[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1000]
[Page 578-587]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 1000_GENERAL
Subpart A_General Provisions
Sec.
1000.1 General.
1000.3 Definitions.
Subpart B_Statements of Policy and Interpretation
1000.15 Examples of electronic products subject to the Radiation Control
for Health and Safety Act of 1968.
Subpart C_Radiation Protection Recommendations
1000.50 Recommendation for the use of specific area gonad shielding on
patients during medical diagnostic x-ray procedures.
1000.55 Recommendation for quality assurance programs in diagnostic
radiology facilities.
1000.60 Recommendation on administratively required dental x-ray
examinations.
Authority: 21 U.S.C. 360hh-360ss.
Source: 38 FR 28624, Oct. 15, 1973, unless otherwise noted.
Subpart A_General Provisions
Sec. 1000.1 General.
References in this subchapter J to regulatory sections of the Code
of Federal Regulations are to chapter I of title 21 unless otherwise
noted.
[50 FR 33688, Aug. 20, 1985]
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Sec. 1000.3 Definitions.
As used in this subchapter J:
(a) Accidental radiation occurrence means a single event or series
of events that has/have resulted in injurious or potentially injurious
exposure of any person to electronic product radiation as a result of
the manufacturing, testing, or use of an electronic product.
(b) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360hh-360ss).
(c) Chassis family means a group of one or more models with all of
the following common characteristics:
(1) The same circuitry in the high voltage, horizontal oscillator,
and power supply sections;
(2) The same worst component failures;
(3) The same type of high voltage hold-down or safety circuits; and
(4) The same design and installation.
(d) Commerce means:
(1) Commerce between any place in any State and any place outside
thereof, and
(2) Commerce wholly within the District of Columbia.
(e) Component, for the purposes of this part, means an essential
functional part of a subassembly or of an assembled electronic product,
and which may affect the quantity, quality, direction, or radiation
emission of the finished product.
(f) Dealer means a person engaged in the business of offering
electronic products for sale to purchasers, without regard to whether
such person is or has been primarily engaged in such business, and
includes persons who offer such products for lease or as prizes or
awards.
(g) Director means the Director of the Center for Devices and
Radiological Health.
(h) Distributor means a person engaged in the business of offering
electronic products for sale to dealers, without regard to whether such
person is or has been primarily or customarily engaged in such business.
(i) Electromagnetic radiation includes the entire electromagnetic
spectrum of radiation of any wavelength. The electromagnetic spectrum
illustrated in figure 1 includes, but is not limited to, gamma rays, x-
rays, ultra-violet, visible, infrared, microwave, radiowave, and low
frequency radiation.
[GRAPHIC] [TIFF OMITTED] TR01FE93.029
(j) Electronic product means:
(1) Any manufactured or assembled product which, when in operation:
(i) Contains or acts as part of an electronic circuit and
(ii) Emits (or in the absence of effective shielding or other
controls would emit) electronic product radiation, or
(2) Any manufactured or assembled article that is intended for use
as a component, part, or accessory of a product described in paragraph
(j)(1) of this section and which, when in operation, emits (or in the
absence of effective shielding or other controls would emit) such
radiation.
(k) Electronic product radiation means:
(1) Any ionizing or nonionizing electromagnetic or particulate
radiation, or
(2) Any sonic, infrasonic, or ultrasonic wave that is emitted from
an electronic product as the result of the operation of an electronic
circuit in such product.
(l) Federal standard means a performance standard issued pursuant to
section 534 of the Federal Food, Drug, and Cosmetic Act.
(m) Infrasonic, sonic (or audible) and ultrasonic waves refer to
energy transmitted as an alteration (pressure, particle displacement or
density) in a property of an elastic medium (gas, liquid or solid) that
can be detected by an instrument or listener.
(n) Manufacturer means any person engaged in the business of
manufacturing, assembling, or importing electronic products.
(o) Model means any identifiable, unique electronic product design,
and refers to products having the same structural and electrical design
characteristics and to which the manufacturer has assigned a specific
designation to differentiate between it and other products produced by
that manufacturer.
(p) Model family means products having similar design and radiation
characteristics but different manufacturer model numbers.
(q) Modified model means a product that is redesigned so that actual
or potential radiation emission, the manner of compliance with a
standard, or the manner of radiation safety testing is affected.
(r) Particulate radiation is defined as:
(1) Charged particles, such as protons, electrons, alpha particles,
or heavy particles, which have sufficient kinetic energy to produce
ionization or atomic or electron excitation by collision, electrical
attractions or electrical repulsion; or
(2) Uncharged particles, such as neutrons, which can initiate a
nuclear transformation or liberate charged particles having sufficient
kinetic energy to produce ionization or atomic or electron excitation.
(s) Phototherapy product means any ultraviolet lamp, or product
containing such lamp, that is intended for irradiation of any part of
the living human body by light in the wavelength range of 200 to 400
nanometers, in order to perform a therapeutic function.
(t) Purchaser means the first person who, for value, or as an award
or prize, acquires an electronic product for purposes other than resale,
and includes a person who leases an electronic product for purposes
other than subleasing.
(u) State means a State, the District of Columbia, the Commonwealth
of Puerto Rico, the Virgin Islands, Guam, and American Samoa.
[60 FR 48380, Sept. 19, 1995; 61 FR 13422, Mar. 27, 1996]
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Subpart B_Statements of Policy and Interpretation
Sec. 1000.15 Examples of electronic products subject to the Radiation
Control for Health and Safety Act of 1968.
The following listed electronic products are intended to serve as
illustrative examples of sources of electronic product radiation to
which the regulations of this part apply.
(a) Examples of electronic products which may emit x-rays and other
ionizing electromagnetic radiation, electrons, neutrons, and other
particulate radiation include:
Ionizing electromagnetic radiation:
Television receivers.
Accelerators.
X-ray machines (industrial, medical, research, educational).
Particulate radiation and ionizing electromagnetic radiation:
Electron microscopes.
Neutron generators.
(b) Examples of electronic products which may emit ultraviolet,
visible, infrared, microwaves, radio and low frequency electromagnetic
radiation include:
Ultraviolet:
Biochemical and medical analyzers.
Tanning and therapeutic lamps.
Sanitizing and sterilizing devices.
Black light sources.
Welding equipment.
Visible:
White light devices.
Infrared:
Alarm systems.
Diathermy units.
Dryers, ovens, and heaters.
Microwave:
Alarm systems.
Diathermy units.
Dryers, ovens, and heaters.
Medico-biological heaters.
Microwave power generating devices.
Radar devices.
Remote control devices.
Signal generators.
Radio and low frequency:
Cauterizers.
Diathermy units.
Power generation and transmission equipment.
Signal generators.
Electromedical equipment.
(c) Examples of electronic products which may emit coherent
electromagnetic radiation produced by stimulated emission include:
Laser:
Art-form, experimental and educational devices.
Biomedical analyzers.
Cauterizing, burning and welding devices.
Cutting and drilling devices.
Communications transmitters.
Rangefinding devices.
Maser:
Communications transmitters.
(d) Examples of electronic products which may emit infrasonic,
sonic, and ultrasonic vibrations resulting from operation of an
electronic circuit include:
Infrasonic:
Vibrators.
Sonic:
Electronic oscillators.
Sound amplification equipment.
Ultrasonic:
Cauterizers.
Cell and tissue disintegrators.
Cleaners.
Diagnostic and nondestructive testing equipment.
Ranging and detection equipment.
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Subpart C_Radiation Protection Recommendations
Sec. 1000.50 Recommendation for the use of specific area gonad
shielding on patients during medical diagnostic x-ray
procedures.
Specific area gonad shielding covers an area slightly larger than
the region of the gonads. It may therefore be used without interfering
with the objectives of the examination to protect the germinal tissue of
patients from radiation exposure that may cause genetic mutations during
many medical x-ray procedures in which the gonads lie within or are in
close proximity to the x-ray field. Such shielding should be provided
when the following conditions exist:
(a) The gonads will lie within the primary x-ray field, or within
close proximity (about 5 centimeters), despite proper beam limitation.
Except as provided in paragraph (b) or (c) of this section:
(1) Specific area testicular shielding should always be used during
those examinations in which the testes usually are in the primary x-ray
field, such as examinations of the pelvis, hip, and upper femur;
(2) Specific area testicular shielding may also be warranted during
other examinations of the abdominal region in which the testes may lie
within or in close proximity to the primary x-ray field, depending upon
the size of the patient and the examination techniques and equipment
employed. Some examples of these are: Abdominal, lumbar spine and
lumbosacral spine examinations, intravenous pyelograms, and abdominal
scout film for barium enemas and upper GI series. Each x-ray facility
should evaluate its procedures, techniques, and equipment and compile a
list of such examinations for which specific area testicular shielding
should be routinely considered for use. As a basis for judgment,
specific area testicular shielding should be considered for all
examinations of male patients in which the pubic symphysis will be
visualized on the film;
(3) Specific area gonad shielding should never be used as a
substitute for careful patient positioning, the use of correct technique
factors and film processing, or proper beam limitation (confinement of
the x-ray field to the area of diagnostic interest), because this could
result in unnecessary doses to other sensitive tissues and could
adversely affect the quality of the radiograph; and
(4) Specific area gonad shielding should provide attenuation of x-
rays at least equivalent to that afforded by 0.25 millimeter of lead.
(b) The clinical objectives of the examination will not be
compromised.
(1) Specific area testicular shielding usually does not obscure
needed information except in a few cases such as oblique views of the
hip, retrograde urethrograms and voiding cystourethrograms,
visualization of the rectum and, occasionally, the pubic symphysis.
Consequently, specific area testicular shielding should be considered
for use in the majority of x-ray examinations of male patients in which
the testes will lie within the primary beam or within 5 centimeters of
its edge. It is not always possible to position shields on male patients
so that no bone is obscured. Therefore, if all bone structure of the
pelvic area must be visualized for a particular patient, the use of
shielding should be carefully evaluated. The decision concerning the
applicability of shielding for an individual patient is dependent upon
consideration of the patient's unique anthropometric characteristics and
the diagnostic information needs of the examination.
(2) The use of specific area ovarian shielding is frequently
impractical at present because the exact location of the ovaries is
difficult to estimate, and the shield may obscure visualization of
portions of adjacent structures such as the spine, ureters, and small
and large bowels. However, it may be possible for
practitioners to use specific area ovarian shielding during selected
views in some examinations.
(c) The patient has a reasonable reproductive potential.
(1) Specific area shielding need not be used on patients who cannot
or are not likely to have children in the future.
(2) The following table of statistical data regarding the average
number of children expected by potential parents in various age
categories during their remaining lifetimes is provided for x-ray
facilities that wish to use it as a basis for judging reproductive
potential:
Expected Number of Future Children Versus Age of Potential Parent \1\
------------------------------------------------------------------------
Male Female
Age parent parent
------------------------------------------------------------------------
Fetus............................................... 2.6 2.6
0 to 4.............................................. 2.6 2.5
5 to 9.............................................. 2.7 2.5
10 to 14............................................ 2.7 2.6
15 to 19............................................ 2.7 2.6
20 to 24............................................ 2.6 2.2
25 to 29............................................ 2.0 1.4
30 to 34............................................ 1.1 .6
35 to 39............................................ .5 .2
40 to 44............................................ .2 .04
45 to 49............................................ .07 0
50 to 54............................................ .03 0
55 to 64............................................ .01 0
Over 65............................................. 0 0
------------------------------------------------------------------------
\1\ Derived from data published by the National Center for Health
Statistics, ``Final Natality Statistics 1970,'' HRA 74-1120, vol. 22,
No. 12, Mar. 20, 1974.
[41 FR 30328, July 23, 1976; 41 FR 31812, July 30, 1976]
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Sec. 1000.55 Recommendation for quality assurance programs in
diagnostic radiology facilities.
(a) Applicability. Quality assurance programs as described in
paragraph (c) of this section are recommended for all diagnostic
radiology facilities.
(b) Definitions. As used in this section, the following definitions
apply:
(1) Diagnostic radiology facility means any facility in which an x-
ray system(s) is used in any procedure that involves irradiation of any
part of the human body for the purpose of diagnosis or visualization.
Offices of individual physicians, dentists, podiatrists, and
chiropractors, as well as mobile laboratories, clinics, and hospitals
are all examples of diagnostic radiology facilities.
(2) Quality assurance means the planned and systematic actions that
provide adequate confidence that a diagnostic x-ray facility will
produce consistently high quality images with minimum exposure of the
patients and healing arts personnel. The determination of what
constitutes high quality will be made by the facility producing the
images. Quality assurance actions include both ``quality control''
techniques and ``quality administration'' procedures.
(3) Quality assurance program means an organized entity designed to
provide ``quality assurance'' for a diagnostic radiology facility. The
nature and extent of this program will vary with the size and type of
the facility, the type of examinations conducted, and other factors.
(4) Quality control techniques are those techniques used in the
monitoring (or testing) and maintenance of the components of an x-ray
system. The quality control techniques thus are concerned directly with
the equipment.
(5) Quality administration procedures are those management actions
intended to guarantee that monitoring techniques are properly performed
and evaluated and that necessary corrective measures are taken in
response to monitoring results. These procedures provide the
organizational framework for the quality assurance program.
(6) X-ray system means an assemblage of components for the
controlled production of diagnostic images with x-rays. It includes
minimally an x-ray high voltage generator, an x-ray control, a tube-
housing assembly, a beam-limiting device, and the necessary supporting
structures. Other components that function with the system, such as
image receptors, image processors, view boxes, and darkrooms, are also
parts of the system.
(c) Elements. A quality assurance program should contain the
elements listed in paragraphs (c)(1) through (10) of this section. The
extent to which each element of the quality assurance program is
implemented should be determined by an analysis of the facility's
objectives and resources conducted by its qualified staff or by
qualified outside consultants. The extent of implementation should be
determined on the
basis of whether the expected benefits in radiation exposure reduction,
improved image quality, and/or financial savings will compensate for the
resources required for the program.
(1) Responsibility. (i) Responsibility and authority for the overall
quality assurance program as well as for monitoring, evaluation, and
corrective measures should be specified and recorded in a quality
assurance manual.
(ii) The owner or practitioner in charge of the facility has primary
responsibility for implementing and maintaining the quality assurance
program.
(iii) Staff technologists will generally be delegated a basic
quality assurance role by the practitioner in charge. Responsibility for
specific quality control monitoring and maintenance techniques or
quality administration procedures may be assigned, provided that the
staff technologists are qualified by training or experience for these
duties. The staff technologists should also be responsible for
identifying problems or potential problems requiring actions beyond the
level of their training. They should bring these problems to the
attention of the practitioner in charge, or his or her representative,
so that assistance in solving the problems may be obtained from inside
or outside the facility.
(iv) In facilities where they are available, physicists, supervisory
technologists, or quality control technologists should have a major role
in the quality assurance program. Such specialized personnel may be
assigned responsibility for day-to-day administration of the program,
may carry out monitoring duties beyond the level of training of the
staff technologist or, if desired by the facility, may relieve the staff
technologists of some or all of their basic monitoring duties. Staff
service engineers may also be assigned responsibility for certain
preventive or corrective maintenance actions.
(v) Responsibility for certain quality control techniques and
corrective measures may be assigned to personnel qualified by training
or experience, such as consultants or industrial representatives, from
outside of the facility, provided there is a written agreement clearly
specifying these services.
(vi) In large facilities, responsibility for long-range planning of
quality assurance goals and activities should be assigned to a quality
assurance committee as described in paragraph (c)(9) of this section.
(2) Purchase specifications. Before purchasing new equipment, the
staff of the diagnostic radiology facility should determine the desired
performance specifications for the equipment. Initially, these
specifications may be stated in terms of the desired performance of the
equipment, or prospective vendors may be informed solely of the
functions the equipment should be able to perform and asked to provide
the performance specifications of items from their equipment line that
can perform these functions. In either case, the responses of the
prospective vendors should serve as the basis for negotiations to
establish the final purchase specifications, taking into account the
state of the art and balancing the need for the specified performance
levels with the cost of the equipment to meet them. The final purchase
specifications should be in writing and should include performance
specifications. The availability of experienced service personnel should
also be taken into consideration in making the final purchase decisions.
Any understandings with respect to service personnel should be
incorporated into the purchase specifications. After the equipment is
installed, the facility should conduct a testing program, as defined in
its purchase specifications, to ensure that the equipment meets the
agreed upon specifications, including applicable Federal and State
regulatory requirements. The equipment should not be formally accepted
until any necessary corrections have been made by the vendor. The
purchase specifications and the records of the acceptance testing should
be retained throughout the life of the equipment for comparison with
monitoring results in order to assess continued acceptability of
performance.
(3) Monitoring and maintenance. A routine quality control monitoring
and maintenance system incorporating state-of-the-art procedures should
be established and conducted on a regular schedule. The purpose of
monitoring is
to permit evaluation of the performance of the facility's x-ray
system(s) in terms of the standards for image quality established by the
facility (as described in paragraph (c)(4) of this section) and
compliance with applicable Federal and State regulatory requirements.
The maintenance program should include corrective maintenance to
eliminate problems revealed by monitoring or other means before they
have a serious deleterious impact on patient care. To the extent
permitted by the training of the facility staff, the maintenance program
should also include preventive maintenance, which could prevent
unexpected breakdowns of equipment and disruption of departmental
routine.
(i) The parameters to be monitored in a facility should be
determined by that facility on the basis of an analysis of expected
benefits and cost. Such factors as the size and resources of the
facility, the type of examinations conducted, and the quality assurance
problems that have occurred in that or similar facilities should be
taken into account in establishing the monitoring system. The monitoring
frequency should also be based upon need and can be different for
different parameters.
(ii) Although the parameters to be monitored will vary somewhat from
facility to facility, every diagnostic radiology facility should
consider monitoring the following five key components of the x-ray
system:
(a) Film processing.
(b) Basic performance characteristics of the x-ray unit.
(c) Cassettes and grids.
(d) View boxes.
(e) Darkroom.
(iii) Examples of parameters of the above-named components and of
more specialized equipment that may be monitored are as follows:
(a) For film processing:
An index of speed.
An index of contrast.
Base plus fog.
Solution temperatures.
Film artifact identification.
(b) For basic performance characteristics of the x-ray unit:
(1) For fluoroscopic x-ray units:
Table-top exposure rates.
Centering alignment.
Collimation.
kVp accuracy and reproducibility.
mA accuracy and reproducibility.
Exposure time accuracy and reproducibility.
Reproducibility of x-ray output.
Focal spot size consistency.
Half-value layer.
Representative entrance skin exposures.
(2) For image-intensified systems:
Resolution.
Focusing.
Distortion.
Glare.
Low contrast performance.
Physical alignment of camera and collimating lens.
(3) For radiographic x-ray units:
Reproducibility of x-ray output.
Linearity and reproducibility of mA stations.
Reproducibility and accuracy of timer stations.
Reproducibility and accuracy of kVp stations.
Accuracy of source-to-film distance indicators.
Light/x-ray field congruence.
Half-value layer.
Focal spot size consistency.
Representative entrance skin exposures.
(4) For automatic exposure control devices:
Reproducibility.
kVp compensation.
Field sensitivity matching.
Minimum response time.
Backup timer verification.
(c) For cassettes and grids:
(1) For cassettes:
Film/screen contact.
Screen condition.
Light leaks.
Artifact identification.
(2) For grids:
Alignment and focal distance.
Artifact identification.
(d) For view boxes:
Consistency of light output with time.
Consistency of light output from one box to another.
View box surface conditions.
(e) For darkrooms:
Darkroom integrity.
Safe light conditions.
(f) For specialized equipment:
(1) For tomographic systems:
Accuracy of depth and cut indicator.
Thickness of cut plane.
Exposure angle.
Completeness of tomographic motion.
Flatness of tomographic field.
Resolution.
Continuity of exposure.
Flatness of cassette.
Representative entrance skin exposures.
(2) For computerized tomography:
Precision (noise).
Contrast scale.
High and low contrast resolution.
Alignment.
Representative entrance skin exposures.
(iv) The maintenance program should include both preventive and
corrective aspects.
(a) Preventive maintenance. Preventive maintenance should be
performed on a regularly scheduled basis with the goal of preventing
breakdowns due to equipment failing without warning signs detectable by
monitoring. Such actions have been found cost effective if
responsibility is assigned to facility staff members. Possible
preventive maintenance procedures are visual inspection of the
mechanical and electrical characteristics of the x-ray system (covering
such things as checking conditions of cables, watching the tomographic
unit for smoothness of motion, assuring cleanliness with respect to
spilling of contaminants in the examination room or the darkroom, and
listening for unusual noises in the moving parts of the system),
following the manufacturer's recommended procedures for cleaning and
maintenance of the equipment, and regular inspection and replacement of
switches and parts that routinely wear out or fail. The procedures
included would depend upon the background of the staff members
available. Obviously, a large facility with its own service engineers
can do more than an individual practitioner's office.
(b) Corrective maintenance. For maximum effectiveness, the quality
assurance program should make provision, as described in paragraph
(c)(5) of this section, for ascertaining whether potential problems are
developing. If potential or actual problems are detected, corrective
maintenance should be carried out to eliminate them before they cause a
major impact on patient care.
(4) Standards for image quality. Standards of acceptable image
quality should be established. Ideally, these should be objective, e.g.,
acceptability limits for the variations of parameter values, but they
may be subjective, e.g., the opinions of professional personnel, in
cases where adequate objective standards cannot be defined. These
standards should be routinely reviewed and redefined as needed, as
described in paragraph (c)(10) of this section.
(5) Evaluation. The facility's quality assurance program should
include means for two levels of evaluation.
(i) On the first level, the results of the monitoring procedures
should be used to evaluate the performance of the x-ray system(s) to
determine whether corrective actions are needed to adjust the equipment
so that the image quality consistently meets the standards for image
quality. This evaluation should include analysis of trends in the
monitoring data as well as the use of the data to determine the need for
corrective actions on a day-by-day basis. Comparison of monitoring data
with the purchase specifications and acceptance testing results for the
equipment in question is also useful.
(ii) On the second level, the facility quality assurance program
should also include means for evaluating the effectiveness of the
program itself. Possible means include ongoing studies of the retake
rate and the causes of the repeated radiographs, examination of
equipment repair and replacement costs, subjective evaluation of the
radiographs being produced, occurrence and reasons for complaints by
radiologists, and analysis of trends in the results of monitoring
procedures such as sensitometric studies. Of these, ongoing studies of
the retake rate (reject rate) and its causes are often the most useful
and may also provide information of value in the first level of
evaluation. Such studies can be used to evaluate potential for
improvement, to make corrections, and to determine whether the
corrective actions were effective. The number of rejects should be
recorded daily or weekly, depending on the facility's analysis of its
needs. Ideally, the reasons for the rejection
should also be determined and recorded. Should determining these reasons
be impossible on a regular basis with the available staff, the analysis
should be done for a 2-week period after major changes have occurred in
diagnostic procedures or the x-ray system and at least semi-annually.
(6) Records. The program should include provisions for the keeping
of records on the results of the monitoring techniques, any difficulties
detected, the corrective measures applied to these difficulties, and the
effectiveness of these measures. The extent and form of these records
should be determined by the facility on the basis of its needs. The
facility should view these records as a tool for maintaining an
effective quality assurance program and not view the data in them as an
end in itself but rather as a beginning. For example, the records should
be made available to vendors to help them provide better service. More
importantly, the data should be the basis for the evaluation and the
reviews suggested in paragraphs (c)(5) and (10) of this section.
(7) Manual. A quality assurance manual should be written in a format
permitting convenient revision as needed and should be made readily
available to all personnel. The content of the manual should be
determined by the facility staff, but the following items are suggested
as providing essential information:
(i) A list of the individuals responsible for monitoring and
maintenance techniques.
(ii) A list of the parameters to be monitored and the frequency of
monitoring.
(iii) A description of the standards, criteria of quality, or limits
of acceptability that have been established for each of the parameters
monitored.
(iv) A brief description of the procedures to be used for monitoring
each parameter.
(v) A description of procedures to be followed when difficulties are
detected to call these difficulties to the attention of those
responsible for correcting them.
(vi) A list of the publications in which detailed instructions for
monitoring and maintenance procedures can be found. Copies of these
publications should also be readily available to the entire staff, but
they should be separate from the manual. (Publications providing these
instructions can usually be obtained from FDA or private sources,
although the facility may wish to make some modifications to meet its
needs more effectively.)
(vii) A list of the records, with sample forms, that the facility
staff has decided should be kept. The facility staff should also
determine and note in the manual the length of time each type of record
should be kept before discarding.
(viii) A copy of each set of purchase specifications developed for
new equipment and the results of the acceptance testing for that
equipment.
(8) Training. The program should include provisions for appropriate
training for all personnel with quality assurance responsibilities. This
should include both training provided before the quality assurance
responsibilities are assumed and continuing education to keep the
personnel up-to-date. Practical experience with the techniques conducted
under the supervision of experienced instructors, either in the facility
or in a special program, is the most desirable type of training. The use
of self-teaching materials can be an adequate substitute for supervised
instruction, especially in continuing education programs, if supervised
instruction is not available.
(9) Committee. A facility whose size would make it impractical for
all staff members to meet for planning purposes should consider the
establishment of a quality assurance committee whose primary function
would be to maintain lines of communication among all groups with
quality assurance and/or image production or interpretation
responsibilities. For maximum communication, all departments of the
facility with x-ray equipment should be represented. The committee may
also be assigned policy-making duties such as some or all of the
following:
Assign quality assurance responsibilities; maintain acceptable standards
of quality; periodically review program effectiveness, etc.
Alternatively, the
duties of this committee could be assigned to an already-existing
committee such as the Radiation Safety Committee. In smaller facilities,
all staff members should participate in the committee's tasks. The
Quality Assurance Committee should report directly to the head of the
radiology department, or, in facilities where more than one department
operates x-ray equipment, to the chief medical officer of the facility.
The committee should meet on a regular basis.
(10) Review. The facility's quality assurance program should be
reviewed by the Quality Assurance Committee and/or the practitioner in
charge to determine whether its effectiveness could be improved. Items
suggested for inclusion in the review include:
(i) The reports of the monitoring and maintenance techniques to
ensure that they are being performed on schedule and effectively. These
reports should be reviewed at least quarterly.
(ii) The monitoring and maintenance techniques and their schedules
to ensure that they continue to be appropriate and in step with the
latest developments in quality assurance. They should be made current at
least annually.
(iii) The standards for image quality to ensure that they are
consistent with the state-of-the-art and the needs and resources of the
facility. These standards should be evaluated at least annually.
(iv) The results of the evaluations of the effectiveness of the
quality assurance actions to determine whether changes need to be made.
This determination should be made at least annually.
(v) The quality assurance manual should also be reviewed at least
annually to determine whether revision is needed.
[44 FR 71737, Dec. 11, 1979]
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Sec. 1000.60 Recommendation on administratively required dental x-ray
examinations.
(a) The Food and Drug Administration recommends that dental x-ray
examinations be performed only after careful consideration of the dental
or other health needs of the patient, that is, when the patient's
dentist or physician judges them to be necessary for diagnosis,
treatment, or prevention of disease. Administratively required dental x-
ray examinations are those required by a remote third party for reasons
not related to the patient's immediate dental needs. These x-ray
examinations are usually a source of unnecessary radiation exposure to
the patient. Because any unnecessary radiation exposure should be
avoided, third parties should not require dental x-ray examinations
unless they can demonstrate that such examinations provide a direct
clinical benefit to the patient, and the patient's dentist or physician
agrees with that assessment.
(b) Some examples of administrative x-ray examinations that should
not be required by third parties are those intended solely:
(1) To monitor insurance claims or detect fraud;
(2) To satisfy a prerequisite for reimbursement;
(3) To provide training or experience;
(4) To certify qualifications or competence.
(c) This recommendation is not intended to preclude dental x-ray
examinations ordered by the attending practitioner, based on the
patient's history or physical examination, or those performed on
selected populations shown to have significant yields of previously
undiagnosed disease. This recommendation is also not intended to
preclude the administrative use by third parties of dental radiographs
that are taken on the order of the patient's dentist or physician as a
necessary part of the patient's clinical care.
[45 FR 40978, June 17, 1980]
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