Association Between a Recalled Positive Airway Pressure Device and Obstructive Lung Disease: A Province-Based Study

Affiliations

¹ Ottawa Hospital Research Institute, Ottawa; ICES, University of Ottawa, Ottawa, ON; Department of Medicine, University of Ottawa, Ottawa, ON; Faculty of Medicine, and School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON. Electronic address: tkendzerska@toh.ca.
² Ottawa Hospital Research Institute, Ottawa; ICES, University of Ottawa, Ottawa, ON.
³ Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB.
⁴ Divisions of Clinical Pharmacology and Toxicology/Respirology, Western University, London.
⁵ ICES, University of Ottawa, Ottawa, ON; Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON; Department of Medicine, University of Toronto, Toronto, ON.
⁶ Sleep Disorders Program UBC Hospital, Respiratory Division and Department of Medicine, University of British Columbia, Vancouver, BC.
⁷ Department of Medicine, McGill University Health Centre, Montreal, QC.
⁸ Division of Respirology, Critical Care and Sleep Medicine, University of Saskatchewan, Saskatoon, SK.
⁹ Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB; O'Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, AB; Department of Family Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB.
¹⁰ Ottawa Hospital Research Institute, Ottawa; ICES, University of Ottawa, Ottawa, ON; Faculty of Medicine, and School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON.
¹¹ The Centre of Excellence on Partnership with Patients and the Public, Université de Montréal, Montreal, QC, Canada (patient partner).
¹² Division of Pulmonary, Critical Care, and Sleep Medicine, University of California San Diego, La Jolla, CA.
¹³ Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB; O'Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, AB.

PMID: 40383186
DOI: 10.1016/j.chest.2025.05.008

Association Between a Recalled Positive Airway Pressure Device and Obstructive Lung Disease: A Province-Based Study

Tetyana Kendzerska et al. Chest. 2025.

. 2025 May 16:S0012-3692(25)00577-X.

doi: 10.1016/j.chest.2025.05.008. Online ahead of print.

Authors

Affiliations

¹ Ottawa Hospital Research Institute, Ottawa; ICES, University of Ottawa, Ottawa, ON; Department of Medicine, University of Ottawa, Ottawa, ON; Faculty of Medicine, and School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON. Electronic address: tkendzerska@toh.ca.
² Ottawa Hospital Research Institute, Ottawa; ICES, University of Ottawa, Ottawa, ON.
³ Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB.
⁴ Divisions of Clinical Pharmacology and Toxicology/Respirology, Western University, London.
⁵ ICES, University of Ottawa, Ottawa, ON; Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON; Department of Medicine, University of Toronto, Toronto, ON.
⁶ Sleep Disorders Program UBC Hospital, Respiratory Division and Department of Medicine, University of British Columbia, Vancouver, BC.
⁷ Department of Medicine, McGill University Health Centre, Montreal, QC.
⁸ Division of Respirology, Critical Care and Sleep Medicine, University of Saskatchewan, Saskatoon, SK.
⁹ Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB; O'Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, AB; Department of Family Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB.
¹⁰ Ottawa Hospital Research Institute, Ottawa; ICES, University of Ottawa, Ottawa, ON; Faculty of Medicine, and School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON.
¹¹ The Centre of Excellence on Partnership with Patients and the Public, Université de Montréal, Montreal, QC, Canada (patient partner).
¹² Division of Pulmonary, Critical Care, and Sleep Medicine, University of California San Diego, La Jolla, CA.
¹³ Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB; O'Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, AB.

PMID: 40383186
DOI: 10.1016/j.chest.2025.05.008

Abstract

Background: Limited real-world data exist on the health impacts of the Philips Respironics recall for positive airway pressure (PAP) devices.

Research question: What is the relationship between PAP device manufacturer and obstructive lung disease (OLD) development and progression?

Study design and methods: A retrospective longitudinal study was conducted by using Ontario health administrative databases (Canada) on all new adult PAP users (2012-2018) with or without OLD. Individuals were followed up from PAP claim date to death or March 2023. Outcomes included: (1) incident asthma/COPD (primary); and (2) inpatient/outpatient visits for asthma/COPD (secondary). Inverse probability weighting was used to balance baseline characteristics between individuals on recalled vs nonrecalled PAP devices, and weighted cause-specific HRs (csHRs) were calculated.

Results: Among 248,358 individuals (median follow-up > 7 years), 178,390 had no OLD (44,244 [24.8%] claimed recalled devices), and 69,968 had OLD (18,409 [26.3%] claimed recalled devices). In individuals without OLD, weighted analyses showed no significant difference in incident COPD or asthma risk between groups: csHR of 1.05 (95% CI, 0.97-1.15) for COPD and 1.08 (95% CI, 0.91-1.28) for asthma. No significant difference was observed for secondary outcomes in individuals with OLD. Exploratory analyses revealed modest increases in COPD risk within 2 years (csHR, 1.15; 95% CI, 1.00-1.31) and inpatient COPD visits 6 to 10 years following the PAP claim (csHR, 1.37; 95% CI, 1.02-1.86).

Interpretation: In this real-world population study, compared with other manufacturers, recalled devices were not independently associated with OLD development or progression following adjustment. However, early increases in COPD incidence and late effects on inpatient visits warrant further investigation.

Keywords: lung diseases; medical device recalls; obstructive; positive airway pressure therapy; sleep apnea syndromes.

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Conflict of interest statement

Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: T. K. and A. S. G. are supported by the PSI (Physicians' Services Incorporated) foundation. Outside of the submitted work, S. R. P. has received honoraria and grant funding from Jazz Pharmaceuticals. Outside of the submitted work, M. P. has received a fellowship grant from Paladin Labs and contract research from Jazz Pharmaceuticals. Outside of the submitted work, N. T. A. has received a speaker honorarium from Resmed and has been a consultant with EISAI, Jazz, Cerebra, Eli Lilly, and Powell Mansfield. Outside of the submitted work, M. K. is a consultant for Biron Soins du Sommeil; she also reported research funding from Fisher & Paykel Healthcare outside of the submitted work. Outside of the submitted work, the University of California San Diego (UCSD) Sleep Medicine Center received a donation from Resmed. None declared (R. T., K. B., C. M., M. F., K. A. M., S. H., D. R., R. L. O.).

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Association Between a Recalled Positive Airway Pressure Device and Obstructive Lung Disease: A Province-Based Study

Affiliations

Association Between a Recalled Positive Airway Pressure Device and Obstructive Lung Disease: A Province-Based Study

Authors

Affiliations

Abstract

Conflict of interest statement

LinkOut - more resources

Full Text Sources

Research Materials