Are all regulated mammography units in the facility required to be accredited and, if so, what documentation is necessary to establish that this has been done?
Yes. The facility should have documentation showing that each unit has been accredited by the accreditation body or, for new units, showing that the unit has passed a mammography equipment evaluation and that the application for accreditation of the unit has been submitted.
There are three cases where the units in use in the facility may not need to be accredited:
1) The unit is a "loaner" while repairs to the facility’s unit are taking place (limited to 30 days without extenuating documentation such as written verification from a repair service that repairs will take longer)
2) The unit is installed in the facility for evaluation prior to purchase (limited to not more than 90 days), or
3) The unit is an experimental one installed and used under an Investigational Device Exemption (IDE) as described in the Safe Medical Devices Act of 1990 or other FDA approved research protocol. The requirements for accreditation of these units is dependent on the rules of the facility’s accreditation body.
Note: Under both 1) and 2) the unit still must have passed an equipment evaluation and each such unit will be tested by the MQSA inspector, regardless of its accreditation or ownership status.