Dive Brief:
- The Food and Drug Administration has provided additional information about an urgent medical device field correction for products used to clean continuous positive airway pressure (CPAP) machines.
- On Nov. 16, SoClean announced a voluntary field action to address user complaints related to improper set-up and unauthorized modifications of cleaning machines. Philips has claimed that the use of ozone cleaners such as SoClean have contributed to the problems that caused its massive respiratory devices recall.
- The FDA followed up with a safety communication about the SoClean situation. The notice features a bulleted list of recommendations not included in SoClean’s correction filing. As part of the recall, SoClean will provide CPAP accessories and updated user manuals, according to the FDA notice.
Dive Insight:
SoClean sells equipment for maintaining sleep devices. After washing their CPAP devices, users put the mask in the SoClean chamber, connect the hose and turn on the machine. The SoClean machine uses ozone gas to kill bacteria and thereby clean the CPAP mask and hose.
SoClean has received 7,417 complaints “resulting from improper set-up, unauthorized device modifications, and use by individuals for whom the device is not recommended as indicated in the user manual,” according to its safety notice. The complaints equate to 0.33% of all the SoClean2 and SoClean3 units sold. SoClean said 334 complaints were FDA-reportable adverse events.
The complaints — none of which report deaths — communicate problems setting up and turning on the device, a mildew smell in the hose, excessive ozone smell, cough and the exacerbation of preexisting conditions. SoClean’s manual warns that people with lung and cardiovascular diseases may be sensitive to ozone.
To address the complaints, SoClean updated the warning and contraindications and set-up instructions in its manual. The company is also giving users a hose and mask adapter to enable cleaning without ozone entering the CPAP machine. The updated instructions cover the use of the adapter.
Days after SoClean issued the notice, the FDA published a safety communication about the correction. The agency published its communication to provide additional information, notably through a list of six recommendations for consumers, including to always use the hose and mask adapter, never connect SoClean to a CPAP device that is in use and read the new manual.
SoClean’s update comes two years after it sued Philips for $200 million in damages. The lawsuit claimed Philips made false and misleading statements about ozone cleaners that hurt SoClean's business. Philips filed motions to dismiss the case late last year.
