US-based medical equipment manufacturer ReddyPort has received the US Food and Drug Administration (FDA) 510(k) approval for its non-invasive ventilation (NIV) device, ReddyPort elbow.

The ReddyPort elbow features a self-sealing valve that provides uninterrupted oral access to the patient’s mouth without the need for mask removal.

The NIV device enables bedside clinicians to use oral care appliances for routine oral care and dry mouth relief and allows patients and clinicians to use the ReddyPort microphone.

The Joint Commission, baked by the Patient’s Bill of Rights, protects every patient’s ability to communicate with family members and caregivers.

ReddyPort microphone is designed to amplify audible speech tones while reducing background noise, to help patients regain their ability to communicate with caregivers and family members.

The device minimises un-planned mask removal, which often leads to improper fitting of masks, pressure injuries and re-fitting processes, and maintains lung compliance, said the company.

ReddyPort CEO Tony Lair said: “ReddyPort’s patented elbow is central to the eco-system we are building to help mitigate clinical obstacles tied to NIV therapy from dry-mouth, oral biofilm accumulation to speech recognition.”

According to the company, NIV is the first line of therapy commonly used for the treatment of COPD, CHF4, Asthma, pneumonia or ARDS, and to wean patients off mechanical ventilation.

The most common reason for NIV therapy failure is the mask causing persistent dry mouth, formation of biofilm, skin breakdown and difficulty communicating.

When NIV failure occurs, patients are transitioned to invasive ventilation, which is associated with high costs, prolonged stay and diminished outcomes.

Also, the Q2 or Q4 oral care protocols performed on ICU patients are compromised by mask removal that results in alveolar collapse decline in the respiratory status of the NIV patient.

ReddyPort said that its elbow device promotes NIV success by enabling clinicians to provide oral care without removing the mask or loss of therapeutic pressures.

Furthermore, the company claimed that its ReddyPort elbow device has safely delivered 45,000 oral care sessions to patients under FDA Emergency Use Authorisation (EUA).