TY - JOUR
T1 - Rapid response to medical device recalls
T2 - an organized patient-centered team effort
AU - Morgenthaler, Timothy I.
AU - Linginfelter, Emily A.
AU - Gay, Peter C.
AU - Anderson, Sandra E.
AU - Herold, Daniel
AU - Brown, Virginia
AU - Nienow, Joseph M.
N1 - Publisher Copyright:
© 2022 American Academy of Sleep Medicine. All rights reserved.
PY - 2022/2/1
Y1 - 2022/2/1
N2 - 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.
AB - 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.
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U2 - 10.5664/jcsm.9748
DO - 10.5664/jcsm.9748
M3 - Article
C2 - 34705629
AN - SCOPUS:85123968521
SN - 1550-9389
VL - 18
SP - 663
EP - 667
JO - Journal of Clinical Sleep Medicine
JF - Journal of Clinical Sleep Medicine
IS - 2
ER -