Radiation-Emitting Products

Screen-film mammography: Headed the way of xeromammography?

In July 2015, fifteen years after full-field digital mammography (FFDM) first came into clinical use, the number of FFDM units in use as a percentage of all mammography units in use exceeded 97%. Although for the first several years after their introduction, the uptake of FFDM units was relatively slow — not until 2008 did the number of FFDM units reach 50% of the total number of units in use — it has accelerated in recent years. At the present time, there are less than 400 screen-film units currently in use in MQSA-certified facilities.

Yet despite the recent rapid drop in the number of screen-film units since 2008, screen-film facilities have been over-represented in facilities with image quality issues, evidenced by requests from FDA or accreditation bodies for Additional Mammography Reviews (AMR) and the ordering of Patient and Provider Notifications (PPN) by the FDA. When an accreditation body receives or discovers information that suggests inadequate image quality, or if the FDA believes that mammography quality at a facility has been compromised and may present a serious risk to human health, the accreditation body will review a facility's clinical images or other aspects of a facility's practice to assist FDA in determining whether the facility’s practice poses a serious risk to human health. The AMR can help the agency determine whether a facility is in compliance with the quality standards. Based on an evaluation of the results of the AMR, the FDA may determine that mammograms performed by a facility were so inconsistent with established quality standards as to pose a significant risk to individual or public health and direct a facility to conduct a PPN, notifying all at-risk patients and their referring health care providers.

Between 2005 and 2014, facilities using screen-film mammography accounted for 61.5% of all AMR's and 62.6% of all PPN's.

Between 2009—the first year in which screen-film accounted for less than 50% of certified facilities—and 2014—when the use of screen-film had decreased to less than 5% of facilities, screen-film facilities still accounted for 38% of all AMRs and 42% of all PPNs.

In 2014, even with their greatly reduced numbers, facilities using screen-film units nevertheless accounted for one-quarter of all AMRs and two-thirds of all PPN's. With the very small number of screen film units left, and if the current trend continues, it seems that screen film mammography might go the way of xeromammography in the not too distant future. The overrepresentation of this technology in compliance issues serves as food for thought about the appropriateness of the declining use of screen- film mammography in the U.S.
 

Page Last Updated: 09/30/2015
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