Royal Philips has voluntarily recalled breathing devices and ventilators after it found possible health risks linked to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these products.
The recalled products are Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices.
Most of these devices within the recommended five-year service life are part of the first-generation DreamStation product line, the company noted.
So far, millions of Philips’ Bi-Level PAP, CPAP and mechanical ventilator devices have been made using the PE-PUR sound abatement foam. The recall will target three to four million devices, Reuters reported citing the company’s CEO.
Philips learned about the potential risks of the foam to the users upon testing the device, even though they had a low complaint rate of 0.03% last year.
According to the company, the foam could degrade into small particles that can enter the air pathway of the device and be consumed or inhaled by the user. Furthermore, the foam may off-gas some chemicals and could be toxic and have carcinogenic effects.
The degradation of the foam could be aggravated with the use of certain cleaning methods, including ozone, which is not approved. In addition, increased heat and humid conditions could cause degradation.
Taking these issues into account, Philips decided to recall the devices and notify patients and users of possible impacts on health and clinical use linked to this problem.
Royal Philips CEO Frans van Houten said: “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.
“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 programme for the affected devices.”
The company plans to replace the sound abatement foam with new material and has commenced required activities, including seeking necessary regulatory approvals.
Earlier this month, Philips reported positive two-year data from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial of its dissection repair device, Tack Endovascular System (4F).