DreamStation Recall Update for 2022

  • By Clay Rollyson
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The most recent update for the DreamStation Recall

It has been a long 6-7 months in the CPAP world. Most of that due to the unprecedented recall from Philips Respironics. With that being said, there are some relevant updates. Here is what you need to know.

Recent FDA Inspection Findings for DreamStation Recall:

Philips has received a lot of questions regarding the FDA’s published Form 483 report. That is because in that report the FDA documented that a Philips Respironics unit failed the VOC (Volatile Organic Compound) test. That was extremely concerning, because that was the major reason for the initial recall. Many people assumed that the VOC test failure was on the DreamStation 2 CPAP. Fortunately, it was not. The unit that failed was an unreleased design for a specific A-Series Bipap. Thankfully, the DreamStation 2 CPAP as well as the repair kits for DreamStation 1 CPAPs are all still approved as safe and effective.

Updated Recall Patient Recommendations:

When Philips initially announced the recall back in June 2021, the notice said, “Stop using your device immediately”. That was a pretty big shock to DreamStation CPAP users. It was also a pretty scary thing to say. Since that announcement the FDA and Philips have worked together and decided to change that recommendation. Now the recommendation says to “Consult with your Physician”. See the FDA recommendations here. That is a big change for DreamStation users. This means that they believe the risk of something bad happening because of an affected device may not be as potentially harmful as not treating your Sleep Apnea. Of course, you should consult with your Physician to make that decision. For the latest updates and recommendations check out the Philips Recall Website. 

Recall Registration and Remediation Updates:

Philips states that it is working diligently to remediate the millions of devices that were affected by this recall. To date, there have been 4 million devices registered worldwide. Of those 10% have been completely remediated. This means that there is still lots of work still ahead. We have been advised that the recall is estimated to be completed by September of 2022.

Recall Prioritization Requests:

Philips Respironics has been involved in conversations with external parties regarding patient prioritization. As a manufacturer, they do not typically have the clinical background of the patient nor the direct interaction with them required to support the design of formal patient prioritization plans. However, upon request of the FDA, they will be collecting data on the patient registration web site to determine if a prioritization scale for the U.S. based on relevant patient health information from registrations would be a positive step. The scale is used in addition to several pre-requisites (e.g., the availability of a given device in stock). More details will be provided in due course.

What to expect in the first Quarter of 2022 for the Philips Recall:

Philips is still running around the clock in the recall and remediation efforts. They still expect to finalize the remediation of registered recall units by September of 2022. In addition to the massive number of units on the recall list, global supply chains are also disrupted. This means that while Philips does not expect any delays in their plan, things can change. They are ramping up continuously to accelerate the remediation efforts as much as possible.

Should I still be using my DreamStation 1 CPAP?

Continuing to use your DreamStation 1 CPAP is something that you will have to decide on in consultation with your Sleep doctor. This means that you will have to weigh out the risks of potential VOC (Volatile Organic Compounds) and foam degradation against not treating your Sleep Apnea. Philips has been inspecting old DreamStation 1 units pretty closely. Here is what they are saying about that.

Philips updated DreamStation 1 Inspection Statement:

“We are encouraged by the VOC test results to date for the first-generation Dreamstation devices, which we published in December 2021. The results indicate that VOCs do not exceed safe exposure thresholds specified in the applicable safety standards (e.g. ISO 18562). Using conservative health-protective exposure thresholds, the additional testing suggests no increased risk for adverse health effects in the general patient population nor the higher risk patient population as a result of VOC exposure. As we announced in December, it is important to note that the tested DreamStation devices were not exposed to ozone cleaning, as per the device instructions for use.”