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Testing results for affected devices

 

In June 2021, after discovering a potential health risk related to a part in specific CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (FSN 2021-05-A & FSN 2021-06-A). 

 

We continue to work with independent partners to conduct extensive testing and analysis of results on affected devices, including biocompatibility evaluations. 

 

Please check this page for updates frequently as we will add new testing results documents as they become available.

PE-PUR testing results and conclusions

We will continue to add up-to-date information within this section as new testing results become available.

Actualización de Philips Respironics sobre los resultados de las pruebas de PE-PUR y las conclusiones disponibles a fecha

 

16 de mayo de 2023

Actualización del 21 de diciembre de 2022 sobre las pruebas completadas en dispositivos DreamStation de primera generación

 

21 de diciembre de 2022

Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program

 

June 28, 2022

Philips Respironics Summary of PE-PUR Testing Results and Conclusions Available to Date

 

April 25, 2022

Other testing documents

Summary of a systematic literature review of Positive Airway Pressure device use and cancer risk

 

July 25, 2022

 

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.

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