Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
CR78010
UNITED STATES
NUCLEAR REGULATORY COMMISSION
WASHINGTON, D. C. 20555
June 7, 1978
MEMORANDUM FOR: B. H. Grier, Director, Region I
J. P. O'Reilly, Director, Region II
J. G. Keppler, Director, Region III
K. V. Seyfrit, Director, Region IV
R. H. Engelken, Director, Region V
FROM: L. B. Higginbotham, Acting Director, Division of Fuel
Facilities and Material Safety Inspection, IE
SUBJECT: IE CIRCULAR NO. 78-10, CONTROL OF SEALED SOURCES
USED IN RADIATION THERAPY
The subject circular is transmitted for issuance on June 14, 1978. The
circular should be issued to all medical Licensees in categories G and G1.
Also enclosed is a draft copy of the transmittal letter and removable labels
of the medical licensees in categories G and G1 in your Region.
L. B. Higginbotham, Acting Director
Division of Fuel Facilities and
Materials Safety Inspection
Office of Inspection and Enforcement
Enclosures:
1. Draft Transmittal Letter
2. Circular No. 78-10
3. Addressee labels (Removable)
CONTACT: E. D. Flack, IE
49-28188
.
Transmittal letter for Circular 78-10, to each Medical Licensee in
categories G and G1.
Addressee:
The enclosed Circular 78-10, is forwarded to you for information. If there
are any questions related to your understanding of the suggested actions,
please contact this office.
Signature
(Regional Director)
Enclosure:
IE Circular No. 78-10
.
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF INSPECTION AND ENFORCEMENT
WASHINGTON, D. C. 20555
June 14, 1978
IE Circular No. 78-10
CONTROL OF SEALED SOURCES USED IN RADIATION THERAPY
Over the past several months various incidents have been reported to the
Nuclear Regulatory Commission (NRC) which involved the inadequate control
and accounting of NRC-licensed byproduct material used in the topical,
interstitial or intracavitary treatment of cancer. We request that you
inform all individuals in your organization involved with the use of sealed
sources of byproduct material for therapy about this circular. Following are
examples of incidents reported to the NRC:
o A patient while undergoing radiation therapy for cancer had twelve
iridium-192 seeds containing approximately 0.5 mCi each implanted
but only eight removed at the desired time. The remaining four
iridium seeds were noticed missing about three months later.
Licensee follow-up revealed that the remaining four iridium seeds
were still in the patient.
o A patient receiving radiation therapy for cervical cancer had two
radium applicators implanted. Although both were scheduled to be
removed two days later, only one was removed at that time. The
second applicator was noticed, missing about one month later.
Licensee follow-up revealed that the radium loaded applicator was
still in the patient.
o An applicator containing two 79 mCi cesium-137 sources was removed
from a patient and returned to the storage room, but not
immediately dismantled. A routine inventory two weeks later
revealed that one of the two sources had been returned to its
proper storage place but the other was missing. The hospital was
unable to locate the missing source or determine who had
disassembled the applicator.
o Another hospital reported that a 40 mCi cesium-137 uterine implant
was dislodged from a patient and only after an extensive search
was it found in a laundry room floor drain trench.
NRC recommends that the following actions be considered by each licensee
authorized to use sealed sources in topical, interstitial or intracavitary
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IE Circular No. 78-10 June 14, 1978
treatment of cancer. These recommended actions may already be a part of your
program and may be conditions of your license. If you change any procedures
which are conditions of your license, you must notify the Radioisotope
Licensing Branch of NRC so that your license may be amended.
1. Review the adequacy of your procedures for the use and control of
sealed sources in therapy. Such procedures should include:
a. Written instructions covering all phases of use and control. These
instructions should be posted and/or distributed to all
individuals involved with the use of therapeutic sources.
b. Establishment and maintenance of a log containing the physical
location of each source. This log should contain a record by date
of sources received, removed from storage, in use, and removed
from patients. For sources being used in patients, the log should
state the name of the responsible physician and the patient. When
sources are removed from a patient, the sources should be
immediately counted and a comparison made with the log entry when
the sources were removed from storage to assure that all sources
are accounted for.
c. Requirements for survey of each patient using proper radiation
detection instrumentation when radioactive sources are implanted
and removed. In addition, the patient's room, the linen, and
material leaving the room should be surveyed during treatment for
sources that may become dislodged.
d. Requirements for the performance of periodic inventories of all
sealed radioactive sources. These inventories should be performed
on a schedule to assure control of the sealed sources but on a
schedule no less than that required by your license and/or 10 CFR
Part 35.14(b)(5)(v).
e. Suitable control and restriction of access to, and provisions for
security of, radioactive sources.
2. Assure that periodic audits or other management controls are exercised
to ensure that procedures are followed.
No written response to this Circular is required. If you require additional
information regarding this matter, contact the Fuel Facility and Materials
Safety Branch of the appropriate NRC Regional Office.
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