| (3) has completed eight hours of classroom and laboratory
training in basic radionuclide handling techniques specifically applicable
to the use of the device. The training shall include:
(A) radiation physics and instrumentation;
(B) radiation protection;
(C) mathematics pertaining to the use and measurement
of radioactivity; and
(D) radiation biology; and
(4) has completed training in the use of the device
for the uses requested.
(ddd) Use of a sealed source in a remote afterloader
unit, teletherapy unit, or gamma stereotactic radiosurgery unit.
(1) The licensee shall only use sealed sources:
(A) as approved and as provided for in the Sealed Source
and Device Registry in photon-emitting remote afterloader units, teletherapy
units, or gamma stereotactic radiosurgery units to deliver therapeutic
doses for medical uses; or
(B) in research involving photon-emitting remote afterloader
units, teletherapy units, or gamma stereotactic radiosurgery units
in accordance with an active IDE application accepted by the FDA provided
the requirements of subsection (u)(1) of this section are met.
(2) A licensee shall use photon-emitting remote afterloader
units, teletherapy units, or gamma stereotactic radiosurgery units:
(A) approved in the Sealed Source and Device Registry
to deliver a therapeutic dose for medical use. These devices may be
used for therapeutic medical treatments that are not explicitly provided
for in the Sealed Source and Device Registry, but must be used in
accordance with radiation safety conditions and limitations described
in the Sealed Source and Device Registry; or
(B) in research in accordance with an active IDE application
accepted by the FDA provided the requirements of subsection (u)(1)
of this section are met.
(eee) Surveys of patients and human research subjects
treated with a remote afterloader unit.
(1) Before releasing a patient or a human research
subject from licensee control, the licensee shall perform a survey
of the patient or the human research subject and the remote afterloader
unit with a portable radiation detection survey instrument to confirm
that the sealed source(s) has been removed from the patient or human
research subject and returned to the safe shielded position.
(2) The licensee shall maintain a record of the surveys
in accordance with subsection (xxx) of this section for inspection
by the department. The record shall include the following:
(A) date of the survey;
(B) results of the survey;
(C) manufacturer's name, model, and serial number of
the survey instrument used; and
(D) name of the individual who made the survey.
(fff) Installation, maintenance, adjustment, and repair.
(1) Only a person specifically licensed by the department,
the NRC, or an agreement state shall install, maintain, adjust, or
repair a remote afterloader unit, teletherapy unit, or gamma stereotactic
radiosurgery unit that involves work on the sealed source(s) shielding,
the sealed source(s) driving unit, or other electronic or mechanical
component that could expose the sealed source(s), reduce the shielding
around the sealed source(s), or compromise the radiation safety of
the unit or the sealed source(s).
(2) Except for low dose-rate remote afterloader units,
only a person specifically licensed by the department, the NRC, or
an agreement state shall install, replace, relocate, or remove a sealed
source or sealed source contained in other remote afterloader units,
teletherapy units, or gamma stereotactic units.
(3) For a low dose-rate remote afterloader unit, only
a person specifically licensed by the department, the NRC, an agreement
state, or an authorized medical physicist shall install, replace,
relocate, or remove a sealed source(s) contained in the unit.
(4) The licensee shall maintain a record of the installation,
maintenance, adjustment and repair done on remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units in accordance
with subsection (xxx) of this section for inspection by the department.
For each installation, maintenance, adjustment and repair, the record
shall include the date, description of the service, and name(s) of
the individual(s) who performed the work.
(ggg) Safety procedures and instructions for remote
afterloader units, teletherapy units, and gamma stereotactic radiosurgery
units.
(1) A licensee shall do the following:
(A) secure the unit, the console, the console keys,
and the treatment room when not in use or unattended;
(B) permit only individuals approved by the authorized
user, RSO, or authorized medical physicist to be present in the treatment
room during treatment with the sealed source(s);
(C) prevent dual operation of more than one radiation
producing device in a treatment room if applicable; and
(D) develop, implement, and maintain written procedures
for responding to an abnormal situation when the operator is unable
to place the sealed source(s) in the shielded position, or remove
the patient or human research subject from the radiation field with
controls from outside the treatment room. The procedures shall include
the following:
(i) instructions for responding to equipment failures
and the names of the individuals responsible for implementing corrective
actions;
(ii) the process for restricting access to and posting
of the treatment area to minimize the risk of inadvertent exposure;
and
(iii) the names and telephone numbers of the authorized
users, the authorized medical physicist, and the RSO to be contacted
if the unit or console operates abnormally;
(2) A copy of the procedures required by paragraph
(1)(D) of this subsection must be physically located at the unit console.
(3) The licensee shall post instructions at the unit
console to inform the operator of the following:
(A) the location of the procedures required by paragraph
(1)(D) of this subsection; and
(B) the names and telephone numbers of the authorized
users, the authorized medical physicist, and the RSO to be contacted
if the unit or console operates abnormally.
(4) Before the first use for patient treatment of a
new unit or an existing unit with a manufacturer upgrade that affects
the operation and safety of the unit:
(A) a licensee shall ensure that vendor operational
and safety training is provided to all individuals who will operate
the unit. The vendor operational and safety training must be provided
by the device manufacturer or by an individual certified by the device
manufacturer to provide the operational and safety training.
(B) a licensee shall provide operational and safety
instructions initially and at least annually, to all individuals who
operate the unit at the facility, as appropriate to the individual's
assigned duties, to include:
(i) procedures identified in paragraph (1)(D) of this
subsection; and
(ii) operating procedures for the unit.
(5) A licensee shall ensure that operators, authorized
medical physicists, and authorized users participate in drills of
the emergency procedures, initially and at least annually; and
(6) A licensee shall maintain records of the procedures
required by paragraphs (1)(D) and (4)(B)(ii) of this subsection in
accordance with subsection (xxx) of this section for inspection by
the department.
(7) A licensee shall maintain records of individuals
receiving instruction and participating in drills required by paragraphs
(4) and (5) of this subsection in accordance with subsection (xxx)
of this section for inspection by the department. The record shall
include the following:
(A) a list of the topics covered;
(B) date of the instruction or drill;
(C) name(s) of the attendee(s); and
(D) name(s) of the individual(s) who provided the instruction.
(hhh) Safety precautions for remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units. The
licensee shall do the following:
(1) control access to the treatment room by a door
at each entrance;
(2) equip each entrance to the treatment room with
an electrical interlock system that will do the following:
(A) prevent the operator from initiating the treatment
cycle unless each treatment room entrance door is closed;
(B) cause the sealed source(s) to be shielded promptly
when an entrance door is opened; and
Cont'd... |
