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

2. September 19, 2001CIS – Radiation Safety Section2 Outline Mammography overview Regulatory history Inspection results The future Questions

3. September 19, 2001CIS – Radiation Safety Section3 Mammography Overview Mammography is radiography of the breast Need to use appropriate energy spectrum Need high image resolution Specialized equipment

4. September 19, 2001CIS – Radiation Safety Section4 Mammography Machine X-Ray Tube Compression Paddle Film Holder Foot Peddles

5. September 19, 2001CIS – Radiation Safety Section5 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

6. September 19, 2001CIS – Radiation Safety Section6 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

7. September 19, 2001CIS – Radiation Safety Section7 Regulatory History – Cont. 1994 – MQSA interim regulations 1995 – MQSA inspections begin 1999 – MQSA final regulations

8. September 19, 2001CIS – Radiation Safety Section8 Inspections Inspections involve: Equipment checks Personnel credentials review Quality control records review Image processing evaluation

9. September 19, 2001CIS – Radiation Safety Section9 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

10. September 19, 2001CIS – Radiation Safety Section10 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)

11. September 19, 2001CIS – Radiation Safety Section11 Collimation Test

12. September 19, 2001CIS – Radiation Safety Section12 AEC Test

13. September 19, 2001CIS – Radiation Safety Section13 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

14. September 19, 2001CIS – Radiation Safety Section14 Inspection Results – Quality Control Common problems: Failure to perform testing at required intervals Failure to take corrective action when out of limits

15. September 19, 2001CIS – Radiation Safety Section15 Personnel and QC Records Review

16. September 19, 2001CIS – Radiation Safety Section16 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

17. September 19, 2001CIS – Radiation Safety Section17 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

18. September 19, 2001CIS – Radiation Safety Section18 Phantom and Dose Testing Dosimeter Mammography Phantom

19. September 19, 2001CIS – Radiation Safety Section19 Phantom Image Fibers Speck Groups Masses

20. September 19, 2001CIS – Radiation Safety Section20 Phantom Image Failure Rates

21. September 19, 2001CIS – Radiation Safety Section21 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

22. September 19, 2001CIS – Radiation Safety Section22 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

23. September 19, 2001CIS – Radiation Safety Section23 Average Mammography Doses

24. September 19, 2001CIS – Radiation Safety Section24 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

25. September 19, 2001CIS – Radiation Safety Section25 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)

26. September 19, 2001CIS – Radiation Safety Section26 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

27. September 19, 2001CIS – Radiation Safety Section27 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

28. September 19, 2001CIS – Radiation Safety Section28 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

29. September 19, 2001CIS – Radiation Safety Section29 For More Information Radiation Safety Website http://www.cis.state.mi.us/bhs/rss FDA’s Mammography Website http://www.fda.gov/cdrh/mammography/