§ 175.69 Therapeutic Radiation Machines – Electronic Brachytherapy.
RCNY § 175.69
(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.
(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.
(6)The timer must be accurate to within 1 percent of the selected value or 0.1 second, whichever is greater.
(f)QMP support.
(g)Operating procedures.
(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.
(i)Source calibration measurements.
(j)Periodic and day-of-use quality assurance checks.
(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.
(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.
(l)Training.
(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)
