Makers of CPAP cleaners distance themselves from recall

PETERSBOROUGH, N.H. – SoClean is standing by its CPAP cleaning device, after Philips said “unapproved cleaning methods, such as ozone,” may be exacerbating the degradation of sound abatement foam in its first-generation DreamStation product family.  

Philips made the claim as part of a voluntary recall announced June 14 to address identified potential health risks related to the polyester-based polyurethane foam in certain Bi-Level CPAP, CPAP and mechanical ventilator devices.  

“Almost all the machines affected by this recall have no connection to an ozone cleaning device,” the company said in a statement. “SoClean stands behind its product and its use. SoClean will continue to monitor the situation and will provide further updates as needed.” 

Philips says potential health risks include that the foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. 

SoClean points out that, based on its market share data and the number of installed CPAP devices, the large majority of patients do not use the company’s cleaning device. 

“While SoClean would love for all CPAP users to use a cleaning device, nearly 80% of all CPAP users do not,” the company said. “Philips also notes that high heat and humidity environments may contribute to foam degradation.”  

Additionally, SoClean points out the recall also impacts certain vents, and SoClean does not make a cleaning device for vents. 

“Clearly this recall, by Philips’ own admission, was not precipitated due to the use of cleaning devices,” the company said. 

It’s not the first time SoClean and Philips have crossed paths over the use of ozone to clean CPAP devices. In early 2020, Philips said in a letter responding to a customer’s request for written guidance on the use of CPAP cleaning devices that using SoClean on its DreamStation would not automatically void the warranty, but that the company “reserved the right to void a warranty if it is determined that the use of SoClean caused a defect for which a device otherwise under warranty was returned.” 

Kyle Miko, vice president and chief marketing officer for VirtuOx, says Philips’ comments about the use of ozone do not apply to the company’s CPAP cleaning device, because its device does not attach to the CPAP. 

PJ Ruflin, vice president of business development for Sunset Healthcare Solutions, which launched a CPAP cleaning device last year, says the company is “listening to customers to ensure we understand the situation as best as possible and are doing what we can to assist them in managing it.” 

Jackson Buchanon, director of business development for Sleep8, says its cleaning device does not flow ozone over the foam in the CPAP. “We have been in contact with all of our DME partners and are focused on supporting them as they navigate this challenge.”

Responsive Respiratory Inc. says its Purify O3 and Purify O3 Elite are designed for disinfecting and deodorizing accessories like masks, tubing and humidification chambers and not CPAP devices. “This recall does not correlate to RRI’s family of Purify O3 devices,” it says.