Philips Recall Notification for Sleep and Respiratory Care Devices

If you have used Philips’s brand CPAP, Bi-Level PAP, or mechanical ventilator devices, learn the details of the recent recall announcement.

At CPAPmyway, we want to keep you updated on the latest sleep and respiratory care products and industry news to ensure you have the best care, services, and respiratory devices. So keep reading to learn about an important announcement about Philips’s brand CPAP, Bi-Level PAP, and mechanical ventilator devices.

In June 2021, Philips, the maker of continuous and noncontinuous ventilators, issued a recall regarding specific devices using polyester-based polyurethane (PE-PUR) foam. The foam’s purpose is to absorb and reduce noises when consumers use the devices.

The company discovered two primary issues related to the foam:

1. In some cases, the foam may degrade or break into tiny particles, which can then enter a device’s air pathway, leading to patient ingestion or inhalation.
2. The foam may produce chemicals that pose a health and safety risk to device users.

Understanding the Recall Details and Risks

Incidences of patient complaints are low, with only three in 10,000 users reporting an issue. Still, to be on the safe side, Philips followed up the complaints with independent lab testing of the PE-PUR foam. The laboratory test results revealed that there is indeed a low risk of slow degradation due to hydrolysis, which is a chemical breakdown that can occur when a material reacts to water. The tests also showed that the foam could cause chemical emissions from minuscule amounts of organic compounds created during the foam production process.

What It Means: Degradation of PE-PUR Foam

As a result of the chemical reaction from hydrolysis, inhalation or ingestion of foam particulates is possible for anyone using the Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP), or mechanical ventilator devices.

Environmental factors like high humidity and temperatures can accelerate the degradation of the foam, increasing the safety risk. Another factor that can make the foam break down faster is performing unapproved cleaning techniques on these devices.

Because the sound-absorbing foam is open-cell, it may be more vulnerable to deterioration. As the foam breaks down, there is a risk of unhealthy by-products that no patient wants to inhale or ingest. Philips used third-party, independent laboratories to analyze the by-products of the foam and identified the presence of diethylene glycol, commonly referred to as DEG. The lab did not confirm the existence of any other by-products.

The lab testing process involved:

• Analyzing deteriorated foam they put through an accelerated aging process.
• Extracting foam contents to provide field samples for biocompatibility laboratory tests.
• Identifying any toxins that could harm device users.

The test data revealed that most foam particles resulting from the degradation are too large for device users to inhale and also too large to penetrate into the deeper tissue of the lungs.

Lab testing was unable to determine how much chemical exposure a user might experience in the case of foam degradation within a device. But they believed the concentration and exposure risk, even if small, were significant enough to issue the recall.

Risks Associated with Degraded PE-PUR Foam Exposure

What should you watch out for if you or a loved one has experienced exposure to PE-PUR foam degradation through a respiratory device? In a worst-case scenario, the primary health and safety risks include:

• Irritation to eyes, skin, or respiratory system
• Airway inflammation
• Headaches
• Asthma or respiratory distress
• Problems with kidney, liver, or other organs
• Potential increased risk of cancer

In the recall notice, Philips shared the details of some consumer complaints. These patients noticed visible evidence of foam particulates in the device’s airpath, including in the mask, tubing, and humidifier. Philips reported that some users had experienced airway irritation, headaches, chest pressure, coughing, and increased incidence of sinus infections.

Although the consumer complaint rate has been low and there has been no report of patient deaths, Philips is proceeding with the utmost caution. The company acknowledged that not all patients will report complaints or notice the potential foam degradation evidence in their devices.

How to Avoid the Risk of Foam Particle Exposure

According to Philips, using a bacteria filter on a mechanical ventilator device may minimize the risk of inhaling or ingesting hazardous foam particulates. Filter testing revealed a 99.97% rate of effectiveness when using the appropriate filter. However, the filter is unable to reduce the risk of chemical emissions coming from the foam.

What It Means: Chemical Emissions from Degraded PE-PUR Foam

Independent laboratory tests confirmed the emission of specific chemicals from degraded PE-PUR foam. During the foam’s production process, tiny amounts of organic compounds are produced. The two compounds causing the most concern are:

• Dimethyl diazine
• Phenol 2, 6-bis

Testing did not identify how much chemical emission results from the foam in the device—only that it did indeed exist. However, the laboratory findings indicated that the chemicals dissipate to extremely low levels undetectable after 24 to 72 hours of using a new respiratory device.

Risks Associated with Chemical Emissions from Degraded PE-PUR Foam

The specific chemical emissions related to foam degradation do not have available toxicological data. There is also no information about the dangers or necessary limits to exposure. Although there is an absence of data pointing to risks from the chemical emissions, Philips is taking extreme caution to identify possible health effects in a worst-case scenario. These include:

• Headaches
• Dizziness
• Airway inflammation
• Irritation to eyes, skin, or respiratory system
• Hypersensitivity
• Nausea or vomiting
• Potential increase in the risk of cancer

So far, Philips has not received any consumer complaints associated with chemical emissions. Still, the company acknowledged that patients might not recognize exposure or report complaints.

Ongoing Testing and Information to Keep You Safe

Philips will conduct ongoing testing to better identify potential health risks and determine the level of risk related to devices containing the PE-PUR foam. The team at CPAPmyway will pass along any new information we receive. In the meantime, if you have questions about your Philips device or PE-PUR foam or want to learn about other CPAP machines, masks, and affordable sleep apnea supplies, connect with our friendly CPAP specialists now.