{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T18:29:30Z","timestamp":1787164170694,"version":"build-2736575974"},"reference-count":44,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"vor","delay-in-days":197,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000024","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Study Objectives<\/jats:title>\n                    <jats:p>To understand how the Philips positive airway pressure device recall affected patient experiences, clinical practice, and health system responses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>We conducted a qualitative descriptive study using semi-structured interviews with individuals with obstructive sleep apnea (OSA), physicians, respiratory therapists, and health system leaders from November 2022 to August 2023. Emailed responses from Health Canada were also incorporated. Interviews explored participants\u2019 experiences with the recall announcement and communication, their own responses and perceptions of actions taken by others, the overall impact of the recall and suggestions for improving future recall processes. Data were analyzed using an inductive thematic approach with iterative coding and team-based analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We interviewed 47 participants (16 individuals with OSA, 10 physicians, 17 public or private respiratory therapists, 5 health system leaders). Four domains emerged: recall communication, execution, lived experiences, and policy context. Across groups, participants described a fragmented and poorly coordinated recall process with unclear accountability. Participants reported confusion due to inadequate information from Philips. Responsibility for notifying patients and device tracing shifted largely to healthcare providers and vendors, while replacement processes were disorganized and frustrating. Individuals with OSA experienced emotional distress and decisional uncertainty regarding therapy continuation. Providers described moral distress due to limited ability to support patients adequately, and vendors reported logistical and financial strain. While regulatory authorities indicated that standard procedures were followed, participants perceived these to be discordant from the recall process, contributing to erosion of trust.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The Philips positive airway pressure device recall exposed gaps between regulatory frameworks and real-world implementation, with broad individual and system-level impacts. Future recalls should prioritize accountability, coordination, and patient-centered support.<\/jats:p>\n                    <jats:p>Statement of Significance In June 2021, Philips Respironics announced a global recall of over 15 million positive airway pressure devices, related to potential toxic and irritant effects from breakdown of a polyester-based polyurethane foam. This is the first study to deeply explore the recall\u2019s impact as experienced by individuals with obstructive sleep apnea, healthcare providers, and health system leaders. Our findings highlight problems with communication, poor execution of recall processes, and both psychological and financial burdens due to the recall. This study can inform strategies to mitigate the impact of future device recalls.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/sleepadvances\/zpag077","type":"journal-article","created":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T11:47:46Z","timestamp":1784202466000},"source":"Crossref","is-referenced-by-count":0,"title":["Exploring the impact of a medical device recall on individuals with obstructive sleep apnea and healthcare providers: a qualitative study"],"prefix":"10.1093","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4693-0831","authenticated-orcid":false,"given":"Sachin R","family":"Pendharkar","sequence":"first","affiliation":[{"name":"Department of Medicine, Cumming School of Medicine, University of Calgary , Calgary, AB ,","place":["Canada"]},{"name":"Department of Community Health Sciences, Cumming School of Medicine, University of Calgary , Calgary, AB ,","place":["Canada"]},{"name":"O\u2019Brien Institute for Public Health, Cumming School of Medicine, University of Calgary , Calgary, AB ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-8732-4560","authenticated-orcid":false,"given":"Kenneth G","family":"Blades","sequence":"additional","affiliation":[{"name":"Department of Medicine, Cumming School of Medicine, University of Calgary , Calgary, AB ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bashour","family":"Yazji","sequence":"additional","affiliation":[{"name":"Ottawa Blood Disease Center, The Ottawa Hospital Research Institute , Ottawa, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Najib T","family":"Ayas","sequence":"additional","affiliation":[{"name":"Leon Judah Blackmore Sleep Disorders Program, Department of Medicine, University of British Columbia , Vancouver, BC ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert L","family":"Owens","sequence":"additional","affiliation":[{"name":"Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego , La Jolla, CA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6335-0938","authenticated-orcid":false,"given":"Marta","family":"Kaminska","sequence":"additional","affiliation":[{"name":"Respiratory Division and Sleep Laboratory, McGill University Health Center , Montreal, QC ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Constance","family":"Mackenzie","sequence":"additional","affiliation":[{"name":"Divisions of Respirology and Clinical Pharmacology and Toxicology, Department of Medicine, Western University , London, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea S","family":"Gershon","sequence":"additional","affiliation":[{"name":"Division of Respirology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto , Toronto, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana C","family":"Ratycz","sequence":"additional","affiliation":[{"name":"The Centre of Excellence on Partnership with Patients and the Public, Universit\u00e9 de Montr\u00e9al , Montreal, QC, \u00a0","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vadym","family":"Lishchenko","sequence":"additional","affiliation":[{"name":"The Office for Patient Engagement in Research Activities, The Ottawa Hospital Research Institute , Ottawa, ON ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark E","family":"Fenton","sequence":"additional","affiliation":[{"name":"Division of Respirology and Sleep Medicine, University of Saskatchewan , Saskatoon, SK ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kerry 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