Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse.
Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after its major ventilator recall.
In June 2021, Philips Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.
Philips said last year that it wasn’t taking orders for sleep therapy systems as it dealt with the Class I recall that knocked it out of the market for a year. In March, the FDA issued a notification order alerting Philips that its notification efforts on the recall of its ventilators had been inadequate to that point.
In April, the Amsterdam-based company revealed a Department of Justice subpoena for information related to the recall of its respiratory devices. The subpoena sought “information related to events leading to the Respironics recall.” Phillips said its subsidiaries are cooperating with investigators. A May update from FDA’s Center for Devices and Radiological Health (CDRH) proposed an order for Philips to submit a plan for the repair, replacement or refund of the purchase price of the recalled devices manufactured after November 2015.
The agency said last month that it received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown in Philips Respironics’ ventilator devices between April 2021 and April 30, 2022.
At the time of the initial recall notification, Philips Respironics relied on an initial, limited data set and toxicological risk assessment, according to a news release, assuming a worst-case scenario for the possible health risks out of an abundance of caution.
Together with five certified, independent testing laboratories in the U.S. and Europe, along with other qualified third-party experts, the company has conducted a comprehensive test and research program on the PE-PUR foam to better assess and scope the potential health risks related to possible emission of particulates from degraded foam and volatile organic compounds (VOCs).
Philips’ update today aims to provide healthcare providers, patients, and other stakeholders with updated information on the testing results to date. The overall guidance for providers and patients in the recall remains unchanged at present.
Testing results and conclusions covered five device categories, with the first-generation DreamStation devices representing 68% of the registered affected devices globally. The first-generation DreamStation, DreamStation Go and SystemOne CPAP/BiPAP devices represent 95% of the registered affected devices globally. Each device category included testing and analysis performed on new devices with pristine foam, devices with lab-aged foam and used devices.
Philips said that the methods included visual assessment of the foam in returned/used devices to assess the prevalence of visible foam degradation, VOC testing to identify and quantify organic compounds that may be inhaled during device use, particulate matter (PM) testing to determine concentrations of respirable particulates as well as additional physical, chemical and biological testing of the PE-PUR foam related to patient risks if patients were in contact with foam material.
For the U.S. and Canada, prevalence of visible foam degradation for the first-generation DreamStation saw 164 of 36,341 (0.5%) devices with self-reported no ozone use present significant visible foam degradation. Devices with self-reported ozone use were 14 times more likely to have significant foam degradation compared to those with self-reported no ozone use, as 777 of 11,309 devices (7%) showed significant foam degradation.
Philips said 422 devices of the inspected 60,847 returned/used devices are linked to a reported foam degradation complaint, but only 18 of the 422 devices (4%) actually showed visible foam degradation.
The company expects to complete the remaining VOC and PM testing for the affected devices, as well as the degraded foam toxicological risk assessment in the coming months. Philips Respironics will also continue to assess the impact of repeated oxone cleaning on foam degradation in the CPAP/BiPAP devices and the remaining VOC and PM testing and degraded foam toxicological risk assessments for its Trilogy 100/200 and OmniLab ventilator devices (3% and 2% of the affected devices, respectively).
“I deeply regret the concern experienced by patients who rely on the affected Respironics sleep and respiratory devices for their health and quality of life and want to emphasize our commitment to providing them with a resolution as fast as possible,” Philips CEO Frans van Houten said. “More than 1,000 of our colleagues are working extremely hard to achieve this. While certain prolonged tests across the affected product categories are still to be completed, the results to date for the first-generation DreamStation devices, which represent the majority of the registered affected devices, show a very low prevalence of visible foam degradation. In addition, the new and used first-generation DreamStation devices passed volatile organic compound and respirable particulate emission testing.
“This is very encouraging. Results to date also indicate that ozone cleaning significantly exacerbates foam degradation.”