Exploring the impact of a medical device recall on individuals with obstructive sleep apnea and healthcare providers: a qualitative study.

Abstract

Study objectives: To understand how the Philips positive airway pressure device recall affected patient experiences, clinical practice, and health system responses.

Materials and methods: 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' 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.

Results: 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.

Conclusions: 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.