AMA Journal of Ethics

Many devices in current use were marketed before manufacturers were required to demonstrate safety and effectiveness.

Heightened caution, improved physician and patient communication, and equitable access are key priorities.

Lack of training and lack of knowledge can adversely influence a patient’s clinical outcomes.

Information different patients need or want about cybersecurity risk varies, so communicating clearly is always key.

This series of 5 color oil on canvas sketches includes a sequence of images and illuminates one patient’s postoperative experiences.

Breast implant-associated anaplastic large cell lymphoma and breast implant illness have prompted recalls of implants.

Device innovation has potential to improve patient outcomes over time, yet prospective benefits must be considered in light of risks.

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.

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.

This issue invites clinicians, researchers, device representatives, and patient-safety champions to consider how to exercise sufficient caution without stifling innovation.