Rapid response to medical device recalls: an organized patient-centered team effort

Timothy I. Morgenthaler, Emily A. Linginfelter, Peter C. Gay, Sandra E. Anderson, Daniel Herold, Virginia Brown, Joseph M. Nienow

Research output: Contribution to journalArticlepeer-review

Abstract

As more patients depend upon mechanical or electronic technologies for treatment, medical device recalls—like the recent recall of common positive airway pressure treatment devices—impact millions of patients, often causing significant anxiety, extra costs, and interruption of care for patients. When recalls require health care and/durable medical equipment providers to be part of the solution, the burden on practices and businesses can be significant, creating strains on access for new patients and on limited medical supplies. We have observed that having an established and well-organized medical device recall plan in place allows for a rapid response, decreased practice burden, and reduced provider stress. Coupling the organized response with proactive, empathic, and clear communication with patients reduces their anxiety, provides clear directions for how to address the issue constructively, and reduces reactive communications. We share what we believe are key components of a medical device and produce recall procedure as we describe our institutions response in hopes that others can build on these basics as they design their own response plans.

Original languageEnglish (US)
Pages (from-to)663-667
Number of pages5
JournalJournal of Clinical Sleep Medicine
Volume18
Issue number2
DOIs
StatePublished - Feb 1 2022

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology
  • Pulmonary and Respiratory Medicine

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