To:      Nancy Wynne

            Center for Devices and Radiological Health (HFZ-240)

            Food and Drug Administration

            1350 Piccard Drive

            Rockville, MD  20850

            e-mail: nancy.wynne@fda.hhs.gov

 

 

 

From: Richard L. Ellis, M.D.

            Co-Director, Norma J. Vinger Center for Breast Care

            Gundersen Lutheran Medical Center/EB1-002

            1900 South Avenue

            La Crosse, WI  54601

            Phone: 800.362.9567, ext. 52886

            Fax: 608.775.6569

            e-mail: rlellis@gundluth.org

 

 

Date:   October 3, 2007

 

RE:      National Mammography Quality Assurance Advisory Committee: Regulation of Interventional Mammography

 

 

 

I appreciate the opportunity to submit a statement to be added to the record for review and consideration by the National Mammography Quality Assurance Advisory Committee concerning the regulation of interventional mammography for improving the Medical Quality Standards Act (MQSA).  For over 10 years, I have practiced as a clinical breast radiologist subspecializing in the early detection and diagnosis of breast diseases, and I am co-director of our interdisciplinary breast care team. 

 

Listed below are issues that need to be reviewed and addressed by National Mammography Quality Assurance Advisory Committee, as you prepare recommendations for reauthorization of the MQSA. 

 

 

I.          Interventional Mammography

 

Screening mammography examination is but the first link in the imaging chain of care for the early detection and diagnosis of breast cancer.  Additional imaging examinations and image-guided procedures in the continuum of care include:

 

  • Diagnostic mammography;
  • Diagnostic breast ultrasound;
  • Ductography;
  • Breast MRI;
  • Image-guided needle biopsy (stereotactic, ultrasound, and MRI);
  • Image-guided tumor localization (mammography, ultrasound, and MRI); and
  • Surgical specimen radiography (mammography and ultrasound).

 

It is with the patient history and clinical breast examination in combination with the appropriate imaging examinations and image-guided procedures that we, as physicians, provide the best care for our patients in early detection and diagnosis of breast disease.  The MQSA has served the general public very well since its inception in 1992 in helping to ensure universal standard of care for mammography in the United States. However, weak links in the chain of imaging care can occur which negate the advances achieved in mammography through the MQSA.

 

If the intent of screening mammography is to reduce the mortality and morbidity of breast cancer, then early interruption of the disease is paramount.  Over the past 100 years, we have seen advances in surgical techniques that have significantly improved patient morbidity but not mortality.  Likewise, we now have chemo and hormonal therapies that have allowed moderate improvement in patient mortality.  However, it is the advent of early detection and diagnosis, which interrupts breast cancer early in its natural history, that has resulted in the greatest reduction in mortality from breast cancer. 

 

 

II.        Breast Imaging Examinations and Image-guided Procedures: Establishing Universal Training and Accreditation Standards

 

Breast ultrasound is frequently used in the diagnostic evaluation of patients with suspicious findings detected upon mammography, breast self examination, and clinical breast examination to further segregate which patients will require a biopsy for definitive tissue diagnosis.  Given advancements in training and technology, most breast biopsies can be performed under image-guidance to include ultrasound and stereotactic-guided biopsies.  In 1996, through the joint efforts of the American College of Radiology (ACR) and American College of Surgery (ACS), we have a universal stereotactic-guided breast biopsy accreditation program, but which remains under voluntary accreditation.  However, diagnostic breast ultrasound examination and ultrasound-guided breast biopsy have multiple training guidelines and accreditations programs from various institutions and agencies to include the American College of Radiology, American Society of Breast Surgeons (ASBS), and American Institute of Ultrasound in Medicine (AIUM).  Members of the National Mammography Quality Assurance Advisory Committee need to investigate why there are multiple and varied physician training guidelines and accreditation programs for diagnostic breast ultrasound examination and ultrasound-guided biopsy.  The National Mammography Quality Assurance Advisory Committee should insist on the highest standards and advance a single, universal standard for diagnostic breast ultrasound examination and ultrasound-guided biopsy training guidelines and accreditations so that multiple standards and accreditation programs are not propagated.  To whom does it serve when lower standards and accreditation programs are advanced that fall short of current established guidelines of the American College of Radiology?

 

The ACR training standards and accreditation programs are not limited to radiologists but are designed to be physician specific, regardless discipline of medical training.

 

Universal standards and accreditation programs will help ensure that not only mammography but also other breast imaging examinations and image-guided procedures meet an acceptable MQSA (or as advocated by the Institute of Medicine, the Breast Imaging Quality Standards Act) standard for accreditation.  If the National Mammography Quality Assurance Advisory Committee through the MQSA or other agency does not require and enforce universal practice standards and accreditations, then the “qualification” for these examinations and procedures will simply fall to whomever can afford the equipment regardless prior training and performance level. 

 

In the near future, universal standards and accreditation should also be established for breast MRI and imaging-guided breast tumor ablation procedures.

 

I strongly advise the National Mammography Quality Assurance Advisory Committee to advance the established and highest training and accreditation standards provided by the American College of Radiology for breast ultrasound, ultrasound-guided biopsy, stereotactic-guided biopsy, image-guided localization, and specimen radiography as part of the re-authorization of MQSA to BIQSA, as advocated in the report by the Institute of Medicine (Improving Breast Imaging Quality Standards, 2005).  Advancing the highest standards and accreditation programs help ensure women receive the best of care from early detection, diagnosis, and treatment for breast disease.

 

Should you have questions or need additional information, please contact me.

 

Appreciate your sincere consideration.