MQSA and Full Field Digital Mammography (FFDM)

1. MQSA and Full Field Digital Mammography(FFDM) Kish Chakrabarti, PhD Division of Mammography Quality and Radiation Programs (DMQRP) Food and Drug Administration

2. History of Digital Mammography • 1990s Digital spot view mammography is developed to allow faster and more accurate stereotactic biopsy as compared to traditional biopsy. • 2000FDA approves Full Field Digital Mammography (FFDM) system.

3. Approved Full Field Digital Mammography (FFDM) Systems • FDA approved GE’s Senographe 2000D, in January 2000 – hard copy first but soft copy added later. For both hard and soft copy, three more systems were approved: • Fischer’s SenoScan in September 2001 • LORAD’s LDBI in March 2002 • Hologic/Lorad Selenia in October 2002

4. Approval Process of FFDM DMQRP works with the Office of Device Evaluation (ODE) to ensure that all new FFDM systems meet MQSA requirements prior to receiving pre-market approval. DMQRP’s coordination with ODE ensures that these FFDM units can be certified under MQSA as soon as they are approved for marketing by ODE.

5. MQSA Approval Process • In absence of an Accreditation Body, FDA extends the facility’s screen film certificate to include FFDM units • ACR has been approved to accredit GE Senographe 2000 D FFDM units effective February 15, 2003 –the facilities with this system can now have a stand alone MQSA certificate

6. MQSA Approval Process • Until otherwise notified by the FDA, other FFDM systems will be exempt from the MQSA accreditation requirement. • FDA allows the use of these FFDM systems by continuing the policy of extending the SFM (screen film mammography) certificate.

7. Steps for Extension of Screen-Film Certification for Approval of FFDM Uses • Initially the facility has to be SFM certified. If the facility is not certified, they must apply to a FDA-approved accreditation body for screen-film accreditation. • Facility has to provide a list of all personnel who will be working (i.e., interpreting, performing, and surveying) in the facility with the FFDM modality.

8. Necessary Items for FFDM Approval • Facility Status Information • FFDM Unit Identification • Digital Image Receptor Identification • Identification of Printers for Hard Copy Output (even for the facilities with soft copy only, for accreditation purpose and providing images to the patients when requested) • Monitor Identification (if soft copy display is approved and available) • Phantom Identification • Signature of Lead interpreting Physician

9. Necessary Items for FDA Approval • Phantom Image • Personnel Identification and Qualification • Report of Mammography Equipment Evaluation (must have been conducted in accordance with 900.12(e)(10) within the 6 months prior to applying to FDA) • Manufacturer’s Quality Control Program in accordance with 900.12(e)(6)

10. MQSA Final Regulations 21 CFR 900.12(e)(6) Quality control tests—other modalities. For systems with image receptor modalities other than screen-film, the quality assurance program shall be substantially the same as the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems in paragraph (e)(5)(vi) of this section.

11. New Mammographic Modality Training • Medical physicists are required to have 8 hours training in surveying FFDM system(s) before conducting independent surveys and/or equipment evaluations • Hands-on training is strongly recommended

12. New Mammographic Modality Training • Interpreting physicians and radiologic technologists are required to have 8 hours of training in FFDM system(s) before providing services independently using the system • Similar to a SFM requirement, the Quality Control (QC) technologist at a facility using an FFDM unit must be a qualified radiologic technologist who also meets the training requirement for performing FFDM examinations

13. Acceptable Documentation – New Mammography Modality Training • Attestation (only for experience obtained using investigational devices prior to April 28, 1999 as well as for personnel who began or will begin working in the modality after April 28, 1999, training prior to 10/1/94) • Mammography modality- specific CME/CEU certificates • CME/CEU certificates plus agenda, course outline or syllabus • Confirming letters from CME/CEU granting organization • Letters, certificates, or other documents from manufacturers or other formal training courses

14. Number of Approved FFDM Units DMQRP has approved approximately 300 FFDM units since January 2000

15. FFDM Accreditation • American College of Radiology (ACR) conducted a study of 10 facilities with the GE 2000D over a period of 1 ½ years to prepare for its accreditation program • FDA has approved ACR to accredit the GE 2000D FFDM unit beginning February 15, 2003

16. Oversight of FFDM Accreditation • Quarterly reviews for the first year and yearly reviews thereafter which will include reviews of MEE reports and Phantom Images obtained by the ACR. • Same oversight procedures will apply to all future FDA approved accreditation bodies (AB).

17. DualAccreditation • Dual Accreditation – Multiple units located at the same site accredited by different accreditation bodies. • Facilities have the option to choose the same AB for both FFDM and SFM units. Dual accreditation may increase cost and paperwork associated with dealing with two accreditation bodies.

18. MQSA Inspections FFDM Personnel inspection question: • Q1 – New Modality training (8 hours)? (y/n/x) FFDM QA/QC inspection questions: • Q1- Manufacturer recommended QC procedures followed? (y/n) • Q2- Monitor QC done per manufacturer’s recommendation? (y/n) If hard copy display is used for image interpretations • Q3- Manufacturer recommended procedures for printer used? (y/n)

19. Compliance • As of 2-15-03, facilities are cited for any “No” QA/QC answer. • Facilities are cited for “No” answer for Personnel Question from the beginning Our analysis of inspection database indicates that no facility has yet been cited for personnel non compliance

20. Analysis of FFDM Data • FDA’s review of the Medical Physicist MEE reports (~300) indicate that initially many medical physicists tended to skip tests, did not perform the tests as required, or did not adhere to correct action limits. This happened because of several of the following reasons: • Learning process with the new modality and or a new manufacturer FFDM system • Inadequate hands-on training • Lack of proper clarification and proper warning in the QC manual Our analysis of first 6 month QC data sent to FDA from the facilities shows a significant improvement in FFDM QC program since the certification extension program began. The inspectors will further review Medical Physicists annual survey report

21. FFDM QC Test Issues: • The Medical Physicists must take extra care in performing the monitor calibration/check, CNR, SNR and MTF tests as described in the manufacturer QC manual • For GE Senographe 2000 D, contrast disk must not be used with the phantom • For Lorad Selenia, minimum phantom scores must be 4 for fibers, 4 for speck groups and 3 for masses while passing scores for other FFDM and SFM systems are 4,3,3 for fibers, speck groups and masses respectively

22. For more Information on FFDM and MQSA Division of Mammography Quality and Radiation Programs Phone #: 301-594-3332 Fax #: 301-594-3306 http://www.fda.gov/cdrh/mammography/ Kish Chakrabarti, Ph.D. Or Denise Robinson Division of Mammography Quality and Radiation Programs FDA/CDRH/OHIP 1350 Piccard Drive, HFZ-240, Room 230B Rockville, MD 20850