Abstract
The FDA beforehand issued a press release that ozone and UV mild merchandise should not accredited for shopper cleansing of CPAP equipment (masks, tubing). SoClean 2 and three gadgets underwent an 11/16/23 voluntary recall. The FDA posted an FDA SoClean security communication (12/4/23) with further recall suggestions. Unexpectedly, the FDA granted De Novo clearance for SoClean 3+ (8/12/24) as an over-the-counter gadget to be used as an adjunct to cut back bacterial populations with sure suitable CPAP masks and hoses. In accordance with the FDA clearance letter: “This gadget should not be used to interchange the cleansing procedures as beneficial by the CPAP masks and hose producers. SoClean 3+ has been examined to be used with ResMed Mirage FX (nasal masks), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for ResMed AirSense 10 CPAP gadget. The protected use of SoClean 3+ with another respiratory gadgets or equipment has not been established.”
Claimed Capabilities/Measurements
SoClean 3+ is the most recent SoClean gadget. SoClean gadgets clear CPAP masks and hoses utilizing ozone gasoline delivered through an ozone hose. In accordance with the web site, the filter converts the ozone contained throughout the Gadget Disinfector chamber again into oxygen following the cycle. Customers obtain alerts when the filter must be modified (~6 months). The Gadget Disinfector reportedly is not going to function a cycle if the Filter is expired, lacking, or inauthentic.
Mechanism
Ozone is used to wash CPAP equipment.
Sensors
None
Technical Concerns
None
Publications and Associated Abstracts
Quotation: Towle D, Baker V, Schramm C, O’Brien M, Collins MS, Feinn R, Murray TS. Ozone disinfection of dwelling nebulizers successfully kills widespread cystic fibrosis bacterial pathogens. Pediatr Pulmonol. 2018 Might;53(5):599-604. doi: 10.1002/ppul.23990. Epub 2018 Mar 15. PMID: 29542874.
DOI: https://doi.org/10.1002/ppul.23990
URL: https://onlinelibrary.wiley.com/doi/10.1002/ppul.23990
Trade Assist: No
Validation Research: Sure
Comparability Check(s): N/A
Research Abstract: Mouthpiece and nebulizer chambers have been contaminated with bacterial pathogens. Bacterial progress was decided after mock cleansing and after SoClean preliminary and repeated cleansing. 99.99% of (Staph and Pseudomonas) micro organism have been killed after preliminary cleansing. Over 250 hours of repeat ozone publicity didn’t change the outcomes. The authors concluded that SoClean has the potential for dwelling cleansing of respiratory gear. Though circuitously trade supported, the examine used 2 SoClean gadgets that have been donated by SoClean.
The submit SoClean 3+ Bacterial Discount Gadget appeared first on American Academy of Sleep Drugs – Affiliation for Sleep Clinicians and Researchers.
