ML20150D141

Amends 10CFR35.14(b)(5)(vii) to Req Source Counts & Radiat Surveys to Insure the Removal of Radioactive Implants from a Patient After Treatment

ML20150D141
Person / Time
Issue date:	11/14/1978
From:	Gossick L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
RULE-PR-35 10CFR35.14, NUDOCS 7812050042
Download: ML20150D141 (5)

Text

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Title 10 - Energy.  :

.j CHAPTER I.- NUCLEAR REGULATORY COMMISSION.

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PART 35 - HUMAN USES OF BYPRODUCT MATERIAL lf.l.. ; '

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Radiation Surveys of Therapy Patients z.; ,

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AGENCY: U.S. Nuclear Regulatory Commission (NRC) it ~ t ACTIOil: Final . rule  ![._ w g= 5

SUMMARY

Certain NRC licensees are authorized to treat patients with ...

. temporary implants ~ incorporating radioactive material. NRC will ..

- ui require such ' licensees to confirm the removal of the implants :at the l$.

end.of the treatment by (1) a. source count and (2) a radiation. survey of -

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the patient. Failure to account for all implants at the conclusion ,

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• f patient 'reatment has resulted in s,ome instances-of unnecessary diation exposure to patients and' members of the general public.

F EFFECTIVE DATE: The amendment becomes effective on DEC 2 81978 [h. ,

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FOR FURTHER INFORMATION CONTACT: Edward'Podolak, Office of Standards f:

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Development, U.S. Nuclear Regulatory Commission, Washington, D.C. .E

20555 (Phone: 3~01L443-5966 i) .

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i SUPPLEMENTARY INFORMATION: NRC' regulations in 5 35.14(b)(5)(vii) '

require Group VI licensees

• to assure that patients treated with

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cobalt-60, cesium-137 or iridium-192 temporary implants remain

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hospitalized until the implants have been removed. The primary method for confirming that all sources have been removed is to l

l count the' sources implanted and count the sources removed. The-  :

source counting has not always been' performed accurately, or on a i a timely basis.

i Some patients have been discharged from the hospital with radioactive sources still implant'ed. (It is particularly difficult l to count , iridium-192. seeds, which sometimes become dislodged from their encasement in nylon ribbon). Because a backup radiation survey of the patient could have ' prevented these incidents, on June 28, 1978 NRC. published a proposed rule in the FEDERAL REGISTER adding a j requirement for source counting and patient radiation surveys to the.

existing 5:35.14(b)(5)(vii) which prohibits Group VI licensees from discharging patients until all sources are removed. The comment I I period ended August 14, 1978.

The most common types of NRC specific licenses for the medical use of byproduct material are the Group medical licenses under 5 35.14 ,

that apply to those radioactive materials listed in 5 35.100. The radioactive, materials listed in 5 35.100 are divided into six groups,.

each group haviro similar requirements for user training and experi-ence, facilities and equipment, and radiation safety procedures.

Groups.I, II, and III are lists of radiopharmaceuticals for diagnostic procedures; Groups-IV and V are lists of radiopharmaceuticals for therapeutic procedures; and Group VI is a list of radioactive medical -

devices for both diagnostic and therapeutic procedures.

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Twenty-one coments were received. Eleven favored the propos'al without qualification. Three commenters suggested that bulky after-loaded devices that protrude from the body be exempted from the t

radiation survey. One commenter suggested that an x-ray be permitted

?  ! as an alternative to the radiation survey. One commenter asked what

• was meant by "the end of the treatment" and one commenter, while l

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favoring the proposal, suggested that the radiation survey should be

'I performed within one hour of source removal. Four commenters objected f to the proposal because they believe that regulations that define i -

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.  ! what is already good medical pratice are useless. One commenter i

j objected to the proposal because he believes that there are some cases where it would be impossible to survey the patient before discharge.

The wording of the final rule is the same as the proposed and requires a radiation survey of the patient before discharge. The radiation survey is the most positive (active) method of verifying source reraval. The x-ray is a passive method. Although good i

practice would suggest a radiation survey soon after source removal,

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the regulation has to recognize the realities of the clinical setting I where other tasks may have higher priority. Placing a tight time limit on this essentially quality control f unction may interfere with patient care. However, it is extremely unlikely that the licensee will experience difficulty performing the survey between source removal and discharge of the patient.

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The suggestion to exempt afterloaded devices is well made. The devices are bulky relative to the actual source size and it is difficult to imagine that patients would be discharged with these .

devices in-place. However, NRC inspectors, who are familiar with ,

incidents of overexposure from implants remaining in patients, say i l that this is an area where the '! impossible" happens in spite of l 1

great care and precautions. Also, NRC inspectors have investigated

• an incident where a patient was discharged with an afterloaded device {

in-place with the sources loaded. The radiation survey is simple and inexpensive and it will also detect any sources lost in the

• bedclothes or. room were the survey is performed. Therefore, the afterloaded devices will not be exempted from the requirements for a t

radiation survey.

Finally, regulations that define what is generally considered good practice may seem useless o'r may even dismay conscientious i

licensees. However, this is insufficient reason to forgo these regulations when there is evidence that the good practices are not

, universel.

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! Under the Atomic Energy Act of 1954, as amended, the Energy .

I Reorganization Act of 1974, as amended and sections 552 and 553 of title 5 of the United States Code, notice is hereby given that the  !

following amendment to 10 CFR Part 35 is published as a document I subject to codification.  ;

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In 10 CFR Part 35, S 35.14(b)(5)(vii) is amended to read as' l

follows:

l 5 35.14 _ Specific licenses for certain groups of medical uses of l byproductmaterig.

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! (b) Any licensee who is authorized to use byproduct material pursuant to one or more groups in SS 35.14(a) and 35.100 is subject i

to the following conditions:

(5) For Group VI any licensee who possesses and uses sources t

or devices containing byproduct material shall:

(vii) Assure that patients treated with cobalt-60, cesium-137 k or iridium-192 implants remain hospitalized until a source count and a radiation survey of the patient confirm that all implants have been removed.

(Sec.161, Pub. L.83-703, 68 Stat. 948 (42 U.S.C. 2201); Sec. 201, f Pub. L.93-438, 88 Stat.1243 (42 U.S.C. 5841))

Dated at Bethesda, Marylandthis 14th day of l

November 1978.  !

For the Nuclear Regulatory Commission.

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.uf Lee V. Gossick Executive Director for Operations f

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