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Objectives <p>On June 14, 2021, Philips recalled most positive airway pressure (PAP) devices distributed between 2009 and 2021 due to degrading foam with potential toxic effects, yet the impact on patients remains poorly understood. This study explored patient-reported impact among adults with obstructive sleep apnea (OSA) in North America.</p> Methods <p>Between August 2023 and March 2024, adults in Canada and the United States (US) who self-reported an OSA diagnosis and PAP use completed an online survey. In Canada, recruitment was via a market research company, social media, and medical societies; in the US, through social media and medical societies. Survey domains included changes in PAP use, health, and financial effects. Responses were described by country and recall status.</p> Results <p>Of 2,953 unique survey visits in Canada, 632 responded (61.2% men, median age 50 years); of 214 US visits, 90 responded (44.4% men, median age 65.5 years). Among respondents with recalled devices (40.5% in Canada and 65.6% in the US), 18.8% and 5.1%, respectively, reduced PAP use, and 23.0% and 33.9% discontinued therapy. Emotional/mental health effects were reported by 46.1% and 74.6% in Canada and the US, respectively; physical symptoms by 35.9% and 61.0%; and financial impacts by 14.8% and 40.7%. Among those without recalled devices, 19.1% and 21.7% in Canada and the US reduced or stopped PAP, and 25.5% and 65.2% reported emotional effects. </p> Conclusions <p> The Philips recall significantly disrupted PAP use and well-being, with about 40% of patients reducing or discontinuing therapy, highlighting the need for improved communication, patient support, and regulatory coordination.</p>

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Impact of Philips device recall on adults with obstructive sleep apnea treated with PAP therapy: Results of a cross-national patient survey

  • 期刊论文

  • 发表日期：

    2026年4月1日

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  • Tetyana Kendzerska,
  • Kenneth Blades,
  • Monica P. Mallampalli,
  • Marcus Povitz,
  • Rostyslav Vyuha,
  • Constance Mackenzie,
  • Andrea S. Gershon,
  • Najib T. Ayas,
  • Marta Kaminska,
  • Mark E. Fenton,
  • Kerry A. McBrien,
  • Steven Hawken,
  • Mouaz Saymeh,
  • Diana C. Ratycz,
  • Robert L. Owens,
  • Sachin R. Pendharkar

摘要

Objectives

On June 14, 2021, Philips recalled most positive airway pressure (PAP) devices distributed between 2009 and 2021 due to degrading foam with potential toxic effects, yet the impact on patients remains poorly understood. This study explored patient-reported impact among adults with obstructive sleep apnea (OSA) in North America.

Methods

Between August 2023 and March 2024, adults in Canada and the United States (US) who self-reported an OSA diagnosis and PAP use completed an online survey. In Canada, recruitment was via a market research company, social media, and medical societies; in the US, through social media and medical societies. Survey domains included changes in PAP use, health, and financial effects. Responses were described by country and recall status.

Results

Of 2,953 unique survey visits in Canada, 632 responded (61.2% men, median age 50 years); of 214 US visits, 90 responded (44.4% men, median age 65.5 years). Among respondents with recalled devices (40.5% in Canada and 65.6% in the US), 18.8% and 5.1%, respectively, reduced PAP use, and 23.0% and 33.9% discontinued therapy. Emotional/mental health effects were reported by 46.1% and 74.6% in Canada and the US, respectively; physical symptoms by 35.9% and 61.0%; and financial impacts by 14.8% and 40.7%. Among those without recalled devices, 19.1% and 21.7% in Canada and the US reduced or stopped PAP, and 25.5% and 65.2% reported emotional effects.

Conclusions

The Philips recall significantly disrupted PAP use and well-being, with about 40% of patients reducing or discontinuing therapy, highlighting the need for improved communication, patient support, and regulatory coordination.