(By authority conferred on the
director of the department of licensing and regulatory affairsdepartment
of labor and economic opportunity by sections 13515, 13521,
13522, and 13527 of the public health code, 1978 PA 368, MCL 333.13515, 333.13521,
1978 PA 368, 333.13522, and 333.13527 and Executive
Reorganization Order Nos. 1996-1, 1996-2, 2003-1, and 2011-4, and 2019-3,
being MCL 330.3101, 445.2001, 445.2011, and 445.2030, and
125.1998)
R 333.55396 is amended to
the of the Michigan Administrative Code is amended, as
follows:
Rule 396. (1) As used in this section, “handheld dental X-ray system” or “system” means an X-ray system that is used to take radiographs, is designed to be handheld during its operation, and is portable.
(2) A handheld dental X-ray system that meets the requirements described in this section may be used for routine dental radiography in a dental office or a situation in which it is impractical to transfer a patient to a radiation machine that is stationary.
(3) X-ray equipment designed to be hand-held shall meet the requirements of R 333.5373, excluding subrules (9) and (13).
(2)(4)The x-ray tube housing for tubes
designed to be hand-held shall be constructed so that the leakage radiation
measured in air at a distance 5 centimeters from a point on the external
surface does not exceed 0.02 mGy (2 milliroentgens) in 1 hour when operated
under conditions of maximum radiation output permitted by the design or
operating characteristics of the radiation machine.
(3)(5) Operation of a hand-held portable x-ray
system shall meet the requirements of R 333.5376, excluding subrules (3) and
(6).
(4)(6) Protective shielding of at least 0.5
millimeter lead equivalence shall be provided for the operator to protect the
operator’s torso, hands, face, and gonads from backscattered radiation. If the
protective shielding is a backscatter shield attached to the unit, the shield
shall be positioned as close to the patient as possible and the operator shall
take care to remain in a protective position.A person shall not use a
handheld dental X-ray system to perform dental radiography unless the machine
is registered with the department under department rules for registration of
radiation machines and the system, the personnel operating the system, and the
facility in which the system is used meet all of the following requirements:
(a) The system has been approved for human use by the United States Food and Drug Administration and is used in a manner consistent with that approval.
(b) The system has a backscatter shield that meets all of the following requirements:
(i) The shield is composed of a leaded polymer or a lead-equivalent substance that has a substantially equivalent protective capacity.
(ii) The shield has at least 0.5 millimeters of lead or lead-equivalent shielding, as determined by the department.
(iii) The shield is permanently affixed to the system.
(c) The system is calibrated by its manufacturer before its first use and is recalibrated at least every 24 months after the date of the last calibration.
(d) When not in use, the system is stored in a manner that restricts access to the system, such as by storing the system in a locked area of the facility.
(e) Each individual who operates the system is an individual who is authorized to operate a dental radiography machine pursuant to rules promulgated under part 166 of the act.
(f) An individual operating the system is not required to wear a lead apron or other personal monitoring equipment while operating the system if it is determined that the use of the system is in compliance with part 381 of the Michigan occupational safety and health administration occupational health standards, R 325.60601a to R 325.60618 of the Michigan Administrative Code, or equivalent federal occupational safety and health standards; part 33 of the Michigan occupational safety and health administration general industry safety and health standard, R 408.13301 to R 408.13395g of the Michigan Administrative Code, or equivalent federal occupational safety and health standards; R 333.5057 of the Michigan Administrative Code; and R 333.5063 to R 333.5065 of the Michigan Administrative Code. However, upon request, a registrant shall make a lead apron or other personal monitoring equipment available to an individual who operates the system.
(g) The system is not used if the backscatter shield described in subdivision (b) of this rule is broken, missing, or malfunctioning.
(5)(7) An operator shall complete the training
program supplied by the manufacturer and approved by the department before
using the x-ray unit. Records of the training shall be maintained on file for
examination by the department.
(6) Hand-held dental x-ray systems shall not be
used for routine dental radiography in dental offices. This equipment shall
only be for portable use including use in nursing homes, home health care, or
for use on special needs patients.