A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.
AMA J Ethics. 2021; 23(9):E712-720. doi:
10.1001/amajethics.2021.712.
Charles E. Binkley, MD, Michael S. Politz, MA, and Brian P. Green, PhD
If the safe-and-effective standard for judging devices’ potential as therapy or enhancement is inadequate, one might wonder whether BCI regulation should be overseen by the FDA.
AMA J Ethics. 2021; 23(9):E745-749. doi:
10.1001/amajethics.2021.745.
Kim Christiansen discusses her experiences managing limited mobility and chronic pain from a partial spinal cord injury and Dr Natalie Hoff describes good physical therapy care for patients with chronic migraine headaches.
Dr Charles Binkley joins Ethics Talk to discuss his article, coauthored with Michael Politz and Dr Brian Green: "Who, If Not the FDA, Should Regulate Implantable Brain-Computer Interface Devices?"
A lack of consensus guidelines or a belief that current evidence does not support such guidelines might be justified if a clinician expresses a commitment to patient-centered care and shared decision making.
AMA J Ethics. 2018; 20(11):E1007-1016. doi:
10.1001/amajethics.2018.1007.
Parents’ false beliefs can be engaged respectfully to motivate deliberations about shared values and goals, but refusal of clinically indicated treatment could warrant reporting.
AMA J Ethics. 2018; 20(11):E1017-1024. doi:
10.1001/amajethics.2018.1017.