Passing the MQSA Baton
A Message from the Director, Division of Mammography Quality Standards (DMQS): Passing the MQSA Baton
They say, “time flies.” Now I believe them. When I walked through the hallowed doors of FDA in August 1999, I was saying “hello.” Now I am beginning the farewell process. The decision to retire was a difficult one for me. After decades of promoting and advocating for women’s health, first in clinical practice and then directing the MQSA program and consulting in the premarket approval of breast diagnostic and interventional devices, it is hard to give it up. As those of you in the field know very well, involvement in the detection and diagnosis of breast cancer isn’t just a job - it is a passion.
Does anyone remember xeromammography? I do! We have seen so many advances in mammography technology since then…film/screen, then full field digital, then digital breast tomosynthesis. Where will we go next? Throughout it all, the MQSA program and its accrediting, certifying, state, industry, and practicing partners have continued to improve the quality of mammography. Most facilities are sincerely dedicated to practicing quality mammography. Today over 85% of facilities have no violations of the MQSA, and over 99.5 % of facilities have no serious violations.
In the past twenty years of the MQSA program, we eliminated duplicate dose testing, improved an already-innovative inspection software and database, trained hundreds of inspectors, strengthened our collaborations with states and other federal agencies, incorporated new technologies under MQSA, introduced the EQUIP initiative to enhance facility efforts to maintain image quality, and drafted proposed amendments to the MQSA regulations that would address, among other things, breast density reporting, so that women and their healthcare providers can make better-informed breast care decisions. The MQSA program has also served as a model for and aided other nations wanting to develop mammography quality standards.
We have seen many indicators of the improvements of mammography since the MQSA program began. Image quality, as demonstrated by phantom scores, improved, while radiation dose declined. Equipment violations decreased from over 5,000 per year at the beginning of the program, to virtually none today. The MQSA has certainly played a role, along with improved technologies for breast cancer detection and the availability of successful treatments, in the increase in the 5-year breast cancer survival rate from about 84% in 1995, the year inspections under the MQSA began, to today’s 95-99%.
A former boss of mine used to say that one of our best legacies is the high-quality people we hire and mentor, who then continue our missions when we leave. I am pleased to announce that I am fulfilling that goal by welcoming Dr. David Lee as the new DMQS Director, to whom I will pass the baton on March 4, 2019. Dr. Lee is an accomplished fellowship-trained breast imaging radiologist who practiced in the Washington, D.C. area prior to joining another part of FDA in January 2017. His previous clinical leadership roles and experience in the interpretation of breast imaging, in addition to his exposure to regulatory science, helped prepare him for this important role. Dr. Lee is passionate about breast imaging and the importance of a quality mammogram in being able to detect signs of breast cancer. Dr. Lee and I will be working closely together during my remaining time at FDA, so that we can ensure a smooth transition to his leadership.
Many challenges face the mammography community both today and going forward. Issues such as the role of lossy compression, the storage and transfer of mammography data, the use of synthesized mammographic images, and the role of supplemental screening for women with dense breasts are challenges the breast care the community faces, some of which intersect with MQSA. I have every confidence that Dr. Lee, the wonderful, extremely dedicated DMQS staff, and our breast imaging community are ready for the challenges ahead.
Assisting Dr. Lee will be the division’s Deputy Director, Preetham Sudhaker, who assumed that role in October 2018, after serving as DMQS’ Program Management branch chief for eight years. Preet has invaluable MQSA experience and extensive knowledge of and relationships with the FDA’s field operations and our partners there. Under Preet’s leadership, the MQSA inspector training program has undergone significant improvements, including more extensive on-line training, improved preparation of inspector candidates for the hands-on part of the training, and more realistic training scenarios.
Please join me in welcoming Dr. Lee and Mr. Sudhaker to their new positions. You will hear more from them in the coming months. I sincerely thank the entire mammography community for its dedication to the mission of the MQSA program to ensure quality mammography, one of the most important factors in detecting breast cancer in its early, most treatable stages. Words cannot adequately express my heart-felt appreciation for all the support and guidance you have given me over the last 20 years, as well as the wonderful memories I take with me.
Dr. Helen Barr