Medical Device Field Safety Notice (outside of U.S.)
Philips Respironics
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News and Updates > Tools and resources to support your patients
Tools and resources to support your patients
June 26, 2023
While we continue to progress throughout the remediation process, we want you to feel informed about the latest updates and be well-equipped with tools and resources to support your patients.
Resources available to support your patients in the use of their replacement devices
Helping your patients use their replacement device
Once your patient has received their replacement device, we want to make sure that they have the instructions they need to use their device. Please find our selection of resources available for replacement CPAP and BiPAP devices here.
Additional information for Home Care Providers (HCPs) and Clinicians
If your patient has received a DreamStation 2 as a replacement device
Our e-learning course includes helpful materials to become familiar with this solution
Stay informed of the latest testing updates
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. You can find the most up-to-date testing results here.
Understand the steps we take to ensure the safety of replacement CPAP or BiPAP devices
We understand that patients may have concerns around the safety of their devices, so we have outlined the steps we take to ensure their recertified first-generation DreamStation device is safe to use. Please find the full list of details, including a tutorial video, here.
** 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.
