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