Since loaner, demonstration, and investigational mammography units are temporary, must these units be accredited? What steps should a facility take to ensure that it remains in compliance if it uses these units for mammography?
A loaner or demonstration mammography unit may be used for a limited time period before a facility is required to apply to have the unit(s) included under its accreditation. However, a facility should always contact its accreditation body before using such units on patients to determine whether such use is in accord with current policy.
Loaner units (placed in a facility while the facility's unit is undergoing in-house or off-site repair) should not be used for more than 30 days. This period may be extended upon written verification from a repair service that there is a legitimate cause for repairs to exceed 30 days with the concurrence of the accreditation body.
Demonstration units under consideration for purchase by a facility can be used for up to 90 days. However, a facility should contact its accrediting body and follow its requirements for accreditation, prior to use of any demonstration unit on patients. MQSA inspectors will need to see this documentation during any inspection.
If a facility wishes to continue use of such a unit after the specified time period is up, it should apply to its accreditation body to have the unit included under the facility’s accreditation.
Note that the unit still must have passed a mammography equipment evaluation prior to patient use and each such unit will be tested by the MQSA inspector during the MQSA inspection, regardless of its accreditation or ownership status. 21 C.F.R. 900.12(e)(10).
Investigational units are those being used prior to receiving FDA approval for marketing and are being used in accordance with FDA’s investigational device exemption regulations. As such they are exempt from MQSA regulations and do not have to be accredited or certified. 21 C.F.R. 900.2(aa)(2).
The discussion above describes the requirements to comply with MQSA; States may have more stringent requirements regarding the use of these systems.