Informed consent and compulsory medical device registries: ethics and opportunities
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 particul...
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| Published in: | Journal of medical ethics Vol. 48; no. 2; p. 79 |
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| Main Authors: | , |
| Format: | Journal Article |
| Language: | English |
| Published: |
England
01-02-2022
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| Subjects: | |
| Online Access: | Get more information |
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| Summary: | 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. |
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| ISSN: | 1473-4257 |
| DOI: | 10.1136/medethics-2020-107031 |