Information Notice 2003-22, Heightened Awareness for Patients Containing Detectable Amounts of Radiation from Medical Administrations

Heightened Awareness for Patients Containing Detectable Amounts of Radiation from Medical Administrations

ML033390164
Person / Time
Issue date:	12/09/2003
From:	Chris Miller Office of Nuclear Material Safety and Safeguards
To:
Darden T, Howe D, Henderson P
References
IN-03-022
Download: ML033390164 (8)

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555-0001 December 9, 2003 NRC INFORMATION NOTICE 2003-22: HEIGHTENED AWARENESS FOR PATIENTS

CONTAINING DETECTABLE AMOUNTS OF

RADIATION FROM MEDICAL ADMINISTRATIONS

Addressees

All medical licensees and NRC Master Materials License medical use permittees.

Purpose

The U.S. Nuclear Regulatory Commission (NRC) is issuing this Information Notice (IN) to alert

addressees of an event where a radiation detector, installed as part of heightened homeland

security measures, alarmed when a recently released radiopharmaceutical patient passed by it.

In reviewing this notice, licensees are also reminded to emphasize to those patients still

containing detectable amounts of radiation from medical administrations and released with

written instructions in accordance with 10 CFR 35.75, the importance of following those

instructions. This is essential for maintaining doses to other individuals as low as is reasonable

achievable and, presently, to reduce the occurrence of patients triggering with radiation

monitors, installed at public locations for increasing public security in the United States.

It is expected that recipients will review this information for applicability to their licensed

operations 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

On March 20, 2003, a bus traveling from New York to Atlantic City set off a radiation alarm in a

tunnel, as it passed by a radiation detector. When the State Police pulled over the bus, it was

discovered that one of the passengers had received a 370 Megabecquerel (10 millicurie) dose

of iodine-131 earlier that day from a medical procedure. Although the medical licensee

provided the patient with written safety instructions, which included not using public

transportation for 2 days, the patient failed to follow the instructions. This resulted in the

activation of the radiation detector in the tunnel. Subsequent discussions with the patients

physician indicated that the patients actions in taking the trip would have no safety significance

to the members of the public on or near the bus. However, the event resulted in unnecessary

concern and inconvenience to the patient and members of the public, as well as to law

enforcement authorities and other public officials.

Discussion:

Heightened security measures are now in effect throughout the United States. These include, but are not limited to, installation of radiation surveillance equipment at critical infrastructures

and mass congregation events. Therefore, types of incidents such as the one described within

this IN are likely to increase for released patients that still contain detectable amounts of

radiation from medical administrations of radiopharmaceuticals and brachytherapy sources.

These incidents may not be limited to those patients who are required to be provided written

instructions, when released in accordance with 10 CFR 35.75, but could also include patients

administered diagnostic dosages or low-level therapeutic dosages of radiopharmaceuticals. In

the example above, if the patient had been administered less than 259 Megabecquerel

(7 millicurie) of iodine-131, NRC regulations would not have required that the licensee provide

the patient with written instructions, but the patient might still have set off a radiation detection

alarm.

When licensees are required to provide written directions to patients released in accordance

with 10 CFR 35.75, the licensees are expected to, among other things, review with authorized

users the expectation that written instructions provided to patients will be followed. Accordingly, authorized users are expected to evaluate the patients capability to follow recommended

written instructions before release, to determine if release at that time is advisable, and stress

the importance to the patient of following the written instructions.

In view of the event described and its potential for becoming more common, licensees should

consider the following voluntary actions for all patients who still contain detectable amounts of

radiation after receiving diagnostic or therapeutic quantities of radiopharmaceuticals or

brachytherapy implants:

1. Released patients who are administered diagnostic or therapeutic quantities of

radiopharmaceuticals or brachytherapy implants should be aware that their

treatment may have additional implications, because of heightened security

measures. Accordingly, provide all patients that still contain delectable amounts

of radiation with an appropriate explanation about the potential of alarming

radiation monitoring equipment.

2. To assist the patient and avoid unnecessary concern by law enforcement

authorities and other public officials, consider providing the patient with the

licensees business card and written information for law enforcement use, stating

that the radiation received by the patient poses no danger to the public and that

it is allowed by NRC medical use regulations. 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 regional office.

/RA/

Charles L. Miller, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical Contacts: Teresa Darden, Region I Pamela J. Henderson, Region I

610-337-5245 610-337-6952 E-mail: thd@nrc.gov E-mail: pjh1@nrc.gov

Donna-Beth Howe, Ph.D., NMSS

301-415-7848 E-mail: dbh@nrc.gov

Attachments:

1. List of Recently Issued NRC Information Notices

2. List of Recently Issued NMSS Information Notices 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 regional office.

/RA/

Charles L. Miller, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical Contacts: Teresa Darden, Region I Pamela J. Henderson, Region I

610-337-5245 610-337-6952 E-mail: thd@nrc.gov E-mail: pjh1@nrc.gov

Donna-Beth Howe, Ph.D., NMSS

301-415-7848 E-mail: dbh@nrc.gov

Attachments:

1. List of Recently Issued NRC Information Notices

2. List of Recently Issued NMSS Information Notices

ADAMS Accession#:

Document Name: G:\IMNS\Cabrera\IN-R1 Inst. to Patients.wpd

• See previous concurrence or e-mail

OFFICE: DNMS/R-I MSIB MSIB NMSS MSIB IMNS

NAME: PHenderson* ICabrera* Ekraus(fax)* RTorres* TEssig* CMiller

DATE: 8 /19/03 8 /19/03 8/25/03 8/ 29 /03 9 / 2 /03 12/4/03 OFFICIAL RECORD COPY

Attachment 1 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

_____________________________________________________________________________________

Information Date of

Notice No. Subject Issuance Issued to

_____________________________________________________________________________________

2003-21 High-Dose-Rate-Remote- Pending All medical licensees.

Afterloader Equipment Failure

2003-20 Derating Whiting Cranes 10/22/2003 All holders of operating licenses

Purchased Before 1980 for nuclear power reactors, except those who have

permanently ceased operations

and have certified that fuel has

been permanently removed from

the reactor vessel; applicable

decommissioning reactors, fuel

facilities, and independent spent

fuel storage installations.

2003-19 Unanalyzed Condition of 10/06/2003 All holders of operating licenses

Reactor Coolant Pump Seal or construction permits for

Leakoff Line During Postulated pressurized water reactors

Fire Scenarios or Station (PWRs).

Blackout

2003-18 General Electric Type SBM 09/26/2003 All holders of operating licenses

Control Switches With for nuclear power reactors, Defective Cam Followers except those who have

permanently ceased operations

and have certified that fuel has

been permanently removed from

the reactor vessel.

2003-17 Reduced Service Life of 09/29/2003 All holders of operating licenses

Automatic Switch Company for nuclear power reactors.

(ASCO) Solenoid Valves With

Buna-N Material

2003-16 Icing Conditions Between 10/06/2003 All 10 CFR Part 72 licensees and

Bottom of Dry Storage System certificate holders.

and Storage Pad

Note: NRC generic communications may be received in electronic format shortly after they are

issued by subscribing to the NRC listserver as follows:

To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following

command in the message portion:

subscribe gc-nrr firstname lastname

______________________________________________________________________________________

OL = Operating License

CP = Construction Permit

Attachment 2 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

_____________________________________________________________________________________

Information Date of

Notice No. Subject Issuance Issued to

_____________________________________________________________________________________

2003-21 High-Dose-Rate-Remote- Pending All medical licensees.

Afterloader Equipment Failure

2003-20 Derating Whiting Cranes 10/22/2003 All holders of operating licenses

Purchased Before 1980 for nuclear power reactors, except those who have

permanently ceased operations

and have certified that fuel has

been permanently removed from

the reactor vessel; applicable

decommissioning reactors, fuel

facilities, and independent spent

fuel storage installations.

2003-16 Icing Conditions Between 10/06/2003 All 10 CFR Part 72 licensees and

Bottom of Dry Storage System certificate holders.

and Storage Pad

2003-12 Problems Involved in 08/22/2003 All holders of 10 CFR Parts 32, Monitoring Dose to the Hands 33, and 35 licenses.

Resulting from the Handling of

Radiopharmaceuticals

2003-10 Criticality Monitoring System 08/04/2003 All U.S. Nuclear Regulatory

Degradation at BWX Commission (NRC) licensees

Technologies, Inc., Nuclear authorized to possess a critical

Products Division, Lynchburg, mass of special nuclear material.

VA

2003-09 Source Positioning Errors and 07/16/2003 All medical licensees.

System Malfunctions During

Administration of Intravascular

Brachtherapy

Note: NRC generic communications may be received in electronic format shortly after they are issued by

subscribing to the NRC listserver as follows:

To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in the

message portion:

subscribe gc-nrr firstname lastname

______________________________________________________________________________________

OL = Operating License

CP = Construction Permit