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
| 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 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.
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
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