Regulatory Focus™ > News Articles > Screen-Film Mammography Will Soon be ‘Virtually Obsolete,’ FDA Says

Screen-Film Mammography Will Soon be ‘Virtually Obsolete,’ FDA Says

Posted 01 December 2015 | By Zachary Brennan 

Screen-Film Mammography Will Soon be ‘Virtually Obsolete,’ FDA Says

As quality issues with screen-film mammography continue to crop up, the US Food and Drug Administration (FDA) says facilities are almost done transitioning to full field digital mammography (FFDM) units 15 years after they came into clinical use.

Currently, fewer than 400 screen-film units are in use at 5% of the facilities certified under the Mammography Quality Standards Act (MQSA). And although this represents just a sliver of the total mammography units in operation in the US, these screen-film units still account for 25% of the Additional Mammography Reviews (AMRs), which come when mammography quality has been compromised, and 66% of Patient and Provider Notifications (PPNs) by FDA, agency spokeswoman Angela Stark told Focus.

“Based on these compliance issue rates and current trends, the FDA anticipates screen-film mammography usage to become virtually obsolete in the coming years,” Stark said.

Action Report

The prediction comes as FDA on Tuesday officially announced that a North Carolina-based physician practice would no longer use screen-film mammograms after deficiencies were noted in the clinical image quality of images reviewed.

Christie Parker, a nurse at the North Carolina office of Dr. Richard Adelman, explained to Focus that the facility voluntarily stopped conducting mammograms last October and spoke to FDA last week about its decision to stop offering mammograms as they were “too expensive.”

The decision to stop offering mammograms at the site came six months after the American College of Radiology conducted an on-site survey and found 13 of 15 clinical exams reviewed did not meet ACR’s clinical image quality standards.

On 18 November, FDA determined the facility’s MQSA certificate should be placed in a “no longer in effect” status until the facility complied with all requirements of the MQSA.

Work Left to Do

As FDA’s updated MQSA statistics show, as of Tuesday, FDA knows of 281 facilities in the US that still aren’t using FFDM.

And although 281 out of more than 8,700 doesn’t seem like an issue, the agency notes that between 2005 and 2014, facilities using screen-film mammography accounted for 61.5% of all AMRs and 62.6% of all PPNs. Here’s a further breakdown of the inspection statistics from FDA:

Certification statistics as of Dec. 1, 2015 
  
 Total certified facilities / Total accredited units8,735/15,357 
 Certified facilities with FFDM units / Accredited FFDM units8,454/14,998
 Facilities inspected 1,195
 Level 1 violation (the most serious) 0.6%
 Level 2 violation 7.4%
 Level 3 violation  3.6%
 Percent of inspections with no violations 88.5%
 Total annual mammography procedures reported as of Dec. 1, 201539,079,328 

The shift to FFDM units comes as other technology is also in development, including 3D mammography, though as the National Cancer Institute notes, the accuracy of 3D mammography has not yet been compared with 2D mammography in randomized clinical trials so it's unknown whether this new tech is better or worse than the standard mammography at avoiding false positives or identifying cancer early.

MQSA National Statistics

Screen-film mammography: Headed the way of xeromammography?

Full Field Digital Mammography (FFDM) Certification Extension Program

Mammography Facility Adverse Event and Action Report - November 27, 2015: Richard D. Adelman, M.D.


Categories: Regulatory News

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