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September 1, 2021updated 21 Feb 2022 6:41am

Philips to begin replacing DreamStation respiratory devices in US

The company secured US FDA approval to repair the affected DreamStation devices and is discussing a mitigation plan further.

Royal Philips is set to commence the repair and replacement of DreamStation respiratory devices in the US in connection with its voluntary recall of breathing devices and ventilators in June.

The company recalled Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices after finding possible health risks associated with the polyester-based polyurethane (PE-PUR) sound abatement foam used in these products.

More than 50% of the devices used worldwide are in the US, Philips said.

In addition, more than 80% of the registered affected devices in the US so far are part of the first-generation DreamStation product range.

The company obtained authorisation from the US Food and Drug Administration (FDA) to repair the affected DreamStation devices.

As part of the rework, which is expected to begin this month, the PE-PUR sound abatement foam will be replaced with new material.

Philips also commenced the replacement of specific affected first-generation DreamStation CPAP devices in the country with DreamStation 2 CPAP devices.

The company is in ongoing discussions with the FDA on other portions of the recall and mitigation plan.

Furthermore, the company has plans for repair and replacement initiatives in additional countries and intends to commence them in most markets by the end of September.

The aim is to finish the repair and replacement programmes in under a year.

Royal Philips CEO Frans van Houten said: “We fully recognise that the timeframe for remediation of the affected devices places patients in a difficult situation.

“We are mobilised to deliver a solution to them as fast as possible. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients.”

Potential health risks related to the affected devices include exposure to chemical discharges from the foam material and degraded sound abatement foam resulting from unauthorised cleaning methods, including the use of ozone.

Philips added that environments with increased heat and humidity could also cause foam degradation.

So far the company has received limited reports of potential patient impact due to foam degradation.

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