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.
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:
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
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
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.