| (1) If the agency certifying body believes that mammography quality at a facility may have been compromised and presents a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by the agency certifying body, for review by the FDA-approved accreditation body. (2) If the agency certifying body determines that mammography quality at a facility has been compromised and presents a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by the agency certifying body, for review by the FDA-approved accreditation body. The agency certifying body may require such facility to notify patients who received mammograms, and their referring physicians. The notification shall include the deficiencies presenting such risk, the potential consequences to the patient, appropriate remedial measures, and such other relevant information as the agency certifying body may require. Such notification shall occur within a time frame and in a manner specified by the agency. (3) The agency certifying body, the agency accreditation body or another FDA-approved accreditation body, or the FDA may request a targeted clinical image review due to, but not limited to, serious complaints or severe items of non-compliance. (bb) Self-referral mammography. Any person proposing to conduct a self-referral mammography program shall not initiate such a program without prior approval of the agency. When requesting such approval, that person shall submit the following information: (1) the number and type of views (or projections); (2) the age of the population to be examined and the frequency of the exam following established, nationally recognized criteria, such as those of the American Cancer Society, American College of Radiology (ACR), or the National Council on Radiation Protection and Measurements; (3) written procedures to include methods of: (A) advising patients and private physicians of the results of the mammography examination in accordance with subsection (t)(2) of this section; (B) follow-up with patients and physicians in accordance with subsection (t)(3) of this section; and (C) recommending to patients who do not have a physician means of selecting a physician; and (4) methods for educating mammography patients in breast self-examination techniques and on the necessity for follow-up by a physician. (cc) Medical research and investigational devices. (1) Any research using radiation producing devices on humans must be approved by an IRB as required by Title 45, CFR, Part 46 and Title 21, CFR, Part 56. The IRB must include at least one licensed physician to direct any use of radiation in accordance with §289.231(b) of this title. (2) Facilities with mammography machines with investigational device exemptions that are involved in clinical studies must comply with primary regulations that govern the conduct of clinical studies and that apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device. These regulations include the following: (A) 21 CFR, Part 812, Investigational Device Exemptions; (B) 21 CFR, Part 50, Protection of Human Subjects; (C) 21 CFR, Part 56, Institutional Review Boards; (D) 21 CFR, Part 54, Financial Disclosure by Clinical Investigators; and (E) 21 CFR, Part 821, Subpart C, Design Controls of the Quality System Regulation. (dd) Other operating procedures. (1) Operating and safety procedures. Each registrant shall have and implement written operating and safety procedures that shall be made available to each individual operating x-ray equipment, including any restrictions of the operating technique required for the safe operation of the particular system. These procedures shall include, but are not limited to, the items in subsection (hh)(3) of this section. (2) Technique chart. A chart or manual shall be provided or electronically displayed in the vicinity of the control panel of each machine that specifies technique factors to be utilized versus patient's anatomical size. The technique chart shall be used by all operators. (3) Receipt, transfer, and disposal of mammography machines. Each registrant shall maintain records showing the receipt, transfer, and disposal of mammographic machines. These records shall include the date of receipt, transfer, or disposal; the name and signature of the individual making the record; and the manufacturer's model name and serial number from the control panel of the mammographic machine. Records shall be maintained in accordance with subsection (ee) of this section for inspection by the agency. (4) Viewing system. Windows, mirrors, closed circuit television, or an equivalent system shall be provided to permit the operator to continuously observe the patient during irradiation. The operator shall be able to maintain verbal, visual, and aural contact with the patient. (5) Exposure of individuals other than the patient. Only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiation exposure unless such individual's assistance is required. (6) Protective devices. Protective devices shall be utilized when required, as in paragraph (7) of this subsection. (A) Protective devices shall be of no less than 0.25 mm lead equivalent material. (B) Protective devices, including aprons, gloves, and shields shall be checked annually for defects such as holes, cracks, and tears. These checks may be performed by the registrant by visual or tactile means, or x-ray imaging. If a defect is found, protective devices shall be replaced or removed from service until repaired. A record of this test shall be made and maintained by the registrant in accordance with subsection (ee) of this section for inspection by the agency. (7) Holding of patient or image receptor. (A) When a patient or image receptor must be held in position during radiography, mechanical supporting or restraining devices shall be used when the exam permits. (B) If a patient or image receptor must be held by an individual during an exposure, that individual shall be protected with appropriate shielding devices described in paragraph (6) of this subsection. (C) The registrant's written operating and safety procedures required by paragraph (1) of this subsection shall include the following: (i) a list of circumstances in which mechanical holding devices cannot be routinely utilized; and (ii) a procedure used for selecting an individual to hold or support the patient or image receptor. (D) In those cases where the patient must hold the image receptor, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.25 mm lead equivalent material. (8) Calibration, maintenance, and modifications. Each registrant shall maintain records showing calibrations, maintenance, and modifications performed on each mammographic machine. These records shall include the date of the calibration, maintenance, or modification performed; the name of the individual making the record; and the manufacture's model name and serial number of the control panel of the mammographic machine. These records shall be maintained in accordance with subsection (ee) of this section. (ee) Record requirements. Records required by this section shall be maintained for inspection by the agency in accordance with paragraph (3) of this subsection. Records may be maintained electronically in accordance with §289.231(ff)(3) of this title. (1) Records for mammography machines authorized for mobile service operations. (A) Copies of the following shall be kept with mammography machines authorized for mobile services: (i) operating and safety procedures in accordance with subsection (dd)(1) of this section; (ii) medical radiologic technologists' credentials; (iii) current quality control records for at least the last 90 calendar days for on-board processors in accordance with subsection (v)(1) of this section; (iv) current §289.203 of this title, §289.226 of this title, §289.230 of this title, §289.231 of this title, and §289.234 of this title if accredited by the agency accreditation body; (v) copy of certification; (vi) certification of inspection in accordance with subsection (ff)(5) of this section; (vii) notice of failure from last inspection in accordance with subsection (ff)(6) of this section, if applicable; and Cont'd... |
