ML20217G031

1997 Medical Policy Statement

ML20217G031
Person / Time
Issue date:	09/30/1997
From:	NRC
To:
References
RULE-PR-35-MISC NUDOCS 9710090156
Download: ML20217G031 (5)

Text

__ - _-_ _ __ - -__ _ .

i September 30,1997 I

1 1997 MEDICAL POLICY STATEMENT

! NOTE 1

l l

l Following Commission approval of the staffs program to ravise 10 CFR Part 35 and associated guidance documents, the NRC staff initiated development of draft rule language, using a modality based approach. As directed by the Commission, the staff has developed alternatives, with draft rule text, for the more significant issues associated with the regulation of the medical use of byproduct material. These alternatives to regulation in specific areas are intended to help focus the d!scussion during the NRC's public meetings and the meetings with medical professional societies during the Fall of 1997 and to assist the staff in developing the proposed rule language, i The alternatives represent a broad range of possibilities and are being provided to

. stimulate input from members of the public in an effort to encourage all interested parties to provide input into the development of the revised regulation. The NRC staff has not selected any alternative at this time, and is open to additional alternatives which might be proposed that are consistent with the guidance provided by the Commission.

.. U -\ N 'I /10 0 ice b M b

,1 if, I n

\

h #

?$A 35 MISC lR**' " PDR gggggll31H TA

W'60

F d

o 0/25/97 RECOMMENDATION FOR REVISION TO NRC'S 1979 MEDICAL POLICY STATEMENT OPTION 1: Status Quo Current statement of general policy to guide regulation of medical ases of radioisot pes states:

1. The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public. ,

2. The NRC w?i regulate the radiation safety of patients where justified by the risk l to patients and where voluntary standarus, or compliance with these standards,  ;

are inadequate.

3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine.

EIQ1

1. Consistent with NRC's authority in the Atomic Energy Act of 1954, as amended, to .

regulate domestically the uses of byproduct material, including medical use, to protect public health and minimize danger to life and property.

2.- Recognizes that physicians have primary responsibility for protection of their patients, by stating that the NRC will minimize intrusion into medical judgments affecting safety.

3. Regulation of the radiation safety of patients is risk based.

4. For higher risk activities, NRC may elect to circumscribe areas that might otherwise be regarded as within the discretion of the physician.

5. Current statement provides for balance between protection of the patient and avoiding intrusion into the practice of medicine.

GQat 1.- Allows for some, although minimal, NRC involvement in medical judgements affecting patients.

~

l

_ . _ . _ _ _..-- _.~- _ _ _. _ __ _ -

4 f

OPTION 2: Apnl 1997 recommendation of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) t ACMUI recommended statement of general policy to guide regulation of medical uses of radioisotopes would be:

1. [No change.)

2. The NRC will regulate the rad ation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these standards are inadequate. Assessment of the risks justifying such regulations will reference comparable riska and comparablo modes of regulation for other types of medical practice.

. 3. The NRC will not intrude into rredical judgments affecting patients and into other .

areas traditionally considered to be a part of the practice of medicine. 4 ELDL

, 1. Regulation of the radiation safety of patients is risk based.

" 2. Acceptable level of risk associated with regulating the medical use of byproduct material may be lower than in other areas of mecficine.

~

3. Clearly states that NRC will not be involved with the physician patient interface.

l 4. Recognizes that physicians have primary responsibility for protection of their patients.

C0.0A

1. Requires NRC to assess risks in other typss of medical practices, which may be j problematic.-

' 2. Implementation of statements #2 and #3 could be in conflict when the level of risk justifies intrusion.

k 2

---,v -c, <yo -

m---- g -s m>+ -~v,-- - - - - - ~

ii j - DH.lQft1 l Revised statement of general policy to guide regulation of medical uses oi :adioisotopes would

be

l 1. (No change.)

l l 2. The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these l standards are inadequate.

. 3. The NRC will continually strive to minimize involvement in medical judgments i affecting patients and into other areas traditionally considered to be a part of the

practice of medicine.

1 i

l ElQA

1. Consistent with NRC's authority in the Atomic Energy Act of 1954, as amended, to j regulate domestically the uses of byproduct material, including medical use, to protect public health and minimize danger to life and property.

2. Regulation of the radiation safety of patients is risk based.

4

! 3. For higher risk activities, NRC may elect to circumscribe areas that might otherwise be ,

. regarded as within the discretion of the physician. l

4. Recognizes that physicians have primary responsibility for protection of their patients.

S. Provides additional emphasis that NRC's policy is to minimize intrusion into medical

! practice.

l CDDR j 1. Acceptable level of riek associated with regulating the medical use of byproduct material may be lower than for other areas of medicine.

2. Allows for some, although minimal, NRC involvement in medical judgements affecting patients.

3

E t'

s QPTION 4:

Revised statement of general policy to guide regulation of medical uses of radioisotopes would be:

1. [No change.)

2. The NRC will regulate the radiation safety of patients consistent with the risk posed by the rad!eactive materials, in regulating the radiation safety of patients, NRC's role is to assure that the physician's prescription is accurately delivered to the correct patient.

3. The NRC will not intrude into the medical judgement forming the basis of the physicians' prescription.

P.19n

1. Consistent with NRCs authority in the Atomic Energy Act of 1954, as amended, to regulate domestical., the uses of byproduct material, including medical use, to protect public health and minimize danger to life and property.

2. Recogn'zes that physicians have primary responsibility for protection of their patients, by stating that the NRC will not intrude into medical judgements forming the basis of the physicians' prescription.

3. Regulation of the radiation safety of patients is risk based.

CODE

1. NRC's role in regulating the radiation safety of patients is narrowly focused.

4

_=