Due to potential health risks, Philips Respironics voluntarily recalled certain continuous positive airway pressure (CPAP) machines over the summer. , the polyester-based polyurethane (PE-PUR) sound abatement foam runs the risk of breaking down and potentially entering the device’s air pathway. Under these circumstances, it is said that black debris from the foam or certain chemicals may be released into the device’s air pathway, subsequently being inhaled or swallowed by the person using the device.
Not only did this announcement contribute to an immediate shortage of devices and other supplies for sleep apnea treatment, but the recall of over a million machines has led to a supply chain concern: Can truck drivers with sleep apnea legally drive if their CPAP devices are recalled? To address this concern, the Federal Motor Carrier Safety Administration’s (FMCSA) Medical Review Board (MRB) met on Wednesday, September 29, to identify reliable sources of information concerning options for drivers with machines covered by the recall. The goal of convening the MRB also remained to develop an actionable plan to provide prompt solutions for how drivers with OSA can continue operating safely.
Beginning the meeting, Larry Minor, the FMCSA associate administrator for policy and the designated federal officer for the advisory committee, thanked all attendees for engaging in the important conversation surrounding what truck drivers and the medical examiner should know in the event that a driver has OSA. Next, the public comment portion of the agenda consisted of discussion points from various individuals from within both the trucking and sleep medicine spaces.
On behalf of the American Trucking Associations, Safety Policy Specialist Laura Spector related to the Phillips recall. She emphasized that, with millions of devices recalled (many of which were used by CMV drivers), the recall has had widespread implications for commercial driver health, highway safety and interstate commerce. First and foremost, she noted that without appropriate treatment options, many drivers with obstructive sleep apnea (OSA) will be out of compliance with FMCSA’s physical qualifications for drivers regulations and ultimately lose CMV driving privileges.
“Because of this, ATA has asked that Philips prioritize CMV drivers in the repair and replacement of affected CPAP and PAP devices. The current guidance from Philips merely directs drivers to consult with their MEs about whether or not to continue their prescribed treatment with their Philips device,” Spector said. “The MRB should consider providing more detailed guidance to drivers and their MEs who are in need of alternative treatment plans to manage their sleep apnea and stay in compliance with the physical qualification regulations.”
Further, she insisted that industry guidance is a time-sensitive matter and that commercial vehicle drivers with OSA cannot wait to resume their required CPAP treatments. Spector therefore recommends that Philips and the MRB should engage industry stakeholders to ensure thorough consideration of all alternative solutions that would minimize disruptions to commercial drivers’ required CPAP treatments.
Another series of public comments from Natalie P. Hartenbaum, MD, MPH, FACOEM, who is president and chief medical officer at OccuMedix, Inc., highlighted that the American College of Chest Physicians, American Academy of Sleep Medicine (AASM), American Academy of Neurology (AAN), American Thoracic Society (ATS), Alliance of Sleep Apnea Partners (ASAP) and American Sleep Apnea Association (ASAA), to the Centers for Medicare and Medicaid Services (CMS) and private insurance payers to temporarily suspend the 90-day adherence rule to allow patients to have existing equipment repaired or receive new equipment from DME suppliers.
“In response to this issue, I reached out to a few of my sleep medicine colleagues to see what they had been encountering and advising their patients whose use of CPAP or BiPAP devices is related to occupational safety. While some examiners only use a small number of Respironics devices in their practice, others have been significantly impacted by the recall,” Hartenbaum said. “In general, they are pointing out that the risk/benefit ratio of the newer devices is low (Philips reported the risk of issues was 1 in 3,500 machine users in 2020), especially if not exposed to non-traditional cleaning methods such as ozone cleaners.”
She added that her sleep medicine colleagues are recommending that those patients with older machines (or those who have used some non-traditional cleaning methods) try to obtain a new machine, if possible, without waiting for the recall/replacement, as some believe the backlog may be up to a year. Hartenbaum continued that those in safety-sensitive positions are advised to continue treatment. Lastly, the employer medical director/officers and other providers to whom she spoke are continuing to require adequate use of the devices, especially for those patients with moderate to severe obstructive sleep apnea.
Annelise Thornton, MHS, CEO of Population Sleep, shared her work in sleep medicine as a patient-health educator and patient advocate since 2006. Through her experience, she believes the recent CPAP recall represents a significant problem for transportation workers who have sleep apnea as well as for their employers. Yet for those who believe they must choose between using a defective device or forgoing treatment, that oral appliance therapy (OAT) with a mandibular advancement device (MAD) can be used as a temporary treatment while a patient waits for a CPAP replacement or a trial device prior to the prescription of a custom oral appliance.
“This therapy can and does achieve great outcomes ― even for people diagnosed with severe apnea. OAT has been part of official treatment guidelines for nearly 20 years, and reimbursement codes were established by Medicare (CMS) in the mid-2000s. Today, most (if not all) commercial insurance carriers have a policy that addresses oral appliance therapy,” Thornton said. “There’s ample evidence that OAT produces reliable treatment outcomes and is readily accepted by patients.”
A truck driver with OSA himself, Bob Stanton added his firsthand perspective to the CPAP recall issue within the trucking industry. He presented the FMCSA MRB with sources of reliable information for drivers and CME on the Phillips recall, action the MRB could take in response to the recall to ease current certification problems for drivers, and actions that may increase the availability of sleep apnea treatment for drivers during the shortage.
“That FMCSA should request that the Federal Emergency Management Agency (FEMA) utilize powers under section 708 Voluntary agreements of 44 CFR 332 The Defense Production Act of 1950 as amended to apply to the manufacturing and distribution of PAP devices used in the treatment of sleep apnea as a reaction to the FDA recall of Phillips Devices and the resulting shortage of PAP devices,”
Mary Convey, vice president of Corporate Health & Safety Solutions, shared that from these discussions, there was a lot of talk around how to provide “alternative therapy” to CPAP. She believes that the discussion demonstrated a “very confusing” outlook around an oral appliance without any true compliance data or “efficacy,” which can be delivered via PAP. Also, she says the oral appliance could potentially be more costly (in both time and dollars) and would really be nothing but a “sticky” band-aid for drivers faced with a recalled device.
“The consensus from the AASM is for anyone with a recalled device to consult with their physician to weigh the risk versus the reward of this ‘potential danger’ from continuing CPAP use on a recalled device. Most folks I personally know are continuing to use their recalled device as long as there is no evidence of black particles from foam degradation in the device or from any Ozone CPAP cleaner use,” Convey said. “SleepSafe Drivers has been providing trucking fleets sleep and fatigue solutions since 2007, so our focus has also been to keep drivers employed and on the road safely.”
“SleepSafe Drivers has a strong track record of commitment to the commercial driver and our clients. We have chosen to handle the recall ourselves by taking on the device replacement for all our fleet clients and drivers using a system to prioritize replacement for drivers based upon clinical need and physical recertification. Unfortunately, many drivers who received devices via a regular DME provider may be left to wait for the replacement for up to a year,” added Corporate Health & Safety Solutions President and CEO Adrian Knight.
By the conclusion of the FMCSA’s public comment, the MRB finalized the recommendations on length of certification for drivers with established sleep apnea. The general consensus was to allow up to the maximum of 90 days to obtain an alternative form of OSA treatment and provide evidence of appropriate treatment to satisfy the examiner. Also, a driver using an oral appliance device should provide a statement from the treating provider regarding compliance prior to recertification. In regard to the Phillips recall, the bridge oral appliance usage will be accepted until a new CPAP machine becomes available.
Note: FMCSA’s Medical Review Board, established under the auspices of the Federal Advisory Committee Act (FACA) of 1972, Public Law 92-463, provides information, advice, and recommendations to the Secretary of Transportation and to the FMCSA Administrator on the development and implementation of science-based physical qualification standards applicable to interstate commercial motor vehicle drivers. The MRB does not hold regulatory development responsibilities, manage programs, or make decisions affecting such programs. The MRB provides a forum for the development, consideration, and communication of information from a knowledgeable, scientific perspective.
Source: Sleep Lab Magazine Sept/Oct 2021