Weather Update - January 21, 2022
Neurology & Sleep Associates plans to remain open as long as safe driving conditions allow. If you have an appointment scheduled with us for Friday, please first confirm that we are open before heading in. We will post on our Facebook page and website if we close.
Thank you and we hope everyone stays safe and warm!
Dr. Nanavaty and Staff (757) 967-0676 or (757) 934-1900
Sleep Patients with Obstructive Sleep Apnea (OSA) on Philips Respironics CPAP devices
Philips Respironics has released the following statement on December 2, 2021 regarding the CPAP recall:
To our valued customers:
Since we announced a recall of certain products in our Sleep & Respiratory Care portfolio on June 14, 2021, Philips Respironics has been working in close partnership with competent authorities around the world, as well as our customers, clinicians, and patients, to complete the needed repairs associated with this recall.
The U.S. Food & Drug Administration recently provided an update on this recall, having completed an inspection of a Philips Respironics manufacturing facility. The FDA shared its observations from that inspection with Philips, and we are working to respond in accordance with normal practice and timeline.
Importantly, in its observations from the inspection, the FDA has maintained its recommendations related to the continued use of devices for patients and healthcare providers. Philips does not anticipate delay to the recall or replacement program as a result of the FDA report.
Evaluations performed on the silicone-based foam in the DreamStation2 CPAP, repaired DreamStation CPAP/BiPAP devices, and a wide range of mechanical ventilators passed applicable testing. There was one test which the FDA reviewed during its inspection, on a device not currently marketed in the U.S., which is undergoing further analysis. Philips Respironics will also collaborate with the FDA on its request for additional testing.
On Tuesday, Nov. 16, Philips Respironics provided an update to the language included in the recall notifications that have been provided to customers in the U.S. This update aligns the language in the recall notifications to that of the current FDA recommendations. That update can be found at www.philips.com/src-update. For CPAP and BiPAP users, it includes an important update, recommending that they speak with their clinician to determine the risks and benefits of continued therapy on recalled devices. The updated recall notification can be found here.
The previous version of the Urgent Medical Device Recall directed patients to stop use, prior to consulting with their clinician. This update was made to align to the FDA’s recommendations, and to provide clinicians with a wider range of options to consider for each individual patient. The Philips Respironics recommendation for the recall notification on mechanical ventilators remains that patients should not stop or change ventilator use until they have talked to their health care provider.
Philips Respironics continues to focus its resources on the completion of the repair and replacement program. We are encouraged that more than 2 million devices have been registered for the recall by patients in North America, and the pace of our repair and replacement program, which received approval from the FDA on Sept. 1, is accelerating. While we have made progress, we recognize it cannot happen fast enough.
We look forward to sharing additional information with our customers in the days ahead and continuing to partner with you to complete this program.
If you have any questions, regarding your CPAP device, please contact your DME company or our offices.