Radiation-Emitting Products

MQSA National Statistics

In this section of MQSA Insights, we present the most commonly requested national statistics regarding the MQSA program. These statistics are updated on the first of each month.

Certified facilities, as of October 1, 20168,741
Certification statistics, as of May 1, 2017 
  Total certified facilities / Total accredited units8,752/ 17,437
 Certified facilities with FFDM2 units / Accredited FFDM units8,609 / 12,698
 Certified facilities with DBT3,4 units / Accredited DBT units3,293 / 4,569
FY2017 inspection statistics, as of May 1, 2017 
 Facilities inspected4,494
 Total units at inspected facilities8,640
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation.8%
  Level 2 violation510.2%
  Level 3 violation.3%
 Percent of inspections with no violation88.6%
Total annual mammography procedures reported, as of May 1, 2017139,296,997

1 This number is an aggregate of the total number of procedures performed annually as reported by facilities to their accreditation bodies at the time of their re-accreditation, which takes place once every three years. We have aggregated only the numbers reported by MQSA-certified, non-Veterans Hospital Administration facilities. The aggregate number may not reflect the current number of procedures performed at these facilities.

2 FFDM - Full Field Digital Mammography unit.

3 DBT - Digital Breast Tomosynthesis.

4 Facilities with DBT also have FFDM so the DBT facilities count is included within the FFDM facilities count.

5 Based on an analysis of the violation rates for all MQSA citations, the FDA has decided to elevate the five remaining Level 3 citations to Level 2 citations. This change took effect on October 27, 2016. Since all Level 3 citations, if repeated, could have been elevated to a Level 2 with a requirement of a 30 day response to FDA, they should not be viewed as minor in nature, and they should be initially cited as a Level 2. As a consequence, the Level 3 violation rates will approach zero, and the Level 2 violation rates may initially increase but should level off with time.

Page Last Updated: 05/02/2017
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