医生是设备制造商?对重症监护室临床医生创新的监管。

IF 7.7 1区 医学 Q1 CRITICAL CARE MEDICINE
David A Simon, Michael J Young
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引用次数: 0

摘要

重症监护医生是丰富的创新源泉,他们在临床实践中开发新的诊断、预后和治疗工具,包括基于软件的新型工具。其中许多工具都经过验证并有望为患者提供积极帮助,但由于伦理、监管或医疗法律方面的问题尚未解决,医生可能不太可能以非商业方式分发、实施或与其他中心分享这些工具。本视点探讨了重症监护医生在非商业性传播与设备相关的创新时可能面临的障碍和风险,并提出了一个基于风险的评估框架,以促进明确的途径,保障患者的公平使用权,并负责任地实施临床医生在重症监护中产生的技术创新。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Doctors as Device Manufacturers? Regulation of Clinician-Generated Innovation in the ICU.

Critical care physicians are rich sources of innovation, developing new diagnostic, prognostic, and treatment tools they deploy in clinical practice, including novel software-based tools. Many of these tools are validated and promise to actively help patients, but physicians may be unlikely to distribute, implement, or share them with other centers noncommercially because of unsettled ethical, regulatory, or medicolegal concerns. This Viewpoint explores the potential barriers and risks critical care physicians face in disseminating device-related innovations for noncommercial purposes and proposes a framework for risk-based evaluation to foster clear pathways to safeguard equitable patient access and responsible implementation of clinician-generated technological innovations in critical care.

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来源期刊
Critical Care Medicine
Critical Care Medicine 医学-危重病医学
CiteScore
16.30
自引率
5.70%
发文量
728
审稿时长
2 months
期刊介绍: Critical Care Medicine is the premier peer-reviewed, scientific publication in critical care medicine. Directed to those specialists who treat patients in the ICU and CCU, including chest physicians, surgeons, pediatricians, pharmacists/pharmacologists, anesthesiologists, critical care nurses, and other healthcare professionals, Critical Care Medicine covers all aspects of acute and emergency care for the critically ill or injured patient. Each issue presents critical care practitioners with clinical breakthroughs that lead to better patient care, the latest news on promising research, and advances in equipment and techniques.
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