Purpose To understand how the Philips PAP device recall affected patient experiences, clinical practice, and health system responses.

Methods From November 2022 to August 2023, we interviewed individuals with OSA, physicians, respiratory therapists and health system leaders. We also received emailed responses from Health Canada. 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. Interviews were analyzed using an inductive thematic approach.

Results We interviewed 47 participants (16 individuals with OSA, 10 physicians, 17 public or private respiratory therapists, five health system leaders). Themes were organized into four domains: recall communication, execution, participant experiences, and the policy and regulatory context. Participants were confused due to inadequate information from Philips throughout the process. The burden of notifying patients and tracing devices mostly fell to healthcare providers and vendors, while replacement efforts were disorganized and frustrating. Individuals with OSA experienced emotional distress over therapy decisions and difficulties navigating the recall. Healthcare providers described moral distress from being unable to support patients adequately, and vendors faced additional logistical and financial strain. While regulatory authorities reported that Philips followed standard procedures, participants expressed a loss of trust in both the manufacturer and oversight systems.

Conclusions Interviews revealed that poor communication and execution of the Philips recall caused confusion, frustration and significant emotional and financial burden. Collaborative, context-specific strategies are required to improve future recalls.

Financial Disclosures: Tetyana Kendzerska and Andrea S. Gershon are supported by the PSI (Physicians' Services Incorporated) foundation. Outside of the submitted work, Sachin R. Pendharkar has received honoraria and grant funding from Jazz Pharmaceuticals. Outside of the submitted work, Marcus Povitz has received a fellowship grant from Paladin Labs and contract research from Jazz Pharmaceuticals. Outside of the submitted work, Najib Ayas 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, Marta Kaminska is a consultant for Biron Soins du Sommeil; she also reported research funding from Fisher & Paykel 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. Non-financial Disclosures: None

This study was funded by a grant from the Canadian Institutes of Health Research (CIHR).

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