Philips issues urgent product defect correction
Philips is conducting an urgent product defect correction to ensure patient safety, in consultation with the Therapeutic Goods Administration (TGA). The correction addresses identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices.
The majority of the affected devices within the advised five-year service life are in the first-generation DreamStation product family.
Corrective actions include the deployment of updated instructions for use and a repair and replacement program for affected devices. Philips aims to address all affected devices within the scope of this correction.
Globally, Philips has produced millions of Bi-Level PAP, CPAP and mechanical ventilator devices using the PE-PUR sound abatement foam. Despite a low complaint rate (0.03% in 2020), based on testing, Philips determined that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by the use of unapproved cleaning methods, such as Ozone*; and high-heat and high-humidity environments may also contribute to foam degradation.
Following consultation with the TGA, Philips is undertaking an urgent product defect correction to inform patients and customers in Australia of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken.
“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,” Royal Philips CEO Frans van Houten said.
“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.”
Urgent product defect correction advice for patients and customers
Based on the latest analysis of potential health risks, the product defect correction advises patients and customers to take the following actions:
- For patients using affected BiLevel PAP and CPAP devices: stopping treatment suddenly could have an immediate and detrimental effect on patient health. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options.
- For patients using affected life-sustaining mechanical ventilator devices: do not stop or alter your prescribed ventilator therapy. Make an appointment with your physician to discuss whether it is safe to stop therapy or if an alternative ventilator option is required. Philips recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.
Philips has established a registration process that provides instructions on how to locate an affected device serial number and will guide users through the registration process. To register affected devices, patients, users, or caregivers are advised to log on to the product correction website: www.philips.com/SRC-update.
Possible health risks
The company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which it operates. To date, there have been no reports of death as a result of these issues. Philips has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. Philips has received no reports regarding patient impact related to chemical emissions.
Repair and replacement program
In Australia, Philips is working with the local regulatory agencies on the launch and implementation of the permanent corrective action.
The company will replace the current sound abatement foam with new material and has already begun the preparations, which include obtaining the relevant regulatory clearances. While Philips aims to address all affected devices in the scope of this correction, the company is currently unable to confirm the repair or replacement timeframes and will do so when this information is available.
Consumer law rights under the Australian Consumer Law are in addition to any remedy that Philips may provide.
For more information on the status of the product defect correction as well as instructions for customers, users, and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update.
*Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication.
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