The FDA today issued a proposed rule that would modernize mammography quality standards and require mammography facilities to provide more information to patients and healthcare providers.
The proposed rule would be the first update in 20 years, amending regulations issued under the Mammography Quality Standards Act of 1992, which authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections and enforcement of standards. The new proposal could help patients and providers make more informed decisions regarding care, and boost the FDA’s regulatory power over the safety and quality of mammography services, the agency said.
The proposed amendments include:
- Adding specific language about breast density to the mammography results summary letter provided to patients and to the medical report sent to providers. Mammograms of breasts with a higher proportion of dense fibroglandular tissue compared to fatty tissue can be difficult to interpret because the dense tissue can obscure signs of breast cancer, lower the sensitivity of the image and increase the risk of developing breast cancer.
- Codifying three more categories for mammogram assessment, including one titled “known biopsy-proven malignancy,” which would help identify for health care professionals cases in which cancer that is being evaluated by mammography for therapy has already been identified.
- Adding more detailed information about the mammography facility to patient summaries and medical reports for caregivers to aid in post-exam communications.
Proposed changes to boost the FDA’s enforcement powers include:
- Expressly stating that the FDA can directly notify patients and their health care professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that reevaluation or repeat of the mammogram at another certified facility may be needed.
- Requiring facilities to use only FDA-approved or -cleared digital accessory components for mammography, or that facilities use components that otherwise meet the requirements under the rule.
- Strengthening record-keeping requirements to minimize information loss and improve access to and transfer of patient mammography records.
“As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting,” said FDA commissioner Dr. Scott Gottlieb in a prepared statement. “We’re committed to making sure patients have access to high-quality mammography. Today’s proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field.”
According to the National Cancer Institute (NCI), approximately 12.4% of women will be diagnosed with breast cancer at some point during their lifetime. NCI estimates that, in 2018, more than 260,000 women were diagnosed with breast cancer and more than 40,920 women died of the disease. Aside from skin cancer, breast cancer is the most common cancer among women and the second leading cause of death. Mammography can also be an important tool in detecting male breast cancers. According to the NCI, breast cancer may occur in men at any age, but usually occurs in men between 60-70 years of age.
“The FDA is committed to advancing efforts that improve the health of women,” said FDA principal deputy commissioner Dr. Amy Abernethy. “Given that more than half of women over the age of 40 in the U.S. have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy.”
The proposed rule may be found here and is available for public comment for 90 days from publication.
