Bridging the knowledge gap during a health technology crisis: Insights following a global CPAP device recall
Obstructive sleep apnea (OSA) is a disorder that interferes with breathing during sleep and affects millions of people worldwide. The condition has been linked to long-term health complications like cardiovascular disease, diabetes, cognitive issues, and cancer.
The recommended treatment for OSA is a machine that delivers pressurized air through a tube and mask to open the throat during sleep, known as positive airway pressure (PAP) therapy—including bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP).
The recommended treatment for OSA is a machine that delivers pressurized air through a tube and mask to open the throat during sleep, known as positive airway pressure (PAP) therapy—including bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP).
Between 2011 and 2021, the Food and Drug Administration (FDA) in the United States began receiving Medical Device Reports (MDRs) from Philips Respironics, one of the leading global manufacturers of positive airway pressure (PAP) machines. The MDRs documented that the sound-dampening foam used in the ventilation system broke down over time and released particles and possibly toxic chemicals that people could inhale or swallow during use.
While there were no specific reports of injury or death associated with the foam breakdown, Philips voluntarily recalled its 15 million BiPAP and CPAP machines due to potential health risks. Following the recall, a flood of MDRs were submitted to the FDA, including 561 deaths reportedly associated with the foam breakdown.
Importantly, these MDRs included mandatory reports from Philips and voluntary reports from healthcare professionals, consumers and patients. Adverse effects reportedly associated with device breakdown included pneumonia, asthma, infection, headache, cough, difficulty breathing, dizziness, nodules, chest pain, and most worryingly, cancer.
Limited information was provided by Philips, other than to direct consumers to stop using their devices and contact a healthcare provider. Healthcare professionals had little data to support the claim that the breakdown in foam was a direct cause of injury or adverse health outcomes.
Confusion ensued on all sides. “Every person would ask, ‘OK, so am I getting a new machine?’ And we would say, ‘We don’t know – we don’t have one,’” recalls one Respiratory Therapist employed by a Canadian homecare company. “It was horribly awkward, sad and frustrating, with nothing we could do or say to patients to really fix it.”
What does the evidence say?
Dr. Tetyana Kendzerska and her team set out to help fill the evidence gap. An ICES scientist and clinician with The Ottawa Hospital Sleep Centre, Kendzerska has published several studies on the adverse health consequences of OSA, including the link between OSA and cancer. Using ICES data, Kendzerska and her team found that the severity of someone’s OSA and how much it interrupts breathing during sleep (called “nocturnal hypoxemia”) is associated with the development of cancer.
“When the recall was announced, we realized that we could re-utilize linked clinical and ICES data to look at whether there was an association between PAP device manufacturer and cancer risk,” said Kendzerska.
What they found was reassuring. Individuals who had no evidence of cancer at the start of the study and purchased one of the recalled PAP devices did not have a higher risk of cancer after using the device, compared with people who used non-recalled PAP devices. The research team then confirmed these results with a large population-based study of all new adult PAP users identified through Ontario’s funding system, who were free of cancer at baseline and initiated PAP treatment between 2012 and 2018.
While there were some limitations, including unmeasured factors such as smoking status and lack of information on when the PAP devices were used, the authors say that the study provides reassurance, and can help patients make more informed decisions.
What do patients say?
Discussions about the recall were often a source of anxiety for patients. In a soon-to-be published manuscript that involved interviews with patients and healthcare providers, one patient shared with Dr. Kendzerska’s team that they experienced anxiety trying to decide whether to use their PAP machine.
“Normally I would just go to sleep, and it was kind of an automatic thing [to use CPAP],” they said. “But after finding this out about the particles, you’d lay there and worry about it. You know, is it shooting plastic particles into my lungs?”
Another patient said, “I had become so used to the device and comfortable using it that I was really concerned about the implications of not using it. In fact, after a few days of not using it at all I felt really tired.” They waited three months for another machine and then faced difficulties getting comfortable with the new device and its settings.
“Given the lack of solid evidence on the association between the device and adverse health risks, it was extremely difficult for patients and their physicians to make an informed decision,” said Kendzerska. “There are also short-term risks associated with not using PAP, including a decline in quality of life and the risk for injury or accident due to excessive daytime sleepiness.”
Impact of the evidence on patients, providers, and policy
The studies led by Dr. Kendzerska’s team have been instrumental in guiding better communications from Philips to patients and healthcare providers. Their research also supported the Alliance of Sleep Apnea’s report, “Shaping Policy for Better Patient Outcomes,” which examines the far-reaching consequences of the FDA recall. Kendzerska has been invited to speak on the topic at several high-profile meetings and continues to use ICES data to continue to monitor patients’ longer-term outcomes.
“What this work accomplishes is to close the data gap and provide enough evidence to help patients and their healthcare providers make informed choices about what’s best for their health,” says Kendzerska.
Collectively, this work has shaped better communication, influenced policy, and emphasized the importance of real-world evidence in guiding patient care during health technology crises.
Acknowledgements
- Najib Ayas, University of British Columbia, Co-Author
- Kenneth Blades, University of Calgary, Study Coordinator
- Mark Boulos, University of Toronto, Co-Author
- Gregory Bryson, University of Ottawa, Co-Author
- Mark Fenton, University of Saskatchewan, Co-Author
- Anna Gagliardi, University of Toronto, Co-Author
- Andrea Gershon, University of Toronto, Co-Author
- Steven Hawken, The Ottawa Hospital Research Institute, Co-Author
- Marta Kaminska, McGill University Health Centre, Co-Author
- Richard Leung, University of Toronto, Co-Author
- Vadym Lishchenko, Ottawa, Patient Partner
- Charles Mackenzie, Western University, Co-Author
- Atul Malhotra, University of California, Co-Author
- Kerry A McBrien, University of Calgary, Co-Author
- Daniel McIsaac, University of Ottawa, Co-Author
- Brian Murray, University of Toronto, Co-Author
- Robert L. Owens, University of California San Diego, Co-Author
- Sachin R. Pendharkar, University of Calgary, Co-Principal Investigator
- Marcus Povitz, University of Calgary, Co-Author
- Diana Ratycz, Montreal, Patient Partner
- Robert Talarico, The Ottawa Hospital Research Institute, ICES analyst