Respiratory and sleep medicine physicians are being advised to seek additional clinical and legal advice when making decisions on how to manage patients using Philips respiratory ventilator devices that are subject to a recall.
The TGA has issued an alert in relation to the safety hazards of Philips CPAP, bi-level PAP and ventilator devices, and said it is working on a global recall with the manufacturer of the affected devices, with most in the first-generation DreamStation product family.
According to the device manufacturer, the potential health risks arise from sound abatement foam, for which the polyester-based material may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user.
There are also concerns that the foam may give off certain volatile organic chemicals throughout the device’s useful life.
In its safety advisory the company advises that patients. discontinue use of affected BiLevel PAP and CPAP devices, and consult with physicians to determine the most appropriate options for continued treatment, based on the benefits of continuing therapy and potential identified risks.
For life-sustaining mechanical ventilator devices, the company advises that patients no stop or change therapy without consulting with physicians.
“Philips recognizes that in certain care settings, alternate options for therapy may not exist or may be severely limited for patients who require the Trilogy 100 and 200 for emergency, life-sustaining therapy, or in cases where therapy disruption is unacceptable,” it says.
“In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of the Trilogy 100 and 200 may outweigh the risks.”
An inline bacterial filter is recommended if a patient must continue using an affected device, though this will only reduce exposure to degraded foam particles, and not potential Volatile Organic Compounds (VOCs).
The TGA said a full risk assessment is underway including numbers of affected Philips devices supplied in Australia and on potential particulate and chemical exposure risks which will inform further advice to health professionals and consumers.
In the meantime, suppliers are advised to quarantine and remove from sale any unsold units of the affected devices.
The Australasian Sleep Association said it was urgently seeking further information from Philips on how the recall will be handled and the options available for patients.
The Association will not provide detailed clinical advice to members as each patient’s situation should be considered individually, it said.
Advice from groups such as the American Thoracic Society, the American Academy of Sleep Medicine and the European Respiratory Society suggests that “where it is not possible for another device to be used, clinical factors such as comorbidities, severity of symptoms, risks associated with PAP discontinuation, and safety-sensitive roles should inform the decision to continue or discontinue therapy. This decision should be made in concert between the patient and their medical provider.”
Respiratory and sleep medicine clinicians may also wish “to consult with their risk management teams and legal counsel in relation to how these decisions might best be made, and consider the issue of how to record informed patient consent,” the ASA advises.