U.S. Nuclear Regulatory Commission

Technical Assistance Request, Washington University Medical Center, St. Louis, MO; Authorization to Manipulate Low-Dose Afterloading Brachytherapy Devices

HPPOS-310 PDR-9306250064

Title: Technical Assistance Request, Washington University

Medical Center, St. Louis, MO; Authorization to Manipulate

Low-Dose Afterloading Brachytherapy Devices

See the memorandum from J. E. Glenn to J. A. Grobe dated

January 14, 1991. This memo responses to a TAR from Region

III, dated September 26, 1990, regarding an amendment

request by Washington University Medical Center, St. Louis,

Mo. The licensee requests authorization to perform various

operations that require manipulation of cesium-137 sealed

sources from a Low-Dose Afterloading Brachytherapy Devices

by or under the supervision of a licensee brachytherapy

physicist. The request described in a letter from the

licensee, dated August 16, 1990, has been reviewed and the

following direction is given.

Request 1. The licensee requests that the license be

amended to no longer reference a single individual as

having authorization to perform installation, replacement

and/or exchange of iridium-192 sources, but rather the

institutional RSC be authorized to designate a qualified

physicist as a brachytherapy physicist and permit this

individual to perform or oversee these activities. The

licensee also suggests that these activities might be

performed by a full-time brachytherapy technologist under

the supervision of a brachytherapy physicist.

Response 1. Qualified physicists authorized by the

licensee's RSC as brachytherapy physicists must receive

training from the manufacturer in the safe performance of

the proposed activities. Policy and Guidance Directive FC

86-4, "Information Required for Licensing Remote

Afterloading Devices", requires the licensee to submit

training for those individuals who perform source exchanges

in addition to the training described in 10 CFR 19.12. The

license may be amended to authorize the RSC to designate

qualified physicists as brachytherapy physicists,

authorizing only these individuals to perform the proposed

activities, and in conjunction, prohibiting the delegation

of these responsibilities to anyone else except

brachytherapy physicists. Request 2. The licensee requests

that the license be amended to permit manual removal of

cesium-137 sources from the MicroSelectron storage

container by a brachytherapy physicist for the purpose of

performing quality assurance tests, dose measurements, and

visual inspection of the sources as needed to guarantee

safe, dosimetrically accurate and mechanically reliable

patient treatments.

Response 2. NMSS believes that the request should be

denied. We are aware that this institution performs

innovative methods of treatment that might require special

source configurations which sometime result in increased

device "failure" rates; however, troubleshooting on this

unit by the licensee should not be authorized. Based on

the information submitted, it is not clear what basis the

licensee has for proposing activities other than those

currently recommended and described by the manufacturer for

the purpose of quality assurance. The licensee should not

be authorized access to the afterloader device and

radioactive sealed sources, other that recommended by the

manufacturer for routine calibration and quality control.

Request 3. The licensee requests modification of the

license to allow for emergency manual afterloading of

MicroSelectron cesium-137 sources into patients whose

treatment has been interrupted by failure of the

afterloading device.

Response 3. The license may be amended to authorize

emergency manual afterloading of MicroSelectron cesium-137

sources into patients whose treatment has been interrupted

by machine failure. In addition, in cases where the

afterloader device has failed during a patient treatment,

the licensee should be required to perform routine

operational checks on the unit prior to initiating

subsequent patient treatments. This preventative measure

may help to identify and reduce the frequency of generic

device failures, or those failures not attributed to

individual geometric configurations.

It should be emphasized that the emergency manual

afterloading procedures proposed by the licensee only be

used in patients whose treatment has been interrupted by

failure of the remote afterloading device. Since the

licensee's emergency nursing procedures require that the

brachytherapy physicist and implant resident be called in

the event of a detached source in the patient, it is

assumed that it is the brachytherapy physicist or implant

resident that would perform the manual afterloading of the

remote afterloader sources in the event of a machine

malfunction. In addition, this responsibility must not be

delegated to nurses.

The emergency manual use of remote afterloader sources as

proposed by the licensee is being authorized for the

medical benefit of the patient. As will be discussed in

the following item, we do not propose to authorize the

manual use of these remote sources on a routine basis.

Request 4. The licensee requests that the license be

amended to permit the use of MicroSelectron Heyman-Simon

sources as manual afterloading sources on a routing basis.

The licensee states that the sources are restricted to use

in the Heyman-Simon applicator supplied by Nucletron and

would utilize manual afterloading restraining caps that are

also supplied by Nucletron. The justification submitted by

the licensee appears to be financially motivated, in that,

if they were authorized to use the remote afterloader

sources for this purpose, they would be able to avoid

purchasing replacement manual brachytherapy sources.

Response 4. NMSS believes that the request should be

denied. After discussing the proposed use with the Sealed

Source Safety Section of this branch, it is our belief that

the licensee intends on routinely using the sources in a

manner for which they were not designed. Therefore, in

order to evaluate the integrity of the sources and device

when used in a manual rather than remote mode, the licensee

must submit a request containing the appropriate

information necessary for the Sealed Source Safety Section

to perform a Custom Source Review.

Regulatory references: 10 CFR 19.12, 10 CFR 35

Subject codes: 1.3, 1.7, 11.1

Applicability: Byproduct Material