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?"
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.
More frequent use of robotic-assisted surgeries means we need to ask more questions about care quality and equity, informed consent, and conflicts of interest.
AMA J Ethics. 2023;25(8):E605-608. doi:
10.1001/amajethics.2023.605.
The case of Johnson v Kokemoor illuminates the conflict between patients’ right to informed consent and clinicians’ need to learn through practice, a conflict that possibly could be resolved through greater transparency about clinicians’ experience or experience-dependent medical fees.