How the CPAP Crisis is Affecting Patients and Sleep Labs

By Sean B. Gipson, RPSGT

With COVID-19 on the rise again, sleep programs around the world are looking for advice and direction on how to operate during the pandemic struggles we continue to fight. The battle seems to be a losing one with the Delta variant looming and causing admission numbers to climb once again. Just this week, hospitals in the Southwest have re-initiated vaccination clinics, and hospitals are beginning to fill with COVID patients once again. To add fuel to the fire, student-age children are headed back to school despite the COVID climb causing concern in many families, no matter their vaccination status. It’s inevitable that we are on the brink of another COVID surge. The question is how we maintain operations while keeping our labs, employees and patients safe.

Naturally, the answer is to increase sanitation standards with stronger cleaning solutions as well as the number of times the centers are cleaned. For example, some centers that see patients during a daytime clinic in addition to the overnight studies are being cleaned twice (once in the evening and once in the morning). Additionally, once a week a “terminal clean” is done that includes additional sanitation processes such as attention to all surface areas, including the walls. So now that we have all of the surfaces clean, what about the monitoring equipment? The easiest ― though not the most cost-effective ― method is using disposable surface mount electrodes. But what about reusable electrodes, things like snore sensors, respiratory belts and snap electrodes. How are we cleaning these? The answer is soak solutions, some of which may require certain safety equipment and use of ventilation equipment. Not the most cost-effective if these items are not already in place.

The next question that has come up often in recent months is how we clean our lab-based CPAP/BIPAP systems. If you have been isolated in your nocturnal solitary confinement ― what we like to call a sleep lab control room ― with no communication with the outside world during “normal operating hours,” you may have missed the Philips Respironics recall of some 4 million CPAP/BIPAP units on June 14, 2021. Philips Respironics announced this voluntary recall due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in their CPAP and BiPAP machines.

Philips claims that this recall was, in part, due to the insulating foam degradation exacerbated by use of unapproved cleaning methods, such as “ozone sanitizing equipment,” and certain environmental conditions involving high humidity and temperature. Have you checked your sleep lab’s CPAP/BIPAP systems to see if they are on the recall list? You may want to do so, as many labs have found that their systems are in fact included in the recall. The FDA recommends that consumers and health care providers follow the cleaning instructions provided by the CPAP’s manufacturer. This most often includes regular cleaning with soap and water as noted on February 27, 2020, in a news release on FDA.gov. So, it’s back to the basics that seems to be the tried and true. Many labs are also using an in-line filter at the CPAP hose similar to the filters used on ventilators in health care facilities. Hoses and CPAP masks, in most instances, are “single use only.” If you are a lab that reuses masks and hoses with the use of sanitizer soaks or sterilizer cycles, this may be a time to consider the “disposable” route to avoid any accidental negative outcomes.

The only lingering question now is when will the CPAP/BIPAP shortage end? When are the patients who are out there holding recall letters in their hands going to receive replacement systems? When are hospital providers going to get new systems to replace all the units taken offline? When are all the new patients who are being diagnosed with breathing disorders that will require positive airway pressure devices going to get their devices? So many questions; and they all have the same answer: “we do not know.” Unless you have a high-volume account with any of the manufacturers, you are more than likely experiencing a deficit in positive airway device availability. Additionally, you are more than likely paying a much higher rate than you were three months ago for the systems that you may be able to get your hands on. The answer from Philips is that they are waiting for FDA approval of a new insulating foam to replace the recalled systems. Philips has said that they have tripled their production power of this new foam and are waiting for a “go ahead” from the FDA. They additionally are not committing to a replacement schedule as of yet. Lastly, the public has been given no information on which Philips systems will be replaced and which will be repaired.

With this unfortunate answer, many of us have stood with our mouths on the floor and our hands in the air for going on two months, with no light at the end of the tunnel for a positive pressure solution. Alternative solutions to CPAP are taking advantage of the situation and offering their widgets, surgery, oral devices and surgical devices, gaining market share while they have the opportunity. One of the more fundamental problems has now become if positive pressure systems are not widely available, what are sleep specialists offering as solutions to treat obstructive sleep apnea? The dental device world is becoming more and more busy with answers for these patients. Some of these solutions are permanent and some are temporary until the international CPAP shortage is resolved. The new question on the horizon is whether insurance carriers will open the avenues for reimbursement on these items with the first-line treatments becoming less and less available for purchase.

In the meantime, I would recommend that as providers, we become more educated to understand the current market and its solutions and prepare answers for our patients as they come into our clinics and labs with questions. The situation we are currently experiencing, and will continue to endure, unfortunately has no hard solutions in sight. The internet has provided our patients and clinical staff with lots of information, some of which is correct and some of which is incorrect; thus, we become the natural next stop with the answers to those questions. Today, more than ever, is a good time to utilize our social media or in-person and virtual support groups to provide the most up-to-date and accurate information to our patients and their families. Our patients are starving for up-to-date, accurate information in the ever-changing world of sleep medicine and its diagnostics and treatment solutions, as well as the general status of how world events are changing our ability to manage our patients.

Protect your practices, your staff and, most importantly, your patients as we navigate through our day-to-day practices and manage the changes in stride with our best possible solutions.

Sean B. Gipson, RPSGT is an accomplished healthcare executive based in the Dallas Fort-Worth Metroplex. 

Source: Sleep Lab Magazine Jul/Aug 2021

1 Comment

  1. Now add in you are a Commercial Motor Vehicle Operator, Pilot, USCG Master Mariner, or certain employees of Class 1 railroads who MUST maintain CPAP compliance to be legal to work. AKA a safety sensitive position.

    The FMCSA has called an emergency meeting 9/29 to discuss this. See my LinkedIn posts.

    This topic could be another whole article.

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