MRB to recommend 90-day waiver for drivers affected by CPAP recall

Commercial drivers who are impacted by a recall of certain CPAP and BiPAP devices used to treat obstructive sleep apnea may be able to receive a waiver of up to 90 days in order to find a replacement treatment.

That’s the guidance FMCSA’s Medical Review Board is expected to recommend after a virtual meeting on Wednesday, Sept. 29, to discuss the Philips CPAP recall.

In June, Royal Philips issued a voluntary recall for some of its ventilators, as well as CPAP and bi-level PAP machines because of concerns that the sound abatement foam component of the devices might degrade and become toxic or possibly cancerous.

The four-hour meeting included public comment from a number of medical professionals and trucking industry stakeholders, including the Owner-Operator Independent Drivers Association.

The U.S. Food and Drug Administration has classified the Philips Respironics recall as a Class I recall, the most serious type of recall.

“Class I recalls present a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death,” the agency said in a FAQ on its website.

Many of the concerns expressed during the meeting centered on a shortage of CPAP and BiPAP machines, and whether drivers who discontinued using an affected device to treat obstructive sleep apnea could continue to operate a commercial motor vehicle without some form of treatment.

The FDA currently classifies CPAP and BiPaP machines on its device shortage list due to device availability issues compounded by the COVID-19 pandemic and other supply chain issues.

Jay Grimes, OOIDA’s manager of federal affairs, told the board the Association encourages the consideration of alternative treatments like oral devices to help drivers manage obstructive sleep apnea.

“It would be completely unfair for (the Medical Review Board) and FMCSA to further burden and in some cases disqualify drivers who have been dealing with the consequences of the Phillips recall through no fault of their own,” Grimes said. “It’s also unfathomable to think that some drivers with severe cases of (obstructive sleep apnea) would be forced to choose between costly surgeries or giving up their CDL because of this CPAP shortage.

“We strongly encourage (the review board) and FMCSA to find fair and flexible guidelines until the recall issues are resolved, especially for drivers with a proven history of safety and compliance,” Grimes said.

The FDA provided recommendations for people who use an affected device, including that individuals may continue to use an affected device if their health care provider determines that the benefits outweigh the risks identified in the recall notification.

The board’s written recommendation is expected to be submitted to FMCSA.

Class action lawsuit over CPAP recall

Attorneys for an Oregon truck driver are seeking class-action status for a lawsuit against Royal Philips over the recall.

The named plaintiff, Gerry Shelton of Boring, Ore., was diagnosed with sleep apnea in 2020. He purchased a Philips Dreamstation BiPAP machine as part of his treatment.

The lawsuit alleges that Philips had heard complaints from patients of “black particles” in their machines for years but “did not warn the public or its customers about these hazards” until this spring, before issuing a voluntary recall in the U.S. in June.

The lawsuit seeks a refund, replacement with a nondefective device, costs for ongoing medical monitoring, “and all other appropriate damages for all the injuries he has suffered as a result of his defective (device).” LL