- Philips is voluntarily launching a corrective action program. Action needed to partner with regulators to ensure patient safety
- Remedial action includes issue of updated device instructions for use and repair /replacement program
- Philips strives to take the above measures as quickly as possible on all devices
Amsterdam, The Netherlands - Continuing newsletter dated April 26, 2021, Philips announces the launch of a corrective action program for a range of devices for permanent positive airway pressure (CPAP), bi-level positive airway pressure (BiLevel PAP) and mechanical ventilation. The corrective action program aims to address the potential risks associated with polyester-based polyurethane foam (PE-PUR) used in some of these devices. Most of the devices affected by the problem within the stated five-year lifespan are from the first generation DreamStation product line.
Philips has manufactured millions of BiLevel Pap, CPAP and mechanical ventilation devices to date. Despite the low number of complaints about such devices (0.03% in 2020), Philips has used tests to determine the possible risks associated with sound attenuation foam. PE-PUR foam has the potential to break down into particles that can enter the airway of the device and which the user can swallow or inhale. Also, PE-PUR foam can release certain gaseous chemicals. Foam degradation can be exacerbated by the use of unapproved cleaning methods such as ozone cleaning * and the high temperature and humidity in the area where the device is used.
Philips has made the decision to voluntarily launch a corrective action program to educate customers and users about the potential health and clinical implications of patients and to share recommendations for corrective action.
“We deeply regret the inconvenience this has caused users of devices with this problem to take steps to maintain patient safety,” said Frans van Houten, CEO Royal </strong > Philips . - We are actively looking for ways to resolve this situation in close cooperation with regulators, our customers and partners. The measures we are proposing now include updating the instructions for use of the devices and launching a repair /replacement program for the devices. Patient safety is at the heart of everything Philips works ".
Corrective Action Program: Recommendations for Patients and Clients
Based on the analysis of potential risks to patients' health and for precautionary reasons, the corrective action program prescribes the following actions for patients and clients:
- For patients using devices BiLevel PAP and CPAP with identified problem : stop using the device and contact your healthcare professional or durable medical device provider to work with them to determine the best scenario for continuing therapy. If there is no alternative and you believe it is necessary to continue using your device, consult a healthcare professional to determine if you can continue with therapy and to assess the potential risks.
- For life-sustaining ventilator patients with identified problem : Do not stop or change prescribed therapy without consulting your doctor. Philips recognizes that alternative therapy options may not exist or may be limited for patients in whom ventilation is a lifesaving function. In some cases, interrupting therapy may be unacceptable. In these situations, the decision is made by the attending physicians, who determine the possibility of continuing therapy and assess the potential risks.
Potential Health Risks
The company continues to monitor complaints about potential security issues