900.12(e)(10): Mammography equipment evaluations. Additional evaluations of mammography units or image processors shall be conducted whenever a new unit or processor is installed, a unit or processor is disassembled and reassembled at the same or a new location, or major components of a mammography unit or processor equipment are changed or repaired. These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in paragraphs (b) and (e) of this section. All problems shall be corrected before the new or changed equipment is put into service for examinations or film processing. The mammography equipment evaluation shall be performed by a medical physicist or by an individual under the direct supervision of a medical physicist
Approved Alternative Standard:
- Conducting the Mammography Equipment Evaluation After a Software Upgrade Under Medical Physicist Oversight
- Manufacturer's software modification of the AEC
According to Section 900.12(e)(10) of the regulations, mammography equipment evaluations must be conducted by a medical physicist for x-ray units and processors that are newly installed, have been disassembled and reassembled, or have undergone major repairs. Furthermore, such evaluations “shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in paragraphs (b) and (e) of this section.”
For an x-ray unit that is new to the facility, the word “applicable” refers to the following:
Performing all the annual tests listed in section (e)(5) [except (e)(5)(viii), which need not be included if no new cassettes are added], the “other modality” tests listed in (e)(6) (if applicable), the compression device performance test listed in (e)(4)(iii)(B), and the phantom image test listed in (e)(2); and
Verifying that the new x-ray unit meets the equipment standards listed in Sections (b)(1-10). These standards relate to the design aspects of the unit as provided by the manufacturer. Furthermore, if the new unit is a film-screen unit and is the first and/or the only one at the facility, then (b)(11), (b)(12), (b)(14), and (b)(15), which relate to the screen-film combination and the lighting and viewing conditions used at the facility, must also be verified.
Note: If new cassettes are also added, then the screen-film contact test listed in (e)(4)(ii) and the uniformity of screen speed listed in (e)(5)(viii) must be performed.
Note that an evaluation of the facility’s QA program, including the QC tests and corrective actions taken by the facility, is not included in mammography equipment evaluations (as described in paragraphs 1 and 2 above). However, such an evaluation is always included in the annual survey. 21 C.F.R. 900.12(e)(9).
For a new processor, the “applicable” equipment evaluation tests are described in question 7 below.
- When are "mammography equipment evaluations" required and who must conduct the evaluations?
- When performing an annual physics survey or mammography equipment evaluation on a unit with multiple target/filter combinations, what tests or measurements must be performed for each combination?
- Must a currently certified facility or a facility undergoing certification for the first time have the "final" written report of the equipment evaluation before clinically using a newly added or modified unit?
- Can a medical physicist sign-off on mammography equipment evaluation done by a surrogate if the medical physicist was not present during the evaluation?
- What are the minimum tests and/or reviews that the medical physicist must perform for a facility survey, survey of a mammography unit, mammography equipment evaluation of a unit or processor that has been installed or disassembled and reassembled, and an equipment evaluation of a unit or processor that has undergone a major repair?
- While performing a facility survey, unit survey, or equipment evaluation, the medical physicist determines that the unit fails a required test(s) and needs to be adjusted, changed, or repaired. After the adjustment, change, or repair has been completed, does the test(s) have to be repeated and must the medical physicist perform the test(s)?
- What constitutes a mammography equipment evaluation (what tests must the medical physicist perform) for a processor that has undergone major repairs or is a new processor to the facility?
- Must the mammography equipment evaluation report be sent to the facility within 30 days?
- The bucky assembly (cassette holder) is being replaced on our x-ray unit. Is it necessary that the medical physicist test and pass this prior to its use on patients?
- Under what circumstances must our medical physicist actually visit our facility in order to successfully carry out his/her responsibility to oversee our equipment-related quality assurance practices?
- For test failures, equipment evaluations and other adjustments, changes, or repairs, are there specific timeframes defining when the verification test(s) must be performed?