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

Abstract

Limited real-world data exist on the health impacts of the Philips Respironics recall for positive airway pressure (PAP) devices. What is the relationship between PAP device manufacturer and obstructive lung disease (OLD) development and progression? 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 hazard ratios (csHRs) were calculated. 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). 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.