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United States Nuclear Regulatory Commission - Protecting People and the Environment

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                                                      OMB No. 3150-0009
                                                      NRCB 92-03

                                 UNITED STATES
                         NUCLEAR REGULATORY COMMISSION
               OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
                            WASHINGTON, D.C. 20555

                               December 8, 1992

NRC BULLETIN 92-03:  RELEASE OF PATIENTS AFTER BRACHYTHERAPY 

Addressees: (see attached list)

      For Action  -     Brachytherapy Licensees Authorized to use the Omnitron
                        Model 2000 High Dose Rate (HDR) Afterloading
                        Brachytherapy Unit

      For Information - None

Purpose

This Bulletin: (1) notifies addressees about the risk related to the release
of brachytherapy patients without positive assurance that all of the implant
material has been removed prior to the patient's release; (2) requests that
all addressees take the actions specified below; and (3) requires that all 
addressees provide the U.S. Nuclear Regulatory Commission with a report 
stating whether the requested actions have been taken or whether use of the
Omnitron Model 2000 High Dose Rate Unit has been discontinued.

Description of circumstances

According to preliminary information received by the Nuclear Regulatory
Commission, an outpatient being treated with an Omnitron Model 2000 Unit at
the Indiana, Pennsylvania Regional Cancer Center of Oncology Services
Corporation was returned to a nearby nursing home after treatment with the
source remaining in the patient's body.  The treatment took place on 
November 16, 1992, and the patient died on November 21, 1992.  Based on the
patient's medical records, the preliminary conclusion of NRC's consultant
physician is that the patient either died as a result of exposure to
radiation, or that radiation exposure was a major contributor to her death. 
Until the source, approximately 4 curies of Iridium-192, was removed from the
nursing home after the patient's death, it subjected nursing home residents
and staff, as well as visitors, to radiation exposure.  Radiation doses to
these members of the public are still being evaluated. 

Cancer Center personnel experienced difficulty with source placement in one of
the patient's five treatment catheters.  Subsequent investigation after the
patient's death found that a short piece of the cable containing the iridium
source had broken off and remained in the catheter.  Although a wall-mounted
area monitor alarmed when the treatment was completed, the licensee's staff
believed the device was emitting a false signal and chose to ignore it.   
Also, no survey of the patient was conducted utilizing a hand-held survey 


9212080258.

                                                      NRCB 92-03
                                                      December 8, 1992
                                                      Page 2 of 4


instrument to  determine if a source remained in the patient as required by 
10 CFR 35.404(a).

A second incident was reported on December 7, 1992.  A source again separated
from the drive cable on a Omnitron Model 2000 Unit during brachytherapy
treatment of a patient at the Greater Pittsburgh Cancer Center of Oncology
Services Corporation, Pittsburgh, PA.  In this instance, the source separation
was detected at the end of the treatment and recovery of the source was made.

Discussion and Requested Actions

The NRC and the United States Food and Drug Administration (FDA) are
conducting ongoing investigations of the cause of the failures associated with
the Omnitron Model 2000 Unit.  Until the failure analysis information is
available, it is unclear whether the manufacturer will be required to recall
the device, implement design modifications and/or conduct field retrofits to
prevent the recurrence of the problem.  Consequently, all patient treatments
given using this manufacturer's system must be viewed as having a risk of
similar failure.  Therefore, licensees are requested to either discontinue
using the Omnitron 2000 Unit or immediately implement the following actions in
conjunction with any use of the unit:

1.    In accordance with 10 CFR 35.404(a), the licensee shall make a radiation
      survey of the patient with an appropriate radiation detection survey
      instrument to confirm that all sources have been removed.  This survey
      is in addition to any indication of radiation levels provided by  an
      area radiation monitor.  The surveys shall be done immediately after
      completion of the therapy procedure prior to removal of the patient from
      the shielded HDR treatment room, and appropriately documented with
      initials/signatures. 

2.    A licensee shall not conduct any procedure for which a decoupled source
      cannot be removed expeditiously from the patient and placed in a
      shielded condition.  The licensee shall have written emergency
      procedures describing actions to be taken, including surgical
      intervention, should the source not return to the shielded container at
      the conclusion of treatment.  The licensee shall assure that appropriate
      staff and equipment are available immediately, at the location that the
      HDR procedure is performed, to implement the written emergency
      procedures.  Equipment should include shielded storage containers,
      remote handling tools, and, if appropriate, supplies to help surgically
      remove sources from the patient to include scissors and cable cutters. 
      The emergency source removal procedure should minimize exposure to
      healthcare personnel while maximizing safety to the patient.

3.    The licensee shall ensure that personnel are trained in both the routine
      use of the device and emergency procedures to return the source to a 
      safe condition.  Training shall be provided immediately for new
      personnel and retraining provided semiannually for all personnel.  The
      licensee shall retain the records of this training for a period of three
      years. 
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                                                      NRCB 92-03
                                                      December 8, 1992
                                                      Page 3 of 4


Reporting Requirements

All addressees are required to report, in writing, within 15 days of the date
of this Bulletin whether the actions described in this Bulletin have been
taken or whether the use of the Omnitron Model 2000 device has been
discontinued.

Address the required written reports to the U.S. Nuclear Regulatory
Commission, ATTN:  Document Control Desk, Washington, D.C. 20555, under oath
or affirmation, under the provisions of Section 182a, of the Atomic Energy Act
of 1954, as amended.  In addition, submit a copy to the appropriate NRC
Regional Administrator.

The request is covered by Office of Management and Budget Clearance Number
3150-0012, which expires June 30, 1994.  The estimated average number of
burden hours is 20 person-hours per licensee response to this Bulletin. (This
estimate of the average number of burden-hours pertains only to the
preparation of the required report and does not include implementation of the
requested actions).  Send comments about this burden estimate or any other
aspect of this collection of information, including suggestions for reducing
this burden, to the Information and Records Management Branch, Division of
Information Support Services, Office of Information Resources Management, U.S.
Nuclear Regulatory Commission, Washington, D.C.  20555, and to the Office of
Information and Regulatory Affairs, (3150-0012) NEOB-3019, Office of
Management and Budget, Washington, DC 20503.

Licensees should also be aware of the user facility reporting requirement of
the Safe Medical Devices Amendments of 1990.  A user may be required to submit
a report to FDA if a medical device causes or contributes to a death.  In
addition, the user may required to report to the manufacturer any serious
injury or illness involving the device.  For information on user facility
reporting requirements or to determine if they apply to your operation contact
Bryan Benesch, FDA, at (301) 427-1144.

Although no specific request or requirement is intended, the following
information would be helpful to NRC in evaluating the cost of complying with
this Bulletin:

(1)   The licensee staff's time and costs to comply with the requests in this
      Bulletin;

(2)   The licensee staff's time and costs to prepare the requested report and
      documentation; and

(3)   An estimate of the additional long-term costs that will be incurred in
      the future as a result of implementing commitments. 
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                                                      NRCB 92-03
                                                      December 8, 1992
                                                      Page 4 of 4


If you have any questions regarding this matter, please contact the technical
contact listed below or the appropriate NRC Regional Office.


                                              ORIGINAL SIGNED BY


                                          Richard E. Cunningham, Director
                                          Division of Industrial and 
                                             Medical Nuclear Safety
                                          Office of Nuclear Material Safety 
                                            and Safeguards

Technical contact:  Robert L. Ayres, IMAB
                    (301)-504-3423
Attachments:
List of Addressees
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