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: Difference between revisions

From kanterella
Jump to navigation Jump to search
← Older editNewer edit →
VisualWikitext
Created page by program invented by StriderTol
Created page by program invented by StriderTol
Line 15: Line 15:
| page count = 13
| page count = 13
}}
}}
{{#Wiki_filter: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
{{#Wiki_filter:UNITED STATES
 
NUCLEAR REGULATORY COMMISSION
 
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
 
WASHINGTON, D.C. 20555-0001 November 20, 2001 NRC INFORMATION NOTICE 2001-08, SUPPLEMENT 2:                       UPDATE ON RADIATION
 
THERAPY OVEREXPOSURES


IN PANAMA
IN PANAMA
Line 23: Line 31:


==Purpose==
==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
The U.S. Nuclear Regulatory Commission (NRC) is issuing this supplement to information


overexposures that recently occurred in Panama.  All persons in your institution who are
notice (IN) 2001-08, to provide additional information related to the radiation therapy


involved with radiation therapy should review this notice. It is expected that recipients will
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
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
avoid similar problems. However, suggestions contained in this IN are not new NRC


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


==Description of Circumstances==
==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
IN 2001-08, dated June 1, 2001, and Supplement 1, dated June 6, 2001, describe an incident in


deaths.  The International Atomic Energy Agency (IAEA) recently published its report entitled
Panama, involving radiation overexposures of 28 teletherapy patients, resulting in multiple


"Investigation of an Accidental Exposure of Radiotherapy Patients in Panama," which concluded
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
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,
entered into the computerized treatment planning system. The report is available from IAEA,
and can be ordered from its web site at:
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
http://www.iaea.org/worldatom/Books/NewReleases/book26.shtml.


June 22, 2001 (Attachment 1), and an "Urgent Notice" on August 10, 2001 (Attachment 2).  The
The company that supplied the treatment planning software, Multidata Systems International


"Urgent Notice" explains that certain improper data entries will be accepted by the software, but
Corporation (Multidata), in St. Louis, Missouri, issued a Medical Device Safety Alert on


will result in incorrect dose calculations. Multidata is developing a "filter program" to address
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.
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
Discussion
 
According to the IAEA report, one method the Panamanian hospital staff used for the data entry
 
of 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 blocks


treatment planning system, but the software calculated incorrect treatment times.  Using
together (digitized the blocks), as if they were a single block. The data were accepted by the


incorrect treatment times resulted in significant radiation overexposures to patients. 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
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
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
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
relatively easy for the error to occur. These were:
        1)     Several different ways of digitizing blocks were accepted by the computer
 
treatment planning system;
        2)     There was no warning on the computer screen when blocks were digitized in an
 
unacceptable 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
manual); and


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
3)      When blocks were digitized incorrectly, the treatment planning system produced


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
a 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 follow
 
the 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 related
 
to 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
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
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
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
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 firm
 
about 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.


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
The U.S. Food and Drug Administration (FDA) is investigating this incident, and NRC is


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
cooperating 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
marketed medical devices. If you encounter device malfunctions or product problems involving
Line 92: Line 144:
radiation therapy devices or radiation therapy treatment planning systems, particularly those
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
that may be software related, you are strongly encouraged to report such events to MedWatch, the FDAs 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 with
 
specific, 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 to
 
FDA'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 the


through:*Phone at 1-800-FDA-1088; *FAX at 1-800-FDA-0178; 
information in this notice, please contact one of the technical contacts listed below, or the
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.


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


Medical Nuclear Safety
Medical Nuclear Safety
Line 105: Line 179:
Office of Nuclear Material 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
and Safeguards
 
Technical Contacts:     Robert Ayres, NMSS                    Donna-Beth Howe, NMSS
 
(301) 415-5746                       (301) 415-7848 E-mail: rxa1@nrc.gov                  E-mail: dbh@nrc.gov
 
Roberto 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 with
 
specific, 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 to
 
FDA's Center for Devices and Radiological Health, Office of Surveillance and Biometrics, through telephone at (301) 594-2735.


Attachments:1.Medical Device Safety Alert, June 22, 2001
This IN requires no specific action nor written response. If you have any questions about the
2.Urgent Notice, August 10, 2001
3.List of Recently Issued NMSS Information Notices


4.List of Recently Issued NRC Information Notices
information in this notice, please contact one of the technical contacts listed below, or the


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
appropriate NRC regional office.


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
Donald A. Cool, Director


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


Medical Nuclear Safety
Medical Nuclear Safety
Line 123: Line 225:
Office of Nuclear Material 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
and Safeguards
 
Technical Contacts:     Robert Ayres, NMSS                      Donna-Beth Howe, NMSS
 
(301) 415-5746                           (301) 415-7848 E-mail: rxa1@nrc.gov                    E-mail: dbh@nrc.gov
 
Roberto 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
 
DOCUMENT NAME:
Package ML012990347 contains ML012390161 (Information Notice text), ML012990318 (Attachment 1), ML012990328 (Page 1 of Attachment 2) and ML012990335 (Page 2 of
 
Attachment 2)
OFFICE    MSIB      C    Editor      N MSIB            N MSIB        IMNS      N
 
NAME      Torres/Ayres    EKraus/fax      FBrown        JHickey        DCool
 
DATE      8/20/2001 &    8/24/2001 &    ---------------  11/8/01      11/20/2001
            10/26/2001      11/6/2001 OFFICIAL RECORD COPY
 
Attachment 1 IN 2001-08, Supp. 2 See ML012990318
 
Attachment 1 IN 2001-08, Supp. 2 See ML012990318
 
Attachment 2 IN 2001-08, Supp. 2 See ML012990328
 
Attachment 2 IN 2001-08, Supp. 2 See ML012990335
 
Attachment 3 IN 2001-08, Supp. 2 LIST OF RECENTLY ISSUED
 
NMSS INFORMATION NOTICES
 
_____________________________________________________________________________________
Information                                      Date of
 
Notice No.          Subject                      Issuance  Issued to
 
_____________________________________________________________________________________
2001-11        Thefts of Portable Gauges        07/13/2001  All portable Gauge licensees.


Attachments:1.  Medical Device Safety Alert, June 22, 2001
2001-08,       Update on the Investigation of  06/06/01    All medical licensees.
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
Supplement 1   Patient Deaths in Panama, Following Radiation Therapy


Attachment 2)OFFICEMSIBC EditorN MSIBNMSIB IMNSN  NAMETorres/AyresEKraus/fax FBrownJHickeyDCool    DATE 8/20/2001 &
Overexposures
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
2001-08       Treatment Planning System        06/01/01    All medical licensees.


_____________________________________________________________________________________InformationDate of
Errors Result in Deaths of


===Notice No.        SubjectIssuanceIssued to===
Overseas Radiation Therapy


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


===Following Radiation Therapy===
2001-03        Incident Reporting              04/06/01    All industrial radiography
Overexposures06/06/01All medical licensees.2001-08Treatment Planning SystemErrors Result in Deaths of


===Overseas Radiation Therapy===
Requirements for Radiography                licensees.
Patients06/01/01All medical licensees.2001-03Incident ReportingRequirements for Radiography


Licensees04/06/01All industrial radiography
Licensees


licensees.2001-01The Importance of AccurateInventory Controls to Prevent
2001-01        The Importance of Accurate      03/26/01    All material licensees.
 
Inventory Controls to Prevent


the Unauthorized Possession
the Unauthorized Possession


of Radioactive Material03/26/01All material licensees.2000-22Medical MisadministrationsCaused by Human Errors
of Radioactive Material
 
2000-22        Medical Misadministrations      12/18/00    All medical use licensees
 
Caused by Human Errors                       authorized to conduct gamma


===Involving Gamma Stereotactic===
Involving Gamma Stereotactic                 stereotactic radiosurgery
Radiosurgery (GAMMA KNIFE)12/18/00All medical use licenseesauthorized to conduct gamma


stereotactic radiosurgery
Radiosurgery (GAMMA KNIFE)                  treatments.


treatments.2000-19Implementation of Human UseResearch Protocols Involving
2000-19        Implementation of Human Use      12/05/2000  All medical use licensees.
 
Research Protocols Involving
 
U.S. Nuclear Regulatory


===U.S. Nuclear Regulatory===
Commission Regulated
Commission Regulated


Materials12/05/2000All medical use licensees.2000-18Substandard Material Suppliedby Chicago Bullet Proof
Materials
 
2000-18        Substandard Material Supplied    11/29/2000  All 10 CFR Part 50 licensees and
 
by Chicago Bullet Proof                      applicants.
 
Systems                                      All category 1 fuel facilities.
 
All 10 CFR Part 72 licensees and
 
applicants.
 
2000-16        Potential Hazards Due to        10/5/2000  All licensees that process


Systems11/29/2000All 10 CFR Part 50 licensees andapplicants.
Volatilization of Radionuclides              unsealed byproduct material.


All category 1 fuel facilities.
2000-15        Recent Events Resulting in      9/29/2000  All radiography licensees.


===All 10 CFR Part 72 licensees and===
Whole Body Exposures
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.
Exceeding Regulatory Limits


______________________________________________________________________________________OL = Operating License
Attachment 4 IN 2001-08, Supp. 2 LIST OF RECENTLY ISSUED


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


_____________________________________________________________________________________InformationDate of
_____________________________________________________________________________________
Information                                        Date of


===Notice No.         SubjectIssuanceIssued to===
Notice No.             Subject                    Issuance  Issued to
______________________________________________________________________________________2001-16Recent Foreign and DomesticExperience with Degradation of


steam Generator Tubes and
______________________________________________________________________________________
2001-16          Recent Foreign and Domestic    10/31/2001  All holders of operating licenses


Internals10/31/2001All holders of operating licensesfor pressurized-water reactors
Experience with Degradation of             for pressurized-water reactors


(PWR), except those who have
steam Generator Tubes and                  (PWR), except those who have


permanently ceased operations
Internals                                  permanently ceased operations


and have certified that fuel has
and have certified that fuel has
Line 200: Line 361:
been permanently removed from
been permanently removed from


the reactor2001-15Non-Conservative Errors inMinimum Critical Power Ratio
the reactor
 
2001-15          Non-Conservative Errors in      10/29/01    All holders of operating licenses
 
Minimum Critical Power Ratio               or construction permits for boiling


Limits10/29/01All holders of operating licensesor construction permits for boiling
Limits                                      water reactors (BWRs)
2001-14          Problems with Incorrectly-      10/03/01    All holders of operating licenses


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


power reactors except those who
power reactors except those who
Line 214: Line 380:
permanently removed from the
permanently removed from the


reactor vessel2001-13Inadequate Standby LiquidControl System Relief Valve
reactor vessel
 
2001-13          Inadequate Standby Liquid      08/10/01    All holders of operating licenses


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
Control System Relief Valve                for boiling water reactors
 
Margin
 
2001-12           Hydrogen Fire at Nuclear        8/08/01    All holders of operating licenses
 
(ERRATA)          Power Stations                              or construction permits for nuclear


power reactors except those who
power reactors except those who
Line 226: Line 400:
permanently removed from the
permanently removed from the


reactor vessel2001-12Hydrogen Fire at NuclearPower Stations7/13/01All holders of operating licensesor construction permits for nuclear
reactor vessel
 
2001-12          Hydrogen Fire at Nuclear        7/13/01    All holders of operating licenses
 
Power Stations                              or construction permits for nuclear


power reactors except those who
power reactors except those who
Line 236: Line 414:
permanently removed from the
permanently removed from the


reactor vessel}}
reactor vessel
 
______________________________________________________________________________________
OL = Operating License
 
CP = Construction Permit}}


{{Information notice-Nav}}
{{Information notice-Nav}}

Revision as of 04:42, 24 November 2019

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)
v • d • e


UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555-0001 November 20, 2001 NRC INFORMATION NOTICE 2001-08, SUPPLEMENT 2: UPDATE ON RADIATION

THERAPY OVEREXPOSURES

IN PANAMA

Addressees

All medical licensees.

Purpose

The U.S. Nuclear Regulatory Commission (NRC) is issuing this supplement to information

notice (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 in

Panama, 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 International

Corporation (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.

Discussion

According to the IAEA report, one method the Panamanian hospital staff used for the data entry

of 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 blocks

together (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 computer

treatment planning system;

2) There was no warning on the computer screen when blocks were digitized in an

unacceptable way (i.e., any way that is different from the one prescribed in the

manual); and

3) When blocks were digitized incorrectly, the treatment planning system produced

a 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 follow

the 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 related

to 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 firm

about 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 is

cooperating 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 FDAs 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 with

specific, 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 to

FDA'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 the

information in this notice, please contact one of the technical contacts listed below, or the

appropriate NRC regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical Contacts: Robert Ayres, NMSS Donna-Beth Howe, NMSS

(301) 415-5746 (301) 415-7848 E-mail: rxa1@nrc.gov E-mail: dbh@nrc.gov

Roberto 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 with

specific, 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 to

FDA'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 the

information in this notice, please contact one of the technical contacts listed below, or the

appropriate NRC regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical Contacts: Robert Ayres, NMSS Donna-Beth Howe, NMSS

(301) 415-5746 (301) 415-7848 E-mail: rxa1@nrc.gov E-mail: dbh@nrc.gov

Roberto 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

DOCUMENT NAME:

Package ML012990347 contains ML012390161 (Information Notice text), ML012990318 (Attachment 1), ML012990328 (Page 1 of Attachment 2) and ML012990335 (Page 2 of

Attachment 2)

OFFICE MSIB C Editor N MSIB N MSIB IMNS N

NAME Torres/Ayres EKraus/fax FBrown JHickey DCool

DATE 8/20/2001 & 8/24/2001 & --------------- 11/8/01 11/20/2001

10/26/2001 11/6/2001 OFFICIAL RECORD COPY

Attachment 1 IN 2001-08, Supp. 2 See ML012990318

Attachment 1 IN 2001-08, Supp. 2 See ML012990318

Attachment 2 IN 2001-08, Supp. 2 See ML012990328

Attachment 2 IN 2001-08, Supp. 2 See ML012990335

Attachment 3 IN 2001-08, Supp. 2 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

_____________________________________________________________________________________

Information Date of

Notice No. Subject Issuance Issued to

_____________________________________________________________________________________

2001-11 Thefts of Portable Gauges 07/13/2001 All portable Gauge licensees.

2001-08, Update on the Investigation of 06/06/01 All medical licensees.

Supplement 1 Patient Deaths in Panama, Following Radiation Therapy

Overexposures

2001-08 Treatment Planning System 06/01/01 All medical licensees.

Errors Result in Deaths of

Overseas Radiation Therapy

Patients

2001-03 Incident Reporting 04/06/01 All industrial radiography

Requirements for Radiography licensees.

Licensees

2001-01 The Importance of Accurate 03/26/01 All material licensees.

Inventory Controls to Prevent

the Unauthorized Possession

of Radioactive Material

2000-22 Medical Misadministrations 12/18/00 All medical use licensees

Caused by Human Errors authorized to conduct gamma

Involving Gamma Stereotactic stereotactic radiosurgery

Radiosurgery (GAMMA KNIFE) treatments.

2000-19 Implementation of Human Use 12/05/2000 All medical use licensees.

Research Protocols Involving

U.S. Nuclear Regulatory

Commission Regulated

Materials

2000-18 Substandard Material Supplied 11/29/2000 All 10 CFR Part 50 licensees and

by Chicago Bullet Proof applicants.

Systems All category 1 fuel facilities.

All 10 CFR Part 72 licensees and

applicants.

2000-16 Potential Hazards Due to 10/5/2000 All licensees that process

Volatilization of Radionuclides unsealed byproduct material.

2000-15 Recent Events Resulting in 9/29/2000 All radiography licensees.

Whole Body Exposures

Exceeding Regulatory Limits

Attachment 4 IN 2001-08, Supp. 2 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

_____________________________________________________________________________________

Information Date of

Notice No. Subject Issuance Issued to

______________________________________________________________________________________

2001-16 Recent Foreign and Domestic 10/31/2001 All holders of operating licenses

Experience with Degradation of for pressurized-water reactors

steam Generator Tubes and (PWR), except those who have

Internals permanently ceased operations

and have certified that fuel has

been permanently removed from

the reactor

2001-15 Non-Conservative Errors in 10/29/01 All holders of operating licenses

Minimum Critical Power Ratio or construction permits for boiling

Limits water reactors (BWRs)

2001-14 Problems with Incorrectly- 10/03/01 All holders of operating licenses

Installed Swing-Check Valves or 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

2001-13 Inadequate Standby Liquid 08/10/01 All holders of operating licenses

Control System Relief Valve for boiling water reactors

Margin

2001-12 Hydrogen Fire at Nuclear 8/08/01 All holders of operating licenses

(ERRATA) Power Stations or 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

2001-12 Hydrogen Fire at Nuclear 7/13/01 All holders of operating licenses

Power Stations or 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

______________________________________________________________________________________

OL = Operating License

CP = Construction Permit


Retrieved from "https://kanterella.com/w/index.php?title=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&oldid=2202500"