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Mammography Regulatory Issues. Bruce Matkovich Radiation Safety Section Michigan Dept. Of Consumer & Industry Services. Outline. Mammography overview Regulatory history Inspection results The future Questions. Mammography Overview. Mammography is radiography of the breast

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mammography regulatory issues

Mammography Regulatory Issues

Bruce Matkovich

Radiation Safety Section

Michigan Dept. Of Consumer & Industry Services

outline
Outline
  • Mammography overview
  • Regulatory history
  • Inspection results
  • The future
  • Questions

CIS – Radiation Safety Section

mammography overview
Mammography Overview
  • Mammography is radiography of the breast
  • Need to use appropriate energy spectrum
  • Need high image resolution
  • Specialized equipment

CIS – Radiation Safety Section

mammography machine
MammographyMachine

X-Ray Tube

Compression Paddle

Film Holder

Foot Peddles

CIS – Radiation Safety Section

regulatory history
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

regulatory history cont
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

regulatory history cont7
Regulatory History – Cont.
  • 1994 – MQSA interim regulations
  • 1995 – MQSA inspections begin
  • 1999 – MQSA final regulations

CIS – Radiation Safety Section

inspections
Inspections
  • Inspections involve:
    • Equipment checks
    • Personnel credentials review
    • Quality control records review
    • Image processing evaluation

CIS – Radiation Safety Section

inspections cont
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

inspection results equipment
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

collimation test
CollimationTest

CIS – Radiation Safety Section

aec test
AEC Test

CIS – Radiation Safety Section

inspection results personnel credentials
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

inspection results quality control
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

personnel and qc records review
Personnel and QC Records Review

CIS – Radiation Safety Section

inspection results image processing
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

phantom image and dose
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

phantom and dose testing
Phantom and Dose Testing

Dosimeter

Mammography Phantom

CIS – Radiation Safety Section

phantom image
PhantomImage

Fibers

Speck Groups

Masses

CIS – Radiation Safety Section

phantom image failure rates
Phantom Image Failure Rates

CIS – Radiation Safety Section

mean glandular dose
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

mean glandular dose cont
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

average mammography doses
Average Mammography Doses

CIS – Radiation Safety Section

the future
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

the future cont
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

the future cont26
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

the future cont27
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

the future cont28
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

for more information
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