| (a) Purpose. This section establishes requirements
for the use of radiation machines in the healing arts.
(b) Scope.
(1) The registrant shall be responsible for directing
the operation of the radiation machines under the administrative control
of the registrant. The registrant shall assure that the requirements
of this section are met in the operation of such radiation machines.
All usage of such machines under this section shall be made by or
under the supervision of a practitioner of the healing arts.
(2) In addition to the requirements of this section,
all registrants, unless otherwise specified, are subject to the requirements
of §289.203 of this title (relating to Notices, Instructions,
and Reports to Workers; Inspections), §289.204 of this title
(relating to Fees for Certificates of Registration, Radioactive Material
Licenses, Emergency Planning and Implementation, and Other Regulatory
Services), §289.205 of this title (relating to Hearing and Enforcement
Procedures), §289.226 of this title (relating to Registration
of Radiation Machine Use and Services), and §289.231 of this
title (relating to General Provisions and Standards for Protection
Against Machine-Produced Radiation).
(3) The use of mammography radiation machines is subject
to the requirements in §289.230 of this title (relating to Certification
of Mammography Systems and Mammography Machines Used for Interventional
Breast Radiography), and §289.234 of this title (relating to
Mammography Accreditation). The use of dental radiation machines is
subject to the requirements in §289.232 of this title (relating
to Radiation Control Regulations for Dental Radiation Machines). However,
dental radiation machines located in a facility that also has other
healing arts radiation machines will be inspected at the intervals
specified in §289.231(ll)(2) of this title, and equipment performance
evaluations performed at the interval specified for a medical facility
in subsection (o)(1) of this section. The use of radiation machines
for veterinary medicine is subject to the requirements in §289.233
of this title (relating to Radiation Control Regulations for Radiation
Machines in Veterinary Medicine).
(4) An entity that is a "covered entity" as that term
is defined in HIPAA (the Health Insurance Portability and Accountability
Act of 1996, 45 Code of Federal Regulations, Parts 160 and 164) may
be subject to privacy standards governing how information that identifies
a patient can be used and disclosed. Failure to follow HIPAA requirements
may result in the department making a referral of a potential violation
to the U.S. Department of Health and Human Services.
(c) Prohibitions.
(1) The agency may prohibit use of radiation machines
that pose significant threat or endanger occupational and public health
and safety, in accordance with §289.205 of this title and §289.231
of this title.
(2) Individuals shall not be exposed to the useful
beam except for healing arts purposes and unless such exposure has
been authorized by a licensed practitioner of the healing arts. This
provision specifically prohibits intentional exposure for the following
purposes:
(A) exposure of an individual for training, demonstration,
or other non-healing arts purposes;
(B) exposure of an individual for the purpose of healing
arts screening, except as authorized by §289.226(h) of this title;
and
(C) exposure of an individual for the purpose of research,
except as authorized by §289.226(t)(1) of this title.
(3) Non-image-intensified fluoroscopic systems shall
not be used.
(d) Exemptions.
(1) Portable x-ray systems designed to be hand-held
are exempt from the requirements of subsection (i)(11) of this section.
The portable radiation machine shall be held by the tube housing support
or handle.
(2) Individuals who are sole practitioners and sole
operators and the only occupationally exposed individual are exempt
from the following requirements:
(A) §289.203(b) of this title, "Posting of notices
to workers;"
(B) §289.203(c) of this title, "Instructions to
workers;" and
(C) operating and safety procedures in accordance with
subsection (i)(2) of this section.
(3) Registrants are exempt from the posting of the
radiation area requirements in §289.231(x)(1) of this title provided
that the operator has continuous surveillance and access control of
the radiation area.
(e) Definitions. The following words and terms, when
used in this section, shall have the following meanings unless the
context clearly indicates otherwise.
(1) Accessible surface--The external surface of the
enclosure or housing provided by the manufacturer.
(2) Air kerma--The kinetic energy released in air by
ionizing radiation. Kerma is the quotient of dE by dM, where dE is
the sum of the initial kinetic energies of all the charged ionizing
particles liberated by uncharged ionizing particles in air of mass
dM. The SI unit of air kerma is joule per kilogram and the special
name for the unit of kerma is the gray (Gy). For purposes of this
section, when exposure in air measured in roentgen (R) is to be converted
to dose in air measured in gray (Gy), a nationally recognized standard
air conversion factor shall be used.
(3) Aluminum equivalent--The thickness of type 1100
aluminum alloy affording the same attenuation, under specified conditions,
as the material in question. The nominal chemical composition of type
1100 aluminum alloy is 99% minimum aluminum, 0.12% copper.
(4) Attenuate--To reduce the exposure rate upon passage
of radiation through matter.
(5) Attenuation block--A block or stack, having dimensions
20 centimeters (cm) by 20 cm by 3.8 cm, of type 1100 aluminum alloy
or other materials having equivalent attenuation. The nominal chemical
composition of type 1100 aluminum alloy is 99% minimum aluminum, 0.12%
copper.
(6) Automatic exposure control (AEC)--A device that
automatically controls one or more technique factors in order to obtain
a required quantity of radiation at preselected locations (See definition
for phototimer).
(7) Automatic exposure rate control (AERC)--A device
that automatically controls one or more technique factors in order
to obtain a required quantity of radiation per unit time at preselected
locations.
(8) Barrier (See definition for protective barrier).
(9) Beam axis--A line from the source through the centers
of the x-ray fields.
(10) Beam-limiting device--A device that provides a
means to restrict the dimensions of the x-ray field.
(11) Beam quality (diagnostic x-ray)--A term that describes
the penetrating power of the x-ray beam. This is identified numerically
by half-value layer and is influenced by kilovolt peak (kVp) and filtration.
(12) Bone densitometer--A device intended for medical
purposes to measure bone density and mineral content by x-ray transmission
measurements through the bone and adjacent tissues.
(13) Calibration of instruments--The comparative response
or reading of an instrument relative to a series of known radiation
values over the range of the instrument.
(14) Category 1 continuing medical education units
(CMEU)--Educational activities designated as Category I and approved
by the Accreditation Council for Continuing Medical Education, the
American Osteopathic Association, a state medical society, or an equivalent
organization.
(15) Central axis of the beam--A line passing through
the virtual source and the center of the plane figure formed by the
edge of the first beam-limiting device.
(16) Certified x-ray systems--X-ray systems that have
been certified in accordance with Title 21, Code of Federal Regulations
(CFR).
(17) Certified radiologist--A physician certified by
the American Board of Radiology, the American Osteopathic Board of
Radiology, the Royal College of Physicians and Surgeons of Canada,
or Le College des Medecins du Quebec.
(18) Coefficient of variation or C--The ratio of the
standard deviation to the mean value of a population of observations.
It is estimated using the following equation:
Attached Graphic
(19) Collimator--A device or mechanism by which the
x-ray beam is restricted in size.
(20) Computed tomography (CT)--The production of a
tomogram by the acquisition and computer processing of x-ray transmission
data.
(21) Computed tomography dose index (CTDI)--CTDI represents
the average absorbed dose along the z-axis from a series of contiguous
irradiations. CTDI approximates the average central dose values associated
with a spatially complex dose distribution in a reference acrylic
phantom for one particular set of exam techniques. CTDI is defined
exclusively for axial scanning.
(22) Control panel--The part of the radiation machine
control upon which are mounted the switches, knobs, push buttons,
and other hardware necessary for manually setting the technique factors.
(23) CT conditions of operation--All selectable parameters
governing the operation of a CT system including, but not limited
to, nominal tomographic section thickness, filtration, and the technique
factors as defined in this subsection.
(24) CT gantry--The tube housing assemblies, beam-limiting
devices, detectors, and the supporting structures and frames that
hold these components.
(25) Cumulative air kerma (CAK)--The air kerma accumulated
at a specific point in space relative to the fluoroscopic gantry during
a procedure. CAK does not include tissue backscatter and is measured
in Gy. Some manufacturers identify CAK as cumulative dose (CD).
(26) Diagnostic source assembly--The tube housing assembly
with a beam-limiting device attached.
(27) Diagnostic x-ray system--An x-ray system designed
for irradiation of any part of the human body for the purpose of diagnosis
or visualization.
(28) Dose-area product (DAP)--Dose-area product is
the integral of air kerma (absorbed dose to air) across the entire
x-ray beam emitted from the x-ray tube. DAP is a surrogate measurement
for the entire amount of energy delivered to the patient by the beam.
DAP is measured in R x cm2 (cGy x cm2 ).
(29) Dose-length product (DLP)--DLP is the CTDIvol multiplied by the scan length (slice thickness
x number of slices) in centimeters. It reflects the total energy absorbed
attributable to the complete scan acquisition but is independent of
what is actually scanned.
(30) Entrance exposure (Entrance air kerma)--The entrance
exposure in air expressed in roentgens (R) or the entrance dose in
air (air kerma) expressed in gray (Gy), measured at the point where
the center of the useful beam enters the patient.
(31) Entrance exposure rate (air kerma rate)--The exposure
(air kerma) per unit time at the point where the center of the useful
beam enters the patient.
(32) Field emission equipment--Equipment that uses
an x-ray tube in which electron emission from the cathode is due solely
to the action of an electric field.
(33) Field size--The dimensions along the major axes
of an area in a plane perpendicular to the central axis of the beam
at the normal treatment or examination source-to-image distance and
defined by the intersection of the major axes and the 50% isodose
line.
(34) Filter--Material placed in the useful beam to
preferentially absorb selected radiations.
(35) Fluoroscopic system--A system in which x-ray photons
produce a fluoroscopic image. It includes the image receptors such
as the image intensifier and spot-film device, electrical interlocks,
if any, and structural material providing linkage between the image
receptor and diagnostic source assembly.
(36) Fluoroscopically-Guided Interventional (FGI) Procedures--An
interventional diagnostic or therapeutic procedure performed via percutaneous
or other access routes, usually with local anesthesia or intravenous
sedation, which uses external ionizing radiation in the form of fluoroscopy
to localize or characterize a lesion, diagnostic site, or treatment
site, to monitor the procedure, and to control and document therapy.
FGI procedures may include but not be limited to:
(A) TIPS creation (transjugular intrahepatic portosystemic
shunt);
(B) Embolization (any location, any lesion);
(C) Stroke therapy;
(D) Biliary drainage;
(E) Angioplasty with or without stent placement;
(F) Stent-graft placement;
(G) Chemoembolization;
(H) Angiography and intervention for gastrointestinal
hemorrhage;
(I) Carotid stent placement;
(J) RF (radiofrequency) cardiac ablation;
(K) Complex placement of cardiac EP (electrophysiology)
devices; and
Cont'd... |
