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OMB No. 3150-0012 NRCB 93-01 UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555 April 20, 1993 NRC BULLETIN 93-01: RELEASE OF PATIENTS AFTER BRACHYTHERAPY TREATMENT WITH REMOTE AFTERLOADING DEVICES Addressees - Brachytherapy Licensees Authorized to Use Afterloading Brachytherapy Unit(s) Capable of Delivering Dose Rates Greater than 500 RADS (centigray) per Hour at 1 Centimeter Purpose The U.S. Nuclear Regulatory Commission (NRC) is issuing this Bulletin: (1) to notify addressees about the risk involved in releasing brachytherapy patients without positive assurance that all implant material has been removed before the patient's release, and the need to plan and train for both normal and emergency procedures; (2) requesting that all addressees take the actions specified below; and (3) requiring that all addressees provide the U.S. Nuclear Regulatory Commission with a report stating whether the requested actions have been taken or, if not applicable, state why the requested actions do not apply. Description of Circumstances According to information received by the NRC, an outpatient being treated with an Omnitron Model 2000 remote afterloading unit at the Indiana Regional Cancer Center (IRCC) in Indiana, Pennsylvania, of Oncology Services Corporation was returned to a nearby nursing home, after treatment, with the radioactive source remaining in her body. The treatment took place on November 16, 1992, and the patient died on November 21, 1992. The cause of death of this patient, as listed in the official autopsy report, is "Acute Radiational Exposure And Consequences Thereof." Until the source, approximately 4 curies of iridium-192, was recovered after the patient's death, it subjected nursing home residents and staff, as well as visitors, to radiation exposure. Radiation doses to the 94 individuals associated with the event ranged from 40 mrem to 22 rem. An investigation after the patient's death determined that IRCC personnel experienced difficulty with source placement in one of the patient's five treatment catheters. The investigation found that a short piece of the cable containing the iridium source had broken off and remained in one of the catheters. The investigation also found that, although a wall-mounted area monitor alarmed at various times when the source should have been retracted, the licensee's staff believed the area monitor was emitting a false signal and chose to ignore it. Also, no survey of the patient was performed by the 9304140122. NRCB 93-01 April 20, 1993 Page 2 of 5 licensee, using a hand-held survey instrument, despite the area radiation alarm condition. A second incident was reported by Oncology Services Corporation on December 7, 1992. A subsequent investigation found that a source again separated from the drive cable on an Omnitron Model 2000 Unit, located at the licensee's Greater Pittsburgh Cancer Center during brachytherapy treatment of a patient, and lodged in the catheter, external to the patient. The investigation determined that the physicist detected the source separation during the treatment after hearing an audible alarm from the remote afterloader and observing the area radiation monitor alarm; he confirmed the source had not been fully retracted using a portable survey meter and, thereafter, cut the catheter behind the source and immediately removed the patient from the treatment room. The remaining portion of the catheter was then removed from the patient, and both the catheter and patient were again scanned with a survey instrument, to confirm that no part of the source remained within the catheter or patient. In this incident, the licensee's staff reacted promptly and appropriately, and no excessive unintended exposures were received by either the patient or the staff. Discussion Irrespective of the terminology used by the remote afterloading device manufacturer, if the device is capable of using a single source to produce exposure rates in excess of 500 rads (centigray) per hour at one centimeter, then this Bulletin applies. Thus, for the purposes of this Bulletin, all remote afterloading brachytherapy units capable of producing exposure rates in excess of 500 rads (centigray) per hour at one centimeter will be referred to as High-Dose-Rate (HDR) afterloaders. However, NRC is aware of one special type of remote afterloading device, commonly known as a pulsed dose rate afterloader, that uses a single source capable of delivering dose rates up to 4800 rads (centigray) per hour, but is used to provide the equivalent of a low dose treatment by inserting the source for a given fraction of each hour. For this special class of device, a licensee may submit an alternative, to the procedure set forth in item 3, for insuring that control of the source is maintained during treatment. Any such alternative submitted will be carefully evaluated for adequacy in maintaining control of the source. NRC and the U. S. Food and Drug Administration (FDA) are conducting ongoing investigations of the cause of the source wire failures associated with the Omnitron Model 2000 Unit. Until complete failure analysis information is available, all patient treatments using this manufacturer's system must be viewed as having a high risk for similar failures. Although NRC has no recent reports of such failures of other HDR models, similar failures are possible. For example, an incident occurred in August, 1988, where, because of an incomplete weld, the end cap of a Nucletron MicroSelectron-HDR became detached from the source capsule and resulted in three out of seven iridium-192 elements inside the capsule being deposited in both the head and close-ended applicator of the HDR. Given the severe consequence associated with loss of control of one of these high-activity sources, users of all HDRs need to be especially vigilant, in all their operations, to minimize the effects of any machine or procedural errors that could lead to loss of control of the source. . NRCB 93-01 April 20, 1993 Page 3 of 5 Based on what is presently known about the Indiana, Pennsylvania incident, it is clear that if radiation surveys of the patient had been made with a hand held survey instrument, before releasing the patient from the facility, the consequences of that incident would have been largely avoided. Although rare, the loss of control of one or more of these high-activity radiation sources has great potential for causing injury or death to patients, workers, and members of the public. Requested Actions Because the consequences of such a loss of control are so severe, NRC, through this Bulletin, is alerting appropriate medical licensees and expects them to implement the following measures to minimize the possibility of such an event occurring again. Therefore, licensees using HDR afterloaders are requested to either immediately implement the following actions in conjunction with any use of the unit and to respond in writing, stating their commitment to these actions or, else, stating why these requested actions do not apply to their facility: 1. In accordance with 10 CFR 35.404(a), following removal of the source, the licensee shall make a radiation survey of the patient with an appropriate radiation detection survey instrument, as specified in 10 CFR 35.420, to confirm that all sources have been removed. For surveys associated with HDR procedures, the licensee must use a portable radiation measurement survey instrument, capable of measuring dose rates of 1 millirem per hour to at least 1000 millirem per hour. It is important to use calibrated survey instruments with appropriate sensitivity, since the high exposure rates associated with these sources can easily overload some survey instrument detectors, resulting in a false low reading. This survey of the patient must be done whether or not there is any indication of radiation levels provided by an area radiation monitor. The surveys shall be performed immediately after completion of the therapy procedure before removal of the patient from the treatment room, and appropriately documented in accordance with 10 CFR 35.404(b). The required area monitor provides an immediate indication of a possible problem and thus serves a useful function as an early warning device. This area monitor will provide a visible indication of an exposed or partially exposed source, and must be observable immediately on entry into the treatment vault. It must be equipped with an independent source of backup power and checked with a dedicated check source for proper operation each day of use of the HDR device. However, it has neither the accuracy nor the sensitivity required to comply with the survey requirements of 10 CFR 35.404(a). 2. A 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 not begin any treatment procedure for which a decoupled or jammed source cannot be removed expeditiously from the patient and placed in a shielded condition. The licensee shall ensure that appropriate staff and equipment are available immediately, at the location that the HDR . NRCB 93-01 April 20, 1993 Page 4 of 5 procedure is performed, to implement the written emergency procedures. Equipment shall include shielded storage containers, remote handling tools, and, if appropriate, supplies necessary to surgically remove applicators or sources from the patient, to include scissors and cable cutters. The emergency source removal procedure should minimize exposure to health care personnel while maximizing safety of the patient. 3. During all patient treatments, both the authorized user and either the medical physicist or radiation safety officer must be physically present. Physical presence, for this purpose, is defined as within audible range of normal human speech. 4. The licensee shall ensure that personnel are trained in both the routine use of the HDR afterloading device and emergency procedures necessary to return the source to a safe condition. Training shall be provided immediately to new personnel and periodic retraining, not to exceed 12 month intervals, shall be provided for all personnel. The licensee shall retain records of this training for a period of 3 years. Reporting Requirements All addressees are required to report, in writing, within 30 days of the date of this Bulletin, whether the actions described in this Bulletin have been taken, or stating why they do not apply to their facility. 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. This 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 Device Act 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 be 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. . NRCB 93-01 April 20, 1993 Page 5 of 5 The following information, although no specific request nor requirement is intended, 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. If you have any questions about 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: 1. List of Recently Issued NMSS Bulletins 2. List of Recently Issued NRC Bulletins .
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