Philips Respironics has announced major changes to the product portfolio it will sell in the United States going forward.
As part of the changes, Philips has “streamlined” its portfolio, enabling the company to focus on programs best-suited to changing market dynamics. The changes, Philips noted in a Jan. 25 announcement, will also help it “most effectively” serve patients and customers moving forward.
“In the U.S. and U.S. territories, Philips Respironics will focus on the sale of consumables and accessories, including masks, and will not return to the sale of hospital ventilation products, certain home ventilation products, portable and stationary oxygen concentrators and sleep diagnostic products,” the announcement stated.
Founded in 1891, Philips, with global headquarters in Amsterdam, originally focused on incandescent light bulbs before branching out to consumer electronics, then people-centric health technology.
To accompany the announcement, the manufacturer provided a list of affected products.
On Jan. 29, Philips said it had reached an agreement “on the terms of a consent decree with the U.S. Department of Justice representing the U.S. Food & Drug Administration (FDA),” the company said. “The consent decree primarily focuses on Philips Respironics’ business operations in the U.S. Until the relevant requirements of the consent decree are met, Philips Respironics will not sell new CPAP or BiPAP sleep therapy devices or other respiratory care devices in the U.S.”
End-of-service support to continue
In the announcement, Philips said it would continue “to support customers and patients through the end of service for these products, as well as products that will continue to be actively sold.”
A list of discontinued products, which accompanied the announcement, showed end-of-service dates five years after the shipment discontinuation date, with the exception of V60/V60Plus ventilators, which showed an August 2022 shipment discontinuation date and a December 2029 end-of-service date.
Several products showed shipment discontinuation dates of Jan. 25, the day of Philips’ announcement. Those products were the Alice 6 and Alice NightOne sleep diagnostic machines, DreamStation Go portable PAP system, EverFlo home oxygen system, OmniLab Advanced+ titration system, SimplyGo and SimplyGo Mini portable oxygen concentrators, and Trilogy EVO and EV300 home ventilators.
Philips said the discontinued list only includes products that are within their current service lives.
“Customers will be contacted directly regarding any order cancellations resulting from our portfolio changes,” the announcement said.
The 2021 Philips Respironics Recall
The announcement added that the portfolio changes “will not affect our commitment to the remediation of devices impacted by the June 2021 recall of certain CPAP, BiPAP, and mechanical ventilator devices.”
That voluntary recall and field safety notice was implemented “to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices,” the company said at that time.
PE-PUR foam was used to reduce sound and vibration from the affected devices. A November 2021 letter to patients who used the impacted products said the recall was due to the possibility that the foam “may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user” and that the foam “may off-gas certain chemicals,” which could happen “during initial operation and may possibly continue throughout the device’s useful life.”
The letter added that the PE-PUR foam’s degradation or off-gassing “can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.”
Philips Respironics said it had “received complaints” about “black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask.” The company said risks of being exposed to the particles include skin, eye, and respiratory tract irritation, inflammation, headache, asthma, impact on other organs such as the kidneys and liver, and carcinogenic effects.
Off-gassing risks include headache; dizziness; irritation to the eyes, nose, respiratory tract, and skin; nausea; vomiting; and carcinogenic effects.
Based on the results from independent laboratory testing since June 2021, Philips Respironics said it and third-party experts “concluded that use of the sleep therapy devices is not expected to result in appreciable harm to health in patients. Further testing related to the sleep therapy and ventilator devices remains ongoing.”
The company added that in October 2023, it agreed to recommendations from the FDA to carry out additional testing on Philips Respironics sleep and respiratory devices “to supplement current test data.” Philips Respironics said at the time that it was in discussions with the FDA on the details of further testing.
In the Jan. 25 announcement, Philips Respironics said it had “remediated” more than 99 percent “of the sleep therapy device registrations that are complete and actionable.” That remediation consisted of replacing the PE-PUR foam “with new silicone sound abatement foam through a comprehensive repair involving the replacement of several components or a replacement of the device.”
