The Department of Justice recently took decisive action against Philips, filing a consent decree of permanent injunction in response to the ongoing recall of sleep apnea and respiratory devices. This move, aimed at ensuring patient safety and regulatory compliance, imposes restrictions on Philips, preventing the company from producing or selling new continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines in the United States until specific conditions are met. The decree also imposes restrictions on exporting devices intended for U.S. patients affected by the recall, emphasizing the prioritization of remediation efforts for domestic users over commercial distribution abroad.
This consent decree, which has been finalized and filed in the U.S. District Court for the Western District of Pennsylvania, is a culmination of the FDA’s efforts to address the serious concerns surrounding Philips Respironics’ operations in the United States. The agreement outlines clear mandates for Philips, showing the severity of the situation and the necessity for thorough remediation measures. By targeting Philips Respironics’ facilities across Pennsylvania, including manufacturing sites, service centers, and headquarters, the decree ensures that the company’s operations are closely scrutinized to prevent further lapses in regulatory compliance.
The beginning of the recall dates back to June 2021 when Philips initiated the recall of respiratory devices due to concerns over the breakdown of foam used in the devices, posing potential health risks to users. The recall, affecting over 15 million devices globally, prompted an extensive investigation by the FDA, which uncovered violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the FDA’s inspection revealed deficiencies in meeting good manufacturing practice requirements and a lack of transparency in disclosing device corrections. These findings outlined the urgent need for corrective action to protect patient safety and uphold regulatory standards.
As part of the consent decree, Philips is mandated to implement a Recall Remediation Plan in collaboration with the FDA. This plan, which is tailored to different device types, outlines specific remediation options and timelines for completion to ensure timely assistance to affected patients. The decree introduces new provisions, such as a remediation payment option for recalled devices, signaling a departure from traditional enforcement measures. By prioritizing patient relief and offering innovative solutions, the FDA aims to address the challenges posed by the recall effectively.
To address concerns regarding the safety and efficacy of replacement materials, Philips is required to engage an independent testing expert to evaluate the new silicone-based foam intended to replace or rework affected machines. Additionally, the company must retain an independent expert to inspect its sleep and respiratory care facilities outside Pennsylvania, ensuring compliance with federal regulations. These measures outline the FDA’s commitment to upholding patient safety and holding manufacturers accountable for ensuring the effectiveness of medical devices.
Despite these challenges, Philips remains committed to servicing existing devices and providing accessories and replacement parts to customers in the United States. While sales of respiratory devices are halted under the decree, the company continues to operate globally, subject to compliance with regulatory requirements. As efforts to rectify the recall unfold, the FDA emphasizes its dedication to safeguarding patient interests and maintaining the integrity of the medical device industry.
