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Medical devices
SAFER framework for moving forward on the medical device right to repair
  1. Shuhan He1,
  2. Debbie Lai2,
  3. Grace Jin3,
  4. Jarone Lee4
  1. 1 Lab of Computer Science, Massachusetts General Hospital / Harvard Medical School, Boston, Massachusetts, USA
  2. 2 Act Now Coalition, San Francisco, CA, USA
  3. 3 Stanford University School of Medicine, Stanford, California, USA
  4. 4 Department of Surgery and Emergency Medicine, Massachusetts General Hospital / Harvard Medical School, Boston, MA, USA
  1. Correspondence to Dr Jarone Lee, Massachusetts General Hospital, Boston, Massachusetts, USA; Jarone.Lee{at}mgh.harvard.edu

Abstract

Across various industries, the right to repair (RTR) movement has gained momentum as more than 20 states have proposed RTR laws to expand access to repair of consumer products. Medical device equipment shortages during the COVID-19 pandemic demonstrated that stronger repair mechanisms are necessary for the US health system to become more efficient, affordable and sustainable. We propose a 5-point SAFER framework including safety and security, adaptability, fiscal, environmental and regulatory factors for consideration in implementing medical device RTR. The healthcare community can help advance RTR legislation in a manner that serves our patients and healthcare system best.

  • health care facilities, manpower, and services
  • health care quality, access, and evaluation
  • health care economics and organizations

https://doi.org/10.1136/bmjinnov-2022-000936

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    Footnotes

    • Twitter @Grace__Jin, @JaroneLeeMD

    • Contributors SH, JL and DL contributed to conceptualisation, and all authors contributed to literature search, writing, review and editing of this paper.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests Unrelated to this manuscript, JL consults for Butterfly Network and has grant support from Beckman Coulter and Nihon-Kohden Corporation. SH serves on the Advisory Board of Covid Act Now, Safeter.App, and is the co-Founder of ConductScience Inc. SH receives research funding from the Foundation for Opioid Response Efforts (FORE), personal fees from Boston Globe, Maze Eng, the American College of Emergency Physicians, Withings, Conduct Science, Curative Medical Associates and VIO Med Spa New England.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • © Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.