Implantable brain-computer interface (BCI) and other devices with potential for both therapeutic purposes and human enhancement are being rapidly developed. The distinction between therapeutic and enhancement uses of these devices is not well defined. While the US Food and Drug…
Many devices in current use were marketed before the US Food and Drug Administration (FDA) began regulating devices in 1976. Thus, manufacturers of these devices were not required to demonstrate safety and effectiveness, which presents both clinical and ethical problem…
Recent research has highlighted device representatives’ roles in surgical cases. Additional review of cases based on actual events suggests that lack of training on the part of a surgeon and surgical team and lack of knowledge and training on the…
The number of new medical devices cleared by the US Food and Drug Administration (FDA) through the 510(k) pathway that has subsequently been associated with safety risks has led to discussion of approaches to regulation and communication of device risks….
This article examines the history of device oversight by the US Food and Drug Administration (FDA). Significant regulatory changes occurred in response to injuries caused by Dalkon Shield intrauterine devices. This article summarizes those changes as well as continued efforts…
Medical school education must better align with patient care needs for a rapidly changing population. One challenge is to eliminate bias in merit-based admissions to more equitably review candidates with the structural competency skills desperately needed to promote public health…
Increasing focus on health equity is placing a spotlight on health professionals’ roles. Recent public health crises the opioid epidemic, maternal mortality, and the COVID-19 pandemic have renewed focus on racial and ethnic inequity and underscored that trust is foundational…
The United States has not yet decided to ensure that every citizen has access to health care services at reasonable cost. The United States spends more on health care than any other country by far. Yet the health status of…
Eliminating racial inequity in health outcomes has historically been complicated by a lack of clear methods to quantify the problems and study interventions’ effects. Health care organizations’ investment in electronic health record systems for millions of patients, however, presents opportunities…
This commentary on a case considers balancing prospective benefits and harms of robotic technology use and argues that health care organizations should invest in centralizing robotic expertise in departments rather than having a mere collection of surgeons trained in robotics….
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