WASHINGTON, D.C. — The United States Food and Drug Administration has issued a crucial announcement concerning a voluntary correction by Philips Respironics regarding their Trilogy Evo series ventilators. This correction addresses potential risks associated with the use of in-line nebulizers, which may impact the accuracy of patient therapy if not properly managed.
Philips Respironics has proactively communicated an Urgent Medical Device Correction, alerting health systems and equipment distributors about the necessary measures to mitigate potential risks. The company emphasizes that patients should continue their prescribed therapy unless advised otherwise by their healthcare providers, underscoring the importance of consulting medical professionals before making any changes.
The core of the issue lies in the possibility of aerosol deposits forming on the ventilator’s flow sensors when in-line nebulizers are used inappropriately. Although no specific complaints have been reported, and no patient fatalities have resulted from this concern, the potential exists for inaccurate flow measurements. Such inaccuracies could lead to the ventilator becoming inoperative or causing variations in the delivery of tidal volume and oxygen concentration.
The FDA has outlined specific steps for users of the Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators. These include ensuring alarm settings are correct, having alternate ventilation sources ready, and using external FiO2 analyzers when necessary. For users employing in-line nebulizers, the agency advises following precise placement instructions and maintaining backup devices to ensure uninterrupted therapy.
This correction is part of Philips Respironics’ ongoing quality management efforts, aiming to ensure patient safety and the efficacy of their devices. Patients and healthcare providers are encouraged to remain vigilant and report any adverse events to the FDA’s MedWatch Program.
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