– Philips Respironics has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients. Philips made the announcement following an assessment by the company and an outside medical panel. At the time of the recall in June, Philips relied on an initial, limited data set and toxicological risk assessment. Since then, using ISO 18562 guidance, certified testing laboratories and a qualified third-party expert have conducted VOC toxicological risk assessments based on the initial and new VOC testing performed to date. Philips has made this data available to the U.S. Food and Drug Administration and other authorizations. Philips noted that the tested DreamStation devices were not exposed to ozone cleaning, in accordance with the instructions for use. Additionally, the company noted the new assessment is limited to the evaluation of VOCs for first-generation DreamStation devices and does not evaluate the risks of potential foam particulates or cover other devices affected by the recall. It says further health risk assessments are ongoing. Philips expects comprehensive particulate testing and analyses to be completed in the second quarter of 2022, noting that testing protocols in compliance with the full extent of the relevant ISO standards for all affected product platforms require long lead times of multiple months.
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