Mammography Regulatory Issues

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Mammography Regulatory Issues

• Bruce Matkovich
• Radiation Safety Section
• Michigan Dept. Of Consumer Industry Services

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Outline

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

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Mammography Overview

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

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MammographyMachine
X-Ray Tube Compression Paddle Film Holder Foot
Peddles
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Regulatory History

• 1988 American College of Radiologys
  Mammography Accreditation Program
• Voluntary
• 1989 Michigan Public Act 56
• Essentially required ACR accreditation
• Outlawed general purpose machines
• 1991 Annual state inspections begin

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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

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Regulatory History Cont.

• 1994 MQSA interim regulations
• 1995 MQSA inspections begin
• 1999 MQSA final regulations

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Inspections

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

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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

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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)

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CollimationTest
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AEC Test
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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

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Inspection Results Quality Control

• Common problems
• Failure to perform testing at required intervals
• Failure to take corrective action when out of
  limits

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Personnel and QC Records Review
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Inspection Results Image Processing

• Common problems
• Under processing determined using the
  Sensitometric Technique for the Evaluation of
  Processing (STEP)
• STEP compares the facilitys processor to an
  optimized processor

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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

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Phantom and Dose Testing
Dosimeter Mammography Phantom
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PhantomImage
Fibers Speck Groups Masses
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Phantom Image Failure Rates
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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

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Mean Glandular Dose Cont.

• Changes in imaging technology are driving doses
  up
• Michigans low dose limit is controversial
• Michigan does not want to obstruct image quality
  improvement

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Average Mammography Doses
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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

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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)

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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

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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

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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

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For More Information

• Radiation Safety Website
• http//www.cis.state.mi.us/bhs/rss
• FDAs Mammography Website
• http//www.fda.gov/cdrh/mammography/