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.
Beatrice L. Brown joins Ethics Talk to discuss her article, coauthored with Dr Aaron S Kesselheim: "How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices?"
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?"
Douglas E. Paull, MD, MS and Paul N. Uhlig, MD, MPA
Risk managers can help patient-subjects and clinician-researchers make informed novel device implantation decisions in the absence of preclinical trial data.
AMA J Ethics. 2020;22(11):E911-918. doi:
10.1001/amajethics.2020.911.