Continuous positive air pressure machines are under review by the Federal Motor Carrier Safety Administration’s medical review board in regards to a voluntary recall of the technology and the new uncertainties brought with it.
Truckers utilizing these machines may be at risk for significant health complications. The voluntary recall, which was announced at the end of June by the U.S. Food and Drug Administration on its website, claimed that certain CPAP machines may increase high chances of risk to those with sleep apnea due to potential chemical and debris exposure during usage. CPAP machines are meant to help in the treatment of obstructive sleep apnea–an affliction many truck drivers suffer from that causes difficulties in breathing properly during sleep.
Specifically, the FDA noted that its safety announcement was meant for those using Philips Respironics ventilators, CPAP, and BiPAP machines, alerting them that this particular brand had recalled some of its products. Those who use these machines would need to reach out to their health care providers for advice and other possible treatment solutions, the FDA added.
“The polyester-based polyurethane sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway,” said the FDA in its announcement. “If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.”
In fact, many users had complained about particles and black debris appearing in the products’ airways–debris which was seen throughout the devices’ tubing, masks, humidifiers, and the device outlets, said Philips Respironics at the time of the recall.
“Philips also has received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection,” the company noted. “The potential risks of particulate exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g kidneys and liver), and toxic carcinogenic effects.”
The possible risks of off-gassing chemical exposure also include dizziness, hypersensitivity, nausea, and vomiting, added the company. In July, the issues with Philips’ devices earned the classification of the most serious recall specification–a Class I recall.
“These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment,” said the company in its initial voluntary recall announcement.
Fortunately, there have been no death reports resulting from these potential issues.
“We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible,” said Philips Respironics. “The company has developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process.”
FMCSA will now urge the medical board to determine the best methods of helping its National Registry of Certified Medical Examiners, as well as CPAP-using truck drivers, to find new options for drivers in need of these kinds of devices, said an agency spokeswoman. However, FMCSA is not yet aware of the number of truck drivers using Philips CPAP machines, specifically.
“While FMCSA regulations do not specifically address sleep apnea, they do prescribe that a person with a medical history or clinical diagnosis of any condition likely to interfere with their ability to drive safely cannot be medically qualified to operate a CMV in interstate commerce,” added OccuMedix president and chief Natalie Hartenbaum, who wrote an article on these recalls. “However, most cases of sleep apnea can be successfully treated. The most common treatment is the CPAP machine. But, what if drivers can’t use their CPAP [machines]?”
Nearly 28% of commercial drivers have sleep apnea, Hartenbaum noted.
“It’s scary because sleep apnea is a health risk to drivers in terms of drowsiness,” said OccMed corporate director of medical surveillance and medical review board member, Brian Morris. “There have been high-profile accidents for people involved with drivers with sleep apnea that were not treated properly. We may have to step away and not enforce CPAP use if the equipment has serious health risks.”