In March of 2023, the U.S. Food and Drug Administration (FDA) published updates to their mammography regulations to facilitate better reporting of information and an improved experience for patients. The announcement means change is imminent for many healthcare providers, who will need to adjust policies and make updates to equipment to be compliant.

Required Notification of Breast Density

The first regulation update is that mammography facilities now have to notify patients regarding the density of their breasts. The FDA has provided specific language explaining how breast density can influence the accuracy of a mammogram, as it can make cancers more difficult to detect. Approximately half of women over 40 years old in the U.S. have dense breast tissue, which has been identified as a risk factor for developing breast cancer (1). The FDA recommends that patients with dense breasts talk to their health care provider about any possible risks. This could lead to the recommendation of more frequent mammograms. 

The usage of mammography skin markers is important for patients with dense breasts, as they can guide radiologists to focus on areas of density or areas of concern that might otherwise be overlooked. 

Improving the Mammography Experience for Patients

Another recent change amends regulations issued under the Mammography Quality Standards Act (MQSA) of 1992. The MQSA allows the FDA to oversee the accreditation, certification, annual inspections and enforcement of standards in mammography facilities to help ensure these facilities give patients the quality care they need (1). 

Regulations are being modernized by incorporating current mammography best practices to improve breast cancer detection and empower patients with more information on the care they receive. If patients need a further evaluation or a repeat mammogram, it’s crucial they receive all the information and communication tools they need to understand their treatment plan. 

The new regulations also emphasize that mammography facilities should be equipped with up-to-date equipment that meets quality standards. This drives more accurate results and ensures patients are comfortable and confident in their mammography experience and results.  

Change in Mammography is Imminent

These new amendments will cause significant changes for healthcare providers as they are required to be implemented by August of 2024 (18 months from the March announcement), with the FDA overseeing key areas of enforcement and patient communication at mammography facilities. 

The FDA is focused on improving the mammogram experience for patients and creating a better system for collecting and reporting information. PDC provides solutions to help Breast Health Centers through these changes, helping to make the mammogram procedure seamless for providers and a comfortable experience for patients.

Featured Patient Experience Solutions:

  • Comfort Cushion™ – Helps technicians capture accurate imaging while also making patients feel comfortable during the mammogram
  • Spee-D-Cool™ Breast Cold Packs – Reduce patient discomfort before and after a biopsy or minor surgical procedure
  • Mammography Wipes – Improve the patient experience with cleansing wipes for before and after a mammography exam
  • Mammography Skin Markers – Help improve communication, give accurate diagnosis, and reduce image retakes

Request Mammography Samples

With the FDA mammography standards becoming more regularly enforced, now is the best time to ensure your facility is up to date with the latest and best mammography solutions. PDC has over 65 years of experience with healthcare solutions that improve the patient experience, making us the perfect partner whether you are making a big change or just updating your supplies and equipment. Connect with a PDC expert today for more information and best practices to improve the patient experience.  

Source: FDA

Notable Changes from the FDA Mammogram Standards Announcement
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Notable Changes from the FDA Mammogram Standards Announcement
In 2023 the FDA published updates to their mammography regulations, change is imminent and many healthcare providers will need to adjust.
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