N.H. Admin. Code § He-P 4047.11

Current through Register No. 45, November 7, 2024

Section He-P 4047.11 - Electronic Brachytherapy

(a) Electronic brachytherapy devices shall be subject to the requirements of He-P 4047.11 and shall be exempt from the requirements of He-P 4047.06, and which are:

(1) An electronic brachytherapy device that does not meet the requirement of He-P 4047.11 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 U.S. Food and Drug Administration (FDA) unless participating in a research study approved by the registrant's Institutional Review Board.

(b) Each facility location authorized to use an electronic brachytherapy device shall possess appropriately calibrated portable monitoring equipment which shall as a minimum:

(1) Include a portable radiation measurement survey instrument capable of measuring dose rate over the range of 10 µSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour, and

(2) Be operable and calibrated in accordance with He-P 4047.08 for the applicable electronic brachytherapy source energy.

(c) In addition to shielding adequate to meet the requirements of He-P 4047.09, the treatment room shall meet the following design requirements:

(1) If applicable, provision shall be made to prevent simultaneous operation of more than one therapeutic radiation machine 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;

(4) The electronic brachytherapy device shall not be used for patient irradiation unless patient can be observed;

(5) For electronic brachytherapy devices capable of operating below 50kV, radiation shielding for the staff in the room shall be available:

a. Either as a portable shield; or

b. As localized shielded material around the treatment site; and

(6) For electronic brachytherapy devices capable of operating at greater than 150 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:

1. Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

2. Cause the source to be shielded when an entrance door is opened; and

3. 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) Each electronic brachytherapy device shall have the following electrical safety features:

(1) The high voltage transformer shall be electronically isolated to prevent electrical and magnetic interference with the surrounding environment and ancillary equipment;

(2) The high voltage transformer shall be isolated from personnel 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; and

(4) Equipment manufactured shall be in compliance with the most current revision of the following International Electrotechnical Commission (IEC) Documents which are incorporated by reference and included in Appendix A:

a. IEC 60601-1 1998 + A1+A2: 1995;

b. IEC 60601-1-2:2001;

c. IEC 60601-2-8: 1999; and

d. IEC 60601-2-17; 2004.

(e) The control panel in addition to the displays required by other provisions in He-P 4047.11, 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; and

(5) Include an access control (locking) device that will prevent unauthorized use of the electronic brachytherapy device.

(f) A suitable irradiation control device or timer shall be provided to terminate the irradiation after a preset time interval or integrated charge on a dosimeter-based monitor. Timers shall:

(1) Be provided at the control panel and shall indicate planned setting and the time elapsed or remaining;

(2) Not permit an exposure if set at zero;

(3) 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 reinstated, it shall be necessary to reset the elapsed time indicator;

(4) Terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation;

(5) Permit setting of exposure times as short as 0.1 seconds; and

(6) Be accurate to within 1 percent of the selected value or 0.1 seconds, whichever is greater.

(g) The services of a radiation therapy physicist shall be required in facilities having electronic brachytherapy devices. The radiation therapy physicist shall be responsible for:

(1) Evaluation of the output from the electronic brachytherapy source;

(2) Generation of the necessary dosimetric information;

(3) Supervision and review of treatment calculations prior to initial treatment of any treatment site:

(4) Establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required in He-P 4047.11(j);

(5) Consultation with the authorized user in treatment planning, as needed;

(6) Performing calculations and assessments regarding patient treatments that may constitute a misadministration; and

(7) Determining which persons in the treatment room require monitoring when the beam is energized.

(h) Operating procedures shall be as follows:

(1) Only individuals approved by the authorized user, radiation safety officer or radiation therapy 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 He-P 4047.04(a) , and He-P 4047.11(i) through He-P 4047.11(k) have been met;

(3) The electronic brachytherapy device shall be secured to prevent unauthorized use;

(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 equipment failures and the names of the individuals responsible for implementing corrective actions; and

b. The names and telephone numbers of the authorized users, radiation safety officer and the radiation therapy physicist to be contacted if the device or console operates abnormally;

(7) A copy of the current operating and emergency procedures shall be maintained at the control console or panel during electronic brachytherapy device operation. If the 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 to inform the operator of the names and telephone numbers of the authorized users, the radiation safety officer, and the radiation therapy physicist to be contacted if the device or console operates abnormally;

(9) The radiation safety officer, and an authorized user shall be notified as soon as possible if the patient has medical emergency, suffers injury or dies. The radiation safety officer or radiation therapy physicist shall inform the manufacturer of the event;

(10) If the radiation therapy physicist is not a full time employee of the registrant, the operating procedures, required in He-P 4047.11(h) shall also specifically address how the radiation therapy physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the radiation therapy physicist can be contacted.

(i) Calibration procedures shall include:

(1) 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;

(2) Calibration of electronic brachytherapy source output shall utilize a dosimetry system described in He- 4047.05(h);

(3) Calibration of electronic brachytherapy source output shall include, as applicable, determination of:

a. The output within 2 percent of the expected value, if applicable, or determination of the output if there is no expected value;

b. Timer accuracy and linearity over the typical range of use;

c. Proper operation of back exposure control device;

d. Evaluation that the relative dose distribution about the source is within 5 percent of that expected; and

e. Source positioning accuracy within 1 millimeter of the applicator;

(4) Calibration of the x-ray source output required in by He-P 4047.11(i) above, shall be in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy, and if that published recommendation is not available, then from the manufacturer's suggested calibration protocol; and

(5) The registrant shall maintain a record of each calibration in an auditable form for the duration of registration. The record shall include:

a. The date of the calibration;

b. The manufacturer's name;

c. The model number and serial number for the electronic brachytherapy device;

d. A unique identifier for its electronic brachytherapy source;

e. The model numbers and serial numbers of the instrument(s) used to calibrate the electronic brachytherapy device; and

f. The name and signature of the radiation therapy physicist responsible for performing the calibration.

(j) Quality assurance checks shall be conducted as follows:

(1) Quality assurance checks shall be performed on each electronic brachytherapy device subject to He-P 4047.11:

a. At the beginning of each day of use;

b. Each time the device is moved to a new room or site, intended to include each day of use at each operating location and

c. After each x-ray tube installation;

(2) The registrant shall perform periodic quality assurance checks required by He-P 4047.11(j) (1) in accordance with procedures established by the Radiation Therapy Physicist;

(3) To satisfy the requirements of He-P 4047.11(j) (1), radiation output quality assurance checks shall include as a minimum:

a. Verification that output of the electronic brachytherapy source falls within 3 percent of expected values, as appropriate for the device, as determined by:

1. Output as a function of time; or

2. Output as a function of setting on a monitor chamber;

b. Verification of the consistency of the dose distribution to within 3 percent of that found during calibration required by He-P 4047.11(i); and

c. Validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within one mm;

(4) The registrant shall use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in He-P 4047.05(h) to make the quality assurance checks required in He-P 4047.11(j) (3);

(5) The registrant shall review the results of each radiation output quality assurance check according to the following procedures:

a. An authorized user and radiation therapy 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 radiation therapy 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 user or radiation therapy physicist within 2 business days; and

c. The radiation therapy physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days;

(6) To satisfy the requirement of He-P 4047.11(i) (1), 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 He-P 4047.11(j) (6) indicate the malfunction of any system, a registrant shall secure the control console in the OFF position and not use the electronic brachytherapy device except as might be necessary to repair, replace, or check the malfunctioning system; and

(8) The registrant shall maintain a record of each quality assurance check required by He-P 4047.11(j) (3) and He-P 4047.11(j) (6) in an auditable form for 3 years as follows:

a. The record shall include:

1. Date of the quality assurance check;

2. Manufacturer's name, model number and serial number for the electronic brachytherapy device;

3. Name and signature of the individual who performed the periodic quality assurance check; and

4. Name and signature of the radiation therapy physicist who reviewed the quality assurance check; and

b. For radiation output quality assurance checks required by He-P 4047.11(j) (3), the record shall also include:

1. The unique identifier for the electronic brachytherapy source; and

2. The manufacturer's name, model number and serial number for the instrument(s) used to measure the radiation output of the electronic brachytherapy device.

(k) The registrant 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. All acceptance testing shall:

(1) Be performed by, or under the direct supervision of, a radiation therapy physicist; and

(2) At a minimum, 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;

(3) Compare the position indicators in the applicator to the actual position of the source or planned dwell positions, as appropriate, at a time of commissioning; and

(4) Include procedures prior to each patient treatment regimen, for the parameters for the treatment to be evaluated and approved by the authorized user and the radiation therapy physicist for correctness through means independent of that used for the determination of the parameters.

(l) The following training shall be required:

(1) A registrant 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 He-P 4047.11(h) . If the interval between patients exceeds one year, retraining of the individuals shall be provided;

(2) In addition to the requirements of He-P 4047.04(e) for the therapeutic radiation machine authorized users and He-P 4047.04(k) for radiation therapy physicists, these individuals shall also receive device specific instruction initially from the manufacturer, and annually from either the manufacturer or other authorized manufacturer 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 FDA;

d. Emergency procedures, including an emergency drill; and

e. The registrant's quality assurance program; and

(3) A registrant shall retain a record of individuals receiving instruction required by He-P 4047.11(l) (1) and (2) for 3 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.

(m) A registrant 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; and

(3) Perform, at each location on each day of use, all of the required quality assurance checks specified in He-P 4047.11(j) to assure proper operation of the device.

N.H. Admin. Code § He-P 4047.11

Derived From Volume XXXV Number 32, Filed August 13, 2015, Proposed by #10894, Effective 7/21/2015, Expires 7/21/2025.