Information Notice 1999-32, Effect of Year 2000 Issue on Medical Licensees

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.

<http://www.iee.org.uk>

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.

<http://www.nerc.com>

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:_