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?"
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.
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.
Because the choice of surgical equipment has long-term consequences for patients and trainees, physicians who are deciding whether to accept donations of it should consider whether the donated equipment is what they would buy if they had the money to buy the best.
AMA J Ethics. 2015;17(8):734-738. doi:
10.1001/journalofethics.2015.17.8.ecas2-1508.
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.
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.