Philips: recalled CPAPs unlikely to cause appreciable harm

Jan 09, 2024

May 16, 2023 By Sean Whooley

The Amsterdam-based medtech giant says third-party test results determined that issues around its respiratory devices are unlikely to cause appreciable harm to health. These now-completed risk assessments fall in line with results shared by Philips in late 2022. At that point, testing covered just over two-thirds of registered devices in the recall. To date, risk assessments are complete for approximately 95% of registered devices.

In a news release, CEO Roy Jakobs said Philips’ "first priority" remains the health and well-being of patients. He explained that the test and research program offers clarity on safety and helps provide replacement devices to patients.

"The third-party risk assessments for the sleep therapy devices presented today are positive and reassuring, and we are making good progress with the remediation of the affected devices," Jakobs said. "The relevant competent authorities globally, including the FDA, are still reviewing the test results and assessments. We share the same objective to ensure patient safety and quality in the delivery of healthcare, and we remain committed to working closely with these agencies. The completion of testing and remediation of the affected devices remain our highest priorities."

In 2021, Philips stopped taking orders of sleep therapy systems as it handled a Class I recall. The Respironics subsidiary recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines.

It attributed the recall to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam degradation, meaning foam particles could enter a device's air pathway. This could cause a range of potential health problems and toxic, carcinogenic effects for the user.

Recent developments in the recall include the FDA questioning the numbers provided by Philips for its device replacement program. The agency said Philips distributed considerably fewer remediated CPAPs and respiratory devices than the 2.46 million listed on its website.

Here's a timeline breaking down how the Philips recall unfolded.

The data came from testing evaluating exposure to particulate matter (PM) emissions or volatile organic compounds (VOCs). Results cover the following device categories (organized by air path design) followed by the type and amount of devices evaluated:

20 devices (VOC)

63 devices (PM)

21 devices (VOC)

96 devices (PM)

33 devices (VOC)

24 devices (PM)

4 devices (VOC)

8 devices (PM)

N/A (VOC)

N/A (PM)

3 devices (VOC)

6 devices (PM)

7 devices (VOC)

7 devices (PM)

7 devices (VOC)

7 devices (PM)

20 devices (VOC)

20 devices (PM)

Results demonstrated varying degrees of foam degradation, Philips said. Used devices ranged from no degradation visible to severe visible degradation. Testing intentionally exposed new devices and devices with lab-aged foam to significantly elevated temperatures and humidity to accelerate degradation. Based on the visual inspection of foam in first-generation DreamStation devices, the testing found low visible foam degradation.

Still, the company says expanded testing and toxicological risk assessments on multiple devices showed no appreciable harm to health from exposure to PM emissions or VOCs.

Philips said tested PM emissions of used devices with visible degradation proved not statistically different than PM emissions from used devices without degradation. According to the company, this suggests that degradation did not contribute to appreciable elevated levels of respirable particles.

According to the company, Ozone cleaning of these devices exacerbates foam degradation. However, this method also remains unlikely to result in harm to patients.

Philips Respironics continues to run various tests and analyses, the company said. That includes assessments for System One and DreamStation Go devices. It also extends to Trilogy 100/200 and OmniLab Advanced Plus ventilator devices. Those devices contain a different type of PE-PUR foam than first-generation DreamStation devices. Philips expects to provide an update on this testing in the third quarter of this year.

The company said patients currently using an affected sleep therapy device yet to be remediated or registered should register their devices to facilitate the remediation. Philips continues to advise patients using non-remediated devices to contact their physician or care provider. This enables them to decide on a suitable treatment, which could include stopping or continuing use of the affected device.

Philips advises patients to follow instructions and recommended cleaning and replacement guides. Ozone and UV light cleaning remain unapproved as cleaning methods for sleep therapy devices or masks. Patients should not use those methods to clean their devices.

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance, Respiratory Tagged With: Philips, Philips Respironics