FDA Approved: SoClean 2 Ozone Sanitiser

SoClean 2 CPAP Sanitiser

Due to the Phillips Respironics recall, the SoClean 2 CPAP (Continuous Positive Airway Pressure) sanitising device has received significant damage to its reputation – SoClean seeks more than $200 million in damages from Phillips.

As a CPAP therapy user, you may be wondering if the SoClean 2 is safe to use – the simple answer is yes it is safe to use.

This page will give you a better insight into the safety of the SoClean 2.

Why was SoClean affected by the Phillips recall?

SoClean 2 CPAP sanitiser.
The SoClean 2 CPAP Sanitiser

Phillips Respironics made a poor choice of materials when using polyester-based polyurethane foam for sound abatement in its DreamStation 1. This material is known for breaking down in heated/humid environments (CPAP humidification). This led Phillips to recall millions of their Dreamstation devices as inhaling the broken-down foam had potential health risks.

Phillips claimed that “cleaning methods such as Ozone may contribute to foam degradation” of their Dreamstation recalled devices.

In multiple lawsuits by Phillips, the SoClean Ozone sanitiser was named as ‘unsafe’ and ‘unhealthy’. 

However, the statements made by Phillips have been deemed incorrect by the Food and Drug Administration (FDA) as they stated: “although the use of ozone cleaners by device users may have exacerbated the degradation of the PE-PUR foam, evidence indicates that the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents, nor did the use of ozone to clean the products constitute a failure to exercise due care” – May 2022.

Philips conducted testing on SoClean devices between 2017 to April 2018. A Philips employee familiar with the testing stated: “Early signs were favourable that SoClean did not affect our DreamStation devices.”

It was also discovered that Phillips recalled 20 serial numbers for different products, including products incompatible with the SoClean sanitiser. The Food And Drug Administration found that Philips initiated no formal investigation, risk analysis, or corrective measures in response to at least 222,000 complaints between 2008 and 2017 that “could potentially be related to foam degradation.”

The misleading and dishonest information regarding SoClean has led to CPAP users avoiding purchasing the device. 

SoClean’s response

SoClean 2 CPAP Sanitiser in use on a bedside table.
SoClean 2 CPAP sanitiser in use on a bedside table

The statements made by Phillips ultimately led to SoClean losing thousands of customers.

SoClean responded to Phillips’s statements: “While it was suggested the foam degradation may be exacerbated by using an ozone cleaner, almost 90% of the products being recalled have no connection to an ozone cleaning device. The lawsuits have not been properly investigated, have no basis in fact, and are without any legal merit.”

SoClean CEO Robert Wilkins expressed how SoClean intends to “restore its hard-earned reputation, and correct the record for a consuming public that has been intentionally misled by Philips.” 

Prior to Philips’ statements, SoClean enjoyed an exceptionally high customer satisfaction rate, with more than 90% ranking their experience with SoClean as “Very Satisfying” or “Extremely Satisfying.” 

To find out more about adding the SoClean sanitiser to your CPAP cleaning routine click here.

If you need any guidance or help please contact us to speak with one of our friendly team.

Author daniellemyatt