Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA.
- clinical ethics
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Contributors Both authors contributed equally to the conception, drafting and revision of this manuscript and approve its final form.
Funding DK is supported in part by the Greenwall Faculty Scholars Program in Bioethics. DK also reports serving as a consultant to the Circulatory Systems Advisory Panel of the Food and Drug Administration, and to Firefly Health.
Competing interests This work was supported by the Greenwall Foundation.
Provenance and peer review Not commissioned; externally peer reviewed.
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