Literature DB >> 34705629

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

Timothy I Morgenthaler1, Emily A Linginfelter2, Peter C Gay1, Sandra E Anderson1, Daniel Herold1, Virginia Brown1, Joseph M Nienow3.   

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. CITATION: Morgenthaler TI, Linginfelter EA, Gay PC, et al. Rapid response to medical device recalls: an organized patient-centered team effort. J Clin Sleep Med. 2022;18(2):663-667.
© 2022 American Academy of Sleep Medicine.

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Year:  2022        PMID: 34705629      PMCID: PMC8805014          DOI: 10.5664/jcsm.9748

Source DB:  PubMed          Journal:  J Clin Sleep Med        ISSN: 1550-9389            Impact factor:   4.062


  2 in total

1.  An exploratory analysis of U.S. FDA Class I medical device recalls: 2014-2018.

Authors:  Alfred Sarkissian
Journal:  J Med Eng Technol       Date:  2019-03-21

2.  Drug and medical device product failures and the stability of the pharmaceutical supply chain.

Authors:  Alex N Livingston; T Joseph Mattingly
Journal:  J Am Pharm Assoc (2003)       Date:  2020-08-01
  2 in total

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