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.

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Approved Full Field Digital Mammography (FFDM)
Systems

• FDA approved GEs Senographe 2000D, in January
  2000 hard copy first but soft copy added later.
  
• For both hard and soft copy, three more systems
  were approved
• Fischers SenoScan in September 2001
• LORADs LDBI in March 2002
• Hologic/Lorad Selenia in October 2002

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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.
• DMQRPs coordination with ODE ensures that these
  FFDM units can be certified under MQSA as soon as
  they are approved for marketing by ODE.

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MQSA Approval Process

• In absence of an Accreditation Body, FDA extends
  the facilitys 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

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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.

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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.

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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

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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)
• Manufacturers Quality Control Program in
  accordance with 900.12(e)(6)

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MQSA Final Regulations

• 21 CFR 900.12(e)(6)
• Quality control testsother 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.

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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

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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

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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

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Number of Approved FFDM Units

• DMQRP has approved approximately 300 FFDM units
  since January 2000

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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

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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).

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Dual Accreditation

• 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.

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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 manufacturers
  recommendation? (y/n)
• If hard copy display is used for image
  interpretations
• Q3- Manufacturer recommended procedures for
  printer used? (y/n)

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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

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Analysis of FFDM Data

• FDAs 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

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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

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For more Information on FFDM and MQSA

• Division of Mammography Quality and Radiation
  Programs
• Phone [phone]
• Fax [phone]
• 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