Following the recall notification issued by Philips in the US market, the Dutch medical equipment company will voluntarily recall impacted machines, including breathing devices and ventilators in India, an industry source confirmed to BusinessToday.In.
Philips has issued a field-safety notice for the rest of the world where they are selling these devices. The field safety notice is commonly understood as the communication sent out by medical device manufacturers on the actions they may take about their products.
Responding to BusinessToday.In's query, Philips India clarified, "On June 14, 2021, Philips issued a Field Safety Notice for specific Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. This notice and consequent precautionary actions are applicable exclusively to the specified products in India and no other products are affected or included in the same."
However, this does not include Covid-19 products, including oxygen concentrators, respiratory drug delivery products, airway clearance products, ventilators Trilogy EVO, and Trilogy EVO OBM & Trilogy EV 300 sold by Philips in India.
Philips also stated that customers using the impacted products should contact their physicians to determine whether they can continue using the equipment or take other appropriate actions regarding their therapy. Customers can also call its helpline number 18002587678 for support and more information.
Philips has identified potential health risks related to the polyester-based polyurethane sound abatement foam component in specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices, also sold in India.
The company said that majority of the affected devices in the advised 5-year service life are in the first-generation DreamStation product family. The risks include that the PE-PUR foam may degrade into particles, which may enter the device's air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.
The foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.
"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 program for the affected devices," said Frans van Houten, CEO of Royal Philips in the global press statement issued by the company.
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