Nearly 4 million of Philips’ flagship DreamStation devices used to treat obstructive sleep apnea have been recalled in the U.S. and Canada, leaving professional truck drivers with questions about whether they can continue to drive legally without their Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) machines.
Oregon-based truck driver Gerry Shelton filed a class action complaint against Koninklijke Philips N.V., Philips North America LLC and Philips RS North America LLC (Philips) in late June.
According to court filings, Shelton claims he had to stop driving because he “cannot drive with untreated sleep apnea” after the DreamStation BiPAP machine that he purchased in 2020 was recalled. The recall by Philips Respironics states that some of its sleep and respiratory care machines, including a number of its mechanical ventilators, manufactured before April 26, 2021, contain polyester-based polyurethane foam, known as PE-PUR, for sound abatement. The company said this foam, which can break down and be inhaled or ingested, could result in “serious injury which can be life-threatening or cause permanent impairment.”
Shelton claims that he went into atrial fibrillation because he is unable “to get sufficient sleep without the use of an appropriate device to help him breathe properly,” according to court documents filed in the U.S. District Court for the District of Massachusetts.
Duane DeBruyne, a Federal Motor Carrier Safety Administration spokesman, said treatment is in fact required for some drivers to continue driving.
“Understanding that every situation is unique, for many commercial drivers with obstructive sleep apnea (OSA), their underlying USDOT medical certificate requires treatment in order to remain valid,” DeBruyne told FreightWaves. “For those drivers affected by the recall, in order to maintain the validity of their USDOT medical certificate, we urge them to work with their medical providers to find alternatives wherever possible — and for CPAP manufacturers to provide all available assistance to drivers impacted by recalls.”
Click here to find out if your Philips CPAP or BiPAP machine has been recalled.
The website, CPAP.com, recently posted an article answering questions about what truck drivers diagnosed with moderate to severe sleep apnea must do to maintain compliance with the FMCSA to keep their DOT-issued medical cards.
Philips’ recall notice advised customers using affected CPAP and BiPAP products to discontinue use of the device and work with their physicians or durable medical equipment providers “to determine the most appropriate options for continued treatment.”
As part of the company’s repair and replacement program, it states that “the first-generation DreamStation product families will be modified with a different sound abatement foam and shipped upon receipt of the required regulatory clearances.”
However, the company has not set a timeline for when the recalled breathing machines will be repaired.
In April, Philips launched its DreamStation 2 platform that doesn’t contain PE-PUR sound abatement foam.
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