Philips has provided some answers to questions about its global recall.
Sixteen different Philips CPAP, Bi-Level PAP devices and mechanical ventilators have been recalled globally due to an issue with degrading sound abatement foam that contains chemicals that have toxic effects on human health.
The issue was spotted as part of Philips’ quality management system processes and the global recall was voluntary.
The polyester-based polyurethane sound abatement foam component in these devices can degrade when exposed to unapproved cleaning methods such as ozone, or when exposed to the high heat and humidity that is typical in certain regions of the world, Philips said.
When the foam breaks down, it can release toxic chemicals, which can come in contact with the patient’s airway, skin and eyes and lead to irritation and other health risks.
“To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask),” the company said.
“Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. To date, Philips has not received reports of patient impact or serious harm as a result of this issue.”
According to Philips, the potential health risks from being expose to the degraded foam include irritation, inflammatory responses, headache, asthma, adverse effects to other organs including kidneys and liver and toxic carcinogenic affects.
Exposure to chemical emissions can lead to headache, dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea, vomiting, toxic and carcinogenic effects.
A detailed series of pages on Philips’ website provides information about which devices were affected and how patients and doctors should respond.
The company advises that patients using life-sustaining mechanical ventilator devices continue to do so until they receive instructions from their doctor.
If alternative ventilator options are not available, Philips recommends using an inline bacterial filter.
For patients using BiLevel PAP and CPAP devices, Philips advises discontinuing use of the device and exploring other options.
Philips said it was certain that no further products were affected by this issue.
“Philips is working tirelessly to remedy this issue by replacing the affected devices,” the company said.
The majority of the affected devices were in the first-generation DreamStation product family, including the DreamStation ASV and the DreamStation AVAPS.
The TGA is doing a full risk assessment to determine the impact on Australian patients and advised pharmacies to quarantine and remove from sale any unsold units of the affected devices.
The Australasian Sleep Association (ASA) said it was “urgently seeking further information from Philips” and will be hosting an online member forum on Monday 28 June at 4.30pm AEST to provide more information.
“These organisations suggest 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,” the ASA said.