A surgeon’s perspective regarding the regulatory, compliance, and legal issues involved with physician-modified devices

Physician-modified endovascular devices are becoming commonplace in a modern climate where innovation outpaces regulated technological advancement. Off-label use of medical devices occurs on a daily basis throughout many institutions across the United States and when performed by physicians, is both...

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Veröffentlicht in:	Journal of vascular surgery 2013-03, Vol.57 (3), p.829-831
1. Verfasser:	Starnes, Benjamin W., MD
Format:	Artikel
Sprache:	eng
Schlagworte:	Aortic Aneurysm - surgery Attitude of Health Personnel Blood Vessel Prosthesis - standards Blood Vessel Prosthesis Implantation - adverse effects Blood Vessel Prosthesis Implantation - instrumentation Blood Vessel Prosthesis Implantation - legislation & jurisprudence Blood Vessel Prosthesis Implantation - standards Device Approval - legislation & jurisprudence Device Approval - standards Diffusion of Innovation Endovascular Procedures - adverse effects Endovascular Procedures - instrumentation Endovascular Procedures - legislation & jurisprudence Endovascular Procedures - standards Guideline Adherence Health Knowledge, Attitudes, Practice Humans Liability, Legal Patient Safety Perception Practice Guidelines as Topic Prosthesis Design Risk Assessment Risk Factors Stents - standards Surgery Treatment Outcome United States United States Food and Drug Administration - legislation & jurisprudence United States Food and Drug Administration - standards
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Beschreibung
Zusammenfassung:	Physician-modified endovascular devices are becoming commonplace in a modern climate where innovation outpaces regulated technological advancement. Off-label use of medical devices occurs on a daily basis throughout many institutions across the United States and when performed by physicians, is both legal and unregulated. The purpose of this invited commentary is to review the regulatory, compliance, and legal issues regarding the practice of medical device modification.
ISSN:	0741-5214 1097-6809
DOI:	10.1016/j.jvs.2012.11.043