Information Notice 1992-84, Release of Patients Treated with Temporary Implants

Release of Patients Treated with Temporary Implants

ML031190728
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	12/17/1992
From:	Cunningham R NRC/NMSS/IMNS
To:
References
IN-92-084, NUDOCS 9212170204
Download: ML031190728 (6)

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UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 December 17, 1992 NRC INFORMATION NOTICE 92-84: RELEASE OF PATIENTS TREATED WITH TEMPORARY

IMPLANTS

Addressees

93 JAN -8 R7':3 All Nuclear Regulatory Commission Medic~lULJ censRs phi;

Purpose

The purpose of this notice is to inform licensees ab6ut concerns about

releasing brachytherapy patients without positive assurance that all implant

material (sources) have been removed from patients before their release.

These concerns encompass all brachytherapy procedures, including both manual

and remote afterloading techniques, using temporary implants. It is expected

that recipients will review the information for applicability to their

facilities and consider actions, as appropriate to avoid similar problems.

However, suggestions contained in this information notice are not new NRC

requirements; therefore, no specific action or written response is required.

Description of Circumstances

According to preliminary information that the Nuclear Regulatory Commission

received, an outpatient, being treated with an-Omnitron Model 2000 High Dose

Rate (HDR) Afterloading Brachytherapy treatment system, at a freestanding

cancer center, was returned to a nearby nursing home, after treatment, with

the source remaining in the patient's body. The treatment took place November

16, 1992; the patient died 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. He noted that the symptoms and

timing of the symptoms were consistent with severe, acute radiation syndrome.

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. This catheter was removed and the

patient returned to the nursing home, with the remaining four catheters in

place. 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 one of the catheters. Although a wall-mounted area monitor alarmed when v

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 IttC-I

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IN 92-84 December 17, 1992 patient was conducted, using a hand-held survey 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, and lodged in the catheter, external to the patient.

In this instance, the physicist detected the source separation during the

treatment; he 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 scanned

with a survey instrument, to confirm that no part of the source remained

within either the catheter or patient.

Additionally, failure to perform proper radiation surveys, after treatment of

the patients with low-dose manual brachytherapy procedures, has led to loss of

control of one or more sources. NRC has received several recent reports of

such incidents, where the sources were eventually discovered in normal trash, at a disposal facility.

Discussion

The NRC and the U. S. Food and Drug Administration are conducting ongoing

investigations of the cause of the failures associated with the Omnitron Model

2000 Unit. Until 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 using this

manufacturer's system must be viewed as having a high risk for similar

failures. Although NRC has no recent reports of similar failures of other HDR

models, such failures are possible. Because of the severe consequence of the

lost of control of one of these high-activity sources, users of all HDRs need

to be especially vigilant, in all of their operations, to minimize the effects

of any machine or procedural errors that could lead to loss of control of the

source.

Preliminary information, from the NRC investigation team at the cancer center

site involved in the November 16, 1992 incident, is that the room monitor

often produced false alarm indications; thus licensee personnel considered it

to be unreliable. It would appear that licensee personnel had been

conditioned, by repetitive false alarms, to ignore any information provided by

this primary radiation safety device. This device was used in place of a

portable radiation survey instrument, needed to conduct surveys required by

10 CFR 35.404(a).

Based on what is presently known about this incident, it is clear that if

proper radiation surveys of the patient had been made, before releasing the

patient from the facility, the consequences of this 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. Thus, because the

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IN 92-84 December 17, 1992 consequences of such a loss of control are so severe, NRC" through this

information notice, is alerting all medical licensees and expects them to

consider all reasonable measures to minimize the possibility of such an event

ever occurring again.

All licensees are reminded-that, in accordance with 10 CFR 35.404(a), the

licensee shall perform a radiation survey of all patients being treated with

brachytherapy sources, with an appropriate radiation detection or measurement

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

needs to 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 survey instruments with appropriate sensitivity, since the high exposure rates associated with these sources can easily

saturate survey instruments, resulting in a false negative reading. This

survey is in addition to any indication of radiation levels provided by an

area radiation monitor. An area monitor provides an immediate indication of a

possible problem and thus serves a useful function as an early warning device.

However, it has neither the accuracy nor sensitivity required to comply with

the survey requirements of 10 CFR 35.404(a). 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).

It is expected that licensees will carefully consider the risks associated

with any procedure for which a decoupled source cannot be removed

expeditiously, from the patient, and placed in a shielded condition. NRC

Bulletin 92-03, dated December 8, 1992, requested all Omnitron HDR licensees

to 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. This would include providing for the

necessary staff and equipment to be immediately available, 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 (including scissors and cable

cutters) to help surgically remove sources from the patient. The emergency

source-removal procedure should minimize exposure to health-care personnel, while maximizing safety to the patient.

The licensee should train personnel in both the routine use of brachytherapy

sources and devices and emergency procedures to return sources to a safe

shielded condition. This training should include emergency procedures and cry

runs, for coupled and decoupled sources that either remain in the patient or

remain exposed external to the patient. Licensees are also reminded of the

general requirements, such as those contained in 10 CFR Part 19, 10 CFR

35.410, and license conditions, to have personnel trained to perform assigned

tasks in a manner that assures radiation safety. Training should be provided

immediately for new personnel, and retraining provided semiannually, for al

personnel. The records of this training should be maintained for a period of

three years.

IN 92-84 December 17, 1992 This information notice requires no specific action or written response. If

you have any questions about the information provided, please contact the

technical contact listed below, or the appropriate NRC regional office.

Rsg a nnEnn am, 'rector

Div sion 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 Information Notices

2. List of Recently Issued NRC Information Notices

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K> Attachmtw{ 1 IN 92-84 December'17, 1992 Page 1 of I

LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. . Subject Issuance Issued to

92-72 Employee Training 10/18/92 All U.S. Nuclear Regulatory

and Shipper Registra- Commission licensees.

tion Requirements for

Transporting Radioactive

Materials

92-62 Emergency Response 08/24/92 All U.S. Nuclear Regulatory

Information Require- Commission licensees.

ments for Radioactive

Material Shipments

92-58 Uranium Hexafluoride 08/12/92 All fuel Cycle Licensees.

Cylinders - Deviations

in Coupling Welds -

`"-38 Implementation Date for 05/12/92 All holders of OLs or CPs

the Revision to the EPA for nuclear power reactors, Manual of Protective non-power reactors and

Action Guides and Pro- materials licensees author- tective Actions for ized to possess large

Nuclear Incidents quantities of radioactive

material.

92-37 Implementation of the 05/08/92 All Nuclear Regulatory

Deliberate Misconduct Rule Commission Licensees.

-2-34 New Exposure Limits for 05/06/92 All licensees whose opera- Airborne Uranium and tions can cause airborne

Thorium concentrations of uranium

and thorium.

Uranium Oxide Fires at 02/21/92 All fuel cycle and uranium

Fuel Cycle Facilities fuel research and develop- ment licensees.

92-11 Soil and Water Contamina- 02/05/92 All uranium fuel fabrica- tion at Fuel Cycle Facil- tion and conversion facil- ities ities.

C -

Yttachment 2 4 .

IN 92-84 December 17, 1992 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

88-23, Potential for Gas 12/18/92 All holders of OLs or CPs

Supp. 4 Binding of High-Pres- for nuclear power reactors.

sure Safety Injection

Pumps during A Design

Basis Accident

92-83 Thrust Limits for 12/17/92 All holders of OLs or CPs

Limitorque Actuators for nuclear power reactors.

and Potential Over- stressing of Motor- Operated Valves

92-82 Results of Thermo-Lag 12/15/92 All holders of OLs or CPs

330-1 Combustibility for nuclear power reactors.

Testing

92-81 Potential Deficiency 12/11/92 All holders of OLs or CPs

of Electrical Cables for nuclear power reactors.

with Bonded Hypalon

Jackets

92-80 Results of Thermo-Lag 12/07/92 All holders of OLs or CPs

330-1 Combustibility for nuclear power reactors.

Testing

92-79 Non-Power Reactor 12/01/92 All holders of OLs or CPs

Emergency Event Response for test and research

reactors.

92-78 Piston to Cylinder 11/30/92 All holders of OLs or CPs

Liner Tin Smearing on for nuclear power reactors.

Cooper-Bessemer KSV

Diesel Engines

92-77 Questionable Selection 11/17/92 All holders of OLs or CPs

and Review to Deter- for nuclear power reactors.

mine Suitability of

Electropneumatic Relays

for Certain Applications

OL = Operating License

CP = Construction Permit