The Food and Drug Administration (FDA) has recently issued warning letters to four companies concerning their marketing of devices intended to clean continuous positive airway pressure (CPAP) machines. These devices, which claim to employ methods such as ozone gas or ultraviolet (UV) light, lack FDA clearance or approval. Specifically, the FDA has advised that it has not authorized any devices for cleaning or disinfecting CPAP machines. It also highlighted that ozone can be harmful, especially at concentrations high enough to effectively kill bacteria, and can exacerbate respiratory diseases. UV light, while alternative, comes with risks of burns or eye damage.
The companies that received the FDA’s warnings in August are Leel Tech, Natures Pillows and Top Dog Direct, Adventure Innovations, and Shenzhen Moyeah Intelligent Life Technology. Leel Tech responded to FDA’s prior contact by stating that they act as an agent for CPAP cleaner machines rather than manufacture them directly. Leel plans to sell off its remaining stock. Natures Pillows, after a similar previous encounter with the FDA in 2021, argued that its ozone cleaners should be exempt from stringent regulatory requirements, a claim with which the FDA disagreed.
Adventure Innovations and Shenzhen Moyeah have both asserted their stance against FDA’s classification of their products as medical devices, with Shenzhen Moyeah failing to respond to the FDA’s communications.
These communications culminated in the FDA’s issuance of warning letters in 2023, requesting that the companies cease distribution of the unapproved and falsely marketed products. The major concern is that these devices can misbrand or adulterate the CPAP machines.
Further scrutiny of such cleaning devices was heightened after Philips’ 2021 recall of over 15 million respiratory devices. Philips cited concerns that ozone cleaners could degrade soundproofing foam in its devices, potentially causing users to inhale harmful particles. Following the recall, Philips has undertaken extensive efforts to resolve the issues, including reaching considerable civil settlements and agreeing to stop sales of most respiratory machines in the U.S. under a consent decree with the Department of Justice.
The interaction with ozone cleaners was certain to exacerbate deterioration of the foam under hot and humid conditions, as per the FDA’s notes in the recall. Philips is also in litigation, having countersued SoClean, another CPAP cleaner manufacturer. Philips alleges that SoClean’s machines were sold without appropriate FDA approvals and were marketed as compatible with its devices, contributing to the need for a substantial personal injury settlement Philips agreed to earlier due to damages claimed by users of its respiratory devices.
In an interesting turnaround, the FDA did clear the SoClean 3+ device in August to reduce bacteria on certain masks and hoses after cleaning. However, the FDA reiterated that external machines are not required for cleaning CPAP devices as routine soap and water are usually sufficient for most accessories.
This tightening of regulations and oversight underscores the FDA’s ongoing commitment to ensuring the safety and efficacy of medical devices. The reliance on regulatory compliance ensures that products used in healthcare settings, particularly for conditions such as sleep apnea treated by CPAP machines, do not pose additional risks to users.
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