Jun. 15—Medical equipment company Philips has issued a recall on some products to address possible health risks associated with a foam component meant to help reduce noise.
The polyester-based polyurethane foam in its Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices could "degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user," according to a Philips news release. The foam's degradation could also release additional chemicals.
In April, officials from the Amsterdam-based company, which has several local branches in southwestern Pennsylvania, notified shareholders that it was working with regulatory agencies to take the appropriate action.
"We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety," said Frans van Houten, CEO of Royal Philips. "In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices."
The majority of affected devices are part of Philips' first-generation DreamStation product family.
The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting and possible toxic and carcinogenic effects. Philips has received no reports of patients being affected by chemical emissions.
The recall advises the following steps to minimize risk:
—For patients using affected Bi-Level PAP and CPAP devices: Discontinue use of the device and work with a physician or durable medical equipment provider to determine the most appropriate options for continued treatment. To continue use of the device due to lack of alternatives, consult with a physician to determine if the benefit of continuing therapy outweighs the risks
—For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter prescribed therapy until after consulting a physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.
The company will replace the current sound abatement foam with a new material and has begun the preparations, which include obtaining the relevant regulatory clearances.
As part of the program, the first-generation DreamStation product families will be modified with a different sound abatement foam and shipped upon receipt of the required regulatory clearances. Philips' recently launched next-generation CPAP platform, DreamStation 2, is not affected by the issue.
An estimated 3-4 million devices are affected by the recall.
Patrick Varine is a Tribune-Review staff writer. You can contact Patrick at 724-850-2862, email@example.com or via Twitter .