Requirements for Mammography Diagnostic Monitor

Sep 10

1. Minimum Resolution

Facilities must use high-resolution monitors—ideally at least 5 megapixels for single head, or 12 megapixels for dual-screen monitor—to ensure clear visualization of subtle breast tissues such as calcifications and masses. This is strongly recommended by the FDA and ACR under MQSA regulations.

2. Display Characteristics

Displays are expected to satisfy technical criteria including luminance, contrast, and proper lookup table (LUT) configurations to maintain image fidelity and diagnostic precision.

3. Functional Capabilities

Monitors must support essential image manipulation features—zooming, panning, and viewing images at full resolution—to facilitate accurate interpretation.

4. Quality Assurance and Oversight

MQSA mandates that display quality is maintained as part of a facility’s overall Quality Control (QC) program:

QC Manuals: Facilities must keep current QC manuals for all on-site and off-site diagnostic displays.
QC Records: Reports of periodic QC tests must be maintained—from monitor performance to calibration.
Medical Physicist Evaluations: Annual evaluations conducted by qualified medical physicists must be documented and available during MQSA inspections.

5. Inspections and Compliance

During inspections, facilities must demonstrate compliance with display QC:

Present QC manuals and test records for all monitors used during the inspection year.
Provide medical physicist credentials and their evaluation reports for each display.
Show evidence that routine QC and preventive maintenance have been performed and documented.

Summary:

Resolution: Use at least 5-megapixel monitors.

Image Quality: Ensure proper luminance, contrast, and LUT settings.

Usability: Support zoom, pan, full-resolution display.

Quality Assurance: Maintain QC manuals, test logs, and physicist reports.

Inspection Readiness: Be able to present QC documentation and credentials.

Reference:

RANZCR (Royal Australian and New Zealand College of Radiologists) Standards of Practice
Mammography Quality Standards Act (MQSA)
AAPM TG18 (U.S. – American Association of Physicists in Medicine)
Canadian Association of Radiologists (CAR) Mammography Accreditation Program (MAP)
DIN 6868-157 (Germany, widely referenced in EU)
IEC 62563-1 (International Electrotechnical Commission)
Japanese Industrial Standards (JIS Z 4752) and JSMP guidelines (Japan Society of Medical Physics)

Yida Zhang