Philips has agreed to the terms of a consent decree related to the American business operations of Philips Respironics.
“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.,” the company said in a Jan. 29 announcement.
Reduction in product portfolio
The consent decree announcement followed a Jan. 25 bulletin from Philips Respironics that said it was reducing its product portfolio going forward. The company “will not return to the sale of hospital ventilation products, certain home ventilation products, portable and stationary oxygen concentrators and sleep diagnostic products,” that bulletin said.
In June 2021, Philips Respironics announced a voluntary recall of CPAP, BiPAP, and mechanical ventilator products that used sound-abatement polyester-based polyurethane (PE-PUR) foam.
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 recall and field safety notice was implemented “to address potential health risks related to the PE-PUR sound abatement foam in these devices,” the company said at that time. Degraded PE-PUR foam could be inhaled or ingested by device users, and the foam could off-gas harmful chemicals, all of which could potentially lead to a range of patient symptoms, from irritation to the eyes, skin, or respiratory tract, to impact on organs such as the kidneys and liver.
Philips: Service for devices will continue
The bulletin noted that the consent decree “is being finalized and will be submitted to the relevant U.S. court for approval.”
The consent decree is from the U.S. Department of Justice on behalf of the U.S. Food & Drug Administration (FDA), and it “primarily focuses on Philips Respironics’ business operations in the U.S.,” the announcement from Philips said.
Philips Respironics “will continue to service sleep and respiratory care devices already with healthcare providers and patients, and supply accessories (including patient interfaces), consumables (including patient circuits), and replacement parts (including repair kits),” the announcement added.
Internationally, Philips Respironics will provide new sleep and respiratory care devices, accessories, consumables, and replacement parts and services, “subject to certain requirements,” the company said.
Philips said agreeing to the consent decree is “providing clarity and a roadmap to demonstrate compliance and to restore the business.”
Philips’ CEO speaks out on consent decree, sales growth
Roy Jakobs, CEO of Royal Philips, addressed the consent decree as part of the Jan. 29 announcement of Philips’ sales results.
“Our strong results in 2023 were driven by solid execution of the first year of our three-year plan to create value with sustainable impact,” Jakobs said. “While there is more work to be done, the progress we achieved in a volatile world lays a solid foundation for sustained performance.”
He also acknowledged the impact of the 2021 device recall. “Patient safety and quality remain Philips’ highest priority across the company, “ Jakobs said. “Resolving the consequences of the Respironics recall for our patients and customers is a key focus area, and I acknowledge and apologize for the distress and concern caused. We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”
The CEO said Philips is improving supply chain reliability and has taken steps to “simplify our organization.”
The latest announcement said Philips would release additional details once the consent decree is finalized.