IA-85-471, Discusses Policy & Guidance Directive Fc 85-1;Licensing Lixiscope & Bone Mineral Analyzer. Revised Directive Provides Comprehensive Guidance Re User & Instructor Qualifications & Human Use at Temporary Job Sites
| ML20134D220 | |
| Person / Time | |
|---|---|
| Issue date: | 01/25/1985 |
| From: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20134D205 | List: |
| References | |
| FOIA-85-471, FRN-53FR24077 AC80-2-50, NUDOCS 8508190147 | |
| Download: ML20134D220 (6) | |
Text
. . . ..-- e UNITED OTATES p '[ U' 5
$, NUCLEAR HEGULATORY Commission
. y i.,
2 i VJ ASHINGTON D C 205 %
j- ,t..@wp - ,{
J M E5 E33 Sfld /
MEM0PAliDUM FOR: Regional Administrators Branch Chiefs Division of Fuel Cycle and Material Safety Richard E. Cunningham, Director FRO:i:
Division of Fuel Cycle and Material Safety POLICY Ai!D GUIDANCE DIRECTIVE FC 85-1; SU3 JECT:
LICEliSING THE LIXISCOPE Ai1D B0i1E MIftERAL ANALYZER
- 1. Introduction Policy and Guidance Directive FC 83-24, dated i;ovember 10, 1983, provided guidance on licensing human use of lixiscopes and bone mineral analyzers.
' However, additional questions have been raised about licensing policy for these devices. In particular, questions are being raised about instructors' and customers' qualifications, because in many cases these devices are being distributed to sales representatives and customers who had no previous training or experience in radiation safety This prior to their interest in the
(- lixiscopes and bone mineral analyzers.
revised directive rore com.prehensive guidance, particularly with respect to: (a) user quali-provides fications, (b) instructor qualifications, and (c) human use at temporary 4
job s.
- 2. Training Criteria for Human Use of Lixiscope,s and Bone Mineral Analyzers by Physicians Currently, lixiscopes and bone mineral analyzers containing iodine-125 or americium-241 may be distributed to: (a) medical institutions holding broad licenses, (b) group medical licensees, and (c) certain specifically .
licensed medical institutions and. physicians. By definition, broad medical licensees and Group VI licensees have users who possess adequate training and experience to use these devices. Other specifically licensed institu-tions and physicians must demonstrate that proposed physician-users have -
adequate training.
Proposed physician-users are considered to have adequate training and experience if they:
- a. Are specifically named as an authorized user on a f;uclear Regulatory Co.re.issicn (t;RC) or Agreement State license to use byproduct material specified in one or nore of Groups I through VI, inclusive, of Section 35.103, or 8508190147 850716 PDR FOIA ROBINSOB5-471 PDR
Multiple Addressees -2~
,d b. Are certified by the American Board of i;uclear Medicine, or the American Board of Radiology in Radiology, Therapeutic Radiology, or Diagnostic Radiology with Special Competence in iluclear Radiology (certification as a British " Fellow of the Faculty of Radiology" or " fellow of the Royal College of Radiology" or Canadian certification from the Royal College of Physicians and Surgeons in therapeutic radiology is also acceptable),
or
- c. Are specifically named (or have in the past been specifically named) as a user on an 14RC or Agreement State license authorizing use of the lixiscope or bone mineral analyzer, or
- d. As a minimum, have received a total of eight hours of training as described in Enclosure 1 of this directive.
The training described in Enclosure 1 must have been received within five years of the date of the application, except as follows: if more than five years have elapsed since the completion of training in the topics in
. Groups A and B of Enclosure 1, then the proposed physician-user must be able to demonstrate his continuing involvement with radioactive materials or radiation-producing equipment (e.g., physician routinely performing x-ray examinations in his office or hospital).
is'ote Supplement A of Form i1RC-313M may be used to document this training.
ig that the training need not have been received all at one time, at one Y institution, or from one instructor. The following individuals are consid-ered by the i!RC to be qualified to provide the formal training as described in Enclosure 1: a health physicist certified by the American Board of Health Physics, an institution licensed by the State to provide education in the medical arts, an flRC or Agreement State licensee whose license authorizes medical use of the lixiscope and/or bone mineral analyzer, and/or other instructors who may be found qualified on a case-by-case basis (see Item f5 below). Additionally, all applicants shall provide written evidence, such as a signed certificate of completion, that they have successfully completed the training described in Enclosure 1.
- 3. Training Criteria for Human Use of Lixiscopes by Dentists or Podiatrists
~The liRC staff has been advised that dentists and podiatrists may be interested in u:ing the lixiscope on their patients and has considered whether these professionals meet the definition of a " physician" found in 10 CFR 35.3(b). Enclosure 2 discusses this matter in greater detail and concludes that an exemption can be granted provided that the proposed podiatrist-user or dentist-user:
- a. Is licensed to practice dentistry or podiatry by a State or territory of the United States, District of Columbia, or Comu naealth of Paerto Rico, and A
JAN 2 51355 Hultiple Adressees
- b. As a minimum, has received a total of eight hours of training as described in Enclosure 1 and Item #2.d. above.
In these cases, Condition 12 of the license should be worded as follows:
"Notwithstanding the provisions of Sections 35.3(b) and 35.13 of 10 CFR Part 35 and pursuant to Section 30.ll(a) of 10 CFR Part 30, the lixiscope may be used by (podiatrists's or dentist's name) o to practice (podiatry or dentistry)."However, Office of the Executive Legal Directo with Headquarters staff. staff recommends that, in each of these cases, the o show that the exemption was granted in accordance with the policy and guidance in this directive and document that the criteria of Sections 3a. and b. above are satisfied.
- 4. Training Criteria for Non-Human Use of Lixiscopes Lixi, Inc.,
The lixiscope may also be licensed for various non-human uses.
the manufacturer, has designed a short course and manual for safe non-human(the use of the lixiscope. Lixi, Inc., Stan A. Huber Consultants, Inc.
consulting company who helped develop the course), and Lixiscope of America, Inc., a marketing organization, have all described in their license applications their instructors' qualifications and their programs for teaching the course. The course covers basically the same topics in For students with no previous
( Enclosure 1 as related to non-human use.
training or experience in radiation safety, all topics a minimum of 5-6 hours is spent on the course.
arecertificates Course covered and by these three licensees may be accepted as evidence of adequate training issued for non-human use.
However, the reviewer may wish to verify on a case-by-case basis that the instruction was actually provided by a paid employee of the licensee, and that the appropriate number of hours was devoted to training.
Other licensees in either Agreement or non-Agreement States, particularly sales representatives, might also offer lixiscope training courses.
If these courses have been evaluated and approved by WRC or an Agreement State as part of a license application, they may be accepted as evidence of adequate training.
In evaluating proposed courses, the NRC staff should pay careful attention to the course topics, length of the course, and instructors' qualifications (see Item !5 below).
Applications may be received for proposed users who have not completed a formal lixiscope course, but who have other training and experience.
The training and experience should be reviewed on a case-by-case basis, considering its relevance, length of time, and instructors' qualificaticns The applicant must demor. strate that his training (see Item e5 below).
covers the canufacturer's " device specific" instructions and literature.
A shortened version of the formal courses discussed above is one
' acceptable way to meet this requirement.
i
M 2 iliG5
-Multipledddressees I
.g 5. Instructors' Qualifications for.Lixiscope Training d
A A person who merely obtains the minimum training required for a license to use the lixiscope is not qualified to be a lixiscope instructor.
Although this position has been stated verbally and in writing by the is This l
NRC staff on many occasions, confusion persists on this point.
l in part because NRC does not license instructors as such, but rather
- licenses possession of radioactive material. Also, the manufacturer's i marketing strategy has involved sales representatives who had no previous knowledge of radiation safety prior to involvement with lixiscopes.
i Because of the wide variety of training and experience among people in the radiation safety professions, exact criteria cannot be established for instructors. However, the following information is provided to
' assist in evaluation, particularly where the instructor's training appears to be minimal:
- a. Lixi, Inc., has established the following minimum qualifications ,
for its instructors: high school graduate, completion of the
- users' training course, and completion of 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> additional training covering regulations, radiation safety, and use of the device.
~
- b. Consistent with Item 62.d above and general medical licensing
-policy, physicians, podiatrists, and dentists who are licensed to
- [. use the lixiscope are considered qualified to instruct other physicians, podiatrists, and dentists.
'A
- 6. Human Use of the Lixiscope and Bone Mineral Analyzers at Temporary i Job Sites 4
' 'In the past, NRC has not routinely authorized human use of radioactive material at non-medical temporary job sites;"for examole, shopping centers, i
sporting events, and conventions. Any applications involving such use j should be referred to Headquarters. (Human use at medical facilities
- such as hospitals, clinics, doctors' offices, and nursing homes may be i
licensed without coordination with Headquarters.)
- 7. Physical Presence of Users for Non-Human Use of Lixiscopes In order to avoid misunderstandings as to whether lixiscopes are used by trained people, licenses for non-human use should specify that an' authorized
-user must be-physically present during use.
4
- 8. Personnel Monitoring and-Survey Meters for Routine Use'of Lixiscopes t
Individual reviewers may make a case-by-case determination as to whether personnel ronitoring or survey meters are required for routine use of lixiscopes. For intermittent use, such as in research and development or l
medical use, .we have not usually required personnel monitors or' survey l y meters. However, for continuous use by an operator, who constantly places j his hand near the radiation beam, personnel monitoring may be appropriate;
'- for example, an inspector on an assembly.line. Where personnel monitoring is required, extremity monitors are preferable to whole body monitors.
F
I Multiple Addressees JMi 2 51985 f -
t!e have not normally required survey meters for routine use of lixiscopes.
However, the new 10 CFR Part 35 uill probably require that a survey meter be available for users of sealed diagnostic sources. Therefore, when the new Part 35 becomes effective, it should be reviewed for applicable requirements.
- 9. Exchange of Lixiscope Sources The lixiscope is designed so that the entire source assembly can be removed by .the user, returned to the manufacturer for a new source, and reinstalled by the user. Users need not remove the source from its shielded container, and they should not normally be authorized to perform this operation.
Any request from a user, service company, distributor, or manufacturer to remove sources from their shielded positions for service or exchange should be carefully reviewed. Some iodine-125 sources contain iodine-126 as an impurity. The sources must be held for decay prior to distribution in order to avoid excessive radiation levels on the surface of the lixiscope. -
This directive supersedes Policy and Guidance Directive FC 83-24, dated November 10, 1983. If you have further questions, please contact Vandy Miller (FTS: 427-4002).
,.F
./..,h
( ,. /
Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety, NASS
Enclosures:
- l. Training Criteria for Medical Users of Lixiscope and Bone Mineral Analyzer Devices
- 2. Memo from VLMiller to RECunninghan dtd
,1/7/83 9
9
\.
Recomended Vedical Users Training for Lixiscope
'~
and Bone Pineral Analyzer Diagnostic Devices Grouc A - Basic Padiation Physics and Instementation (3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />)
- 1. Ataric Structure
- 2. Decay Process and Types of Brissions (especially ga7nt radiation)
- 3. Radioactivity - Definitions and Units (curies, rots, and sub-units)
- 4. Interactions of Radiation with Patter
- 5. Half-Life, Inverse Square Law and Half-Value Layers (tire, distance, and shielding)
- 6. Decay constant formula and use of Decay Tables '
- 7. Inverse Square law formala .and exa ples
- 8. Calculation of Padiation Dose in Air, Tissue and Bone
- 9. Radiation Dase - Dose Pate, Time and Average Dase
- 10. Characteristics of Sealed Sources (co pared to radioactive liquids and other physical foes)
Grouo' B - Padiation Bioloav (3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />) .
- 1. Acute and chronic exposures
- 2. S:ratic and genetic effects
- 3. Basis of Paxir::am Per:nissible Dase
- 4. Typical Screatic effects at various dose levels
- 5. Genetic effecs and Genetically Significant Dose
- 6. Pactors Affecting Biolcgical Da. -
age (dose, dose rate, type of rn% tion, type of tissue, amount of tissue, biolcgical variation and chenical rolifiers)
Grouc C - Radiation Protection (2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />) -
- 1. Principles of Radiation Safety and ALA3A Panage ent Program
- 2. " Standards for Padiation Protection" 10 CFR Part 20 and " Instructions to Padiation Workers" 10 CFR Part 19, and Equivalent Agreer.ent State Regulations
- 3. License Conditions for Padiation Safety Progra:n
- 4. Radioactive Snipnent Receiving, Opening, Handling, Storage and Security Procedures
- 5. Padiation labels and required posting and documents
- 6. Routine proper use, inventory and accountability procedures for sealed sources, or devices con'% sealed sources
- 7. Irak Test of Sealed Sources and contriimtion control
- 8. 5%tment Returns, DC7T Regulations and Supplier Instructions and Ebms
- 9. Radiation Detec' don Instrmenta' don ,
- 10. NRC Draft Regulatory Guide " Instruction Concerning kadiation Expsure" dated Pay 1933 and URC Regalatory Guide 8.13 " Instructions Cbncerning ,
Prenatal Radiation Exposure" dated Noverber 1975 :
- 11. Title 10 CPR Part 35 "Pedical Use of Radionuclides" and NRC Pagulatory l Guide 10.8 Procedures and License applica' dons (
- 12. Padiation Safety References, ICRP and ICFP Ptfolica' dons l
- 13. Review and discussion of the sealed scarce " device specific" tranafacturer I literature and instructions l 1 .
1 1
Enclosure 1 ,
l 4
_ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ . _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ l
s .
. .- 5 .
- UNITED STATES o** %
.?b k NUCLEAR REGULATORY COMMISSION f d j w AssiNcioN. D. c. 20555
/ NOV 7 1933 FEMORAND(.M FOR: Richard E. h aingham, Director Division of Ebel Cycle and Paterial Safety FRCM: Vandy L. Miller, Chief Faterial Licensing Branch Division of Ebel Cycle and Paterial Safety SL'17ECT: USE G 'HE LIXISCDPS BY PODIATRISTS AND DTE In the past, the authorized user condition on licenses permitting htran use
'of licensed material, has regaired that the users be pihysicians as defined ,
in 10 GR 35.3(b) . Individuals who (1) hold doctor of medicine (M.D.) or dcctor of osteopathy (D.O.) degrees and (2) are licensed by a Sta'a or territory of the United States, District of Cbitrbia or Camonealth of Puerto Rico to dispense drugs in the practice of medicine imet the require- ,
ments of 10 GR 35.3(b) .
The gaestion has arisen as to whether podiatrists and dentists are physicians
- as defined by 10 GR 35.3(b) because merbers of these treo professions have expressed interest in using the Lixiscope, a hand-held device containing
(. byproduct r aterial that can be used in a tranner similar to a fltoroscope to examine the feet and toes (the interest of the podiatrists) aM, if the device available as of Farch 1983 is rodified, to exa-2.ne the teeth and jaw area (the interest of the dentists).
Because raerbers of both of these professional groups are scretimes licensed by a State or territory of the United States, Distrirx. of Cblirbia or Ctrnon-wealth of Puerto Rico to practice podiatry or dentis'q but not medicine, they do rreet part of the definition in 10 GR 35.3(b). khether rarbers of these groups are licensed to " dispense drugs" can be de'armined, on a case-by-case basis, when the NRC staff mertber verifies with a particular jurisdiction that the proposed user is licensed. The key issue is what constitutes the " practice of redicine." Dependiy. upon hcw " medicine" is defined, podiatry and dentis'4 coald be excluded because the practioners are involved with only a limited portion of the htman tcdy.
The NRC staff has decided to take a conservative approach to this issue, to asstr.e that podiatrists and dentists are ICT physicians aM 'w consider whether an exe:ption, pursuant to 10 GR 30.ll(a), could be granted to -
$0'
_g o n,yM Wo *w G S - .
Enclosurra 2
1 t...-* 1 l
,b , .
1 1
NOV l Richard E. Cunningham 7 1933 1
( allow pcdiatrists and dentists to use the Lixiscope for htran use m con-nection with their practice of podiatry and dentistry, respectively. 'Ibe NRC staff believes that such an exe ption is pen-itted by law, would not endanger life or pM or the ccrron deferse and security and muld be in the ptiblic interest. The follcwing pints have been considered:
- 1. ne Lixiscope is a diagnostic tcol tha' reey provide useful infortration to dentists and podiatrists in the care of their '
patients. Dentists and p,htrists who are careful in their use of the Lixiscope r ay be'able to obtain needed infocration nore gelckly and with less radiation exposure to their patients than vould be true if other tools wre used.
- 2. Before so:in an exe:ption is granted, the IE staff verifies that the preposed yodiatrist-user or dentist-user (a) is licensed by a State or territory of the United S'ates, District of Cblt::foia or Ctnronwalth of Puerto Rico and (b) neets or exceeds the nihi:ntra training criteria that NRC has established. ,
- 3. We reA6'eist's or dentist's use of the Lixiscooe is lirited to use in the practice of podiatry or den'ls'ay, respectively. This wuld be done by license condition.
- 4. All other aspects of the review of an application for a license to use a Lixiscope are essentially the sa:r.e, regard-less of whether the pro;nsed user is a rnedical dcctor, dcctor of ostecpathy, podiatrist or den' dst.
Since the Spring of 1933, the Khc has been pursuing a change in 1Z's regulations to clarify the issue of whether p:.diatrists and dentists are incitded within the 10 GR 35.3(b) definition. Until the publication of the final rule dange to Part 35, the NRC staff on its own ini* dative (as provided for in 10 GR 30.11[a])will exerpt pdiatrists and dentists fran the definition in 10 GR 35.3(b) regarding their use of the T3 rig in the practice of podiatry and dentistry, respectively, PRCVIDED points 2 and 4 as listed above are rnet by the agplicant and the license is con-i ditioned as described in point 3.
/~
ff s
./.bb? ff { u .
j Vandy L. Licensing Branch
'ill , O'd f lhte
- Division of Ebel Cycle and Paterial Safety,10'.55
( O
_ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ . __ _ _ _ . . _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ . _ . _ _ _ _ _ . _ _ _ _ _ _ . . _ _ _ _ _ _ _ . _ _ _ _ _ . . _ _ _ _ _ _ . _ _ . _ _ _ . _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ . . _ _ _ _ _ . . _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ . .