By Larry Earl, MD; Burke Mays; and William Kellenberger
From a concerned CME: “I am reaching out to ask for details surrounding any decisions FMCSA has made about the Phillips CPAP recall in regards to CDL drivers. Our providers aren’t sure how to answer the drivers’ questions about their non-compliance due to the recall. And due to the guidelines, we can’t pass them. Any insights you can give are very appreciated!”
The short answer to the question above is you are not going to be able to tell your drivers anything conclusive that will help for now. Philips Respironics has voluntarily recalled certain ventilators, BiPAP, and CPAP machines due to potential health risks. The polyester-based polyurethane (PE-PUR) 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. 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.
On June 30, 2021, the FDA issued a safety communication: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks. Decisions for drivers to continue using their machines should be made on an individual basis. Definitive answers regarding the risks of continued use are not available at this point. Government agencies are not likely to offer dispensation from the PAP compliance requirement for drivers who have recalled machines.
The American Academy of Sleep Medicine “suggests that the medical provider prescribes for their patient a PAP device that is not affected by the recall. However, in the case that this is not an option or another device is unavailable, then it is the AASM viewpoint that clinical factors such as comorbidities, severity of symptoms, risks associated with PAP discontinuation, and safety-sensitive roles should inform the decision to continue or discontinue therapy. This decision should be made in concert between the patient and their medical provider. The ultimate judgment regarding any specific care must be made by the treating clinician and the patient, taking into consideration the individual circumstances of the patient, available treatment options, and resources. The AASM advises that patients contact their medical provider as soon as possible to discuss whether to continue or discontinue treatment.”
Drivers have three choices in the short run – replace the machines, continue using the recalled machines, or stop driving and stop using the recalled machines.
This is what the two main manufacturers of PAP devices are doing:
- Philips/Respironics promises a recall process, but there isn’t a reliable one in place that allows a patient to replace their machine. They are asking for special FDA approval for their proposed repair solutions to existing Dreamstations. They are also ramping up to produce the previously approved Dreamstation 2 machines. However, the Dreamstation 2’s are on hold until the FDA can re-examine and re-approve the Dreamstation 2.
- ResMed is the biggest player stepping in to take up the slack. They are trying to fill the gap (more like a cavern) but they have not been able to meet the demand. Their manufacturing ramp-up time has begun but will take at least another 3-6 months. They are working around the clock to fill orders all over the world. The new ResMed machines only solve the demand for new sales.
There are no timetables for either ResMed or Respironics. The remaining US manufacturers who produce PAP machines are months behind in filling PAP orders. All machine prices have gone up, making the issue more critical for drivers.
The unfortunate fact is this problem is going to be with us for years, not months.
For now, to repair or replace a recalled PAP with the new Respironics Dreamstation 2 machine a patient MUST take two actions:
- Contact the DME that sold the machine and request the DME to register the need for replacement, which they do on the Respironics site.
- Go to the Respironics site and register as individuals for a repair/replacement. They will download the device to Respironics so they can see who is using the PAP and who is looking for a FREE machine.
Through various sources, our understanding is that Respironics is prioritizing the machine replacements or repairs. At this time, machines older than the Dreamstations are the lowest priority for repair or replacement. Respironics has no “loaner” program in place when the machines are turned in for repair. Loaners would be up to the DME to coordinate the repair. Also, there is no schedule for repairs. New Dreamstation 1 machines seem to have the highest priority. They are replaced with Dreamstation 2 machines or Dreamstation 1 machines with the newly approved sound abatement foam. Users must buy new/used machines. This information seems to be changing daily.
OUR RECOMMENDATION
- Let drivers know there is no definitive information that continued use of the recalled machines for a bit longer until they can be repaired or replaced adds any significant risk.
- There is no guidance from FMCSA or other agencies regarding any “forbearance” or extension of short-term certifications or pending determinations while awaiting testing or treatment for sleep apnea.
- If drivers choose not to use the machines and fall out of compliance, they should be medically unqualified.
OF SPECIAL NOTE
Bill Kellenberger and Burke Mays represent our vendor member, Express Medical Solutions. They have some limited inventory of PAP machines and can otherwise be helpful to your drivers in sorting out their individual options. Please contact them at info@expressms.net, call Bill at (563) 370-3111 or Burke at (563) 200-3829.
