Philips provides ‘encouraging’ testing update

AMSTERDAM – A comprehensive testing and research program on the PE-PUR foam in certain CPAP, BiPAP and mechanical ventilator devices has shown very low prevalence of visible degradation, Philips announced in an update on June 28. 

In first-generation DreamStation devices, which represent 68% of registered affected devices globally, testing found:  

• 164 of 36,341 (0.5%) devices with self-reported no ozone use showed significant visible foam degradation. 
• 777 of 11,309 (7%) devices with self-reported ozone use showed significant visible foam degradation. 
• 422 devices of the inspected 60,847 returned/used devices are linked to a reported foam degradation complaint; however, only 18 out of these 422 devices (4%) actually showed visible foam degradation. 

“While certain prolonged tests across the affected product categories are still to be completed, the results to date for the first-generation DreamStation devices, which represent the majority of the registered affected devices, show a very low prevalence of visible foam degradation,” said Frans van Houten, CEO of Royal Philips. “In addition, the new and used first-generation DreamStation devices passed volatile organic compound and respirable particulate emission testing. This is very encouraging. Results to date also indicate that ozone cleaning significantly exacerbates foam degradation.” 

Five certified, independent testing laboratories in the U.S. and Europe conducted testing in accordance with ISO 18562 and ISO 10993 standards. 

The labs also conducted testing on volatile organic compounds (VOCs) and particulate matter (PM) and found: 

• VOC emissions are below established limits based on ISO 18562-3 testing and evaluation of new, lab-aged and used devices. Exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not anticipated to result in long-term health consequences for patients. 
• New devices and used devices (including used devices with visible foam degradation) were tested and were all found to be compliant with ISO 18562-2 allowable limits for PM emissions.  
• Tested PM emissions of used devices with degradation were not statistically different than PM emissions without degradation, suggesting that degradation did not contribute to appreciable elevated levels of respirable particles in the devices tested.  

Philips has also engaged independent testing laboratories to perform additional VOC testing on silicone-based foam. Based on draft reports, no safety issues have been identified. The company expects the assessment to be completed and the final reports subjected to FDA review in the coming months. 

Philips also expects to complete the remaining VOC and PM testing for these devices, as well as the degraded foam toxicological risk assessments (in accordance with ISO 10993), in the coming months.  

The company noted the overall guidance for health care providers and patients in the recall notification/field safety notice remains unchanged at this time.