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.
Eitan Neidich, Alon B. Neidich, David A. Axelrod, MD, and John P. Roberts, MD
Geographic disparities in availability of organs for transplant have spawned for-profit companies that help patients get on waitlists in more than one region and arrange travel for them if an organ becomes available.
The United States government’s insistence that organs can only be procured through altruism, rather than being exchanged or purchased, contributes to the very exploitation of people of color in developing countries it sought to prevent.
U.S. courts have ruled that device manufacturer representatives’ presence in the operating room does not make them responsible for the supervision of physicians or liable for the practice of unauthorized medicine.
Physicians should recognize the influence that small gift-giving has on prescribing patterns and consequently interactions between pharmaceutical representatives and medical students and residents should be limited.