Use of Equipment and Level 1 Noncompliances
Whenever facility equipment is tested or records are reviewed pertaining to equipment, inspectors should make sure that the equipment is currently being used for mammography. If FDA finds problems on an x-ray system or processor that ultimately results in a regulatory action, we might not be able to take action against the facility, should we learn some time later that the system had never been used for mammography at the time of the inspection. In most situations, this will not be a problem. However, when a facility has several x-ray systems and/or processors, make sure that you talk with someone who knows that all systems are used for mammography and covered under current FDA regulations (x-ray systems routinely used for mammography, not units used exclusively for localization, biopsy, stereotactic, or investigational units ). Equipment inspected should be currently used, rather than out of service or awaiting final clearance to be used (final clearance would mean all assembly and testing has been completed).