNS NAME GPurdy/LL
JHickey DCool DATE 12/16/1999
12/ /1999 12/ /1999 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
UI-I-IIAL
I-UIKU k;UI-Y -Prootea Dy: a-_ /uispatcnea
Dy:_OFC Section B/MSIB MSIB INS m NAME GPurdy/LL
JHick, DATE 12/9/1999
12/ Jý /1999 12/t/ /1999