Sam Brusco, Associate Editor05.16.23
Philips has offered an update about the comprehensive test and research program its Respironics subsidiary is conducting to assess possible health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in some sleep therapy and ventilator devices under the June 2021 recall/safety notice.
Philips said the risk assessments were completed for the CPAP/BiPAP sleep therapy devices under the recall—the first generation DreamStation, System One, and DreamStation Go devices—representing about 95% of the registered devices worldwide. These assessments build on past updates in December 2021, June 2022, and December 2022.
Tests and analyses have also been completed for first-gen DreamStations exposed to ozone cleaning.
According to Philips, the test and research program was conducted together with five independent, certified testing labs, and results were reviewed and assessed by third-party qualified experts, Philips Respironics, and an external medical panel.
The applied test methods, Philips said, were in accordance with ISO 18562 and ISO 10993 standards. Testing was performed on multiple used devices with varying amounts of patient usage and observed visual foam degradation, as well as on lab-aged foam intentionally degraded to different degrees.
“Our first priority is the health and well-being of patients,” Roy Jakobs, CEO of Philips told the press. “We have therefore focused on the comprehensive test and research program to gain more clarity about the safety of the affected devices, and on providing replacement devices to patients. The third-party risk assessments for the sleep therapy devices presented today are positive and reassuring, and we are making good progress with the remediation of the affected devices. The relevant competent authorities globally, including the FDA, are still reviewing the test results and assessments. We share the same objective to ensure patient safety and quality in the delivery of healthcare, and we remain committed to working closely with these agencies. The completion of testing and remediation of the affected devices remain our highest priorities.”
Philips concluded from its tests that results indicate the exposure to volatile organic compound (VOC) emissions is “unlikely to result in an appreciable harm to health in patients.” The company said results indicate exposure to particulate matter (PM) emissions from degraded foam in the devices—including possible respirable and non-respirable particulates—isn’t likely to result in appreciable harm to health as well.
The company also said prevalence of visible degradation of foam for inspected, used, first-gen DreamStations was found to be low.
For first-gen DreamStations exposed to ozone cleaning, VOC emissions from assessed devices were “unlikely” to cause appreciable harm to health, as well as exposure to PM emissions due to the cleaning. Philips concluded that while ozone cleaning exacerbates the foam’s degradation, ozone-induced degradations is again “unlikely” to result in appreciable harm to health.
Philips Respironics said it provided the summary of the completed test results and analyses for the CPAP BiPAP machines to the FDA and other authorities. The FDA is still considering the data and analyses Philips provided and may reach a different conclusion.
The company urged providers, patients, and other stakeholders to use the complete update issued today for any decision making and shouldn’t solely rely on the review in its issued press release. To date, a total of about 4.3 million devices were remediated globally, of which about 2.3 million are in the U.S.
Philips said the risk assessments were completed for the CPAP/BiPAP sleep therapy devices under the recall—the first generation DreamStation, System One, and DreamStation Go devices—representing about 95% of the registered devices worldwide. These assessments build on past updates in December 2021, June 2022, and December 2022.
Tests and analyses have also been completed for first-gen DreamStations exposed to ozone cleaning.
According to Philips, the test and research program was conducted together with five independent, certified testing labs, and results were reviewed and assessed by third-party qualified experts, Philips Respironics, and an external medical panel.
The applied test methods, Philips said, were in accordance with ISO 18562 and ISO 10993 standards. Testing was performed on multiple used devices with varying amounts of patient usage and observed visual foam degradation, as well as on lab-aged foam intentionally degraded to different degrees.
“Our first priority is the health and well-being of patients,” Roy Jakobs, CEO of Philips told the press. “We have therefore focused on the comprehensive test and research program to gain more clarity about the safety of the affected devices, and on providing replacement devices to patients. The third-party risk assessments for the sleep therapy devices presented today are positive and reassuring, and we are making good progress with the remediation of the affected devices. The relevant competent authorities globally, including the FDA, are still reviewing the test results and assessments. We share the same objective to ensure patient safety and quality in the delivery of healthcare, and we remain committed to working closely with these agencies. The completion of testing and remediation of the affected devices remain our highest priorities.”
Philips concluded from its tests that results indicate the exposure to volatile organic compound (VOC) emissions is “unlikely to result in an appreciable harm to health in patients.” The company said results indicate exposure to particulate matter (PM) emissions from degraded foam in the devices—including possible respirable and non-respirable particulates—isn’t likely to result in appreciable harm to health as well.
The company also said prevalence of visible degradation of foam for inspected, used, first-gen DreamStations was found to be low.
For first-gen DreamStations exposed to ozone cleaning, VOC emissions from assessed devices were “unlikely” to cause appreciable harm to health, as well as exposure to PM emissions due to the cleaning. Philips concluded that while ozone cleaning exacerbates the foam’s degradation, ozone-induced degradations is again “unlikely” to result in appreciable harm to health.
Philips Respironics said it provided the summary of the completed test results and analyses for the CPAP BiPAP machines to the FDA and other authorities. The FDA is still considering the data and analyses Philips provided and may reach a different conclusion.
The company urged providers, patients, and other stakeholders to use the complete update issued today for any decision making and shouldn’t solely rely on the review in its issued press release. To date, a total of about 4.3 million devices were remediated globally, of which about 2.3 million are in the U.S.
