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FDA Finds Widespread Process Deficiencies at Mammography Facilities

Posted 25 August 2017 | By Michael Mezher 

FDA Finds Widespread Process Deficiencies at Mammography Facilities

The US Food and Drug Administration (FDA) says that nearly half of all mammography facilities inspected in the first six months of 2017 had at least one deficiency under a new inspection program aimed at improving image quality, according to data released by the agency on Friday.

In January, FDA launched the initiative, referred to as EQUIP (Enhancing Quality Using the Inspection Program), aimed at identifying process and systems related deficiencies at mammography facilities that could lead to poor quality images in response to a recent uptick in compliance issues.

"Last year, we analyzed [Mammography Quality Standards Act] MQSA compliance cases and found that almost 50% of the additional mammography reviews and subsequent patient and provider notifications ordered did indeed come from image review processes," Helen Barr, director of the Division of Mammography Quality Standards within the Center for Devices and Radiological Health, said in a training video posted by FDA in June.

In the past, mammography facility inspections tended to focus on the equipment used for imaging.

"In today's world, equipment is not usually the issue, the quality of the images themselves is," she said, adding that patient positioning and compression are the two most common issues resulting in poor quality images.

Under EQUIP, FDA introduced a set of six questions to address during mammography facility inspections, such as whether facilities conduct regular reviews of image quality or whether such a review has taken place since the last time the facility was inspected.

And, while FDA says that 44% of all facilities inspected from 1 January 2017 through 30 June 2017 were marked deficient in at least one of the EQUIP questions, the agency says it will not issue citations for EQUIP-related deficiencies until 2018.

FDA EQUIP Data (1 January 2017-30 June 2017)
QuestionNumber of deficient inspections (out of 4,166)Percent of total inspections
Question 1(a) - There is no system in place that includes a mechanism for providing ongoing IP feedback on image quality54213%
Question 1(b) - There is no system in place that includes a mechanism for documenting any  needed corrective action and the effectiveness of any corrective action taken1,04525%
Question 2(a) - There is no mechanism in place for regular reviews of image quality attributes of a sample of mammograms performed by each active RT and a sample of  mammograms accepted for interpretation by each active IP1,42134%
Question 2(b) - There is no documentation of review since the last inspection1,26330%
Question 3(a) - There is no system in place for LIP oversight, including review of the frequency of performance of all required tests80319%
Question 3(b) - There is no system in place for LIP review to determine whether appropriate  corrective actions were performed when needed93722%

While FDA says it expected Question 2 to be the most challenging for facilities to address, the agency says it believes that regular image quality reviews "can potentially lead to systemic remedies that improve a facility's image quality."


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