Polyester-based polyurethane (PE-PUR) foam is ubiquitous across industrial products. PE-PUR foam is largely used for its low density and sound insulating properties. For these reasons, polyurethane foam is often employed on sleep and respiratory care devices. PE-PUR foam is also a type of polymeric foam, belonging to a family of similarly lightweight, high-strength foams. But this foam is currently under scrutiny after a product recall from Dutch medical equipment company, Philips. In June 2021, the company voluntarily recalled several models of ventilator and CPAP machines. It cited evidence of the PE-PUR sound abatement foam degrading into particles that users could potentially inhale. Since PE-PUR foam contains isocyanates, a highly toxic chemical class, this recall raises patient safety alarm bells. For attorneys pursuing PE-PUR foam-related cases, here’s what you need to know about foam toxicity and the ongoing recall.
Polyester-based polyurethane foams first entered the market in 1937. They belong to a class of compounds known broadly as polymeric foams. PE-PUR foam is popularly used for insulation, structural, and comfort purposes. A common application is within ventilator and CPAP machines. The PE-PUR foam is used to decrease sound and vibration in the devices.
PE-PUR foams are formulated using isocyanates. Isocyanates are a family of chemical compounds that are characterized by a high reactivity and low molecular weight. They’re often used in the production of polyurethanes, however, isocyanate exposure can have adverse health effects.
Respiratory issues are the most common complication from isocyanate exposure. Health impacts range from shortness of breath and dry cough to asthma, bronchitis, and pneumonia, depending on exposure length.
Over the past 30 years, research has also linked isocyanate exposure to cancer. Studies haven’t explicitly named PE-PUR foam as a carcinogen. Though there have been other isocyanate-containing products identified as carcinogenic. Given this tangential relationship, further investigation into PE-PUR foam’s carcinogenic potential is wholly warranted.
In June 2021, Philips announced a voluntary recall of several of its sleep apnea devices and ventilators. The recall targets between three and four million devices. Philips explained the devices use a PE-PUR sound abatement foam that could degrade into particles or off-gas chemicals.
The models subject to the recall are:
Diethylene glycol (DEG) is among the chemicals released by PE-PUR foam on Philips devices. DEG is a highly toxic, colorless, odorless chemical. It’s often used in antifreeze, brake fluid, and lubricants. Exposure to diethylene glycol can have severe effects. Health complications range from nausea and vomiting to coma or even death.
Beyond external factors, PE-PUR foam is also susceptible to microbial degradation. Common airborne bacteria can play a role in decomposition. The presence and impact of certain bacteria will depend on the environment where the devices were used. Bacterial factors will be less prevalent in well-maintained healthcare facilities.
This Litigation Guide was medically reviewed by Arumugarajah Tharaneetharan, M.D., Ph.D.
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