ML20202D132
| ML20202D132 | |
| Person / Time | |
|---|---|
| Issue date: | 10/29/1976 |
| From: | Karen Chapman, Minogue R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| References | |
| SECY-76-529, SECY-76-529-R, NUDOCS 9902010312 | |
| Download: ML20202D132 (50) | |
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- UNITED' STAT **
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- ' October 29, 1976 C R RE " " ..( COMMISSION SECY 76- 529 I
INFO" .AflON REPORT For: The r .issioners from: .,0bert B. Minogue, Director, Office of Standards Development and l Kenneth R. Chapman, Director, Office of Nuclear Materials Safety and Safeguards Thru: Executive Director for Operations
Subject:
THE ISSUES CONCERNING NRC INVOLVEMENT IN THE REGULATION OF NUCLEAR MEDICINE
Purpose:
To provide the opportunity to brief the Commission on the key issues concerning NRC's involvement in regulating nuclear medicine.
Discussion: As a part of the Comission's rey'iew of NRC regulations, the staff is preparing a paper which will identify the key issues concerning NRC's present and future involvement in regulating nuclear medicine. This task includes (1) providing a historical p(erspective on AEC-NRC policies regarding nuclear medicine;2 of nuclear medicine, as well as the often overla of other federal, state, and private agencies; (pping activities
- 3) identifying
.the key issues; and (4) recommending a future course of action for NRC. The first steps are accomplished, and the staff desires to brief the Comission on the key issues before a recomendation is prepared. We believe that.it would be advantageous to obtain a rense of the Comission on the key issues before proceeding to develop a staff recomendation.
Coordination: The briefing mate' rials enclosed in this paper have been coordinated with the Offices of Inspection and Enforcement,
. State programs and the Executive Legal Director.
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(ff ,j Robert B. Minogue, Director %Kenneth R. Chapman, Director Office of Standards Development Office of Nuclifar Materials Safety and Safeguards
Enclosure:
Materials for Comission Briefing on Nuclear Medicine DISTRIBUTION Comissioners
Contact:
Comission Staff Offices Robert F. Barker, SD, Ext. 443-6976 Exec Dir for Operations Richard L. Cunningham, NMSS, Ext. 492-7553 Secretariat SECY NCTTE: This briefing will be scheduled in the near future. ) ,, 9 g 20 g 2 761029 [~ ['76-529 R PDR
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- ' NUCLEAR RE'"" ' .d COMMis310N SECY 76 529 October 29, 1976 l lNFO"..A flON REPORT For: The c assioners From_:
..obert B. Minogue, Director, Office of Standards Development and Kenneth R. Chapman, Director, Office of Nuclear Materials Safety and Safeguards Thru: Executive Director for Operations V
Subject:
THE ISSUES CONCERNING NRC INVOLVEMENT IN THE REGULATION OF NUCLEAR MEDICINE
Purpose:
To provide the opportunity to brief the Comission on the key issues concerning NRC's involvement in regulating nuclear medicine.
Discussion: As a part of the Comission's review of NRC regulations, the staff is preparing a paper which will identify the key issues concernir.g NRC's present and future involvement in regulating nuclear medicine. This task includes (1) providing a historical p(erspective on AEC-NRC policies regarding nuclear medicine c
of nuclear medicine, as well as the often overla of other federal, state, and private agencies; (pping activities
- 3) identifying
.the key issues; and (4) recomending a future course of action for NRC. The first steps are accomplished, atid the staff desires to brief the Comission on the key issues before a recommendation is prepaned. We believe that it would be adventepeous to obtain a sense of the Comission on the key issues bein proceeding to develop a staff recomendation.
Coordination: The briefing mate' rials enclosed in this paper have been coordinated with the Offices of Inspection and Enforcement,
, State Programs and the Executive Legal Director.
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[g y Robert B. Minogue, Director %Kenneth R. Chapman, Director Office of Standards Development Office of NucWar Materials Safety and Safeguards
Enclosure:
Materials for Comission Briefing on Nuclear Medicine DISTRIBUTION Commissioners
Contact:
Comission Staff Offices Robert F. Barker, SD, Ext. 443-6976 Exec Dir for Operations Richard L. Cunningham, NMSS, Ext. 492-7553 Secretariat SECY NOTE: This briefing will be scheduled in the near future. ) ,, 9 9902010312 761029 ) ['
POR SECY 76-529 R PDR
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.. :.1 E. Podolak 10/14/76 BACKGIOUND ON THE REGULA'IORY CONTROL OF NUCLEAR MEDICINE i
PREFACE We Staff has identified, in this preface, some key issues that can be I
considered in review of the discussion of riuclear medicine which follows. l i
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%e Food and Drug Administration (FDA) is recognized as being the lead agency in regulating nuclear medicine. However, FDA is limited by its statutory authority to regulating the manufa'cture of drugs and devices (including radioactive drugs and devices) offered for interstate camerce.
We FDA does not have the authority to regulate the use of a drug or device.
In contrast, the NBC's statutory authority to regulate byproduct, source i
and special nuclear material is not limited in this area and can cover all aspects of both the manufacture and use of drugs and devices involving such materials. 'Ihis basic difference in regulatory authority emphasizes the I- central issue, "How far does NRC want to go in regulating nuclear medicine?".
'Ihe NRC program of control to protect the health and safety of the worker, the patient and the general public in the medical uses of byproduct, source and special nuclear material is basically a licensing program. The NRC licenses the possession and use of such materials by manufacturers, l distributers, pharmacies, researchers, medical institutions and private
- physicians. The licensing program consists of four steps, (1) the license application, (2) staff review, (3) granting the license with certain conditions (or denying the license) and (4) inspection and enforcement.
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c Under NRC regulations a prospective licensee must sutruit an application 1
for a license which contains basic information concerning the available facilities and equipment, the radiation safety program and the users qual-l ifications. An applicant for the hinnan use of byproduct material subnits !
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supplemental information pertaining to the purpose for which the licensed l.
material will be used (specific corxlitions to be diagnosed or treated),
special equipnent and facilities, and the users clinical experience.
L The NRC Staff reviews the license application to determine the applicant's 1
ability, (1) to satisfy NRC regulations, (2) to provide radiation safety for l 1
employees and the public and (3) to liinit offsite releases.
l' Basic information in the byproduct material license application includes:
(a) he names, training and experience of irx31vidual users; (b) te name, training and experience of the radiation safety officer;
'(c) Possession limits for each radioisotope; (d) Purposes for use; l
(e) Number, type, method and frequency of calibration for radiation i
detection instruments; (f) Facilities and Equipnent; (g) Radiation Protection Program; (h) Waste disposal.
2 Supplemental information for human use includes:
(a) Using physician's name, clinical training and experience and radio-isotope handling training and experience; (b) Specific conditions or diseases to be diagnosed and treated; (c) Investigative proposals for experimental or non-routine use; (d) Quality assurance procedures for material not obtained in pre-calibrated dosage form; (e) Description of dose calibrators and diagnostic instrumentation l (f) Method and frequency of calibration of survey instruments and dose calibrators.
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A license is granted if after a thorough review, th- att determines that the applicant has met the criteria in the rem cions and can carry out the proposed activities safely. 'Ihe licensee is required to ccrnply with the applicable NRC regulations and all conditions in the license. License condi-tions include portions of the license application.
Follow-up inspections of licensees for compliance with NRC regulations and license conditions are conducted on a scheduled sampling basis.
Some specific issues related to the central issue are:
- 1. Should the NRC evaluate physicians qualifications?
- radiation safety qualifications? - clinical qualifications?
- 2. Should the NRC place restrictions on the use by a physician of radioactive drugs or devices that have been approved by FDA?
- 3. Should the NRC require a physician to report the misadministration of radioactive material or radiation from radioactive material to the NRC?
- to the patient or a responsible relative?
- 4. Should the NRC evaluate the qualifications of paramedical personnel, such as, technologists, nurses and radiological physicists? Should the review be limited to radiation safety qualifications?
- 5. Should the NRC ensure that the patient receives what is prescribed? (e.g.,
by requiring the periodic calibration of teletherapy devices, or the use of dose calibrators to measure all doses of radioactive drugs pric to administration, or the periodic calibration of diagnostic equipment, such as, scanners and garrrna cameras to minimize " retakes"?)
Clearly this list is not exhaustive.
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R. F _ak 10/14/76 BACKGROUND ON THE REGUIAF an'ROL OF NUCLEAR MEDICINE I.- INTRODUCTION 2e patice of medicine involves two broad areas: clinical medicine (diagnosis and treatment of disease) and blamedical research (study of normal body function and the disease process). ;
he use of radioisotopes in medicine started in the mid 1920's, when clinicians used isotopes of radium, a naturally occurring radioisotope, to determine the velocity of the blood flow by measuring the transit time from arm to arm. The measurements were made in both normal persons and patients with various diseases.
Blood circulation measurements remain a important tool of diagnostic nuclear medicine, which, over the years, has grown to include such techniques as (1) measuring the uptake of radioactive drugs by individual organs (for such purposes as assessing thyroid function);
(2) " imaging" or measuring the distribution of radioactive drugs amore organs or within an organ (to detect the presence of tumors, for example); (3) estimating the size of certain body pools (such as red blood cell and blood plasma voltanes); and (4) measuring the components in biological samples (such as protein binding sites and hormones in blood and urine). The first three examples of diagnostic use are termed in vivo (inside the bcriy), since radioactive drugs are administered to b
the patient. The fourth example, measuring the components of biological l'
i samples, is termed in vitro (outside the body), since the assay is per-formed in a test tube in a clinical laboratory and no radioisotop2 is
- introduced into the patient.
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i-The utepeutic aspect of nuclear medicine involves the ure of radioactile substances to treat both malignant and non-malignant direases ano dis-orders. Therapeutic techniaues include (1) the use of radioactive droos internally (for example the treatment of hyperthyroidicm); (2) the une of the use of radioactive devices both as implants and on the surfcce of the body (termed "brachytheracy" or therapy from a short distance); and (3) the use of radicactive devices external to the body (termed " teletherapy" j 1
or therapy from a distance). l I
i Nuclear medicine has provided a battery of new tools for both the !
clinician and the researcher and has grown from 38 medical institutions 1
using radioisotopes in 1946 to 6346 NRC licenses and an eouivalent 2
number of NRC Agreement State licenses . Based on discussions with the industry and other agencies, the Staff has estitrated 30 million nuclear 3
medicine procedures per year are conducted at an estimate i cost of 1.6 4
billion dollars .
1 1,355 medical institution licenses 701 private practice licenses 470 teletherapy licenses 3,820 general licenses for medical use.
2 3,967 Agreement State medical licenses (institution and private practice). Data on general medical licenses not available, not all Agreement States have general licenses.
3 Breakdown of nuclear medicine procedures:
13 million in vivo radioactive drug 10 million In vitro diagnostic 7 million teletherapy (.3 million patients / year x 25 procedures / patient) plus an unknown number of brachytherapy procedures 3reakdown of cost:
S100 million in vivo and in vitro sales S 89 million EIagnostic imaging and scanning device, naler
$1.15 billion for 23 million in vivo and in vitro procedures assumino an average of $50 per procedure, (exclusive ot materials sno ecuipment costs)
S300 million for teletherapy ($1000 per patient)
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The major cteps involved in the nuclear medicine industry are:
- Production of the radioisotope, usually by irradiation ot~ ntable elementa in an accelerator or nuclear reactor. chemical n t ut a-tion of the radioisotope from the target material may be necennary.
A few marufacturers of the final drug or device have their own radioisotooe production facilities (both reactors and accelerators).
A few medical institutions use accelerators to produce very short-lived radioisotopes.
- Manufacture of the final radioactive drug or device. In the manufacture of an in vivo radioactive drun or an in vitro test kit, the radioisotope is combined (often in complicated chemical processes) with the non-radioactive coreponents and packaged for delivery to the user. For brachytherapy devices, the radio-isotope may be alloyed with or encapsulated in an inert material in the form of a " seed", " needle" or " plaque". For teletherapy 60 137 devices, the radioisotope (usually Co or Cs) is doubly encapsulated ar.d then enclosed in a heavy shield for transportation and use.
In the U.S., 6 major radiopharmaceutical houses oroduce most of the prepackaged racioactive drugs and g vitro ciagnostics usea in most medical institutions, clinical laboratories and private (physician) offices.
x A grey area in the manufacture of radioactive arcas and 1
devices is the " nuclear pharmacy." Tne activitien of noctrar pharmacies range from performing simple manioulations, sucn as
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measuring out individual doses of radioactive drugs which b:
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'been manufactured elsewhere, to petforming conplex yeal procedures and preparina radioactive drugs fr: . raw materials. ;
L Their'busineos may extend from servicing a single medical-1 institution to dispensing radioactive drugs to an entire geographic region and in most cases, their activities are l )
carried out within the state borders in which they are located.
There is no clean line to decide when a nuclear charmacy has i
gone beyond the ordinary practice of pharmacy (comoounding and dispensing), and becomes a manufacturer, a determination
'of most importance to the Food and Drug Administration.
- Distribution of the radioactive drug or device. The radioactive drug or device is transported between the manufacturer and the user (medical institution, clinical laboratory and the physician's ;
t private office) by comerical transportation (passenger and carao l aircraft, train, bus, truck and taxi) and private auto. The l inner packages are often shielded and the inner and outer containers are labeled. Transportation of radioactivo drugn is the largest contribution to the total population exposure from the normal transportation of radioactive material (NURCG-0034).
A part of the distribution process for teletherapy devices includes the installation of the device in specially shielded rooms by NBC and Agreement State licensed service companies, i
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- Use of the radioactive drug or device can be as simple as placin<1 I
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a radioactive capsule into a patient's mouth or arawin<r a prepared raoicactive orug into a syringe and injectina it into
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. ., 1 a patient. The use of a raaioacti" .ug ma) invcise "cluting" !
3 a radioisotope generator - .ombininq the radioisotope with j l
i I l a chemical reagent " .- to produce the final dosage Iorm. ;
.i The drug then un be drawn up into a syringe and injected into the patient. Technicians ano nurses assist the physician who is primarily responsible for the delivery of the nuclear medicine service to the patient. The preparation of the radioactive drug is usually either by a technician or a pharmacist, and the injec-tion is usually performed by technicans or nurses when state and i
local laws permit. The' diagnostic equipment (i.e ccanners and l
scintillation " cameras") often are operated by technicians.
! Technicians also operate the-teletherapy devices.
- Disposal of the radioactive drugs and devices usually follows the traditional methods of decay, dilution and dispersal through the L sewage system, or collection and land burial. The most widely 99m used radioactive drug ( Tc) has a half-life of 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> and the waste material is often held for decay and disposed as non-radio-active waste. Patients excrete much of the administered radio-active drug which usually goes directly into the sewer. liowever, sealed sources in teletherapy and brachytherapy are used over ana 3
A radioisotope generator (or " cow") is a shielded device purchased from a drug manufacturer containing a carent-daughter radioisotope (such as Mo .
Tc-99m). The radioisotope is adsorbed on a column that is arranged so a I solution can be fed through the column to wash out ("elute") only the l daughter radioisotope (Tc-99m). The parent has a longer half-life than the f l daughter and continuously " generates" the daughter radioisotope which is eluted when needed. The Mo Tc-99m generator is usually eluted every 24
- hours and replaced once'a week (because the parent has decayed below i
useful levels).
4 The reagent kit is also purchased from a drug manufacturer ana usually recuircs only simple manipulations such as adding the radioisotone to a vial and shakina.
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w:r until they have decayed beyond usef ulnenn at which t iw they ,
are often returned to the manufacturer, l
Considerations of' radiation safety in nuclear medicine can be divideo into three areas of concern (1) the radiation safety of the workers (2) the radiation safety of the general public and (3) the radiation safety of the patient.
L During the production of radioisotopes and during manufacture, dis--
tribution, use and disposal, the radiation exposure of workers must be i kept within acceptable limits. A recent study of 47 medical institutions indicates that the radiation exposure of medical workers is comparable to
(' that of irdustrial radiographers and nuclear reactor personnel. The 1
general radiation safety considerations in nuclear medicine are similar i
to those in the rest of the nuclear industry: (1) training of personnel, l' (2) adequacy'of facilities and eauipment, and (3) control of releases of j I
l l radioactivity. The radiation exposure to workers is in part a function !
of the quantity of radioactive material handled, which is in turn a func-tion of the nunber and types of nuclear medical procedures performed.
The increase in the use of nuclear medicine over the past 30 years and the trend to shorter half-life radioisotopes has been accompanied l: :/
L by an increase in the exposure to workers. The general public is exposed l
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L to the radioactive effluents from the drug and device manufacturers and medical institutions. The extent of this exposure is not known. The BEIR report predicts cumulative patient dose from diagnostic nuclear medicine alone will reach 3.3 million person-rem / year by 1%0. This com-pares to exposure from background radiation of 10 million person-rem / year.
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Of major importance to the practice of medicine is the safety and efficacy of drugs and devices with respect to the patient. In nuclear-medicine this includes radiation safety. Any drug or device must be shown to be effective in diagnosis or. treatment. flarmful side effects (or adverse reactions) must be of lesser significance than the intended i effect. The safety and effectiveness of both the drug or device and the associated nuclear medicine procedures, parallel safety and efficacy con-siderations for non-radioactive drugs and devices. Prior to routine manufacture and use, the safety and efficacy of both radioactive and non-radioactive drugs and devices is established with elaborate pro-grams of animal testing followed by investigational testing in humans.
The labeling of the drug or device lists the uses for which the product has been shown to be safe and effective. Durino manufacture, special precautions are taken to establish and maintain the purity of radioactive and non-radioactive components of the radioactive drugs and devices. The radioisotope purity, chemical purity, sterility and freedom from fever producing substances (pyrogens) is checked through quality control testina of samples from each lot. Most cuality control testing is completed before 99m a product is released, however, in the case of Tc and other short half-life radioactive drugs, sterility and pyrogen tests are not completed until'after the product is released.
In nuclear medicine, virtually every element in the clinical situation bears in some way on the raaiation exposure to the patient. The traininq of physicians and paramedical personnel (i.e., technicians, nursen, etc.),
the cuality assurance controls on dosage preparation and the coality assurance controls on the ciagnostic and therapeutic instrumentation all
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play a role in determining the radiation exposure a oatient receives. ;
Tey factors in protecting the patient from unnecessary or excesE se f
exposure are (1) the choice of.the proceduce, drug or device including the desired. radiation dose (i.e.,the prescription), and (2) assuring the patient receives exactly what was prescribed [i.e.,(a) performing
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quality control tests (e.g. radioactive assay and checks on the chemical '
and physical form) to assure that the prescribed dosage of a radioactive drug has been accurately prepared, (b) quality control tests on the diagnostic ecuipment to' insure proper operation (minimizing " retakes"),
(c) quality control tests on therapeutic devices (e.g. calibration),
(d) patient identification and (e) care in diagnosis and follow up (e.g. removal of all implants, examination for unexpected reactions)].
II. CONTROLS OVER THE PRACTICE OF NUCLEAR MEDICINE Research in the area of nuclear medicine includes the testing of radio- l i
active drugs and devices (1) in the test tube, (2) in animals and (3) in i i
humans. Testing in humans can be distinguished between testing to study l normal body function and the disease process (biomedical research) and testing related to the development of a specific drug or device (clinical medicine). This paper deals only with that research which is identified with the development of a specific drug or device.
Clinical medicine, including clinical medicine research, is the sub-ject of often overlapping controls by a host of governmental and private organizations. Organizations currercly involved in regulating nuclear medicine include NRC, the 25 NRC Agreement States, the Food and Drug Administration (FDA/DHEW) the Social Security Administration (SSA/DHEW),
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the Environmental Protection Agency (EPA), the Occupatin" stety i and Health Administration (OSHA), the Joint Cor-' e on Accreditation of Hospitals (JCAH), State health deparr .o,' and at least 13 different peer groups, including the America- Pnarmaceutical Association and the r
American Board of Nuclear Medicine chartered by American Medical Associa-tion. The activities of each of these control groups are discussed briefly in the following paragraphs. l NUCLEAR REGULA'IORY COMMISSION AND THE AGREEMENT STATES The NRC and the Agreement S'ates regulate .the manufacture, distribution and clinical use of byproduct, source and special nuclear material in nuclear medicine. NRC regulates virtually all aspects of the radiation safety of I the workers and the general public and certain aspects of the safety and efficacy with respect to the patient. For many years the AEC regulated the safety and efficacy of radioactive drugs and devices with respect to the patient (in consultation with their Advisory Ccmittee on the Medical Uses of Radio-isotopes) because the FDA exempted those radioactive drugs controlled by the AEC and radioactive devices were not regulated by the FDA. In 1974 the FDA announced its intention to terminate the exemption for AEC controlled drugs and the AEC withdrew from regulating the safety and efficacy of radioactive t drugs. 'Ihe NRC continues to evaluate the safety and efficacy with respect to the patient of certain radioactive devices, for example, bone mineral analyzers, Pu-238 pacemakers and brachytherapy sources. The NRC does not regulate naturally ;
occurring and accelerator-produced radioactive material (NARM); however , the Agreement States (and most non-agreement states) do regulate NAIN. For nuclear medicine, licenses are issued to manufacturers, pnarmacies, medical institutions, and individual physicians. NRC licenrees are inspected on a scheduled sampling basis for compliance with NRC regulations and license conditions.
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' -J' FOOD AND DRUG ADMIT" arION (FDA)
We Pure _vod Drug and Cosmetic Act of 1938 entablinhni t he aut hor i t y for FDA to regulate the safety of drugs offered for interstate commerce through controlling the product labeling. Legislative amendments in 1962 gave the FDA tighter control over drug safety and introduced controls over the efficacy of drugs (to foreclose the marketing of safe, adequately labeled drugs that did not work). The Pure Food, Drug and Cosmetic Act of 1938 (as amended) provided FDA the authority to control the manufacture of drugs, including radioactive drugs, but did not provide authority for PDA j
l to control the use of these drugs. Specifically, FDA has no authority to l
regulate the way in which a prescription drug is used by a licensed phy-
- sician (including uses not approved in the labeling). At the same time, FDA requires the manufacturer to carry out investigational programs to )
establish the safety and efficacy of new drugs and it can take years l l' to substantiate, through clinical trials, a new use for a drug already ,
I approved for other uses. Legislative amendments in 1976 gave the FDA authority to regulate medical devices similar to its authority to regulate the safety and efficacy of drugs.
We FDA employs a system of pre-market approval for drugs and pre-market l The approval, performance standards or general controls for medical devices.
FDA does regulate the use of radioactive drugs and devices during the inves-tigational stage before they are approved for routine use. The FDA discovers violations of its regulation thru periodic inspections, sample analysis and t consumer complaints.
1 J IAL SECURITY ADMINISTRATION (SSA)
'Ihe SSA controls medical services, includinq nuclear malicine, by cont r ollirvi the reimbursment process Ior tiedicare and Medicaid. The SSA set n nt arv1.ndn for medical services and then contracts with the individual states for state personnel to conduct periodic inspections of medicare and medicaid providers for empliance with SSA regulations. 'Ihe Joint Commission on Accreditation of Hospital's accredition is accepted as evidence of satisfyiry SSA requirements.
ENVIRONMEtTI'AL PMJnfTION AGENCY (EPA)
'Ihe Environmental Protection Agency regulates the use of radioactive material
, irdirectly through the drinking water standards and directly through Federal Radiation Council guidance. The EPA is contemplating preparing federal guidance to limit patient exposures from nuclear medicine services provided at federal facilities.
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA)
OSHA jurisdiction basically covers the workplace. The Williams-Steiger Occupational Safety and Health Act of 1970 specifically excludes OSHA from jurisdiction in those areas covered by the Atmic Energy Act of 1954 as amended. 'Ihus OSHA, in establishing and enforcing standards to provide safe places of employment, regulates the use of NARM along with other hazardous material but does not regulate the use of byproduct, source, or spocial nuclear material.
JOINT COMMISSION ON ACCREDITATION OF HOSPITALS (JCAH)
THE JCAH is a private, voluntary organization that (1) establishes stardards for the operation of hospitals and other health care facilities and services and (2) corducts periodic survey (inspection) and accreditation programs.
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l JCAH accreditation is necessary for a hospital to qualify as a teaching-facility for physician residency programs. JCAH accreditation also fulfills j
the SSA requirements for Medicare and Medicaid. JCAH and SSA standards are i similar and include specific standards for the delivery of nuclear medicine services. )
PEER GROUPS We peer groups are voluntary organizations that provide various services for their membership, including education, certification, cuanunication, lobbying, l i
and other special interest activities. The major peer groups are the Society of Nuclear Medicine, the American Board of Nuclear Medicine, the American College of Radiology, the American College of Nuclear Medicine, the American College of Nuclear Physicians, the American Society of Clinical Pathology, the American Registry of Radiologic Technologists, the Registry of Medical Technologists, the American Association of' Physicists in Medicine, the Health Physics Society, the American Board of Health Physics, the American Pharmaceutical Association, and the American National Stardards Institute.
STATE HEALTH DEPAR'1MENTS he individual states have police powers to protect the health and safety of their citizens. Each state licenses individual physicians for the practice of medicine within its borders. Each state has pharmacy laws and licenses individual pharmacies (including the " nuclear pharmacies") that prepare drugs for intrastate distribution. Each state licenses pharmacists and nurses, and at least two states license nuclear medicine technologists. Naturally occurring and accelerator produced radioactive material (NARM) are regulated by the NRC Agreement States and most non-agreement states. Regulation of NARM by non-agreement states consists of licensing (5 states) or registration
~(16 states) and may or may not include inspections.
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III. CURRENT STAFF ACTIVITIES CONCERNING NUFTPAR MEDIC A. PAPERS CURREtflLY BEFORE THE COPHISSION_
(1):
SPECIFIC LICENSES FOR INDIVIDUAIE AND INSTIMP ; (SECY-76
...g publication of a proposed We staff has prepared a paper recomery' rule requiring that all medical institutions providing nuclear medicine. services be licensed rather than the individual physicians 21s will ensure that the institu-practicing within the' institutions. k tion itself is responsible for the radiation safety of all wor ers, its patients and public who may be exposed to radiation from any of activities.
We proposed rule would continue the licensing of individu A related change would physicians practicing outside of institutions.
revise the name and function of the presently required institutiona ccanittee from a " medical isotopes comittee" to a "raliation safety comittee" .
(2) SPECIFIC LICENSES FROM HUMAN USE OF BYPROD SOUprrs (SECY-76-420)
%e staff has prepared a paper recommending the publication of a ru h
that would require the periodic calibration and checking of telet erapy r
We rule would also require that the person performing the devices.
calibration meet minimum training requirements.
B. PAPERS IN FINAL STAGES OF PREPARATION (1)- Pu-238 IN PACEMAKERS We Final Envirornental Statement for the use of Pu-238 23, 1976. The staf f is developing a pacemakers was issued July proposed rule to establish general licenses for the implantation possession by the patient of cardiac pacemakers using Pu-238 p
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(2) DELETION OF DIAGJOSTIC PROCEDURF" ~ . M PS I, II AND III
'Ihe staff is developing a ssed rule that would delete the specifica-tion of the diagnosM. procedures for the radionuclides listed in 1
l Groups I, II, and III of the group medical licenses. Section 35.100 lists groups of medical uses of radioisotopes that have similar requirements for user training and experience, facilities and equipuent, 1
l and radiation safety procedures. Deleting the diagnostic procedures from the first three 535.100 Groups will be a step toward deregulating nuclear medicine.
C. PAPERS UNDER STAFF CONSIDERATION (1) MISADMINISTRATION REPORTING REQUIREMEfff In 1973 the ABC published proposed amendments to its regulations (SECY-R 621) that would (1) require a physician to report to the
! Commission and to the patient misadministrations of byproduct material, (2) define the duties that could be delegated by the physician to l paramedical personnel, and (3) require the appropriate training of paramedical personnel. Miadministration was defined as the administra-tion of a radioactive drug, or radiation from a source (1) other than 1
the one intended, (2) to the wrong patient, or (3) outside of the intended dose range prescribed by the physician or by a route of admin-1 istration other than intended by the physician. The proposed rule was based on a 1972 General Accounting Office (GAO) recaumendation that in turn was based on GAO's review of the AEC's investigations of l twelve instances of misadministrations of radioactive material (involving l
20 patients) between 1961 and 19'2. The staf f is developing a new paper to recommend appropritate action on the proposed rule.
l l
l
1 4 .,
(2) PETITIONS-here is a petition under consideration that requests NRC to add a new
-75 radioisotope ( Se) to the general license for the use of specific types of byproduct material for _in vitro clinical tests in 531.11. There is a second petition under consideration that requests NRC to add a calibra-129 241 tion source (mixed I and Am) to the radioisotopes permitted urder the general license In 5 31.11.
(3) ALARA GUIDE FOR MEDICAL INSTInfrIONS
%e staff is preparing a guide for medical institutions to aid them in implementing the 10 CFR Part 20 requirements to keep radiation exposures as low as reasonably achievable, economic and social con-siderations being taken into account (AIARA).
4
l STATE REGULATION OF NARM kGREEN,E!JT STATESI LICENSING STATES REGISTRATION STATES OTHER STATES (and territories) 1 Alabama lilinois Alaska Delaware issues permit Arizona Michigan Connecticut District of Columbia registers radium i Arkansas New Jersey Hawail ' lowa noprogram California Pennsylvania Indiana, Montana registers radium Colorado Virginia Maine Puerto Rico no program t Florida Massachusettes Rhode Island I - no program Georgia Minnesota Virgin Islands i .
no program Idaho Missouri Kansas Ohio Kentucky Oklahoma Loulslana South Dakota Maryland Utah 4
j Mississlool - Varcent,
^
M2raska West Virsinia
! Nevada Wisconsin 1
New Hampshire Wyoming i
New Mexico New York l North Carolina North Dakota .
Oregon South Carolina Tennessee Texas Washington I licenses agreement material and NARM 2
Licenses NARM only
./
- GROUPS CONTROLLING NUCLEAR MEDICINE 1
r i
NUCLEAR
, [ T REGULATORY COMMISSION (NRC)
SOCIAL SECURITY FOOD AND DRUG ADMINISTRATION (SSA, ADMINISTRATION (FDA) ,
ENVIRONMENTAL JOINT COMMISSION ON PROTECTION NUCLEAR ACCREDITATION OF HOSPITALS AGENCY (EPA)
(JCAH) l MEDICINE '
r i
OCCUPATIONAL SAFETY
^ PEER !
HEALTH ADMINISTRATION (OSHA) GROUPS
( ll AGREEMENT L
STATE HEALTH i
STATES DEPARTMENTS i
i
__---____-_---___--__---_-____-___-_____--_--__--_____----_j
- ^
- 2. >
NUCLEAR MEDICINE :
i 4 !
l APPLICATION OF NUCLEAR SCIENCE AND RELATED .
t TECHNOLOGY TO STUDY, DIAGNOSIS AND TREATc1ENT- t INCLUDES BIOMEDICAL RESEARCH OF DISEASE. i
- AND CLINICAL MEDICINE i
-1 4
3 .
SOME HISTORICAL NOTES ON LICENSING NUCLEAR MEDICINE BY AEC-NRC 14 C FOR CANCER RESEARCH AUt 2nd; 1946- AEC ESTABLISHED; 1st SHIPMENT OF ICAL 38 INSTITUTIONS " AUTHORIZED TO PROCURE" RADIOISOTOPES FOR ME USE.
1948- ADVISORY COMMITTEE ON ISOTOPES DISTRIBUTION SUBCOMMITTEE ON HUMAN USES FORMED; AEC-SPONSORED TRAINING COURSE IN RADIOlSOTOt TECHNIOUES OPENED AT ORINS.
1950- AEC INITI ATED COOPERATIVE VISITATION WITH STATE HEALTH DEPART- ;
MENTS TO RADIOlSOTOPE USERS.
-CRITERI A FOR " BROAD LICENSES" AND PHYSICI ANS FOR PRIVATE PRACTICE 1951 - FDA ACCEPTED FIRST EFFECTIVE NEW DRUG CONTAINING RADIOISOTOPE 1953- AEC PUBLISHED CRITERI A FOR HUMAN USE OF RADIOISOTOPES IN F.R.
1954 - 870 INSTITUTIONS AUTHORIZED FOR MEDICAL USE.
1956 " AUTHORIZATIONS" CONVERTED TO LICENSES UNDER REVISED ACT OF 1954.
1958- PHYSICI AN CLINICAL TRAINING COURSE OPENED AT ORINS; RESTRUCTURED IN 1962;1028 PHYSICI ANS TRAINED TO DATE.
1962- FIRST STATE (KENTUCKY) ENTERED INTO A SECTION 274 AGREEM AEC.
1963 - FDA EXEMPTED THOSE R ADIOACTIVE DRUGS CONTROLLED BY AEC. ,
i
a 0
HISTOR_ICAL NOTES CONT'D 1965- ADOPTION OF THE MEDICAL GENERAL LICENSE (3.820 REGISTERED BY NRC TO DATE).
1967-GROUP LICENSING ADOPTED.
1971 - AMERICAN BOARD OF NUCLEAR MEDICINE BEGINS C'ERTIFYING PHYSICIANS 2,200 PHYSICI ANS HAVE BEEN CERTIFIED TO DATE.
1972- BEIR REPORT PREDICTS CUMULATIVE PATIENT DOSE FROM DI AGNOSTIC NUCLEAR MEDICINE ALONE TO REACH 3.3 MILLION PERSON-REM / YEAR BY 1980 (VS 10 MILLION PERSON-REM / YEAR FROM BACKGROUND RADI ATION).
1973-IN F.R. FDA & AEC STATED THAT FDA REGULATES THE SAFETY AND EFFICACY OF RADIOACTIVE DRUGS WITH RESPECT TO THE PATIENT AND THE AEC REGULATES THE RADIATION SAFETY OF EMPLOYEES AND PUBLIC.
1976-THE FDA TERMINATED THE EXEMPTION FOR RADIOACTIVE DRUGS EFFECTIVE AUG. 20;
-THE MEDICAL DEVICE ACT SIGNED MAY 28;
-2210 NRC AND 2997 AGREEMENT STATE MEDICAL LICENSEES; (EXCLUDING GENERAL MEDICAL LICENSEES).
- 30 MILLION NUCLEAR MEDICINE PROCEDURES / YEAR (DI AGNOSTIC AND TH E R APEUTIC);
-1.6 BILLION DOLLARS / YEAR PAID BY CONSUMER FOR NUCLEAR MEDICINE S E R VICES.
_ __u
- 5. -
PRINCIPAL REGULATORY AUTHORITY FOR NUCLEAR MEDICINE RADI0 ACTIVE MATERI AL BYPRODUCT, SOURCE, NARM ACTIVITY SNM FDA MANUFACTJRE NRC FDA AG. STATES STATES .
USE NRC AG. STATES STATES
GROUPS EXERCISING CONTROL ;
OVER NUCLEAR MEDICINE
~
NUCLEAR REGULATORY COMMISSION (NRC)
FOOD AND DRUG ADMINISTRATION (FDA)
SOCIAL SECURITY ADMINISTRATION (SSA)
ENVIRONMENTAL PROTECTION AGENCY (EPA)
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA)
JOINT COMMISSION ON ACCREDITATION OF HOSPITALS t 'CAH)
PEER GROUPS (NRC) AGREEMENT STATES STATE HEALTH DEPARTMENTS ,
~~
7 l 1 FOOD AND DRUG ADMINISTRATION (DHEW)
BUREAU OF DRUGS j i
L BUREAU OF BIOLOGICS !
BUREAU OF MEDICAL DEVICES BUREAU OF RADIOLOGICAL HEALTH ;
i EXECUTIVE DIRECTOR OF REGIONAL OPERATIONS l
. r
,9 SOCIAL SECURITY ADMINISTRATION i
BASIS OF CONTROL MEDICARE & MEDICAID ' REIMBURSEMENT HOW EFFECTED STANDARDS PUBt ISHED IN THE FEDERAL REGISTER INSPECTIONS PERFORMED BY STATE HEALTH PERSONNEL UNDER SSA CONTRACT JOINT COMMISSION ON ACCREDITATION OF HOSPITALS (JCAH)
INSPECTION AND ACCREDITATION ACCEPTED AS COMPLI ANCE WITH SSA REGULATIONS I
STATE CONTROLS STATE HEALTH DEPARTMENT - POLICE POWERS (HEALTH AND SAFETY-OF CITIZENS)
PHYSICIAN LICENSING PARAMEDICAL LICENSING PHARMACY LICENSING ,
PHARMACIST LICENSING REGULATE USE OF NARM
- AGREEMENT STATES - NRC AGREEMENT TO REGULATE BYPRODUCT, SOURCE AND SNM NATURALLY OCCURRING AND ACCELERATOR PRODUCED RADIOACTIVE MATERI AL (N ARM)
l /u; *
! PEER GROUPS SOCIETY OF NUCLEAR MEDICINE AMERICAN BOARD OF NUCLEAR MEDICINE AMERICAN COLLEGE OF RADIOLOGY AMERICAN SOCIETY OF CLINICAL . PATHOLOGY AMERICAN COLLEGE OF NUCLEAR PHYSICIANS AMERICAN COLLEGE OF NUCLEAR MEDICINE AMERICAN REGISTRY OF RADIOLOGIC TECHNOLOGISTS REGISTRY OF MEDICAL TECHNOLOGISTS AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE :
HEALTH PHYSICS SOCIETY I
AMERICAN BOARD OF HEALTH PHYSICS l AMERICAN PHARMACEUTICAL ASSOCI ATION i AMERICAN NATIONAL STANDARDS INSTITUTE i
= .
fr.
COMPARISON OF CONTROLS PEER AGREEMENT STATE NRC FDA EPA OSHA GROUP JCAH SSA STATES HEALTH AUTHORITY Federal Federal Federal Federal Charter Charter Federal State Statute State Statute Statute Statute Statute Statute (Voluntary) (Voluntary) Statute NRC Agree- (Police Powers) ment CFR CFR CFR CFR Published Published CFR State St. Regulation STANDARDS &
REGULATIONS Criteria Criteria Regulation LICENSING Prior Prior (none) (none) Certification Accreditation Certi- Prior Prior /. roval?
Approval Approval ification Approval (licensint card)
Scheduled Scheduled (none) Scheduled (none) Announced Random Scheduled Scheduled INSPECTION Special Special Special Special Special ENFORCEMENT Fines Felony Fines Fines Loss of Loss of Funds Fines Loss of medical Loss of Fines Certificatien Accreditation Loss of license License Seizure License Other Loss of NDA
a
/2 .
WHAT IS NUCLEAR MEDICINE? WHO IS INVOLVED IN'lTS REGULATIG'l?
AGREEa !T STATE NRC FDA EPA OSHA JCAH SSA GROUP . STATL HEALTH
- 1. ISOTOPE PRODUCTION A. BYPRODUCT MATERIAL e e g
- 8. SOURCE MATERIAL e # e C. SPECIAL NUCLEAR MATERIAL e # e D.NARM e e s,
- 11. MANUFACTURE AND DISTRIBUTION A. RADIOPHARMACEUTICAL HOUSE e
- 1. LABE LING G G g
- 2. OUALITY ASSUR ANCE G 3 PACKAGING S S e
- 4. TR ANSPORT ATION O 9 g B. DEVICE MANUFACTURER
- 1. TELETHER APY & BRACHYTHER APY a SOURCE G G e e
- b. SHIELD. HOLDER. ELECTRO MECH. # 9 e e
- c. ASSEMBLY. OOAllTY ASSUR ANCE G S e e
- d. INSTALLATION # e e
- 2. PACEMAKER e POWER SOURCE G G
- b. ASSEMBLY. QUAllTV ASSUR ANCE 8 9 3 OTHER O O G e C. MEDtCAL INSTITUTION
- 1. NUCLE AR PH ARMACY G G g e S S S 2 DEVICES 3 QUAllTY ASSURANCE e
e r
13.*
WHAT IS NUCLEAR MEDICINE? WHO IS INVOLVED IN ITS REGULATION?
hRC FDA EPA OSHA JCAtt $$A GROUP STATES. HEALTH lli POSSES $60N & USE A PHY$tOtAN e totperat Locaust ePsattstt6 e 3 Ctencat QuatorecateOses e e e e e e 3 manearsOsa sartiv QuatseeCateOsas e e e a e e e olvct Ctenicat QuatteeCateOsas e o e e e. e 8 CLINICAL L ABORATORY a veCweeCat QuatescatsOms e e a naciarsOse sa9tTT GUAL6peCateONS e g C. MEDet. AL INSTtTUTION e saceterets e e e e e 2 EOuerestNT a sunwEv #NStuesENT5 e e h 0054 Cateemaf0As e e e e e a OsaGesOETC sessimunesestS e e e e e e TEttfeetRaPV HeStaLLatsoas e e e TELETeetnaPV CateSRatsOsas e e e e 3 m4DeateOes tap 57V 'mOGnaas e veOmatas e e o e Puetc e e e s Pa f st e r e e e e esestatutsOes COtsMeTTE ES a Mt DeC at esOTOPE S COMate t t E E e e e e e naOscaCTevt OmuG AElt amCoe Coed e e DE veCE COMemTIE ES e e ROuereattf Oestettsuveces e S PattENT SELECTeDes e e 6 PeOCEDuet SELECTsON e e 7 DeuG SEttCTeose e 3 DEvett SEtsCteces e e 9 SPECapeCateose Of 0054 to PanaMtDeCAL Qual 6FeCATIOceS e e e tt PeevsaceST OuaL8'eCAYeoseS e e e s3 mac OuataaCstape g e e 13 044GesO5s1 e thsin uant % Ta f eO4 e e e e e eastEmpattaTIOne e se test testasov Catommastom eteneopsCe e e g tS ADvtR54 AE ALTeONS e e e 16 tetSADesease$f ma TeOssS 17 patetesT esahaGEasEsst e e et Quat e T V assunseeCE G e e e e tv OtSPO$at A R&DeOCHEwiC AL E FFLUENT S e e B ikCRETA.5EnAGE) e C Suntat e e e
19 ISGTOl'E PRODUCTION
. BYPRODUCT MATERI AL SPECI AL NUCLEAR MAT. ,
SOUR <C2 M ATERI AL NARM FDA MANUFACTURE & DIST.
PHARMACEUTICAL MFGR. JCAH & SSA '
DEVICE MANUFACTURER MEDICAL INSTITUTION EPA POSSESSION MEDICAL INSTITUTION CLINICAL LABORATORY OSHA -
PHYSICI AN USE MEDICAL INSTITUTION PEER GROUPS CLINICAL LABORATORY PHYSICI AN AGREEMENT STATE DISPOSAL -
MEDICAL EFFLUENT EXCRETA STATE HEALTH BURI AL _.
ISOTOPE PRODUCTION BYPRODUCT MATERI AL. NRC SPECI AL NUCLEAR MAT.
SOURCE MATERI AL NARM FDA-MANUFACTURE & DIST.
PHARMACEUTICAL MFGR. JCAH & SSA DEVICE MANUFACTURER MEDICAL INSTITUTION EPA POSSESSION MEDICAL INSTITUTION CLINICAL LABORATORY OSHA PHYSICIAN USE MEDICAL INSTITUTION PEER GROUPS CLINICAL LABORATORY PHYSICIAN AGREEMENT STATE DISPOSAL MEDICAL EFFLUENT EXCRETA STATE HEALTH BURIAL
tt. .'
ISOTOPE PRODUCTION NRC BYPRODUCT MATERI AL SPECIAL NUCLEAR MAT.
SOURCE MATERI AL .FDA NARM MANUFACTURE & DIST.
PHARMACEUTICAL MFGR. JCAH & SSA -
DEVICE MANUFACTURER MEDICAL INSTITUTION EPA POSSESSION MEDICAL INSTITUTION CLINICAL LABORATORY OSHA FHYSICIAN ,
USE PEER GROUPS MEDICAL INSTITUTION CLINICAL LABORATORY PHYSICI AN AGREEMENT STATE-DISPOSAL MEDICAL EFFLUENT EXCRETA STATE HEALTH BURI AL
--.-,---_-------_g, - --- - - - - - - - - - - - - -- - - - - . - - - _ - - - - - - - - - , - - - , . - - - - . - _ - - - , - - - - - _ - - , -- - - _ - - - _ -- - - - - - _ . - - _ . - - - - - - - - - - - - - - - - - _ - - - . - - - - - - - - - -
5
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~
ISOTOPE PRODUCTION BYPRODUCT MATERI AL- NRC SPECI AL NUCLEAR MAT.
SOURCE MATERIAL NARM FDA MANUF/ JURE & DIST.
PHARMACEUTICAL MFGR. JCAH & SSA DEVICE MANUFACTURER MEDICAL INSTITUTION
^ '
POSSESSION MEDICAL INSTITUTION CLINICAL LABORATORY OSHA PHYSICI AN USE PEER GROUPS MEDICAL INSTITUTION CLINICAL LABOR ATORY PHYSICI AN AGREEMENT STATE i DISPOSAL MEDICAL EFFLUENT EXCRETA STATE HEALTH BURI AL ,
.. - _ --- . _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ - - _ _ _ _ - - _ _ _ _ _ _ - _ _ _ _ - _ _ - _ _ _ _ _ - _ - _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ - - _ _ _ _ _ _ - - - _ _ - - - _ _ _ _ - - _ _ - _ - - _ _ - - - _ . - _ _ _ _ _ _ - _ . - . _ _ - _ . _ _ - _ _ _ - _ _ - - = _ _ _ _ _ _ _ _ _ _ _ _ _ - - _ _ - - _ _
/.
ISOTOPE PRODUCTION BYPRODUCT MATERIAL NRC SPECIAL NUCLEAR MAT.
SOURCE MATERIAL NARM FDA i MANUFACTURE & DIST.
- PHARMACEUTICAL MFGR. .
JCAH & SSA
- DEVICE MANUFACTURER MEDICAL INSTITUTION '
POSSESS!ON ^ '
, MEDICAL INSTITUTION !
CLINICAL LABORATORY PHYSICIAN OSHA-5 USE -
MEDICAL INSTIT8; TION PEER GROUPS !
CLINICAL LABORATORY '
PHYSICI AN AGREEMENT STATE ,
DISPOSAL t MEDICAL EFFLUENT r EXCRETA STATE HEALTH-i BURIAL i
. _ _ . _ . . . .- - . _ _ __ .- . _ _ _ . , . . - a.
!?. : ,
ISOTOPE PRODUCTION NRC~
BYPRODUCT -M ATERI AL -
SPECI AL NUCLEAR MAT.
SOURCE MATERIAL NARM- FDA MANUFACTURE & DIST.
PHARMACEUTICAL MFGR. JCAH & SSA DEVICE MANUFACTURER MEDICAL INSTITUTION EPA-POSSESSION MEDICAL INSTITUTION CLINICAL LABORATORY OSHA i PHYSICIAN USE MEDICAL INSTITUTION -- PEER GROUPS
' ^ ^ '
H SIC AGREEMENT STAl .
f DISPOSAL MEDICAL EFFLUENT STATE HEALTH ;
BURI AL ,
~_ ...m _. m _. __ ._ .____ __ .,_-..- - __-.m._._-.____ __._m.__ ____ .______ _ . _ .__._ _ _ . . - .___.___.m__.._______._-_._______ .______ _ _ _ _ _ _________. _ _ . _ -
m ____ .
2c ISOTOPE PRODUCTION NRC BYPRODUCT MATERI AL SPEC AL NUCLEAR MAT. '
SOUR :E MATERI AL NARM FDA MANUFACTURE & DIST.
PHARMACEUTICAL MFGR. JCAH & SSA DEVICE MANUFACTURER MEDICAL INSTITUTION POSSESSION MEDICAL INSTITUTION CLINICAL LABORATORY PHYSICI AN USE PEER GROUPS MEDICAL INSTITUTION _
CLINICAL LABORATORY PHYSICI AN AGREEMENT STATE i DISPOSAL MEDICAL EFFLUENT EXCRETA STATE HEALTH BURI AL
2/.
ISOTOPE PRODUCTION BYPRODUCT MATERI AL NRC SPECI AL NUCLEAR MAT.
SOURCE MATERI AL NARM FDA MANUFACTURE & DIST.
PHARMACEUTICAL MFGR. JCAH & SSA DEVICE MANUFACTURER MEDICAL INSTITUTION
-EPA POSSESSION MEDICAL INSTITUTION CLINICAL LABORATORY OSHA PHYSICI AN USE PEER GROUPS MEDICAL INSTITUTION CLINICAL LABORATORY PHYSICI AN AGREEMENT STATE DISPOSAL MEDICAL EFFLUENT RETA STATE HEALTH
4
}2 ;
SPECIFIC AREAS OF CONCERN (OTHER THAN NARM)
PEER JCAH AGREEMENT STATE NRC FDA EPA OSHA GROUP & SSA STATES HEALTH I. ISOTOPE PRODUCTION A. RADIATION SAFETY OF WORKERS * *
- B. RADIATION SAFETY OF PUBLIC * *
- C. SAFETY & EFFICACY FOR PATIENT *
(RADIATION & OTHER)
- 11. MANUFACTURE & DISTRIBUTION A. RADIATION SAFETY OF WORKERS * *
- B. RADIATION SAFETY OF PUBLIC * *
- C. RADIATION SAFETY OF DEVICE *
- D. SAFETY & EFFICACY FOR PATIENT
- 1. LIMITED DISTRIBUTION (IND) * *
- 2. ROUTINE DISTRIBUTION (NDA) *
- lit. POSSESSION & USE
- w A. RADIATION SAFETY OF WORKERS B. RADIATION SAFETY OF PUBLIC * * * ,
C. RADIATION SAFETY OF DEVICE ;
D. SAFETY & EFFICACY FOR PATIENT
- 1. INVESTIGATIONAL USE (IND)
- 2. ROUTINE USE (NDA)
IV. DISPOSAL A. RADIATION SAFETY OF WORKERS B. RADIATION SAFETY OF PUBLIC t
e AREAS OF CONCERN
- 1. RADI ATION SAFETY OF THE WORKERS
- 11. RADI ATION SAFETY OF THE GENERAL PUBLIC III. RADIATION SAFETY OF THE PATIENT A. SAFETY AND EFFICACY OF DRUG OR MEDICAL DEVICE WITH RESPECT TO PATIENT B. PRESCRIPTION (SELECTION OF PATIENT, PROCEDURE AND DRUG / DEVICE)
C. PATIENT RECEIVES WHAT IS PRESCRIBED (QUALITY ASSURANCE TESTS AND CALIBRATIONS)
h '
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2.q .
NRC'S INVOLVEMENT BY AREAS OF CONCERN RADIATION SAFETY RADIATION SAFETY RADIATION SAFETY OF PATIENT OF WORKERS OF PUBLIC SAFETY & EFFICACY PRESCRIPTION PATIENT
- l. ISOTOPE PRODUCTION
- e A. BYPRODUCT MATERIAL
- O B. SOURCE MATERI AL C. SPECIAL NUCLEAR MATERIAL
- 'e e D.NAftM
- 11. MANUFACTURE AND DISTRIBUTION A. RADIOPHARMACEUTICAL HOUSE 1, LABELING G
- 2. QUAllTY ASSURANCE S S
't PACKAGING O G
- 4. TRANSPORTATION B. DEVICE MANUFACTURER
- 1. TELETHERAPY & BRACHYTHERAPY S 9
- a. SOURCE
- b. SHIELD. HOLDER, ELECTRO MECH. O e G
- c. ASSEMBLY. QUALITY ASSURANCE
- d. INSTALL ATION O e
- 2. PACEMAKER G G S a POWEH SOURCE 9 4 e b ASSEM*JLY. QUALITY ASSUR ANC E S 9 9 3.OTHER -
C. MEDICAL INSTITUTION O O
- 1. NUCLEAR PHARMACY S S
- 2. DEVICES
- 3. QUALITY ASSUR ANCE
4 u
- 1 t
NRC'S INVOLVEMENT BY AREAS OF CONCERN R ADIATION SAF ETY RADIATION SAFETY RADIATION SAFETY OF PATIENT OF WORKERS OF PUBLIC 1AFETY & EFFICACY PRESCRIPTION PATIENT 111 POSSES $10N & USE A PHYSICIAN 1 Mf D4C At L tCINSt (PR ACTICll 2 CLINICAL QUAltflCAfl0NS 9 9 9 3 81 ADsA f TON SAf f TY OuaLipeC Af TONS 9 4 Of veCf CLINICAL OUAttf tCATiONS S B. CLINICAL LABOR ATORY l
1 TECHNtC AL QUALIFICAf TONS 7 RADaAT DN SAf f fV OUAteFeCAT80NS 9 0 l
C MEDICAL INSTITUTION
, f AC, LIT,5 5 . .
l 2 E OUIPME NT e SURviv INSTUMENTS e e h DOSL C Ak iSH AIDMS .
O l c DIAGNOSTIC #NSIRUMINTE 4 0 af f f LE THERAPY #N%1 AL& ATION S S l e Titt THER A#f CAL f3 RATION 5 3 RADtATION SAFETV PROGR AM e WORafRS 9 h PugLIC 9 e PATIENT 4 INSTITUTION COMMITTffl e Mf DIC AL ISOTOPE S COMMif f f f G G l e flADt0ACYtvf DRUG RESI ARCH COM e Of WICE COMMITTIEl d EOUIPMENT DsSTRieUTION t
5 PAfif NT SELECYe0N 6 6 PROCEDURE SELfCTION #
7 DRUG SELECTION 9 0-O Of vaCE SE LECTsON 9 0 9 SPICtf tC ATION Of DOSE 10 PARAMf DICAL OuAleFICAf TONS 11 PHYSICIST OUALIFICAT60NS 12 RSO OUAUNCATIONS 9 6 12 DLAGNOSil e tNSTRUMENTATION O t #NTERPRET Af tDN O 14 f f L t TMIR APV C A t tRR A f SON 4Pt itIODI tb ADVLR$f Rf ACTIONS 16 MfSADMINISTR Af TONS i!
17 PATalNT MANAGEMENT 9 9 9 $
i 95 OUALITY A&SURANCE O O 8 9 i
i IV DISPOSAt A H ADeLKHE MIC Af i f f l uf NT 9 g.
! It i MCHI I A (SIWAGi l 4 6: ,t,t,t. A . .
l ;
t l
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e
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,- r n ,, - - , - . , - - , - - - - , --..n,-n..- . , . , - , - - .e,r-. - , , - - . -,, - , , ,,,-r , , e
8I J i
PRESENT NRC CONTROLS
- 1. & II. RADIATION SAFETY OF WORKERS AND THE GENERAL PUBLIC Physician Radiation Safety Qualifications Radiation Safety Officer Radiation Safety Qualifications Physical Facilities Survey Instruments Radiation Safety Program Institutional Medical isotopes Committee Radiopharmaceutical preparation and administration procedures Administrative controls Waste Disposal Ill. RADI ATION SAFETY OF THE PATIENT A. SAFETY AND EFFICACY OF THE DRUG OR MEDICAL DEVICE WITH RESPECT TO THE PATIENT (Pacemaker efficacy) (brachytherapy )
B. PRESCRIPTION Physician Clinical Qualifications Specification of Clinical Procedures in the " Group" Licenses Review of Diagnostic Instrumentation Institutional Medical isotopes Committee C. ENSURE THAT THE PATIENT RECEIVES WHAT IS PRESCRIBED Requirement to use " Dose Calibrators" with radioisotope generators and kits ;l&E Teletherapy Checks
~
c 2 .
PAPERS RELATED TO NRC'S !NVOLVEMENT IN REGULATING NUCLEAR MEDICINE
- 1. MISADMINISTRATION REPORTING RULE (Proposed 1973; Staff developed action paper SECY-R 621; Staff developing new paper to recommend disposition of proposed rule)
- 2. SPECIFIC LICENSES FOR INDIVIDUALS AND INSTITUTIONS SECY-76-383 (Returned to staff 9-9-76)
- 3. SPECIFIC LICENSES FOR HUMAN USE OF BYPRODUCT MATERIAL IN SEALED SOURCES SECY-76420 (Returned to staff 9-9-76)
- 4. Pu-238 IN PACEMAKERS (FES issued 7-23-76; Staff developing a proposed rule for routine use)
- 5. DELETION OF DI AGNOSTIC PROCEDURES FOR GROUPS 1,11, AND lli (Proposed
! rule under development)
- *s'
. z. ' , -
-HOW ISSUES FIT FUTURE PAPERS
- 1. SPECIFIC LICENSES FOR HUMAN USES OF BYPRODUCT MATERIAL IN SEALED SOURCES SECY-76-420 (teletherapy calibration) lli.B. ENSURE THAT THE PATIENT RECEIVES WHAT IS PRESCRIBED.
- 2. SPECIFIC LICENSES FOR INDIVIDUALS AND INSTITUTIONS SECY-76-383 (physician licensing)
- 1. & II. RADI ATION SAFETY OF WORKERS AND THE GENERAL PUBLIC.
- 3. MISADMINISTRATION REPORTING RULE 111. C. ENSURE THAT THE PATIENT RECEIVES WHAT IS PRESCRIBED.
- 4. DELETION OF DIAGNOSTIC PROCEDURES FOR GROUPS 1, ll, lil 111. PRESCRIPTION (SELECTION OF THE PROCEDURE BY THE PHYSICI AN).
- 5. Pu-238 IN PACEMAKERS II. RADI ATION SAFETY OF THE GENERAL PUBLIC.
1i1. A. SAFETY AND EFFICACY OF THE DRUG OR MEDICAL DEVICE WITH RESPECT TO THE PATIENT.
o.;
n,'
p '.
- SCHEDULE TIME FACTORS INCREMENTAL TIME ALTE RNATIVES FACTOR
- ADVANCED NOTICE OF PROPOSED RULEMAKING 3 MO. HS l
PUBLIC MEETING OF NRC MEDICAL ADVISORY COMMITTEE 2 MONTH.
AGREEMENT STATE MEETING 1 WEEK
" PROPOSED" POLICY STATEMENT 3 MONTHS ROLICY STATEMENT (BASIC) 3 MONTHS
- Assumes " Commission Priority" - Certain times can run concurrently.
o.j c
a; 3 _s, EXAMPLE SCHEDULE OCTOBER ORAL BRIEFING TO IDENTIFY ISSUES FOR (JOINT NMSS-SD)
COMMISSIONERS DECEMBER NRC MEDICAL ADVISORY COMMITTEE (NMSS)
MEETING (PUBLIC)
JANUARY PUBLISH ADVANCED NOTICE OF PROPOSED (SD prepared for NMSS)
RULEMAKING IN F.R.
APRIL PUBLICATION IN F.R. OF NRC POLICY (SD prepared for NMSS)
STATEMENT
- - - - - - - - - - . _ - - - - - - - - - - - - - - . - - - - - - - - _ - - - _ _ _ _ _ _ . - - . - - - _ - - - - - - - - H