Manufacturer's Software Modification of the AEC
This alternative standard was approved on September 24, 2001. It has no time limit.
The final regulation and its alternative standard are stated below:
21 CFR 900.12(e)(10) states:
(10) Mammography equipment evaluations. Additional evaluations of mammography units or image processors shall be conducted whenever a unit or processor is installed, a unit or processor is dissembled 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.
The alternative applies to the specific situations described below, in which manufacturer’s software modifications have been made to specific units. In such cases, an onsite mammography equipment evaluation performed by the medical physicist is not required. Instead, all that is required is oversight by the medical physicist.
The approved alternative standard states that for:
the modification of the AEC component of SenographeTM 700T or 800T mammography systems described in the GE Medical System’s Field Modification Instruction (FMI) 11451, "Seno 700/800T Optical Density Optimization", and
the optimization of the AEC component of the SenographeTM DMR mammography systems described in the GE Medical System’s FMI 11450, "DMR V1/V2/+ Optical Density Optimization".
Verification testing to demonstrate that the affected equipment meets the applicable standards must be carried out after these actions are completed. However, the verification testing may be performed under Medical Physicist Oversight. Medical Physicist Oversight means that the medical physicist is consulted as to whether an on-site visit is required or if other personnel can verify that the standards are met, with direction by telephone or printed material from the medical physicist as needed.