外科医生视角下的与医生修改医疗器械相关的监管、合规和法律问题。

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

机构信息

Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, WA, USA.

出版信息

J Vasc Surg. 2013 Mar;57(3):829-31. doi: 10.1016/j.jvs.2012.11.043.

DOI:10.1016/j.jvs.2012.11.043

Abstract

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.

摘要

在创新速度超过受监管的技术进步的现代环境中，医生修改的血管内设备变得越来越普遍。在美国的许多医疗机构中，医疗器械的超适应证使用每天都在发生，而当医生进行这种操作时，它既合法又不受监管。本特邀评论的目的是回顾与医疗器械修改实践相关的监管、合规和法律问题。