Providers on vents: It’s ‘very challenging to keep track of what’s happening’

• Philips announced on Nov. 7 that it was temporarily pausing its Trilogy 100/200 remediation program while it investigates a limited number of complaints on these units. 
• The company then announced on Nov. 13 that it detected two issues with corrected Trilogy 100/200 ventilators following the complaints. 
• Philips plans to release an RP kit in the first quarter of 2023 and subsequently start to work with authorities to resume the remediation process.   

YARMOUTH, Maine – A pause of the remediation program for Philips Trilogy 100/200 vents, as well as a pause in the shipment of Trilogy Evo vents, has some providers caught between a rock and a hard place. 

Philips in November announced it had temporarily paused its remediation program for its Trilogy 100/200 vents while it investigates a limited number of complaints on repaired units. The company also announced a delay of several weeks beyond its initial four- to six-week timeline. 

“We recognize they are under the microscope of the FDA, but we need communication,” says Chris Burgess, vice president of clinical services for Med Emporium in North Carolina. “We have to be able to plan and move forward. We have patients to take care of.” 

Philips reported the identified problems for the repaired Trilogy 100/200 vents are the following: the potential for silicone foam separation and the presence of trace amounts of air pathway particulate matter after repair/rework. 

The pause has thrown a wrench in Med Emporium’s operations, Burgess says. After the successful repair and return of an initial batch of Trilogy 100/200 vents, the company shipped another pallet of about 90 devices to Philips just as the pause went into effect. 

“Essentially, they are holding (our) vents hostage,” he said. “They can’t remediate them, and the FDA says they can’t release them back to us.” 

At the same time, providers are facing a pause on shipments for Trilogy Evo vents – a development that caught them by surprise. Philips said, in an email to HME News in early December, that those devices will begin shipping again “very shortly.” 

“You can’t purchase Evos because they’re on hold,” said Roxanne Venard, president of Ascent Respiratory Care in Colorado. “On the subject of ventilators, it’s very challenging to keep track of what’s happening because the communication is very poor.” 

Longer term, providers worry patient access will be impacted if the situation drags on and bumps up against the end of a public health emergency. Under the PHE, the FDA approved certain equipment to help with pandemic-driven demand. 

“What happens when that goes away?” Venard said. 

• Read initial provider reaction to the recall of Trilogy 100/200 events in 2021.