30 Aug Philips recall action for CPAP and Bi-Level devices
Our office was notified on June 18 of the Philips global recall of CPAP, BiPAP devices and mechanical ventilators due to risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. A theoretical risk of VOC exposure has also been noted however no case reports of confirmed patient harm.
Australian Sleep Physicians were unaware of this recall until this announcement. We remain actively engaged with global specialists along with the TGA and FDA (North America) to assist in seeking further details on this recall.
At this time, we have not been provided with the relevant scientific and medical evidence from Philips, or regulatory authorities relating to this recall. Without this evidence we’re aware we cannot provide clarification on what risk represents to our patients.
Currently all information being obtained remains from online statements by Philips (Australia) and the Australian TGA. The TGA and The Australasian Sleep Association (representing all Sleep Physicians) are regularly and pro-actively seeking updates on this information.
The Australasian Sleep Association has the following link summarising this:
The Australian TGA are providing updated information about how to respond to the defect correction action.
www.tga.gov.au/alert/philips-recall-action-cpap-bi-level-pap-devices-and-mechanical-ventilators
The Philips (Australia) information weblink is below.
www.philips.com.au/healthcare/e/sleep/communications/src-update
Philips has a registration process to determine if your unit is affected.
You will need submit your device serial number via this online registration link.
www.philipssrcupdate.expertinquiry.com/?ulang=en
Philips (Australia) can also be contacted on 1800 009 579 (have a copy of your purchase invoice, serial number and confirmation number on hand).
Our team remain unclear about the Philips decision regarding refunds/reimbursements. Therefore, we would appreciate feedback on your outcome. This can allow us to further assist other people.
Recommendations of Action to Consider:
- Continue CPAP/ BiPAP therapy with the installation of an inline (HEPA) filter – this has been made a consensus recommendation by the Australasian Sleep Physicians
- Discontinue CPAP and BiPAP therapy and register your CPAP device online with Philips.
- Philips (Australia) have indicated they do not have replacement units available to the repair and replacement program of affected CPAP and BiPAP devices.
HEPA filters have been studied extensively with CPAP and ICU mechanical ventilators.
For current patients we are providing the ‘Sureguard clearline inline filter’. When attached to a CPAP they remove 99.97% of particles down to 3 microns in diameter.
If you wish to continue using your CPAP unit with a HEPA filter these can be collected from our main reception. Alternatively you can purchase these online.
Our team appreciate this recall has caused significant concern and inconvenience however we shall endeavour to assist everyone as best we can.