Philips CPAP Recall – What to do?

Philips CPAP Recall – What to do?

Philips CPAP Recall: What to do?

The recall of Philips CPAP machines has caused confusion for four million CPAP users. While BlueSleep did not provide these devices and is not involved in the recall process, you deserve to be informed.

About the recall

Philips recalled several of its continuous positive airway pressure (CPAP) and BiLevel Positive Airway Pressure (BiLevel PAP) devices, and mechanical ventilators (such as Dreamstation, REMStar SE, Dreamstation BiPAP, Trilogy 100/200 – see the full list at Philips is working with home care/durable medical equipment (DME) suppliers to ensure that safe replacement or repair can be provided to our patients who are affected by this recall.

According to the Wall Street Journal:

“Royal Philips NV has recalled millions of sleep apnea and ventilator machines over concerns that a type of foam used in the devices could degrade and release harmful, possibly cancer-causing, particles. The recall affects three million to four million machines, more than half of which are in the U.S., a company spokesman said Monday. About 80% are machines for aiding people with sleep apnea, a condition that causes a person to stop breathing for short periods during sleep. The rest are life-supporting mechanical ventilators. Philips said after receiving a small number of patient complaints it was concerned that a type of foam used to dampen the machines’ sound may degrade into particles that are swallowed or inhaled by the user. These particles could cause headaches or breathing problems and might be carcinogenic, the company said, adding that gases released by the foam could also be harmful.” 

Recalled machines

  • SystemOne (Q series)
  • DreamStation CPAP, Auto CPAP, BiPAP
  • DreamStation GO CPAP, APAP
  • Dorma 400, 500 CPAP
  • REMStar SE Auto CPAP
  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne ASV4
  • C Series ASV, S/T, AVAPS
  • OmniLab Advanced Plus In-Lab Titration Device17:52

What should you do before receiving a replacement machine?

Get a new sleep apnea test if you were diagnosed several years ago or have gained or lost significant weight. It’s important to evaluate the current severity of your sleep apnea to make an informed decision about treatments. Home sleep testing is an easy way to discover if your sleep apnea is better or worse. 

What are the alternatives to CPAP?

A custom-made, medical oral appliance (a mandibular advancement device) for treating sleep apnea is very effective. This is a medical treatment - not a dental treatment. When ordered by the BlueSleep team, the device is covered by most medical insurance plans. Oral appliance therapy, or Mandibular Advancement Devices such as: Prosomnus, Dynaflex, Glidewell Silent night, Herbst, Panthera, EMA, Somnomed appliances, are all very effective for most cases of sleep apnea.  Dr. Jordan Stern and colleagues from BlueSleep published a study showing that oral appliance therapy is as good or better than CPAP therapy in most cases.

Oral appliances for sleep apnea are custom made and can be fitted with compliance monitoring chips for trucking or transit employers, if necessary or required. 

How do I find out if I'm a candidate for an oral appliance for Sleep Apnea treatment?

A Mandibular Advancement Device fits on the teeth and helps keep the jaw in a position that supports breathing when you’re sleeping. It fits snugly on the top and bottom teeth and helps keep the airway (the breathing passages) from collapsing when sleeping on your back, and when in deep sleep. Because these appliances fit on the teeth, the teeth need to be healthy, and not currently undergoing any orthodontic or other treatment. 

You need a recent sleep study confirming the diagnosis of sleep apnea within the past several years. Home sleep studies are easy to do from the comfort of your own home, in case you don’t have a recent sleep study.

What’s the process for getting an oral appliance for Sleep Apnea?  

  • Make a BlueSleep telehealth appointment online and complete the sleep questionnaire. If you’ve already completed a sleep study, have your results available for your telemedicine appointment. 
  • Meet with our sleep specialists. We’ll then ship you a home sleep test, if needed.  We’ll review the results of your new home sleep test, or your recent sleep test, and discuss treatment alternatives to CPAP. 
  • If you’re a candidate for an oral appliance, you can visit our facility for a dental scan so we can order the custom-made oral appliance. We can also ship a dental impression kit to your home for a small fee.  
  • When you receive the kit, we’ll help you take impressions of your teeth, supervised by our staff online. The impressions will be sent to the lab, and the device will be custom made and shipped to your home. We’ll show you how to use it, and adjust it with a face-to-face video visit.  
  • After using the device for 4-6 weeks, you’ll repeat the home sleep test to ensure the appliance is properly adjusted and effective.

How long does it take to get an oral appliance for Sleep Apnea?

Each case is different, so we can’t say for sure until we’ve diagnosed your snoring and sleep apnea. Most of the time, you can get an appointment the same day. We can only treat patients in the following States: NY, NJ, FL,TX, VA, CA.

  • All insurances require pre-authorization for the oral appliance treatment. Good news! We’re in-network for most major insurance companies that cover oral appliance treatments for sleep apnea.
  • The pre-authorization process can take from one to four weeks (sometimes longer). Once we have pre-authorization, we’ll inform you of any unmet deductibles, copays, or coinsurance. We also recommend you contact your insurance company to learn more about your coverage.
  • All medical insurance companies require a doctor’s visit and a note that confirms the diagnosis of sleep apnea explaining why oral appliance therapy is a good treatment for your sleep apnea.  
  • The BlueSleep medical visits are by telemedicine. After reviewing your medical information and the results of a recent or new sleep test taken from the comfort of your home, our providers will schedule you for a digital impression of your teeth, or send an impression/mold kit to your home.
  • The scans or impressions are then sent to the dental lab, and the appliance is made. The custom-fabrication process may take two to three weeks.  
  • The new appliance will be shipped to your home, and you’ll schedule a telemedicine visit to learn how to use and adjust the appliance.  
  • Four to six weeks later, you’ll conduct an easy home sleep test to confirm that the appliance is effective.

Your health and safety are our top priority. Make sure to schedule an appointment ASAP.