Dr. Amy J. Reed
The Amy J. Reed Medical Collaborative for Medical Device Safety was formed to honor the legacy Dr. Amy Josephine Reed MD, PhD. She was an anesthesiologist and intensive care physician. Dr. Reed was a member of the clinical faculty at Harvard Medical School’s Beth Israel Deaconess Medical Center - and subsequently, at the Hospital of the University of Pennsylvania.
At age 44, Dr. Reed died on May 17, 2017, of oncological complications related to use of an unsafely marketed medical device known as a Power Morcellator. Her complication in 2013 was the index case that triggered a global public health campaign in women’s health and medical device safety in the 510(k) regulatory space at the Food and Drug Administration (FDA).
Dr. Reed’s public health campaign led to the achievement of an FDA black box warning on Power Morcellator devices and caused several manufacturers to withdraw their version of this medical device from the global marketplace.
Importantly, Dr. Reed’s efforts highlighted a critical deficit in physician reporting of adverse events and safety failures by physicians and hospitals in the case of 510(k) medical devices. These findings led several US Representatives to propose a bill named the Medical Device Guardians Act to ensure robust medical device adverse event reporting by Physicians.
Dr. Reed’s public health advocacy was highly significant in that she was able to foster a hybrid academic-activist approach to promoting reform towards 510(k) safety at the FDA’s Center for Devices and Radiological Health (CDRH).
Aside from her accomplished academic standing as a physician-scientist, Dr. Reed’s most significant life achievement was her six children, of whom she was proud.
The Amy J. Reed Medical Device Safety Collaborative aims to emulate Dr. Reed’s Academic-activist model in a medical-legal collaboration between Northeastern University School of Law and Tufts Medical Center. The collaborative’s goal is to identify safety failures in the medical device regulatory arena using an evidence-based approach - and to effect change through academic collaborations or legal approaches to various stakeholders.