CAMBRIDGE, Mass. – There’s only a “small risk” that the sound abatement foam in the first-generation DreamStation is being compromised by outside factors, including ozone cleaners, but Philips has chosen to be proactive and fix or replace these CPAP devices in the U.S., says CEO Frans van Houten.
The occurrence rate of deterioration of the foam is about 0.03%, based on internal user reports and testing, the company says.
“The use of ozone is typically a U.S. issue and then within the U.S. it is related to certain regions where certain companies have been very active in marketing that method,” said van Houten during a recent conference call to discuss the company’s first quarter financial results. “The FDA put out a safety notice to say don’t use ozone for sleep apnea machines. Nevertheless, we cannot control that. Our prime concern is,& let’s take this small risk out of the market and deal with it proactively.”
The FDA in 2020 issued a safety communication informing patients and health care providers that devices to clean, disinfect or sanitize CPAP devices or accessories using ozone gas or ultraviolet light are not legally marketed for this use, so their effectiveness is unknown.
Being proactive will come at a cost for Philips, which has set aside EUR 250 million as a result of its decision to stop production of the first-generation DreamStations and to fix or replace those units already in the market, even if they don’t have “symptoms.”
“The installed base is very high, given that Philips is the market leader in sleep apnea,” van Houten said. “There are several millions (of these devices) out there and that relates to the magnitude of the provision.”
Philips has engaged the relevant regulatory agencies, but the company maintains that the first-generation DreamStations are safe to continue to use to the best of its knowledge and that the recently launched second-generation DreamStations are not affected at all because they have a different design.
“If the discussion with regulators leads us to a different conclusion (about the first-generation DreamStation), then that can change,” van Houten said. “But at this time, we think that this is the best course of action.”
Around the same time the FDA published its safety communication, manufacturers of CPAP devices advised their provider customers that using ozone to clean their products could affect warranties, and manufacturers of cleaning devices notified their provider customers that they would replace or cover the cost of replacing damaged products.
“What is the root cause and why did people choose a certain way of cleaning the device – that can be an endless debate,” van Houten said. “At this time, that should not be the debate. We should just deal with the issue and then later on we can sort out how this came about.”