December 21, 2022 - Update on completed testing for first-generation DreamStation devices Based on the extensive testing and analysis that we have done over the past 18 months – working with five independent certified laboratories, as well as third party experts and physicians - we now have a complete set of results** for the first-generation DreamStation devices.
Jan Kimpen, Chief Medical Officer, discusses what the test results mean for healthcare providers and their patients
Jan Bennik, Head of Test and Research Program, explains the details behind the testing results
** Philips Respironics has provided the data and analyses to the FDA and other competent authorities. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions. Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented here. Philips Respironics’ guidance for healthcare providers and patients remains unchanged. Philips Respironics will continue with the remediation program.
November 23, 2022 - Philips provides an update related to Trilogy 100/200 repairs These problems do not affect any of the CPAP or BiPAP sleep apnea devices that have been remediated.
Philips Respironics has detected two problems with corrected Trilogy 100/200 ventilators following a limited number of complaints from the US and Japan.
July 25, 2022 - Summary of a systematic literature review of Positive Airway Pressure device use and cancer risk
Philips Respironics engaged external scientific experts to perform an independent systematic literature review of epidemiological studies to evaluate whether use of Continuous or Bilevel Positive Airway Pressure (PAP) devices increases the risk of cancer in obstructive sleep apnea (OSA) patients.
Based on 13 epidemiological studies identified from the 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 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.
June 28, 2022 - Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program.
Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice
Technical Project Manager Jan Bennik speaks about the test and research program
May 24, 2022 - An analysis was published online in the European Respiratory Journal that concluded that sustained and adherent CPAP therapy of OSA using Philips Respironics devices, compared with other manufacturers’ devices, was not associated with an increased risk of cancer after a median follow-up time of 7.2 years. The analysis and conclusion were based on data from a large multicenter cohort study involving 4,447 OSA patients on CPAP devices between 2007 and 2018, including 1,648 Philips Respironics CPAP users. Philips Respironics was not involved in the study or the analysis.
Dec 15, 2021 - A completely independent Canadian study was published in the American Journal of Respiratory and Critical Care Medicine. This study did not show a higher risk in patients with CPAP compared to patients using a device from another manufacturer.
