FDA Displeased with Philips CPAP Tests

FDA Displeased with Philips CPAP Tests

Introduction

Federal regulators have issued an update on a Philips CPAP recall issued in 2021, saying that they are “unsatisfied” with both the status of the recall and the manufacturer’s testing of the sound abatement foam that was found to breakdown and release particles directly into the sleep apnea machines’ air pathways.

On October 5, the U.S. Food and Drug Administration (FDA) released an update on the Philips CPAP recall, stating that they are continuing to monitor the recall's status more than two years after its initial announcement.

The recall has impacted millions of CPAP, BiPAP, and mechanical ventilators sold since 2009, all of which contained a flawed polyester-based polyurethane (PE-PUR) foam designed to reduce noise during machine use. However, consumers reported finding small black particles and debris in various parts of the machines, including tubes and face masks.

Due to the serious health risks associated with the Philips CPAP foam, consumers were advised to stop using their machines unless they were needed for life-supporting treatment. This has led to thousands of lawsuits being filed by former users who developed conditions such as cancer, lung damage, and other respiratory injuries after using the recalled devices.

The FDA's update emphasizes that they are actively monitoring the progress of the recall and providing new information to device users, patient care facilities, and other stakeholders. Furthermore, they express their dissatisfaction with the current status of the recall and their commitment to taking measures to safeguard the health and safety of individuals using these devices.

Following the recall, the FDA mandated that Philips conduct "extensive" testing on the sound-dampening foam to assess potential health risks associated with particles and volatile organic compounds (VOCs) released as the foam degrades.

However, the agency has expressed dissatisfaction with the testing conducted by Philips thus far and has called on the company to perform additional testing to more accurately evaluate the risks to CPAP users.

In the words of FDA officials, "The FDA has examined the information and data provided by Philips and believes that the testing and analysis shared by Philips to date are insufficient to comprehensively assess the risks posed to users by the recalled devices. Although Philips has concluded that the exposure to foam particles and VOCs from these devices is 'unlikely to result in appreciable harm to the health of patients,' the FDA believes that additional testing is warranted."