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Equipment Evaluation After a Software Upgrade
Under Medical Physicist Oversight

This alternative standard was approved on May 31, 2002. It defines the conditions under which the mammography equipment evaluations performed after some computer software upgrades may be performed either by a medical physicist on site or under the conditions of Medical Physicist Oversight. If these conditions are not met the mammography equipment evaluation after the upgrade must be performed by a medical physicist on site.

The original standard is contained within 21 CFR 900.12(e)(10).

(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 approved alternative and the conditions for its use are:

Software changes or upgrades are considered by FDA to be major repairs, thus the facility must have a mammography equipment evaluation performed after installation of such a change or upgrade. The mammography equipment evaluation must be performed and all failures to meet the applicable standards must be corrected before the affected equipment is used for patient examinations. The tests to be included in the mammography equipment evaluation must be specified by the manufacturer. The specified tests must be adequate for determining whether all of the standards of 21 CFR 900.12(b) and (e) that are applicable to the upgrade are met. If the tests included in the mammography equipment evaluation are all tests that are performed by the quality control technologist as part of the quality assurance program required by the manufacturer, then the mammography equipment evaluation may be conducted either during an onsite visit by a medical physicist or under Medical Physicist Oversight. If any of the necessary tests after the software upgrade are required to be performed by the medical physicist, the mammography equipment evaluation must be performed in its entirety by the medical physicist on site.

Additional conditions for using this alternative requirement in association with a software upgrade are that:

  1. The manufacturer must notify FDA of its intention to install the upgrade. The notification must include a brief description of the upgrade, the model(s) of the units that will be upgraded, and a copy of the information to be provided to each facility describing the upgrade and the facility’s post installation responsibilities. The manufacturer must receive confirmation from FDA that the upgrade is covered by the alternative requirement before beginning installation.

  2. By the completion of each individual upgrade, the manufacturer must inform the facility in writing of its post installation responsibilities under the alternative requirement, which are that the facility must:

  • conduct a mammography equipment evaluation after installation of the upgrade, either during a medical physicist onsite visit or under Medical Physicist Oversight,

  • include in its mammography equipment evaluation the tests specified by the manufacturer,

  • perform the mammography equipment evaluation and correct all test failures before the affected equipment is used for patient examinations, and

  • keep records of the test results and follow-up actions in accordance with 21 CFR 900.12(d)(2).

 

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