Continuing to use an affected device, if a patient’s health care provider determines that the benefits outweigh the risks identified in the recall notification. 
Using another similar device that is not part of the recall. Our update in November 2021 provides broadened guidance regarding affected CPAP, BiLevel PAP and Mechanical Ventilator devices, and mechanical ventilators, as follows:įor patients using BiLevel PAP and CPAP devices, talk to a health care provider to decide on a suitable treatment for medical conditions, which may include:. If you have not done so already, please click here to begin the device registration process. As we continue to work through the voluntary recall, we assure you that we are fully committed to supporting all patients and will continue to partner with clinicians and business customers to complete recall efforts. 
The latest results of the testing and analysis we have done over the past 18 months can be found here. Since the recall, we’ve carried out a test and research program to learn more about the polyester-based polyurethane (PE-PUR) sound abatement foam, working with independent laboratories and third party experts and physicians. It is important that patients feel confident using their devices. With devices ready for patients, we are asking customers and clinicians to help get these devices to those who need them by reminding patients that they may need to take specific action in the Patient Portal to receive their replacement device. We are committed to completing the remediation of all registered devices and have substantially increased the production of replacement devices.
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