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.
Rachel Koch, MD, John G. Meara, MD, DMD, MBA, and Anji E. Wall, MD, PhD
Single-procedure interventions with minimal follow-up and clear quality-of-life gain are well suited for surgical mission trips. But not all risks and benefits are easily assessed.
AMA J Ethics. 2019;21(9):E729-734. doi:
10.1001/amajethics.2019.729.
Ashok, a Nepali man with neurofibromatosis, has undergone 3 surgeries to remove facially disfiguring tumors. His portrait is one of over 200 exhibited by this artist-researcher and mother.
AMA J Ethics. 2020;22(6):E513-524. doi:
10.1001/amajethics.2020.513.
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.
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.