MQSA Requirements for the Mammography Equipment Evaluations (MEE), April 21, 2020

(2020) MQSA Requirements for the Mammography Equipment Evaluations (MEE), April 21, 2020. Public Health, Department of (Health and Human Services, Department of)

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Abstract

When a mammography facility installs new radiographic equipment (x-ray units or processors), the new equipment must be evaluated by a qualified medical physicist and the accreditation requirements of the facility's accreditation body must be met before the unit is placed into service (21 CFR 900.12(e)(10)). In this context, "new" means "new to the facility" and, therefore, includes used equipment. Mammography equipment evaluations must also be performed whenever equipment is disassembled and then reassembled at the same or a new location or whenever a major component is changed or repaired. The MEE is required even if a full survey has recently been completed to verify that all functions, which may have been affected by the change or repair, have been successfully restored.