Revision History


Mammography equipment must meet all FDA requirements. The following table summarizes section 900.12(b) of the FDA equipment regulations and applies to screen-film (S-F), FFDM and DBT as indicated, unless the facility is using the ACR Digital Mammography QC Manual for FFDM and DBT. In that instance, the facility should use the form provided with the ACR DM QC Manual.


Feature

FDA Equipment Requirement

Applies To

Motion of tube-image receptor assembly

The assembly shall be capable of being fixed in any position where it is designed to operate. Once fixed in any such position, it shall not undergo unintended motion.

S-F & FFDM

This mechanism shall not fail in the event of power interruption

S-F & FFDM

Image receptor sizes

Systems using S-F image receptors shall provide, at a minimum, for operation with image receptors of 18X24 cm and 24X30 cm

S-F

Systems using S-F image receptors shall be equipped with moving grids matched to all image receptor sizes provided.

S-F

Systems used for magnification procedures shall be capable of operation with the grid removed from between the source and image receptor.

S-F & FFDM

Beam limitation and light fields

All systems shall have beam limiting devices that allow the useful beam to extend to or beyond the chest wall edge of the image receptor.

S-F & FFDM

For any mammography system with a light beam that passes through the X-ray beam-limiting device, the light shall provide an average illumination of not less than 160 lux (15 ft-candles) at 100 cm or the maximum source-image receptor distance (SID), whichever is less.

S-F & FFDM (except Fischer)

Magnification

Systems used to perform noninterventional problem-solving procedures shall have radiographic magnification capability available for use by the operator.

S-F & FFDM

Systems used for magnification procedures shall provide, at a minimum, at least one magnification value within the range of 1.4 to 2.0.

S-F & FFDM

Focal spot selection

When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected.

S-F & FFDM

When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material.

S-F & FFDM

When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure.

S-F & FFDM

Application of compression

Each system shall provide an initial power-driven compression activated by hands-free controls operable from both sides of the patient.

S-F & FFDM

Each system shall provide fine adjustment compression controls operable from both sides of the patient.

S-F & FFDM

Compression paddle

Systems shall be equipped with different sized compression paddles that match the sizes of all full field image receptors provided for the system.

S-F & FFDM

The compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied.

S-F & FFDM (except Fischer)

Equipment intended by the manufacturer’s design to not be flat and parallel to the breast support table during compression shall meet the manufacturer’s design specifications and maintenance requirements.

S-F & FFDM

The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor.

S-F & FFDM

The chest wall edge may be bent upward to allow for patient comfort but shall not appear on the image.

S-F & FFDM

Technique factor selection and display

Manual selection of mAs or at least one of its component parts (mA and/or time) shall be available.

S-F & FFDM

The technique factors (kVp and either mA and seconds or mAs) to be used during an exposure shall be indicated before the exposure begins, except when AEC is used, in which case the technique factors that are set prior to the exposure shall be indicated.

S-F & FFDM

Following AEC mode use, the system shall indicate the actual kVp and mAs (or mA and time) used during the exposure.

S-F & FFDM

Automatic exposure control

Each screen-film system shall provide an AEC mode that is operable in all combinations of equipment configuration provided, e.g., grid, non-grid; magnification, non-magnification; and various target-filter combinations.

S-F

The positioning or selection of the detector shall permit flexibility in the placement of the detector under the target tissue. The size and the available positions of the detector shall be clearly indicated at the X-ray input surface of the breast compression paddle. The selected position of the detector shall be clearly indicated.

S-F

The system shall provide means for the operator to vary the selected optical density from the normal (zero) setting.

S-F

X-ray film

The facility shall use X-ray film for mammography that has been designated by the film manufacturer as appropriate for mammography.

S-F

Intensifying screens

The facility shall use intensifying screens for mammography that have been designated by the screen manufacturer as appropriate for mammography and shall use film that is matched to the screen’s spectral output as specified by the manufacturer.

S-F

Film  processing solutions

For processing mammography films, the facility shall use chemical solutions that are capable of developing the films used by the facility in a manner equivalent to the minimum requirements specified by the film manufacturer.

S-F

Lighting

The facility shall make special lights for film illumination, i.e., hot-lights, capable of producing light levels greater than that provided by the view box, available to the interpreting physicians.

S-F & FFDM (for hard copy comparison)

Film masking devices

Facilities shall ensure that film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion of the film are available to all interpreting physicians interpreting for the facility.

S-F & FFDM (for hard copy comparison)


In addition, facilities with FFDM/DBT systems should note the following:

  • Per the Policy Guidance Help System, the FDA requires that the facility be able to provide the medical institution, physician, healthcare provider, patient, or patient’s representative with hard-copy films of final interpretation quality or, when it is acceptable to the recipient (e.g., a transfer between two FFDM facilities), with original or lossless compressed digital images.

  • The FDA has also specified that the decision to maintain a printer and/or the ability to print hard-copy images is left to each individual facility. If a facility chooses to maintain a printer, it must follow all the QC requirements prescribed by the manufacturer of the printer and mammographic unit. The printer must be tested by a qualified medical physicist before the facility performs mammography on patients, and a medical physicist must continue to include that printer QC in the Mammography Equipment Evaluation upon installation, after a major repair, and annually, if required by the printer’s or image receptor’s manufacture quality control program. The facility must also include QC information for the printer in its accreditation application. The FDA also changed their requirements for Certification Extension review to allow for either hard copy or soft copy submission of digital breast tomosynthesis phantom images. The ACR has revised its Mammography Accreditation Program’s requirements to be consistent with these changes.

  • The FDA recommends that only monitors and printers specifically cleared for FFDM use by the FDA’s Office of Device Evaluation (ODE) be used. However, a facility may legally use others.


See the FDA's Policy Guidance Help System for more information. The ACR-AAPM-SIIM Practice Parameter for Determinants of Image Quality in Digital Mammography contains further guidance for FFDM systems.



Revision History for this Article

Date

Section

Description of Revision(s)

12-12-19

All

Article created; FAQs incorporated; No criteria changes




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