FDA Approves ReddyPort® Non-Invasive Ventilation Device
Wednesday, July 19, 2023
ReddyPort, a medical device company, has recently received 510(k) premarket clearance from the US Food and Drug Administration (FDA) for its ReddyPort elbow device used in non-invasive ventilation (NIV). The ReddyPort elbow features a self-sealing valve that allows oral access to the patient's mouth without the need for mask removal. This design helps maintain therapeutic pressure and lung compliance while reducing the risk of complications.
One of the key advantages of the ReddyPort elbow is its ability to facilitate oral care without removing the mask. Bedside clinicians can use ReddyPort's oral care appliances, such as toothbrushes, Yankauers, suction swabs, and applicator swabs, for routine oral care and dry mouth relief. This eliminates the need for unplanned mask removal, which can lead to issues like poorly fitted masks, pressure injuries, and time-consuming re-fitting processes.
Moreover, the ReddyPort elbow enables patients and clinicians to utilize the ReddyPort microphone. This microphone amplifies speech tones while minimizing background noise, improving communication between patients and caregivers. The Joint Commission recognizes the importance of patient communication rights and encourages healthcare providers to facilitate effective communication between patients and their families.
Non-invasive ventilation (NIV) is a crucial therapy for respiratory insufficiency or failure seen in conditions like COPD, CHF, asthma, pneumonia, and ARDS. However, NIV can be challenging due to issues such as dry mouth, biofilm formation, skin breakdown, and difficulty communicating. The ReddyPort elbow aims to address these challenges and improve NIV outcomes.
The ReddyPort elbow has already been used under FDA Emergency Use Authorization (EUA) to provide 45,000 compliant oral care sessions to patients. The FDA clearance for the ReddyPort elbow marks an important milestone for ReddyPort and offers healthcare professionals a valuable tool in non-invasive ventilation.