AMSTERDAM (May 24, 2022)—Philips Respironics saw a sharp increase in medical device reports (MDRs) following the company’s voluntary recall of certain CPAP, BiPAP and mechanical ventilators, the company said in a recent press release. A MDR is one of the surveillance tools the United States Food and Drug Administration (FDA) uses to monitor device performance, detect potential device-related safety issues and contribute to benefit-risk assessments of these products. Manufacturers are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.
In June 2021, Royal Philips’ subsidiary, Philips Respironics, initiated a voluntary recall notification in the U.S./field safety notice in other countries for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and mechanical ventilator devices.
At the time the notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a reasonable worst-case scenario for the possible health risks. Following Philips’ public statements on the issue and possible risks to users in April 2021, and the announcement of the recall notification/field safety notice in June 2021, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation.
This led to an increase from the 30 MDRs that had been filed by Philips Respironics to the FDA between 2011 and April 2021 (there were no reports of patient injury or death among these 30 MDRs), to more than 20,000 MDRs filed by Philips Respironics to the FDA between April 2021 and April 2022.
The submission of a MDR itself is not evidence that the device caused or contributed to the adverse outcome or event, and that the cause of an event cannot typically be determined from this reporting system alone. Philips Respironics investigates all allegations of device malfunction, death or serious injury, the company stated.
“We regret any concern or inconveniences caused by this field action and we are committed to supporting the community of patients who rely on our sleep and respiratory care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs,” said David Ferguson, business leader of Philips Respironics. “We are replacing or repairing the devices related to the Respironics field action as fast as possible and are continuing to update patients and customers about the progress of the program. More than 1,000 of our colleagues are working around the clock on every aspect of the remediation.”
Testing Continues
Since June 2021, together with certified testing laboratories and other qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain volatile organic compounds (VOCs).
In December 2021, Philips provided an update on the VOC test results to-date for the first-generation DreamStation devices. Exposure to the level of VOCs identified to date for the first-generation DreamStation devices (that were not exposed to ozone cleaning) is not typically anticipated to result in long-term health consequences for patients.
Initial testing results suggest that PE-PUR foam degradation in CPAP devices is accelerated by repeated exposure to ozone cleaning. The FDA and Philips have communicated and reiterated that ozone is not an approved cleaning agent. For example, as directed by FDA, Philips has prominently published information on the risk of using ozone cleaners on the landing page of the Philips Respironics field action website.
Comprehensive testing and analyses related to the affected CPAP and BiPAP devices are ongoing and Philips Respironics expects to provide an update in the second quarter of 2022.
Independent of Philips Respironics, in December 2021, an analysis was published in the American Journal of Respiratory and Critical Care Medicine that did not find a higher risk of incident cancer among obstructive sleep apnea (OSA) patients who used a Philips Respironics PAP device as compared to OSA patients who used a PAP device from other manufacturers, or OSA patients without treatment. The analysis and conclusion were based on data from a large multicenter cohort study involving 6,903 OSA patients on PAP devices between 2012 and 2020, including 1,220 Philips Respironics PAP users.
In May 2022, an analysis was published online in the European Respiratory Journal that concluded that sustained and adherent CPAP therapy of OSA using Philips Respironics devices, compared with other manufacturers’ devices, was not associated with an increased risk of cancer after a median follow-up time of 7.2 years. The analysis and conclusion were based on data from a large multicenter cohort study involving 4,447 OSA patients on CPAP devices between 2007 and 2018, including 1,648 Philips Respironics CPAP users. Philips Respironics was not involved in the study or the analysis.
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