Information Notice 2001-08, Supplment 2: Medical Device Safety Alert Issued, Following Radiation Therapy Overexposures in Panama, and Availability of the International Atomic Energy Agency Report

Supplment 2: Medical Device Safety Alert Issued, Following Radiation Therapy Overexposures in Panama, and Availability of the International Atomic Energy Agency Report

ML012390161
Person / Time
Issue date:	11/20/2001
From:	Cool D NRC/NMSS/IMNS
To:
Torres R, NMSS/IMNS, 415-8112
References
FOIA/PA-2002-0061 IN-01-008, Suppl 2
Download: ML012390161 (13)

UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555-0001November 20, 2001NRC INFORMATION NOTICE 2001-08, SUPPLEMENT 2:UPDATE ON RADIATIONTHERAPY OVEREXPOSURES

IN PANAMA

Addressees

All medical licensees.

Purpose

The U.S. Nuclear Regulatory Commission (NRC) is issuing this supplement to informationnotice (IN) 2001-08, to provide additional information related to the radiation therapy

overexposures that recently occurred in Panama. All persons in your institution who are

involved with radiation therapy should review this notice. It is expected that recipients will

review this information for applicability to their facilities and consider actions, as appropriate, to

avoid similar problems. However, suggestions contained in this IN are not new NRC

requirements; therefore, no specific action nor written response is required.

Description of Circumstances

IN 2001-08, dated June 1, 2001, and Supplement 1, dated June 6, 2001, describe an incident inPanama, involving radiation overexposures of 28 teletherapy patients, resulting in multiple

deaths. The International Atomic Energy Agency (IAEA) recently published its report entitled

"Investigation of an Accidental Exposure of Radiotherapy Patients in Panama," which concluded

that the cause of the radiation overexposures was the way the shielding block data were

entered into the computerized treatment planning system. The report is available from IAEA,

and can be ordered from its web site at:

http://www.iaea.org/worldatom/Books/NewReleases/book26.shtml. The company that supplied the treatment planning software, Multidata Systems InternationalCorporation (Multidata), in St. Louis, Missouri, issued a "Medical Device Safety Alert" on

June 22, 2001 (Attachment 1), and an "Urgent Notice" on August 10, 2001 (Attachment 2). The

"Urgent Notice" explains that certain improper data entries will be accepted by the software, but

will result in incorrect dose calculations. Multidata is developing a "filter program" to address

this problem.

DiscussionAccording to the IAEA report, one method the Panamanian hospital staff used for the data entryof shielding blocks caused the treatment planning system to calculate incorrect treatment times. ML012390161 IN 2001-08, Supp. 2 Specifically, the staff modified its procedures and entered data for multiple shielding blockstogether ("digitized" the blocks), as if they were a single block. The data were accepted by the

treatment planning system, but the software calculated incorrect treatment times. Using

incorrect treatment times resulted in significant radiation overexposures to patients. The

hospital staff did not perform independent verification of the computer-calculated treatment

times, so the errors were not identified before treatment. The IAEA report states that there

were several characteristics of the computerized treatment planning system that made it

relatively easy for the error to occur. These were:1)Several different ways of digitizing blocks were accepted by the computertreatment planning system;2)There was no warning on the computer screen when blocks were digitized in anunacceptable way (i.e., any way that is different from the one prescribed in the

manual); and3)When blocks were digitized incorrectly, the treatment planning system produceda diagram that was the same as that produced when the data were entered

correctly, thereby giving the impression that the calculated results were correct.The "Multidata Medical Device Safety Alert," dated June 22, 2001, urges customers to followthe instructions in the user manual, and emphasizes that users should not attempt to operate

the system outside the limitations stated in the user manual. All persons involved in radiation therapy are encouraged to review both the information relatedto this incident, and your treatment planning procedures, to ensure that both your procedures

and written quality management program, required by 10 CFR 35.32, are adequate to avoid

similar radiation therapy errors. The event in Panama demonstrates that licensees should

always be alert to the possibility of introducing unintended errors into the treatment planning

process. In particular, note the importance of independent verification of computer-generated

patient treatment plans. In addition, if you are a Multidata customer, you should have received notices from the firmabout this incident. If you have not received the attached communications from Multidata, you

should contact its Helpdesk at 1-800-225-1130 or helpdesk@multidata-systems.com.The U.S. Food and Drug Administration (FDA) is investigating this incident, and NRC iscooperating with its investigation. Often device users are the first to discover problems with

marketed medical devices. If you encounter device malfunctions or product problems involving

radiation therapy devices or radiation therapy treatment planning systems, particularly those

that may be software related, you are strongly encouraged to report such events to MedWatch, the FDA's voluntary reporting program. You may submit voluntary reports to MedWatch

through:*Phone at 1-800-FDA-1088; *FAX at 1-800-FDA-0178;

IN 2001-08, Supp. 2 *The Internet at http://www.fda.gov/medwatch/ ; or, *Mailing your report to MedWatch, Food and Drug Administration, 5600 Fishers Lane(HF-2), Rockville, MD 20857. Also note that under the Safe Medical Devices Act of 1990, user facilities must comply withspecific, mandatory reporting time frames and requirements, when they become aware that a

medical device may have caused, or contributed to, a patient death or serious injury/illness.Questions concerning FDA's mandatory user facility reporting requirements can be directed toFDA's Center for Devices and Radiological Health, Office of Surveillance and Biometrics, through telephone at (301) 594-2735.This IN requires no specific action nor written response. If you have any questions about theinformation in this notice, please contact one of the technical contacts listed below, or the

appropriate NRC regional office.Donald A. Cool, DirectorDivision of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and SafeguardsTechnical Contacts:Robert Ayres, NMSSDonna-Beth Howe, NMSS (301) 415-5746 (301) 415-7848 E-mail: rxa1@nrc.govE-mail: dbh@nrc.govRoberto J. Torres, NMSS (301) 415-8112 E-mail: rjt@nrc.gov

Attachments:1.Medical Device Safety Alert, June 22, 2001

2.Urgent Notice, August 10, 2001

3.List of Recently Issued NMSS Information Notices

4.List of Recently Issued NRC Information Notices

IN 2001-08, Supp. 2 *The Internet at http://www.fda.gov/medwatch/ ; or, *Mailing your report to MedWatch, Food and Drug Administration, 5600 Fishers Lane(HF-2), Rockville, MD 20857. Also note that under the Safe Medical Devices Act of 1990, user facilities must comply withspecific, mandatory reporting time frames and requirements, when they become aware that a

medical device may have caused, or contributed to, a patient death or serious injury/illness.Questions concerning FDA's mandatory user facility reporting requirements can be directed toFDA's Center for Devices and Radiological Health, Office of Surveillance and Biometrics, through telephone at (301) 594-2735.This IN requires no specific action nor written response. If you have any questions about theinformation in this notice, please contact one of the technical contacts listed below, or the

appropriate NRC regional office.Donald A. Cool, DirectorDivision of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and SafeguardsTechnical Contacts:Robert Ayres, NMSSDonna-Beth Howe, NMSS (301) 415-5746(301) 415-7848 E-mail: rxa1@nrc.govE-mail: dbh@nrc.govRoberto J. Torres, NMSS (301) 415-8112 E-mail: rjt@nrc.gov

Attachments:1. Medical Device Safety Alert, June 22, 2001

2. Urgent Notice, August 10, 2001

3. List of Recently Issued NMSS Information Notices

4. List of Recently Issued NRC Information NoticesDOCUMENT NAME:Package ML012990347 contains ML012390161 (Information Notice text), ML012990318 (Attachment 1), ML012990328 (Page 1 of Attachment 2) and ML012990335 (Page 2 of

Attachment 2)OFFICEMSIBC EditorN MSIBNMSIB IMNSN NAMETorres/AyresEKraus/fax FBrownJHickeyDCool DATE 8/20/2001 &

10/26/2001

8/24/2001 &

11/6/2001 ---------------11/8/0111/20/2001OFFICIAL RECORD COPY

Attachment 1IN 2001-08, Supp. 2 See ML012990318 Attachment 1IN 2001-08, Supp. 2 See ML012990318 Attachment 2IN 2001-08, Supp. 2 See ML012990328 Attachment 2IN 2001-08, Supp. 2 See ML012990335 Attachment 3IN 2001-08, Supp. 2 LIST OF RECENTLY ISSUEDNMSS INFORMATION NOTICES

_____________________________________________________________________________________InformationDate of

Notice No. SubjectIssuanceIssued to

_____________________________________________________________________________________2001-11Thefts of Portable Gauges07/13/2001All portable Gauge licensees.2001-08,Supplement 1Update on the Investigation ofPatient Deaths in Panama,

Following Radiation Therapy

Overexposures06/06/01All medical licensees.2001-08Treatment Planning SystemErrors Result in Deaths of

Overseas Radiation Therapy

Patients06/01/01All medical licensees.2001-03Incident ReportingRequirements for Radiography

Licensees04/06/01All industrial radiography

licensees.2001-01The Importance of AccurateInventory Controls to Prevent

the Unauthorized Possession

of Radioactive Material03/26/01All material licensees.2000-22Medical MisadministrationsCaused by Human Errors

Involving Gamma Stereotactic

Radiosurgery (GAMMA KNIFE)12/18/00All medical use licenseesauthorized to conduct gamma

stereotactic radiosurgery

treatments.2000-19Implementation of Human UseResearch Protocols Involving

U.S. Nuclear Regulatory

Commission Regulated

Materials12/05/2000All medical use licensees.2000-18Substandard Material Suppliedby Chicago Bullet Proof

Systems11/29/2000All 10 CFR Part 50 licensees andapplicants.

All category 1 fuel facilities.

All 10 CFR Part 72 licensees and

applicants.2000-16Potential Hazards Due toVolatilization of Radionuclides10/5/2000All licensees that processunsealed byproduct material.2000-15Recent Events Resulting inWhole Body Exposures

Exceeding Regulatory Limits9/29/2000All radiography licensees.

______________________________________________________________________________________OL = Operating License

CP = Construction PermitAttachment 4IN 2001-08, Supp. 2 LIST OF RECENTLY ISSUEDNRC INFORMATION NOTICES

_____________________________________________________________________________________InformationDate of

Notice No. SubjectIssuanceIssued to

______________________________________________________________________________________2001-16Recent Foreign and DomesticExperience with Degradation of

steam Generator Tubes and

Internals10/31/2001All holders of operating licensesfor pressurized-water reactors

(PWR), except those who have

permanently ceased operations

and have certified that fuel has

been permanently removed from

the reactor2001-15Non-Conservative Errors inMinimum Critical Power Ratio

Limits10/29/01All holders of operating licensesor construction permits for boiling

water reactors (BWRs)2001-14Problems with Incorrectly-Installed Swing-Check Valves10/03/01All holders of operating licensesor construction permits for nuclear

power reactors except those who

have ceased operations and have

certified that fuel has been

permanently removed from the

reactor vessel2001-13Inadequate Standby LiquidControl System Relief Valve

Margin08/10/01All holders of operating licensesfor boiling water reactors2001-12(ERRATA)Hydrogen Fire at NuclearPower Stations8/08/01All holders of operating licensesor construction permits for nuclear

power reactors except those who

have ceased operations and have

certified that fuel has been

permanently removed from the

reactor vessel2001-12Hydrogen Fire at NuclearPower Stations7/13/01All holders of operating licensesor construction permits for nuclear

power reactors except those who

have ceased operations and have

certified that fuel has been

permanently removed from the

reactor vessel