Nov 22, 2022
Philips Respironics provides update on filed MDRs in connection with the voluntary recall notification/field safety notice* for specific CPAP, BiPAP and mechanical ventilator devices
Amsterdam, the Netherlands – In June 2021, Royal Philips’ (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, initiated a voluntary recall notification in the US/field safety notice in other countries for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and mechanical ventilator devices.
At the time the recall notification/field safety notice* was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a reasonable worst-case scenario for the possible health risks. Following Philips’ public statements on the issue and possible risks to users in April 2021, and the announcement of the recall notification/field safety notice in June 2021, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation.
This led to a steep increase by more than 20,000 Medical Device Reports (MDRs) filed by Philips Respironics to the FDA between April 2021 and April 2022. In the following 6 months through October 2022, Philips Respironics filed an additional approximately 70,000 MDRs. The vast majority (93%) of the approximately 90,000 MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury. It is important to note that the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event, and that the cause of an event cannot typically be determined from this reporting system alone. Philips Respironics investigates all allegations of technical malfunction, serious injury or death.
Third-party epidemiological studies
In July 2022, Philips Respironics published a summary of a systematic literature review of Positive Airway Pressure (PAP) device use and cancer risk: Based on 13 epidemiological studies identified from a systematic literature review, no association has been established between use of PAP devices, including Philips Respironics PAP devices, and risk of cancer in patients with obstructive sleep apnea (OSA). Two rigorous independent studies showed no statistical difference in cancer risk between OSA patients who used Philips Respironics PAP devices versus other brands of PAP devices. Eleven other epidemiological studies provided little additional insight into this question, but their results generally suggested no excess risk of cancer associated with PAP use for OSA.
* Voluntary recall notification in the US/field safety notice outside the US.
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 79,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
