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
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.
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
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.
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.
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.
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.
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.
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 cycleAgainst
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
7/6/99conversion, enrichment
and fabrication
facilities
All fuel cycle licensees
and certificates
performing
laboratory
analysis
to determine
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 broadscope 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 99-2999-28 99-2799-2699-2499-23 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 cycle99-3099-2999-01, Rev. 199-2899-2799-2699-25Against
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
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 conyOFFICIAL
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