IE Circular No. 78-10, Control of Sealed Sources Used in Radiation Therapy

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 

                                  1 of 2 
.

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. 

                                  2 of 2