News | March 24, 2015

FDA Takes Action Against New Jersey Mammography Facility for Adverse Event

Facility was found to have serious problems with mammography image quality

March 24, 2015 — The U.S. Food and Drug Administration (FDA) reports it has revoked the Mammography Quality Standards Act (MQSA) certificate for AP Diagnostic Imaging Inc., a facility at 1692 Oak Tree Road in Edison, New Jersey. The facility has ceased performing mammography.

On Sept. 23, 2014, the American College of Radiology (ACR) initiated an Additional Mammography Review (AMR) of mammograms performed by the facility. The AMR was initiated due to serious image quality problems identified during the review of clinical images submitted for accreditation renewal. On Nov. 10, 2014, the ACR notified the facility that mammograms reviewed during the AMR did not meet the ACR’s criteria for clinical image quality and that the deficiencies posed a serious risk to human health.

The facility was undergoing accreditation renewal at the time that the clinical image quality problems were detected by the ACR. The facility did not complete the ACR’s accreditation renewal process, and the facility’s Mammography Quality Standards ACT (MQSA) certificate expired on Oct. 9. 2014.

Based on the deficiencies noted during the AMR, the FDA required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all at-risk patients and their providers of the mammography image quality problems at the facility. The facility successfully completed the PPN and was notified of such by the FDA on Feb. 24, 2015.

As part of the MQSA, Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide.

For more information: www.fda.gov

Related Content

Clinical Trial Testing Topical Gel to Reduce Breast Density
News | Breast Density | June 19, 2018
Women with dense breast tissue soon might be adding a new product to their skincare routine to help them fight breast...
California Women In Favor of Extending State's Breast Density Inform Law
News | Breast Density | June 15, 2018
A recent survey of California women found that 95 percent of respondents want the state’s breast density inform law to...
Women More Likely to Use Other Preventive Health Services Following Mammography
News | Mammography | June 13, 2018
Medicare beneficiaries who undergo breast cancer screening with mammography are more likely than unscreened women to...
How AI and Deep Learning Will Enable Cancer Diagnosis Via Ultrasound

The red outline shows the manually segmented boundary of a carcinoma, while the deep learning-predicted boundaries are shown in blue, green and cyan. Copyright 2018 Kumar et al. under Creative Commons Attribution License.

News | Ultrasound Imaging | June 12, 2018 | Tony Kontzer
June 12, 2018 — Viksit Kumar didn’t know his mother had...
Breast imaging technologies have seen a rapid evolution.

Breast imaging technologies have seen a rapid evolution.

Feature | Women's Health | June 05, 2018 | By Jeff Zagoudis
Breast imaging technologies have evolved rapidly in the last two decades to help physicians detect breast cancers at
Breast Cancer Survivors Not Getting Recommended Number of Mammograms Post-Surgery
News | Mammography | May 24, 2018
Breast cancer survivors are not getting the recommended level of screening post-surgery, according to a newly-published...
Breast Cancer Places Greater Financial Burden on Black Women
News | Women's Health | May 16, 2018
Having breast cancer placed a significantly greater financial strain on black women than white women, according to a...
FDA's MQSA Accreditation Bodies Approved for Tomosynthesis Accreditation

Image courtesy of Fujifilm.

Feature | Mammography | May 14, 2018
On April 9, 2018, the U.S. Food and Drug Administration (FDA) announced that all four of its Mammography Quality...
Overlay Init