Establishing Quality Standards for Mammography Personnel: Key Requirements Under 21 CFR 900.12

21 CFR 900.12 establishes quality standards for personnel involved in mammography, including interpreting physicians, radiologic technologists, and medical physicists. Key elements include:

• Qualifications: Initial qualifications and continuing education requirements for personnel.
• Experience: Necessary experience standards for staff.
• Equipment Standards: Facilities must ensure proper equipment maintenance and effective communication of results.

System Requirements:

• Indication of target material before exposure.
• Use of hands-free compression devices.
• Appropriate x-ray film and intensifying screens.

Quality Assurance Programs:

• Ensure safety, reliability, clarity, and accuracy in mammography.
• Compliance: Facilities must adhere to regulations and manufacturer’s guidelines for equipment cleaning and disinfection.
• If mammographic quality is compromised, clinical images may need to be provided for review. Mobile mammography units are also required to meet these quality standards.

Source:https://www.ecfr.gov/current/title-21/chapter-I/subchapter-I/part-900/subpart-B/section-900.12

Region:  United States of America