Mammography Regulatory Issues

1. Mammography Regulatory Issues Bruce Matkovich Radiation Safety Section Michigan Dept. Of Consumer & Industry Services

2. Outline • Mammography overview • Regulatory history • Inspection results • The future • Questions CIS – Radiation Safety Section

3. Mammography Overview • Mammography is radiography of the breast • Need to use appropriate energy spectrum • Need high image resolution • Specialized equipment CIS – Radiation Safety Section

4. MammographyMachine X-Ray Tube Compression Paddle Film Holder Foot Peddles CIS – Radiation Safety Section

5. Regulatory History • 1988 – American College of Radiology’s Mammography Accreditation Program • Voluntary • 1989 – Michigan Public Act 56 • Essentially required ACR accreditation • Outlawed general purpose machines • 1991 – Annual state inspections begin CIS – Radiation Safety Section

6. Regulatory History – Cont. • 1992 – Federal Mammography Quality Standards Act (MQSA) • Nationwide mammography standards • 1993 – State of Michigan mammography rules • Standards for technologists and physicists • QC and equipment standards • 1994 – Michigan Public Act 100 • Physician qualifications • Interpreters must be board certified CIS – Radiation Safety Section

7. Regulatory History – Cont. • 1994 – MQSA interim regulations • 1995 – MQSA inspections begin • 1999 – MQSA final regulations CIS – Radiation Safety Section

8. Inspections • Inspections involve: • Equipment checks • Personnel credentials review • Quality control records review • Image processing evaluation CIS – Radiation Safety Section

9. Inspections – Cont. • Inspections are scheduled in advance • Typical inspection of a one-machine facility is 4 to 5 hours • MQSA inspection fee is $1549 for a one-machine facility • Michigan inspection fee is $127.88 per tube CIS – Radiation Safety Section

10. Inspection Results – Equipment • Common problems: • Collimation problems (typically problems found with alignment of collimator light to x-ray field) • Automatic exposure control (AEC) tracking (maintaining consistent film darkness with varying patient thickness and density) CIS – Radiation Safety Section

11. CollimationTest CIS – Radiation Safety Section

12. AEC Test CIS – Radiation Safety Section

13. Inspection Results –Personnel Credentials • Common problems: • Lack of documentation to verify compliance with continuing experience or continuing education requirements • Occasionally find personnel that are not qualified CIS – Radiation Safety Section

14. Inspection Results –Quality Control • Common problems: • Failure to perform testing at required intervals • Failure to take corrective action when out of limits CIS – Radiation Safety Section

15. Personnel and QC Records Review CIS – Radiation Safety Section

16. Inspection Results –Image Processing • Common problems: • Under processing – determined using the Sensitometric Technique for the Evaluation of Processing (STEP) • STEP compares the facility’s processor to an optimized processor CIS – Radiation Safety Section

17. Phantom Image and Dose • Mammography phantom image quality and mean glandular dose are important aspects of inspection • Phantom image and dose are obtained simultaneously using clinical techniques for average patient • Phantom image quality and dose are usually found to be in compliance CIS – Radiation Safety Section

18. Phantom and Dose Testing Dosimeter Mammography Phantom CIS – Radiation Safety Section

19. PhantomImage Fibers Speck Groups Masses CIS – Radiation Safety Section

20. Phantom Image Failure Rates CIS – Radiation Safety Section

21. Mean Glandular Dose • 200 millirads per view is the State of Michigan dose limit for an average-size patient • 300 millirads per view is the federal and ACR dose limit for an average-size patient CIS – Radiation Safety Section

22. Mean Glandular Dose – Cont. • Changes in imaging technology are driving doses up • Michigan’s low dose limit is controversial • Michigan does not want to obstruct image quality improvement CIS – Radiation Safety Section

23. Average Mammography Doses CIS – Radiation Safety Section

24. The Future • Digital mammography • Only one FDA approved manufacturer currently • Must be used in a facility that has a screen-film unit • Digital advantages • Digitally enhance images • No film or wet chemistry processing CIS – Radiation Safety Section

25. The Future – Cont. • FDA regulations that take effect October 28, 2002: • AEC must track to within ±0.15 OD of mean OD (currently ±0.30 OD) • Radiation output must be 800 mR/sec at 28 kVp (currently 513 mR/sec) CIS – Radiation Safety Section

26. The Future – Cont. • More FDA regulations that take effect October 28, 2002: • Compression device must have fine adjustment • Maximum compression force for the power drive must be at least 25 lbs. and not more than 45 lbs. • Medical physicist must evaluate system resolution CIS – Radiation Safety Section

27. The Future – Cont. • Proposed Michigan statute revisions to improve consistency with federal mammography standards: • “Medical director” to become “lead interpreting physician” • Physician initial experience and continuing experience requirements same as MQSA CIS – Radiation Safety Section

28. The Future – Cont. • Proposed Michigan statute revision for a surety requirement to insure that patient records are available even if a facility closes. • Dose limit in the Ionizing Radiation Rules would probably be changed CIS – Radiation Safety Section

29. For More Information Radiation Safety Website http://www.cis.state.mi.us/bhs/rss FDA’s Mammography Website http://www.fda.gov/cdrh/mammography/ CIS – Radiation Safety Section