Back to Search
Start Over
How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices?
- Source :
-
AMA Journal of Ethics . Sep2021, Vol. 23 Issue 9, p673-678. 6p. - Publication Year :
- 2021
-
Abstract
- 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. As debate continues over whether the pathway needs to be altered, features of ethical use of 510(k)-cleared devices can include (1) heightened caution with respect to newly cleared 510(k) products until adequate data are gathered through postmarket surveillance, (2) facilitating informed consent by improving physician and patient knowledge of the 510(k) pathway, and (3) basing distribution of these devices on individual risk assessments while ensuring equitable access. [ABSTRACT FROM AUTHOR]
- Subjects :
- *LUMBAR vertebrae surgery
*PROFESSIONS
*INTERVERTEBRAL disk displacement
*SPINAL fusion
*CONTINUING education units
*RISK assessment
*INFORMED consent (Medical law)
*HEALTH literacy
*NEW product development laws
*PHYSICIANS
*DECISION making in clinical medicine
*MEDICAL equipment
*PATIENT safety
*BIOETHICS
Subjects
Details
- Language :
- English
- ISSN :
- 23766980
- Volume :
- 23
- Issue :
- 9
- Database :
- Academic Search Index
- Journal :
- AMA Journal of Ethics
- Publication Type :
- Academic Journal
- Accession number :
- 152240095
- Full Text :
- https://doi.org/10.1001/amajethics.2021.673