The TGA is working with Philips on its global recall action for Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP) devices and mechanical ventilators due to risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.
The majority of the affected devices are in the first-generation DreamStation product family.
A full risk assessment is underway including numbers supplied in Australia and on potential particulate and chemical exposure risks which will inform further advice to health professionals and consumers.
As a precautionary measure, pharmacies are advised to quarantine and remove from sale any unsold units of the affected devices.
We will continue to work with Phillips to ensure that comprehensive information is made available as quickly as possible through formal published announcements on the TGA website and from Phillips directly to customers.
Information for consumers
For devices currently in use in critical or lifesaving situations, patients or caregivers should continue using the devices until an alternative becomes available.
Information for health professionals
Please be aware of the above issue and advise patients accordingly if they seek advice.
Consumers and health professionals are encouraged to report problems with medical devices