SoClean issues field correction 

PETERBOROUGH, N.H. – SoClean on Nov. 16 issued an urgent medical device field correction that provides clarifications to the user manuals for its SoClean2 and SoClean 3 and notifies users of the availability of a hose and mask adapter for the maintenance systems. 

SoClean is revising its labeling to incorporate additional warnings and contraindications, as well as proper and consistent device setup instructions, including use of a hose and mask adapter to reduce potential risks associated with the previous device design and labeling. 

The company is also providing additional clarity and consistency regarding the systems not being intended to replace CPAP manufacturer cleaning instructions but rather to supplement cleaning for masks and tubing. 

The FDA on Nov. 21 also provided additional information on SoClean’s field correction. 

The company says it has received about 7,417 complaints – about 0.33% of all SoClean 2 and SoClean 3 units sold – that are due to improper setup, unauthorized device modifications and use by individuals for whom the systems are not recommended. Of those complaints, 334 were adverse events reportable to the U.S. Food and Drug Administration, with zero deaths. 

SoClean says common complaints include users not being able to set up or turn on the device; mildew smell in the hose; excessive ozone smell; cough; and exacerbation of preexisting condition(s). 

The company noted that, as stated in its user manual, persons with underlying lung diseases, such as asthma and COPD, and those with cardiovascular disease may be sensitive to ozone and should consult with their health care professional before using the systems.