The American College of Radiology (ACR) has received approval from the Food and Drug Administration (FDA) to accredit the Sectra MicroDose L30 full-field digital mammography (FFDM) system, effective last Friday.
Facilities that already use Sectra systems under an FDA-approved, extended Mammography Quality Standards Act (MQSA) certificate will soon be contacted by the society to advise them of this change and how to proceed with accreditation. Such facilities need not take any action towards accreditation until they are contacted by the ACR, and are permitted to operate during the transition period.
As of October 21, the FDA ceased to accept applications to extend existing MQSA certificates to include the use of Sectra MicroDose L30 FFDM systems. Facilities should now contact the ACR for information on how to begin the accreditation process.
Systems requiring accreditation include Carestream DirectView (computed radiography)
Fischer Senoscan; Fuji FCRm (computed radiography); General Electric Senographe 2000D, DS, Essential, and Senographe Care; Lorad Selenia, Selenia S, Selenia Dimensions, and Selenia Encore;
Siemens Mammomat Novation DR, Mammomat Novation S, Mammomat Inspiration, Mammomat Inspiration Pure; and Sectra MicroDose Mammography L30.
Applicants with other FFDM systems must continue to apply to (and be approved) by the FDA for extension of their certificates to include the use of an FFDM unit in order to operate those systems legally.
For more information, contact the ACR at (800) 227-6440.