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PHILIPS PROVIDES UPDATE ON TEST RESULTS FOR CPAP/BIPAP SLEEP THERAPY DEVICES
The risk assessments have now been completed for the CPAP/BiPAP sleep therapy devices under the recall notification/field safety notice.
Royal Philips provided an update on the comprehensive test and research program of its subsidiary Philips Respironics to assess potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific sleep therapy and ventilator devices under the voluntary June 2021 recall notification/field safety notice.
The test and research program has been conducted together with five independent, certified testing laboratories, and the results have been reviewed and assessed by third-party qualified experts and Philips Respironics, as well as an external medical panel.
The applied test methods – comprising test planning, test execution, and interpretation of the results for the completed risk assessments – are in accordance with the applicable ISO 18562 and ISO 10993 industry standards. The design of the applied test methods was further scientifically underpinned based on a thorough consideration and mitigation of inherent testing limitations. For example, testing was performed on multiple user devices with differing amounts of patient usage and observed visual foam degradation, and on Lab-Aged foam that had been intentionally degraded to different degrees. Very conservative assumptions were included in the risk assessments.
Test results and analyses for sleep therapy devices not exposed to ozone cleaning
The completed set of test results and analyses for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices indicate that potential patient exposure to foam particulate matter (PM) and volatile organic compounds (VOCs) from the PE-PUR foam within these devices is unlikely to result in appreciable harm to health in patients.
Summary of ongoing tests
Philips Respironics is in the process of completing various remaining tests and analyses. The risk assessments for System One and DreamStation Go devices (that contain the same foam as the first-generation DreamStation devices) treated with ozone cleaning are being completed. For the Trilogy 100/200 and OmniLab Advanced Plus ventilator devices, VOC and PM testing continues, as well as chemical evaluation and toxicological risk assessment. These devices contain a different type of PE-PUR foam than the first-generation DreamStation devices. Philips Respironics expects to provide an update on this in Q3 2023.
Guidance for healthcare providers and patients
Patients currently using an affected sleep therapy device that has not been remediated and not registered yet, are requested to register their devices to facilitate the remediation.
Philips Respironics continues to advise patients using affected sleep therapy devices that have not been remediated yet to contact their physician or care provider to decide on a suitable treatment for their condition, which may include stopping the use of their device, continuing to use their affected device, using another similar device that is not part of the recall, or using alternative treatments for sleep apnea. Moreover, patients are advised to follow Philips Respironics’ instructions and recommended cleaning and replacement guidelines for their sleep therapy devices and accessories. Ozone and UV light cleaning products are not currently approved cleaning methods for sleep therapy devices or masks and should not be used.
Philips Respironics also continues to advise users of ventilator devices to contact their healthcare providers before making any changes to their therapy.
Scientific underpinning of the test methods
The design of the applied test methods was scientifically underpinned based on a thorough consideration and mitigation of testing limitations that are inherent to any test standard and/or scientific research.