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truck driver health

Drivers Should Have 90 To Replace Their Recalled CPAP Machines, Medical Advisors Recommend

October 19, 2021 by Levinson and Stefani Leave a Comment

We recently reported on the recent recall to certain continuous positive airway pressure machines (CPAP machines), which are vital pieces of equipment and treatment methods for those with mild to severe sleep apnea. Sleep apnea of some level affects nearly one-third of truck drivers.

The recall was announced earlier this year by the U.S. Food and Drug Administration after it found that debris and harmful chemical exposure during usage of these machines posed a severe health risk to users.

Now, medical examiners are recommended by a Federal Motor Carrier Safety Administration medical advisory board to offer alternative treatment methods to truck drivers. Examiners are likely to have 90 days to determine which alternative options will be best for truckers afflicted with sleep apnea, and these methods found must offer the same kind of treatment as the Philips Respironics continuous airway pressure machines that are now being recalled nationwide.

“In response to the CPAP recall, appropriate oral appliance usage for certification is accepted for drivers diagnosed with moderate sleep apnea impacted by the Philips Respironics recall,” said the advisory board regarding its recommendations. “This therapy will be accepted until CPAP machines become available again for treatment.”

Still, drivers with untreated and severe sleep apnea are exempt from this recommendation, the medical examiners noted. The review board is still determining the best ways that qualified drivers with obstructive sleep apnea can continue to work and be medically certified to operate their vehicles, when CPAP machines are the treatment method upon which FMCSA has relied for so long.

If obstructive sleep apnea remains untreated, drivers are at a much higher risk for accident or crash as they could become severely fatigued while behind the wheel. Allowing untreated drivers to continue operating their commercial motor vehicles while a new preferred treatment method is found could cause a major public safety risk, board members said.

Levinson and Stefani’s Ken Levinson weighed in on the issue.

“It seems to me that this treatment is something that should absolutely be provided by trucking companies or some sort of government assistance,” he said. “It’s vital that truckers are able to work safely, and if they fall asleep at the wheel, it can cause a lot of harm and it’s a big issue.”

He added that their lifestyles can cause them to be more susceptible to various health problems, so making sure the medical issues at hand are treated in a proper and timely manner is of the utmost importance.

“Truckers have such a sedentary job that it’s hard for them to stay physically fit, so we need to do everything we can to make sure the trucking companies are conducting proper medical testing before drivers are hired and that they can also access the kind of equipment they need, whether it’s these CPAP machines or other devices to stay safe and healthy,” Levinson said.

The medical advisory board is working on ways to offer examiners various methods and opportunities to address the recall for the health of these truck drivers.

“Our goal today is to come together as a group and to develop some recommendations that we can give to the agency that will hopefully be passed along to our medical examiner community and drivers managing this issue,” said board chair Gina Pervall.

This CPAP machine recall has left a clear shortage in the market for sleep apnea equipment, and Philips Respironics explained that it is working to replace the recalled devices as quickly as possible.

“With millions of devices recalled, and many of them used by commercial motor vehicle drivers, Philips’ recall has widespread implications for commercial driver health, highway safety, and interstate commerce,” said American Trucking Associations safety policy specialist, Laura Spector. “As the medical review board is aware, without appropriate treatment options many drivers with obstructive sleep apnea will be out of compliance with FMCSA’s physical qualifications for driver regulations.”

As to how soon a potential solution will be found, Spector explained that many things are still up in the air.

“Notably, there is no clear timeline indicated when individuals might expect their device to be repaired or replaced,” she said, “with some sources estimating it could take up to one year for devices to be fully operational.”

Recalled CPAP Machines Bring New Obstacles for Drivers With Sleep Apnea

October 2, 2021 by Levinson and Stefani Leave a Comment

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.”

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