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

Area of Science:

• Respiratory Medicine
• Public Health
• Medical Device Safety

Background:

• Limited real-world data exists on the health consequences of the Philips Respironics positive airway pressure (PAP) device recall.
• Understanding the impact of recalled PAP devices on obstructive lung disease (OLD) is crucial for patient safety and healthcare management.

Purpose of the Study:

• To investigate the association between positive airway pressure (PAP) device manufacturer and the development and progression of obstructive lung disease (OLD).
• To assess the real-world health impacts of recalled PAP devices on incident asthma/COPD and healthcare utilization.

Main Methods:

• Retrospective longitudinal study using Ontario health administrative data (2012-2018).
• Included new adult PAP users with or without OLD, followed until death or March 2023.
• Used inverse probability weighting to compare outcomes between recalled and non-recalled PAP devices, calculating weighted cause-specific hazard ratios (csHR).

Main Results:

• Among 248,358 individuals, recalled devices were not significantly associated with incident asthma or COPD in those without pre-existing OLD.
• No significant differences in secondary outcomes (asthma/COPD visits) were observed in individuals with OLD.
• Exploratory analyses indicated a modest increase in COPD risk within two years and inpatient COPD visits 6-10 years post-PAP claim for recalled devices.

Conclusions:

• Recalled positive airway pressure (PAP) devices were not independently linked to obstructive lung disease (OLD) development or progression in this real-world study.
• Early increases in COPD incidence and later effects on inpatient visits associated with recalled devices warrant further investigation.
• Findings emphasize the need for ongoing monitoring of medical device recall impacts on chronic respiratory conditions.