SoClean: There is now a way to regulate performance

PETERBOROUGH, N.H. – SoClean’s Bob Wilkins says the company is trailblazing a new path for bacterial reduction devices for CPAP hoses and masks with its new clearance from the U.S. Food and Drug Administration. 

The company announced in August that its SoClean 3+ now has de-novo clearance from the FDA for use with CPAP accessories (two hoses ResMed ClimateLine Air tubing and SlimLine tubing) and one mask (ResMed Mirage FX mask) for the ResMed AirSense 10 CPAP device. 

Here’s what Wilkins, CEO, had to say about how, as part of the process, it worked with the FDA to create a new Class II category named “respiratory accessory microbial reduction devices” and why that’s so important. 

HME News: Why is the new category so important? 

Bob Wilkins: SoClean created such a big market when inventing our product to help CPAP users with equipment maintenance that it also generated a huge market for potentially unsafe copycat products. Prior to our de-novo clearance, there was no way to regulate product performance requirements. With this new category, that's now possible through FDA standards SoClean helped establish. 

HME: How does this new category give HME providers and CPAP users peace of mind, especially given the legal back-and-forth between SoClean and Philips regarding the safety of these types of devices? 

Wilkins: Consumers can have peace of mind knowing that it’s now possible to regulate product performance requirements through FDA standards that SoClean helped to establish for this new category. “Special controls,” usually device specific, are regulatory requirements designed to provide a reasonable assurance of safety and effectiveness for Class II devices and include performance standards, pre-market data requirements, guidance documents, special labeling requirements and post-market surveillance. 

HME: Why is the SoClean 3+ only approved for certain ResMed devices and accessories? 

Wilkins: Moving forward, SoClean is working to establish additional hoses and masks for use with the SoClean 3+ bacterial reduction device. 

HME: Why is hygiene so important to adherence for CPAP therapy? 

Wilkins: It’s always been an optional add on to the manufacturer’s cleaning instructions. Hand-washing removes organic material (like facial oil and residue), whereas the SoClean 3+ is intended to be used as an adjunct to achieve 99.9% bacterial reduction in CPAP hoses and masks, which is important in preventing bacteria from entering your airway during sleep or as you use your CPAP. This convenient system allows users to feel confident in the fact that they are consistently and easily reducing bacterial build-up in their CPAP hose and mask. 

HME: When will SoClean 3+ be available? 

Wilkins: Since SoClean just received clearance, units of the SoClean 3+ are not yet available. We will communicate to customers how to upgrade their current SoClean devices to a SoClean 3+ within the next 60 days. 

HME: Is the company’s strategy still to sell direct to consumers but also through the HME provider channel? 

Wilkins: Yes, we will sell directly to consumers on www.soclean.com and get the SoClean 3+ into the hands of DME providers as soon as possible.