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MedTech Outlook | Monday, June 28, 2021
Philips has used PE-PUR sound abatement foam in millions of Bi-Level PAP, CPAP, and mechanical ventilator devices. Despite a low complaint rate (0.03 percent in 2020), Philips discovered through tests that this sort of foam poses potential dangers to consumers.
FREMONT, CA: Royal Philips, a leading health technology, recently provided an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement. Within the recommended 5-year service life, the bulk of the impacted devices are from the first-generation DreamStation product family.
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Philips has used PE-PUR sound abatement foam in millions of Bi-Level PAP, CPAP, and mechanical ventilator devices. Despite a low complaint rate (0.03 percent in 2020), Philips discovered through tests that this sort of foam poses potential dangers to consumers. The dangers include the possibility that the PE-PUR foam will deteriorate into particles that will enter the device’s air channel and be eaten or breathed by the user and the possibility that the foam will off-gas certain chemicals. Unapproved cleaning procedures, such as ozone**, may aggravate foam degradation, and high heat and high humidity settings may also lead to foam degradation.As a result, Philips has decided to voluntarily issue a recall notification* to warn patients and customers of the potential consequences of this issue on patient health and clinical use, as well as guidance on how to proceed.
“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” said Frans van Houten, CEO, Royal Philips. “In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips.”
Recall Notification* Advise for Patients and Customers
The recall notification* encourages patients and customers to take the following actions based on the most recent analysis of potential health hazards and out of an abundance of caution:
For Patients Using Affected Bilevel PAP and CPAP Devices: Discontinue use of the device and work with the physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. If one needs to keep using the device because they do not have any other options, talk to the doctor about whether the benefits of continuing therapy with the device exceed the hazards listed in the recall notification.
For Patients Using Affected Life-Sustaining Mechanical Ventilator Devices: Do not discontinue or change the recommended therapy without first consulting the doctor. Philips acknowledges that alternate ventilator options for therapy may not exist or be severely limited for patients who require a ventilator for life-sustaining treatment or in circumstances where therapy disruption is undesirable. In many cases, the benefits of continuing to use these ventilator devices may exceed the hazards stated in the recall letter, at the discretion of the treating clinical team.
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