Therapeutic Radiation Machines – Electronic Brachytherapy.
24 RCNY § 175.69
in effect§ 175.69 Therapeutic Radiation Machines – Electronic Brachytherapy.
(a) Applicability.
(1) An electronic brachytherapy device that does not meet the requirements of this section must not be used for irradiation of patients.
(2) An electronic brachytherapy device must only be utilized for human use applications that is specifically approved by the U.S. Food and Drug Administration, unless participating in a research study approved by the registrant's Institutional Review Board.
(3) Electronic brachytherapy devices are exempt from the requirements of 24 RCNY Health Code § 175.64.
(b) Possession of survey instruments. Each facility location authorized to use an electronic brachytherapy device in accordance with this section must possess appropriately calibrated portable monitoring equipment. At a minimum, such equipment must include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1,000 mrem) per hour. The survey instruments must be operable and calibrated in accordance with 24 RCNY Health Code § 175.66 for the applicable electronic brachytherapy source energy.
(c) Facility design requirements. In addition to shielding adequate to meet the requirements of 24 RCNY Health Code § 175.67, an electronic brachytherapy device treatment room must meet the following design requirements:
(1) If applicable, provision must be made to prevent simultaneous operation of more than one therapeutic radiation machine in a treatment room.
(2) Access to the treatment room must be controlled by a door at each entrance.
(3) Each treatment room must have provisions to permit continuous aural communication and visual observation of the patient from the treatment control panel during irradiation. The electronic brachytherapy device must not be used for patient irradiation unless the patient can be observed.
(4) For electronic brachytherapy devices capable of operating below 150 kV, radiation shielding for the staff in the treatment room must be available, either as a portable shield or as localized shielded material around the treatment site.
(5) For electronic brachytherapy devices capable of operating at greater than 150 kV:
(i) the control panel must be located outside the treatment room; and
(ii) electrical interlocks must be provided for all doors to the treatment room that will:
(A) prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;
(B) cause the source to be shielded when an entrance door is opened; and
(C) 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) Control panel. The control panel, in addition to the displays required by other provisions in this section, must:
(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; and
(5) include an access control (locking) device that will prevent unauthorized use of the electronic brachytherapy device.
(e) Timer. A suitable irradiation control device (timer) must be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor.
(1) A timer must be provided at the treatment control panel. The timer must indicate planned setting and the time elapsed or remaining.
(2) The timer must not permit an exposure if set at zero.
(3) The timer must 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 must be necessary to reset the elapsed time indicator before irradiation can be resumed.
(4) The timer must terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation.
(5) The timer must permit setting of exposure times as short as 0.1 second.
(6) The timer must be accurate to within 1 percent of the selected value or 0.1 second, whichever is greater.
(f) QMP support.
(1) The services of a QMP must be required in facilities having electronic brachytherapy devices. The QMP must be responsible for:
(i) evaluation of the output from the electronic brachytherapy source;
(ii) generation of the necessary dosimetric information;
(iii) supervision and review of treatment calculations prior to initial treatment of any treatment site;
(iv) establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required by subdivision (j) of this section;
(v) consultation with the authorized user in treatment planning, as needed; and
(vi) performing calculations/assessments regarding patient treatments that may constitute a medical event.
(2) If the QMP is not a full-time employee of the registrant, the operating procedures required by subdivision (g) of this section must also specifically address how the QMP is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the QMP can be contacted.
(g) Operating procedures.
(1) Electronic brachytherapy devices must not be made available for medical use, unless the requirements of 24 RCNY Health Code § 175.61(a) and subdivisions (i) and (j) of this section have been met.
(2) The electronic brachytherapy device must be inoperable, either by hardware or password, when unattended by qualified staff or service personnel.
(3) Only individuals approved by the authorized user, radiation safety officer, or QMP shall be present in the treatment room during treatment.
(4) During operation, the electronic brachytherapy device operator must 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 must be used.
(6) Written procedures must be developed, implemented, and maintained for responding to equipment malfunction and any deviation from expected clinical outcomes. These procedures must include:
(i) instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; and
(ii) the names and telephone numbers of the authorized users, the QMP, and the radiation safety officer to be contacted if the device or console operates abnormally.
(7) A copy of the current operating and emergency procedures must be physically located at the electronic brachytherapy device control console. If the control console is integral to the electronic brachytherapy device, the required procedures must be kept where the operator is located during electronic brachytherapy device operation.
(8) Instructions must be posted at the electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the authorized users, the QMP, and the radiation safety officer to be contacted if the device or console operates abnormally.
(9) The radiation safety officer or a designee, and an authorized user must be notified as soon as possible if a medical event occurs. The radiation safety officer or the QMP must inform the Department of the event.
(h) Safety precautions.
(1) A QMP must determine which persons in the treatment room require monitoring when the beam is energized.
(2) An authorized user and a QMP must be physically present during the initiation of all patient treatments involving the electronic brachytherapy device.
(3) A QMP and either an authorized user or a physician or electronic brachytherapy device operator, under the supervision of an authorized user, who has been trained in the operation and emergency response for the electronic brachytherapy device, must be physically present during continuation of all patient treatments involving the electronic brachytherapy device.
(4) When shielding is required by paragraph (4) of subdivision (c) of this section, the electronic brachytherapy device operator must use a survey meter to verify proper placement of the shielding immediately upon initiation of treatment. Alternatively, a QMP must designate shield locations sufficient to meet the requirements of this Article for any individual, other than the patient, in the treatment room.
(5) All personnel in the treatment room are required to remain behind shielding during treatment. A QMP must approve any deviation from this requirement and must designate alternative radiation safety protocols, compatible with patient safety, to provide an equivalent degree of protection.
(i) Source calibration measurements.
(1) Calibration of the electronic brachytherapy source output for an electronic brachytherapy device subject to this section must be performed by, or under the direct supervision of, a QMP.
(2) Calibration of the electronic brachytherapy source output must 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 must utilize a dosimetry system described in 24 RCNY Health Code § 175.61(c).
(4) Calibration of the electronic brachytherapy source output must include, as applicable, the determination of:
(i) the output within 2 percent of the expected value, if applicable, or determination of the output if there is no expected value;
(ii) timer accuracy and linearity over the typical range of use;
(iii) proper operation of back-up exposure control devices;
(iv) evaluation that the relative dose distribution about the source is within 5 percent of that expected; and
(v) source positioning accuracy to within 1 millimeter within the applicator;
(5) Calibration of the x-ray source output required by paragraphs (1) through (4) of this subdivision must 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 must be followed.
(6) The registrant must maintain a record of each calibration in an auditable form for the duration of the registration. The record must include:
(i) the date of the calibration;
(ii) the manufacturer's name, model number and serial number for the electronic brachytherapy device and a unique identifier for its electronic brachytherapy source;
(iii) the model numbers and serial numbers of the instrument used to calibrate the electronic brachytherapy device; and
(iv) the name and signature of the QMP responsible for performing the calibration.
(j) Periodic and day-of-use quality assurance checks.
(1) Quality assurance checks must be performed on each electronic brachytherapy device subject to this section:
(i) at the beginning of each day of use;
(ii) each time the device is moved to a new room or site ("site" here 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
(iii) after each x-ray tube installation.
(2) The registrant must perform periodic quality assurance checks required by paragraph (1) of this subdivision in accordance with procedures established by the QMP.
(3) To satisfy the requirements of paragraph (1) of this subdivision, radiation output quality assurance checks must include as a minimum:
(i) verification that output of the electronic brachytherapy source falls within 3 percent of expected values, as appropriate for the device, as determined by:
(A) output as a function of time, or
(B) output as a function of setting on a monitor chamber.
(ii) verification of the consistency of the dose distribution to within 3 percent of that found during calibration required by subdivision (i) of this section.; and
(iii) validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within 1 mm; and
(4) The registrant must use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in 24 RCNY Health Code § 175.61(c)(1) to make the quality assurance checks required by paragraph (3) of this subdivision.
(5) The registrant must review the results of each radiation output quality assurance check according to the following procedures:
(i) an authorized user and QMP must be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device must not be made available for subsequent medical use until the QMP has determined that all parameters are within their acceptable tolerances
(ii) if all radiation output quality assurance check parameters appear to be within their acceptable range, the quality assurance check must be reviewed and signed by either the authorized user or QMP within 2 days; and
(iii) the QMP must review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days.
(6) To satisfy the requirements of paragraph (1) of this subdivision, safety device quality assurance checks must, at a minimum, assure:
(i) proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console;
(ii) proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable;
(iii) proper operation of radiation monitors, if applicable;
(iv) the integrity of all cables, catheters or parts of the device that carry high voltages; and
(v) 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 by paragraph (6) of this subdivision indicate the malfunction of any system, a registrant must 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 registrant must maintain a record of each quality assurance check required by paragraphs (3) through (7) of this subdivision in an auditable form for 3 years.
(i) The record must include the date of the quality assurance check; the manufacturer's name, model number and serial number for the electronic brachytherapy device; the name and signature of the individual who performed the periodic quality assurance check and the name and signature of the QMP who reviewed the quality assurance check;
(ii) For radiation output quality assurance checks required by paragraph (3) of this subdivision, the record must also include the unique identifier for the electronic brachytherapy source and the manufacturer's name; model number and serial number for the instruments used to measure the radiation output of the electronic brachytherapy device.
(k) Therapy-related computer systems. The registrant must 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 (if available). In the absence of an acceptance testing protocol published by a national professional association, the manufacturer's acceptance testing protocol must be followed.
(1) Acceptance testing must be performed by, or under the direct supervision of, a QMP. At a minimum, the acceptance testing must include, as applicable, verification of:
(i) the source-specific input parameters required by the dose calculation algorithm;
(ii) the accuracy of dose, dwell time, and treatment time calculations at representative points;
(iii) the accuracy of isodose plots and graphic displays;
(iv) the accuracy of the software used to determine radiation source positions from radiographic images; and
(v) 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 must 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 must be evaluated and approved by the authorized user and the QMP for correctness through means independent of that used for the determination of the parameters.
(l) Training.
(1) A registrant must 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 subdivision (g) of this section. If the interval between patients exceeds one year, retraining of the individuals shall be provided.
(2) In addition to the requirements of subdivisions (c) of 24 RCNY Health Code § 175.60 as to authorized users, these individuals must also receive device specific instruction initially from the manufacturer and annually from either the manufacturer or other qualified trainer. The training must be of a duration recommended by a recognized national professional association with expertise in electronic brachytherapy (if available). In the absence of any training protocol recommended by a national professional association, the manufacturer's training protocol must be followed. The training must include, but not be limited to:
(i) device-specific radiation safety requirements;
(ii) device operation;
(iii) clinical use for the types of use approved by the FDA;
(iv) emergency procedures, including an emergency drill; and
(v) the registrant's quality assurance program.
(3) A registrant must retain a record of individuals receiving instruction required by paragraphs (1) and (2) of this subdivision for 3 years. The record must include a list of the topics covered, the date of the instruction, the names of the attendees, and the names of the individuals who provided the instruction.
(m) Mobile electronic brachytherapy service. A registrant providing mobile electronic brachytherapy service must, at 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 subdivision (j) of this section to assure proper operation of the device.
(Added City Record 4/24/2019, eff. 5/24/2019)
Source: City of New York, Charter, Administrative Code and Rules (American Legal Publishing XML export, codelibrary.amlegal.com)URL: https://codelibrary.amlegal.com/codes/newyorkcity/latest/NYCrules/0-0-0-118196Fetched: 10/24/2026