The long awaited Digital Breast Tomosynthesis (DBT) accreditation process is here and not without controversy. Although DBT was approved by the FDA in 2011, facilities are operating under the temporary FDA Certificate Extension Program. The purpose of the temporary “stop-gap” program was to provide an avenue for new technology to be legally used under the Mammography Quality Standards Act (MQSA) while the accreditation programs were being developed.
Fast forward seven years to April 9th 2018. On this date all four FDA MQSA Accrediting Bodies (AB’s), States of Arkansas, Iowa, Texas and the American College of Radiology (ACR) were approved to accredit DBT systems. Each of the individual accrediting bodies established their own accreditation procedures and transitions within the confines of the MQSA requirements for accreditation. The FDA continued to accept applications under the FDA Certificate Extension Program until April 6, 2018. Those facilities will be allowed to use existing DBT units under that certificate extension while transitioning to being accredited. Confused yet? You’re not alone!
The mammography community is scrambling to make sense of the procedures. Several facilities with ACR accreditation renewals caught in the “gap” are speaking out, as well as facilities with multiple sites with multiple pieces of equipment. A recent thread on a Mammography Community forum reflects a significant push back from those responding. Facilities are weighing in on the ACR accreditation process requiring both the FFDM and DBT (even though they are housed in a single unit) to be accredited as two separate units. With that comes the challenge of providing imaging sets for both the FFDM and DBT, and the added expense of accreditation for two units rather that one. Facilities with multiple units/multiple sites, well you get the picture. Twice the paperwork, twice the image sets, and twice the cost! Change is never easy and at this point there seems to be more questions than answers. Facilities should tap into their resources for information and provide feedback. More to come as we move forward!