The Philips Respironics Recall of Ventilators and Positive Airway Pressure Machines—Breakdowns in Medical Device Surveillance

Abstract

Philips Respironics (Philips) initiated one of the largest medical device recalls in history, affecting more than 10 million devices in the United States and 15 million devices worldwide. 1 Philips recalled 14 models of ventilators and positive airway pressure machines (both bilevel positive airway pressure [BPAP] and continuous positive airway pressure [CPAP] machines) using polyester-based polyurethane (PE-PUR) sound abatement foam owing to concerns that foam degradation could harm patients through inhalation of toxic particles and emissions. The US Food and Drug Administration (FDA) categorized this recall as Class I (the most severe designation), indicating reasonable probability that device use could cause serious adverse health consequences or death.In April 2022, Philips received a subpoena from the US Department of Justice for information on events leading to the recall, and as of July 2022, the company was in discussions "regarding the terms of a proposed consent decree to resolve the identified issues." 2 In August 2022, the FDA reported that it had received more than 69 000 reports of adverse eventsincluding cancer, pneumonia, and chest pain-and 168 reports of death linked to the recalled devices. 1 This ongoing public health crisis highlights the need for reforms to medical device regulation in the US to better protect patients.

Adding device identifiers to claims forms—a key step to advance medical device safety

“…3 Patients are left behind during recalls if regulators cannot rapidly identify safety concerns with a specific model. 4 Adding device identifiers to claims forms would be a significant step for improving the timeliness of post market surveillance.…”

Recall of Philips Respironics Ventilators and CPAP Machines—Breakdowns in Medical Device Surveillance

“…To the Editor Dr Kadakia and colleagues described the recall of Philips Respironics (Koninklijke Philips NV) ventilators and continuous positive airway pressure (CPAP) machines and the failure of the US Food and Drug Administration (FDA) to conduct adequate postmarket surveillance. There have been more than 69 000 adverse event reports regarding soundproofing foam in the company’s CPAP machines and other products…”

Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance—Reply

“…Rathi’s larger point still stands that using device clearances as the unit of observation in empirical work will always be imperfect; being unable to identify truly duplicative 510(k) clearances does not mean such clearances do not exist. Ideally, rather than using clearances, researchers could track devices via unique device identifiers (UDIs), as called for by Rathi and others . Using UDIs to identify devices would allow researchers to explicitly describe different device models in circulation, the number of devices in circulation, and which devices were included in recalls.…”