On September 24th, the US Food and Drug Administration (FDA) issued a “Safety Communication” regarding Aims Diagnostic Imaging, located in Manahawkin, NJ. Patients who had mammograms at Aims Diagnostic anytime on or after June 15, 2017 are being made aware of possible problems with the quality of their mammograms.
According to the FDA’s announcment,
“This does not mean the results of the mammograms were inaccurate, but it does mean that health care providers and patients should consider having these mammograms re-evaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if a repeat mammogram or additional medical follow-up is needed.”
The results of the FDA’s annual Mammography Quality Standards Act (MQSA) Inspection at Aims Diagnostic Imaging revealed that required quality control tests were not performed after June 15, 2017, compromising the quality of mammograms performed thereafter. This failure to operate in compliance with MQSA forced the FDA to move to notify affected patients.
Additionally, Aims Diagnostic Imaging failed to comply with an Additional Mammography Review order by not submitting the required mammograms. As a result, the facility lost its accreditation by the American College of Radiology on September 17, 2018.
Because the facility is non-compliant with MQSA and has lost its accreditation, the FDA has placed Aims’ MQSA in “no longer in effect” status. As of September 19, 2018, the facility can no longer legally perform mammograms.
The FDA has the following recommendations for anyone who had a mammogram at Aims Diagnostic Imaging on or after June 15, 2017 and has not had a mammogram at any other MQSA-certified facility since then:
The lack of responsibility Aims Diagnostic Imaging displayed in their failure to comply with MQSA regulations could have disastrous results for patients who depended on their abilities to provide accurate imaging to physicians. A medical malpractice attorney can step in if the consequences are dire. The medical malpractice attorneys at Messa & Associates are experienced in handling complex medical malpractice cases, including but not limited to missed diagnoses, MRSA infections, surgical site infections, foreign objects, and treatment errors/negligence. If you or a loved one has fallen victim to medical negligence at a hospital, nursing home, imaging, or rehab facility, act quickly. Call a medical malpractice attorney from Messa & Associates today, before your rights to legal compensation have expired. Call 877-MessaLaw for a free consultation or submit an inquiry online for a free case evaluation.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More