CDSCO issues medical device alert on Philips continuous, non-continuous ventilators

New Delhi: Addressing the issue of potential health risk due to polyster-based polyurethane (PEPUR) sound abatement foam used in Continuous and Non-continuous Ventilators, the Central Drugs Standard Control Organization (CDSCO) has issued a Medical Device Alert on Philip's Continuous Ventilator, Minimum Ventilatory support, Facility Use, Continuous Ventilator, Non-life Supporting and Non-continuous Ventilator.

Meanwhile, Philips India Limited's issued safety notice and asked its users to discontinue the use of these ventilators. It voluntary recalled of the above-mentioned devices due to two issues with the polyster-based polyurethane (PEPUR) sound abatement foam used in Continuous and Non-continuous Ventilators.

The list included Philips Respironics ventilators, bilevel positive airway pressure (BiPAP), and continuous positive airway pressure (CPAP) machines and their health care providers that Philips Respironics had recalled due to potential health risks.

The above mentioned devices are used to provide breathing assistance. A bi-level positive airway pressure (BiPAP, BiLevel PAP, or BPAP) machine pumps air under pressure into the airway of the lungs. BiPAP machines have a higher pressure when one breathes in and a lower pressure when breathing out.

A Continuous Positive Airway Pressure (CPAP) machine keeps one's airway open by providing a continuous stream of air through a mask. CPAP machines are devices prescribed for people with obstructive sleep apnea to keep their airways open during sleep.

A continuous ventilator device is intended to mechanically control or assist a patient with breathing by delivering a predetermined percentage of oxygen in the breathing gas.

Philips produced millions of Bi-Level PAP, CPAP and mechanical ventilator devices using polyster-based polyurethane (PE-PUR) sound abatement foam.

However, it was revealed that, despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam. 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.

According to the Philips Medical Device Recall notice, the above mentioned risks can cause serious injury, which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.

In light of the above, CDSCO highlighted two causes behind releasing the Medical Device Alert, which are:

1. Polyster-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user.

2. Polyster-based polyurethane (PE-PUR) foam may off-gas certain chemicals.

Further, the release said that foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone, and off-gassing may occur during initial operation and may possibly continue throughout the device's useful life.

Additionally, CDSCO suggested the following immediate measures that users should take:

• Discontinue use of your device and work with your physician or Durable Medical Equipment provider to determine the most appropriate options for continued treatment. To continue use of the device due to a lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in this later.

• Register your device on the recall website, www.philips.com/ src-updates.

• The firm is deploying a permanent corrective action to address the two issues described in the recall notice.

As per the issued Medical Device Alert, the affected items are listed below:

To view the official alert, click the link below: