Philips Respironics, in association with the Dutch consumer electronics leader, has announced new guidance on the use of in-line nebulizers with its Trilogy Evo Ventilators.
The company has issued an urgent medical device correction within the United States for its Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators. For the global market, a field safety notice has been disseminated.
The in-line nebulizer, an accessory often utilized in medical settings, transforms therapeutic liquids such as medications or saline solutions into an aerosol form to address various respiratory conditions.
Philips Respironics has noted that in-line nebulizers placed in certain positions may result in aerosol deposits accumulating over time on the ventilator’s flow sensor. This could lead to inaccurate flow measurements, thereby impacting the effectiveness of therapy.
To date, Philips Respironics has not received any complaints about device malfunctions due to the use of in-line nebulizers, and no patient fatalities have been reported.
Trilogy Evo ventilators, which have not been exposed to in-line nebulizers, remain unaffected and can continue to function as prescribed.
As part of its ongoing quality management processes, Philips Respironics conducted a retrospective review and identified a potential concern with the flow sensors. If aerosol deposits accumulate, this could lead to ventilator inoperability post-standby or shutdown, delaying therapy. Additionally, issues could arise with the over-delivery of air or under-delivery of oxygen in devices set to a specific concentration.
The associated risks for patients might include respiratory discomfort, lung damage from excessive air pressure, low oxygen levels, and difficulty breathing.
The urgent corrections are being distributed to healthcare systems and equipment distributors to ensure patients using these devices at home receive timely information.
Patients are also advised not to cease their therapy without consulting their healthcare professional.