ProPublica and the Pittsburgh Post-Gazette published a report on Sept 27 that alleges Philips Respironics began receiving complaints of issues with the devices in 2010 but failed to report the majority of these warnings to the US Food and Drug Administration.
That same day, a similar report was published by NRC in the Netherlands.
“The articles do not present new facts, and we do not agree with the characterizations made in these articles,” says Philips in a statement.
Philips continues in the statement, “Philips’ priority is patient safety and quality. We understand how important Philips Respironics’ sleep therapy devices and ventilators are to patients that use them. Philips regrets any distress and concern for patients, their families, and care providers in this matter and deeply apologizes for this. Philips acted to protect patient safety by initiating and executing a voluntary recall notification/field safety notice of significant scale. We continue to dedicate all available resources to ensure that patients receive remediated devices.”
Philips says in the statement that it previously responded to ProPublica and the Pittsburgh Post-Gazette in the United States and NRC in the Netherlands.
The company notes that the remediation of the sleep therapy devices is nearing completion, while the remediation of the affected ventilators is ongoing.
“Everyone at Philips is committed to achieving and maintaining the highest standards, building on a culture of integrity and compliance,” says the company in the statement.
Last month, Philips reached an agreement to resolve all economic loss claims related to Philips Respironics’ voluntary recall of certain sleep and respiratory care devices.