A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.
AMA J Ethics. 2021;23(9):E712-720. doi:
10.1001/amajethics.2021.712.
Editorial fellow Dr Ariel Wampler describes what few know about material and device regulation, and Dr Adriane Fugh-Berman explains why we should ask more questions about device representatives’ intraoperative roles during implantations.
Jeffrey Bedard joins Ethics Talk to discuss his article: "What Should Patients Be Told About Device Representatives’ Roles at the Point of Surgical Care?"
Dr Donna-Bea Tillman joins Ethics Talk to discuss her article: "What Should the Public Know About Implantable Material and Device Innovation in the US?"
Carmen Black Parker, MD, Amanda Calhoun, MD, MPH, Ambrose H. Wong, MD, MSEd, Larry Davidson, PhD, and Charles Dike, MBChB, MPH
Psychiatric emergencies, coping stress reactions, and iatrogenic injuries are not responded to with the same vigor as acute medical decompensation. That needs to change.
AMA J Ethics. 2020;22(11):E956-964. doi:
10.1001/amajethics.2020.956.