Current through all regulations passed and filed through March 18, 2024
In addition to the rules in Chapters
3701:1-38 and 3701:1-67 of the Administrative Code, handlers of electronic
brachytherapy equipment shall comply with paragraphs (A) to (N) of this
rule.
(A) Electronic
brachytherapy devices shall be subject to the requirements of this rule, and
shall be exempt from the requirements of rule
3701:1-67-05
of the Administrative Code.
(1) An electronic
brachytherapy device that does not meet the requirements of this rule shall not
be used for irradiation of patients; and
(2) An electronic brachytherapy device shall
only be utilized for human use applications specifically approved by the United
States food and drug administration unless participating in a research study
approved by the handler's institutional review board.
(B) Each facility location authorized to use
an electronic brachytherapy device in accordance with the requirements of this
rule shall possess appropriately
calibrated portable monitoring equipment. As a minimum, such equipment shall
include a portable radiation measurement survey instrument capable of measuring
dose rates over the range ten microsievert (one millirem) per hour to ten
millisievert (one rem) per hour. Each survey instrument shall be operable and
calibrated in accordance with rule
3701:1-67-07
of the Administrative Code for the applicable electronic brachytherapy source
energy.
(C) In addition to
shielding adequate to meet requirements of rule
3701:1-67-08
of the Administrative Code, the treatment room shall meet the following design
requirements:
(1) If applicable, provisions
shall be made to prevent simultaneous operation of more than one piece of
therapy equipment in a treatment room;
(2) Access to the treatment room shall be
controlled by a door at each entrance;
(3) Each treatment room shall have provisions
to permit continuous aural communication and visual observation of the patient
from the treatment control panel during irradiation. The electronic
brachytherapy device shall not be used for patient irradiation unless the
patient can be observed;
(4) For
electronic brachytherapy devices capable of operating below fifty kV, radiation
shielding for the staff in the treatment room shall be available, either as a
portable shield or as localized shielded material around the treatment site;
and
(5) For electronic
brachytherapy devices capable of operating at greater than one hundred fifty
kV:
(a) The control panel shall be located
outside the treatment room; and
(b)
Electrical interlocks shall be provided for all door(s) to the treatment room
that will:
(i) Prevent the operator from
initiating the treatment cycle unless each treatment room entrance door is
closed;
(ii) Cause the source to be
shielded when an entrance door is opened; and
(iii) Prevent the source from being exposed
following an interlock interruption until all treatment room entrance doors are
closed and the source on-off control is reset at the console.
(D) Electrical
safety for electronic brachytherapy devices shall include the following:
(1) The high voltage transformer shall be
electrically isolated to prevent electrical and magnetic interference with the
surrounding environment and ancillary equipment.
(2) The high voltage transformer shall be
isolated from personnel, including the operator, and the environment by a
protective housing that can only be accessed through a cover requiring a tool
for access or with electrical interlocks to prevent operation while
open.
(3) The high voltage
transformer shall have appropriate safety labels warning personnel of potential
electrical shock and/or heat related injuries.
(4) Electronic brachytherapy devices shall be
in compliance with the following "International Electrotechnical Commission"
(IEC) documents which, may be purchased from the "IEC National Committee of
United States of America, ANSI, 25 West 43rd Street, 4th Floor, New York, New
York, 10036, telephone (212) 642-4900,
http://www.iec.ch/":
(a) IEC 60601-1:2005, "General requirements
for basic safety and essential performance";
(b) IEC 60601-1-2:2007, "General requirements
for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility -Requirements and tests";
(c) IEC 60601-2-8:2010, "Particular
requirements for basic safety and essential performance of therapeutic X-ray
equipment operating in the range 10 kV to 1 MV;" and
(d) IEC 60601-2-17:2013, "Particular
requirements for the safety of automatically-controlled brachytherapy
afterloading equipment."
(E) The control panel, in addition to the
displays required by other provisions in this rule, shall:
(1) Provide an indication of whether
electrical power is available at the control panel and if activation of the
electronic brachytherapy source is possible;
(2) Provide an indication of whether x-rays
are being produced;
(3) Provide a
means for indicating electronic brachytherapy source potential and
current;
(4) Provide the means for
terminating an exposure at any time;
(5) Include an access control or locking
device that will prevent unauthorized use of the electronic brachytherapy
device; and
(6) Bear a warning
label indicating that radiation is produced when the therapy equipment is
energized and that the equipment may be dangerous to patients and operators
unless safety and operating instructions are observed.
(F) A suitable irradiation control device or
timer shall be provided to terminate the irradiation after a pre-set time
interval or integrated charge on a dosimeter-based monitor and satisfy the
following:
(1) A timer shall be provided at
the treatment control panel and shall indicate planned setting and the time
elapsed or remaining;
(2) The timer
shall not permit an exposure if set at zero;
(3) The timer shall be a cumulative device
that activates with an indication of "BEAM ON" and retains its reading after
irradiation is interrupted or terminated. After irradiation is terminated and
before irradiation can be reinitiated, it shall be necessary to reset the
elapsed time indicator;
(4) The
timer shall terminate irradiation when a pre-selected time has elapsed, if any
dose monitoring system has not previously terminated irradiation;
(5) The timer shall permit setting of
exposure times as short as 0.1 second; and
(6) The timer shall be accurate to within one
per cent of the selected value or 0.1 second, whichever is greater.
(G) The services of a qualified
medical physicist shall be required in facilities having electronic
brachytherapy devices.
(1) The qualified
medical physicist shall be responsible for:
(a) Evaluation of the output from the
electronic brachytherapy source;
(b) Generation of the necessary dosimetric
information;
(c) Supervision and
review of treatment calculations prior to initial treatment of any treatment
site;
(d) Establishing the periodic
and day-of-use quality assurance checks and reviewing the data from those
checks as required in paragraph (K) of this rule;
(e) Consultation with the authorized
physician or veterinarian in treatment planning, as needed;
(f) Performing calculations/assessments
regarding patient treatments that may constitute a misadministration:
and
(g) Developing a quality
assurance program.
(2) If
the qualified medical physicist is not a full-time employee of the handler, the
operating procedures required by paragraph (H) of this rule, shall also
specifically address how the qualified medical physicist is to be contacted for
problems or emergencies, as well as the specific actions, if any, to be taken
until the qualified medical physicist can be contacted.
(H) Operating procedures for electronic
brachytherapy devices subject to the requirements of this rule shall include:
(1) Only individuals approved by the
authorized physician or veterinarian, individual responsible for radiation
protection, or qualified medical physicist shall be present in the treatment
room during treatment;
(2)
Electronic brachytherapy devices shall not be made available for medical use
unless the requirements of paragraph (G) of rule
3701:1-67-08
of the Administrative Code, and paragraphs (I) and (J) of this rule have been
met;
(3) The electronic
brachytherapy device shall be inoperable, either by hardware or password, when
unattended by qualified staff or service personnel;
(4) During operation, the electronic
brachytherapy device operator shall monitor the position of all persons in the
treatment room, and all persons entering the treatment room, to prevent
entering persons from unshielded exposure from the treatment beam;
(5) If a patient must be held in position
during treatment, mechanical supporting or restraining devices shall be
used;
(6) Written procedures shall
be developed, implemented, and maintained for responding to an abnormal
situation. These procedures shall include:
(a)
Instructions for responding to electronic brachytherapy device failures and the
names of the individuals responsible for implementing corrective actions;
and
(b) The names and telephone
numbers of the authorized physicians or veterinarians, the designated qualified
medical physicist, and the individual responsible for radiation protection to
be contacted if the device or console operates abnormally.
(7) A copy of the current operating and
emergency procedures shall be physically located at the electronic
brachytherapy device control console. If the control console is integral to the
electronic brachytherapy device, the required procedures shall be kept where
the operator is located during electronic brachytherapy device
operation;
(8) Instructions shall
be posted at the electronic brachytherapy device control console or alternate
location identified in paragraph (H)(7) of this rule, to inform the operator of
the names and telephone numbers of the authorized physicians or veterinarians,
the qualified medical physicist, and the individual responsible for radiation
protection to be contacted if the device or console operates abnormally;
and
(9) The individual responsible
for radiation protection, or his/her designee, and an authorized physician or
veterinarian shall be notified as soon as possible if the patient has a medical
emergency, suffers injury or dies. The individual responsible for radiation
protection or the qualified medical physicist shall inform the manufacturer of
the event.
(I) Safety
precautions for electronic brachytherapy devices subject to the requirements of
this rule, shall include:
(1) A qualified
medical physicist shall determine which persons in the treatment room require
monitoring when the beam is energized;
(2) An authorized physician or veterinarian
and a qualified medical physicist shall be physically present during the entire
duration of all patient treatments involving the electronic brachytherapy
device;
(3) When shielding is
required by paragraph (C)(4) of this rule, a qualified medical physicist shall
designate shield locations sufficient to meet the requirements of rule
3701:1-38-12
of the Administrative Code, for any individual, other than the patient, in the
treatment room; and
(4) All
personnel in the treatment room are required to remain behind shielding during
treatment. A qualified medical physicist shall approve any deviation from this
requirement and shall designate alternative radiation safety protocols,
compatible with patient safety, to provide an equivalent degree of
protection.
(J)
Electronic brachytherapy source calibration measurements for an electronic
brachytherapy device subject to the requirements of this rule shall include the
following:
(1) Calibration of the electronic
brachytherapy source output shall be performed by, or under the direct
supervision of, a qualified medical physicist;
(2) Calibration of the electronic
brachytherapy source output shall be made for each electronic brachytherapy
source, or after any repair affecting the x-ray beam generation, or when
indicated by the electronic brachytherapy source quality assurance
checks;
(3) Calibration of the
electronic brachytherapy source output shall utilize a dosimetry system
described in paragraph (G) of rule
3701:1-67-07
of the Administrative Code;
(4)
Calibration of the electronic brachytherapy source output shall include, as
applicable, determination of:
(a) The output
within two per cent of the expected value, if applicable, or determination of
the output if there is no expected value;
(b) Timer and linearity over the typical
range of use;
(c) Proper operation
of back-up exposure control devices;
(d) Evaluation that the relative dose
distribution about the source is within five per cent of that expected;
and
(e) Source positioning accuracy
to within one millimeter within the applicator;
(5) Calibration of the x-ray source output
required by paragraphs (J)(1) to (J)(4) of this rule shall be in accordance
with current published recommendations from a recognized national professional
association with expertise in electronic brachytherapy (when available). In the
absence of a calibration protocol published by a national professional
association, the manufacturer's calibration protocol shall be followed;
and
(6)
A record of each calibration in an auditable form for
as long as the therapy facility exists. The record shall include:
(a) The date of the calibration;
(b) The manufacturer's name, model number and
serial number for the electronic brachytherapy device and a unique identifier
for its electronic brachytherapy source;
(c) The model numbers and serial numbers of
the instrument(s) used to calibrate the electronic brachytherapy device;
and
(d) The name and signature of
the qualified medical physicist responsible for performing the
calibration.
(K) Periodic and day-of-use quality assurance
checks for electronic brachytherapy devices subject to the requirements of this
rule shall include the following:
(1) Quality
assurance checks shall be performed on each electronic brachytherapy device:
(a) At the beginning of each day of
use;
(b) Each time the device is
moved to a new room or site, where site is intended to include each day of use
at each operating location for a self-contained electronic brachytherapy unit
transported in a van or trailer; and
(c) After each x-ray tube
installation.
(2) The
handler shall perform periodic quality assurance checks required by paragraph
(K)(1) of this rule in accordance with procedures established by the qualified
medical physicist;
(3) To satisfy
the requirements of paragraph (K)(1) of this rule, radiation output quality
assurance checks shall include, as a minimum:
(a) Verification that output of the
electronic brachytherapy source falls within three per cent of expected values,
as appropriate for the device, as determined by;
(i) Output as a function of time,
or
(ii) Output as a function of
setting on a monitor chamber.
(b) Verification of the consistency of the
dose distribution to within three per cent of that found during calibration
required by paragraph (J) of this rule; and
(c) Validation of the operation of
positioning methods to ensure that the treatment dose exposes the intended
location within one millimeter; and
(4) The handler shall use a dosimetry system
that has been intercompared within the previous twelve months with the
dosimetry system described in paragraph (B) of rule
3701:1-67-07
of the Administrative Code to make the quality assurance checks required in
paragraph (K)(3) of this rule;
(5)
The handler shall review the results of each radiation output quality assurance
check according to the following procedures:
(a) An authorized physician or veterinarian
and qualified medical physicist shall be immediately notified if any parameter
is not within its acceptable tolerance. The electronic brachytherapy device
shall not be made available for subsequent medical use until the qualified
medical physicist has determined that all parameters are within their
acceptable tolerances;
(b) If all
radiation output quality assurance check parameters appear to be within their
acceptable range, the quality assurance check shall be reviewed and signed by
either the authorized physician or veterinarian or qualified medical physicist
within two days; and
(c) The
qualified medical physicist shall review and sign the results of each radiation
output quality assurance check at intervals not to exceed thirty
days.
(6) To satisfy the
requirements of paragraph (K)(1) of this rule, safety device quality assurance
checks shall, at a minimum, assure:
(a) Proper
operation of radiation exposure indicator lights on the electronic
brachytherapy device and on the control console;
(b) Proper operation of viewing and intercom
systems in each electronic brachytherapy facility, if applicable;
(c) Proper operation of radiation monitors,
if applicable;
(d) The integrity of
all cables, catheters or parts of the device that carry high voltages;
and
(e) Connecting guide tubes,
transfer tubes, transfer-tube-applicator interfaces, and treatment spacers are
free from any defects that interfere with proper operation.
(7) If the results of the safety
device quality assurance checks required in paragraph (K)(6) of this rule
indicate the malfunction of any system, the handler shall
secure the control console in the "OFF" position and not use the electronic
brachytherapy device except as may be necessary to repair, replace, or check
the malfunctioning system.
(8) The
handler shall maintain a record of each quality assurance check required by
paragraphs (K)(3) and (K)(7) of this rule in an auditable form for three years.
(a) The record shall include:
(i) The date of the quality assurance
check;
(ii) The manufacturer's
name, model number, and serial number for the electronic brachytherapy
device;
(iii) The name and
signature of the individual who performed the periodic quality assurance check;
and
(iv) The date, name and
signature of the qualified medical physicist who reviewed the quality assurance
check;
(b) For radiation
output quality assurance checks required by paragraph (K)(3) of this rule, the
record shall also include:
(i) The unique
identifier for the electronic brachytherapy source; and
(ii) The manufacturer's name, model number,
and serial number for the instrument(s) used to measure the radiation output of
the electronic brachytherapy device.
(L) The handler shall perform acceptance
testing on the treatment planning system of electronic brachytherapy-related
computer systems in accordance with current published recommendations from a
recognized national professional association with expertise in electronic
brachytherapy (when available). In the absence of an acceptance testing
protocol published by a national professional association, the manufacturer's
acceptance testing protocol shall be followed.
(1) Acceptance testing shall be performed by,
or under the direct supervision of, a qualified medical physicist. At a
minimum, the acceptance testing shall include, as applicable, verification of:
(a) The source-specific input parameters
required by the dose calculation algorithm;
(b) The accuracy of dose, dwell time, and
treatment time calculations at representative points;
(c) The accuracy of isodose plots and graphic
displays;
(d) The accuracy of the
software used to determine radiation source positions from radiographic images;
and
(e) If the treatment-planning
system is different from the treatment-delivery system, the accuracy of
electronic transfer of the treatment delivery parameters to the treatment
delivery unit from the treatment planning system.
(2) The position indicators in the applicator
shall be compared to the actual position of the source or planned dwell
positions, as appropriate, at the time of commissioning.
(3) Prior to each patient treatment regimen,
the parameters for the treatment shall be evaluated and approved by the
authorized physician or veterinarian and the qualified medical physicist for
correctness through means independent of that used for the determination of the
parameters.
(M) Training
for electronic brachytherapy devices subject to the requirements of this rule
shall include the following:
(1) A handler
shall provide instruction, initially and at least annually, to all individuals
who operate the electronic brachytherapy device, as appropriate to the
individual's assigned duties, in the operating procedures identified in
paragraph (H) of this rule. If the interval between patients exceeds one year,
retraining of the individuals shall be provided.
(2) In addition to the requirements of
paragraph (C) of rule
3701:1-67-02
of the Administrative Code, for authorized physicians or veterinarians of
electronic brachytherapy equipment and paragraph (D) of rule
3701:1-67-02
of the Administrative Code, for qualified medical physicists, these individuals
shall also receive device specific instruction initially from the manufacturer,
and annually from either the manufacturer or other qualified trainer. The
training shall be of a duration recommended by a recognized national
professional association with expertise in electronic brachytherapy (when
available). In the absence of any training protocol recommended by a national
professional association, the manufacturer's training protocol shall be
followed. The training shall include, but not be limited to:
(a) Device-specific radiation safety
requirements;
(b) Device
operation;
(c) Clinical use for the
types of use approved by the United States food and drug
administration;
(d) Emergency
procedures, including an emergency drill; and
(e) The handler's quality assurance
program.
(3) A handler
shall retain a record of individuals receiving instruction required by
paragraphs (M)(1) and (M)(2) for three years. The record shall include:
(a) A list of the topics covered;
(b) The date of the instruction;
(c) The name(s) of the attendee(s);
and
(d) The name(s) of the
individual(s) who provided the instruction.
(N) A handler providing mobile electronic
brachytherapy service shall, as a minimum:
(1)
Check all survey instruments before medical use at each address of use or on
each day of use, whichever is more restrictive.
(2) Account for the electronic brachytherapy
source in the electronic brachytherapy device before departure from the
client's address.
(3) Perform, at
each location on each day of use, all of the required quality assurance checks
specified in paragraph (K) of this rule to assure proper operation of the
device.