Navigating the mammography quality standard act in USA: Role of US FDA and future scopes of regulation-A narrative review

Abstract

Background: The Mammography Quality Standards Act (MQSA) has significant impact on providing high-quality mammography services for the early detection of breast cancer. MQSA emphasizes quality assurance, regulatory compliance, and patient safety. It guides technological integration, ensuring uniform quality across the United States of America (USA). This review synthesizes key MQSA information, analysing compliance, and facilitating policy discussions for improvements, aiming to inspire further policy research in cancer screening by adopting MQSA's success factors.

Methods: The review spanned 1997 to 2023, adhering to Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Databases like PubMed, ScienceDirect, and Google Scholar were searched for relevant literature. Selection criteria covered English-language journals, US Food and Drug Administration (FDA) guidelines, and professional organizational standards, revealing key aspects of MQSA and breast cancer diagnostics in the USA.

Results and discussion: MQSA's legislative aspects guarantee the effectiveness of regulations for high-quality mammography. It addresses technology, emphasizes inspections, and balances compliance with healthcare burdens. Procedural guidelines prioritize patient outcomes, minimize errors, and address access disparities. Regular updates are crucial to align screening services with technological changes, maintaining safety and accuracy nationwide.

Conclusion: The FDA's collaboration with stakeholders, including medical specialists and patient advocacy groups, has contributed to crucial legislative aspects of MQSA. The accuracy of mammography screenings has significantly improved by MQSA's installation of stringent quality and regulatory standards. Compliance with MQSA guidelines led to higher accuracy, safety, and better detection rates. Ongoing efforts must aim to refine guidelines, address emerging challenges, and optimize breast cancer detection.

Keywords: Breast cancer; Health and Human Services (HHS); Mammography; Mammography Quality Standard Act (MQSA); The American College of Radiology (ACR).