FDA proposes new rules for mammography services

28 March 2019 (Last Updated March 28th, 2019 12:07)

The US Food and Drug Administration (FDA) has proposed a new policy intended to modernise and improve the quality of mammography, which is used for breast cancer screening and diagnosis.

The US Food and Drug Administration (FDA) has proposed a new policy intended to modernise and improve the quality of mammography, which is used for breast cancer screening and diagnosis.

The first in more than two decades, these amendments require mammography facilities to provide patients and their healthcare professionals with details on breast density in order to enable more informed decision-making.

Mammography images of breasts with higher fibroglandular tissue versus fatty tissue (dense breasts) could be tough to interpret due to unclear signs of cancer and lower sensitivity.

The US regulator has proposed specific language to explain the effect of breast density on the mammography’s accuracy.

“As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernise our oversight of mammography services.”

In addition, the new rules aim to provide healthcare professionals with more information through three additional categories for mammogram evaluations.

FDA commissioner Scott Gottlieb said: “As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernise our oversight of mammography services by capitalising on a number of important advances in mammography, like the increased use of 3D digital screening tools and the need for more uniform breast density reporting.”

The amendments also involve notifications to patients and their healthcare professionals about mammography facilities’ quality standards and components used.

The FDA has also proposed better record-keeping to reduce information loss and improve access to and transfer of patient records.

The National Cancer Institute (NCI) statistics show that more than 260,000 women were diagnosed with breast cancer last year, and over 40,920 women died from the illness.

The disease is the second leading cause of death in women and may also affect men of any age. Mammography is considered as an important method to detect breast cancer.

A recent study by Yale School of Public Health and School of Medicine found that state breast density notification laws that require reporting of mammogram results are linked to more screening and cancer detection rates.

Moreover, some states also mandate recommendations for women with dense breasts to get further screening tests such as ultrasound and MRI.

It was observed that laws recommending further tests had more rates of breast ultrasound and cancer detection, compared with notifications that only included information about breast density.