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 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 &

10/26/2001

8/24/2001 &

11/6/2001

---

11/8/01

11/20/2001

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,

Supplement 1

Update on the Investigation of

Patient Deaths in Panama,

Following Radiation Therapy

Overexposures

06/06/01 All medical licensees.

2001-08

Treatment Planning System

Errors Result in Deaths of

Overseas Radiation Therapy

Patients

06/01/01 All medical licensees.

2001-03

Incident Reporting

Requirements for Radiography

Licensees

04/06/01

All industrial radiography

licensees.

2001-01

The Importance of Accurate

Inventory Controls to Prevent

the Unauthorized Possession

of Radioactive Material

03/26/01 All material licensees.

2000-22

Medical Misadministrations

Caused by Human Errors

Involving Gamma Stereotactic

Radiosurgery (GAMMA KNIFE)

12/18/00

All medical use licensees

authorized to conduct gamma

stereotactic radiosurgery

treatments.

2000-19

Implementation of Human Use

Research Protocols Involving

U.S. Nuclear Regulatory

Commission Regulated

Materials

12/05/2000

All medical use licensees.

2000-18

Substandard Material Supplied

by Chicago Bullet Proof

Systems

11/29/2000

All 10 CFR Part 50 licensees and

applicants.

All category 1 fuel facilities.

All 10 CFR Part 72 licensees and

applicants.

2000-16

Potential Hazards Due to

Volatilization of Radionuclides

10/5/2000

All licensees that process

unsealed byproduct material.

2000-15

Recent Events Resulting in

Whole Body Exposures

Exceeding Regulatory Limits

9/29/2000

All radiography licensees.

______________________________________________________________________________________

OL = Operating License

CP = Construction Permit

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

Experience with Degradation of

steam Generator Tubes and

Internals

10/31/2001

All holders of operating licenses

for pressurized-water reactors

(PWR), except those who have

permanently ceased operations

and have certified that fuel has

been permanently removed from

the reactor

2001-15 Non-Conservative Errors in

Minimum Critical Power Ratio

Limits

10/29/01

All holders of operating licenses

or construction permits for boiling

water reactors (BWRs)

2001-14 Problems with Incorrectly- Installed Swing-Check Valves

10/03/01

All holders of operating licenses

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

Control System Relief Valve

Margin

08/10/01

All holders of operating licenses

for boiling water reactors

2001-12 (ERRATA)

Hydrogen Fire at Nuclear

Power Stations

8/08/01

All holders of operating licenses

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

Power Stations

7/13/01

All holders of operating licenses

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