Philips Respironics provides testing update

AMSTERDAM – 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. 

The announcement comes after an assessment by an outside medical panel and Philips and is intended to give healthcare providers the most recent data. Overall guidance for physicians and patients in the recall notification remains unchanged. 

At the time of the recall, Philips relied on an initial, limited data set and toxicological risk assessment. Since then, using ISO 18562 guidance, VOC toxicological risk assessments were performed by certified testing laboratories and a qualified third-party expert based on the initial and new VOC testing performed to date. Philips has made this data available to the Food and Drug Administration and other authorities. 

Philips notes that the tested DreamStation devices were not exposed to ozone cleaning, in accordance with the instructions for use. Additionally, this 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. Further health risk assessments are ongoing. 

Philips recently asked HME providers to return to the company any recalled DreamStation 1 devices that patients return to them.  

Comprehensive particulate testing and analyses are expected to be completed in the second quarter of 2022, as 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. Philips will continue to provide updates on findings from these assessments.