Philips continues testing for Trilogy 100/200

AMSTERDAM – Philips officials say additional testing and assessments are needed for its Trilogy 100/200 ventilators after the polyester-based polyurethane (PE-PUR) foam in new and lab-aged devices failed ISO 10993 genotoxicity testing. 

The company says “weight of evidence assessment” for the vents, which passed volatile organic compounds and particulate matter testing, as well as several biocompatibility tests, is ongoing to confirm or exclude potential risks for patients. 

“The foam failed the genotoxicity test under lab conditions, but if a material fails in a lab condition, it doesn’t mean it also fails under the actual usage,” said Steve Klink, spokesperson for the company’s test and research program. “Yes, we found that the material was genotoxic under lab conditions, but we need to do the full assessment to see if it’s an actual risk in real life.” 

Philips is conducting additional chemical characterization, as well as experiments to assess the probability and amount of degraded PE-UR foam that can potentially reach the patient, to support the full toxicological risk assessment. 

Company officials say it had to go through a similar process with the first-generation DreamStation CPAP devices, which have a different type of PE-PUR foam. 

“At the end, it turned out that it was all within the safety limits,” Klink said. “Now, because it was a good outcome for DS1, doesn’t mean it will also be a good outcome for the Trilogy 100/200, but it’s just a step that you need to take, and it’s just too early to make a statement on that.” 

The Trilogy 100/200 vents make up about 3% of the 5.5 million registered recalled devices, or about 170,000 devices. 

• Read how Philips had to put its remediation program for the Trilogy 100/200 on hold recently. 
• Read how the recalls of the Trilogy 100/200 and Evo vents are impacting providers.