Association between a recalled Positive Airway Pressure (PAP) device and obstructive lung disease: A province-based study

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 — We conducted a retrospective longitudinal study using Ontario health administrative databases (Canada) on all new adult PAP users (2012-2018) with or without OLD. Individuals were followed from PAP claim date to death or March 2023. Outcomes included: (i) incident asthma/COPD (primary) and (ii) inpatient/outpatient visits for asthma/COPD (secondary). We used inverse probability weighting to balance baseline characteristics between individuals on recalled versus non-recalled PAP devices and calculated weighted cause-specific hazard ratios (csHR).

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 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 two years (csHR of 1.15, 95% CI: 1.00-1.31) and inpatient COPD visits 6-10 years after PAP claim (csHR of 1.37, 95% CI: 1.02-1.86).

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