Medovate secures CE Mark approval for five of SAFIRA’s components
Milton-based medical device development company Medovate has successfully secured five additional CE Mark regulatory approvals for its game-changing SAFIRA.
SAFIRA – SAFer Injection for Regional Anaesthesia – transforms regional anaesthesia into a one-person procedure, giving the anaesthetist full control of the injection at all times. It also includes a built-in safety mechanism to limit injection pressure helping to reduce the risk of nerve damage and promote patient safety. The device includes an NRFit syringe and a palm operator.
Medovate has now achieved CE Mark regulatory approvals covering five aspects of the SAFIRA: infusion driver, foot pedal, luer syringe, NRFit syringe and palm operator. These latest product range additions are intended to further improve patient safety and offer greater control
Stuart Thomson, managing director at Medovate, said: “Medovate is very proud to launch these next devices in our SAFIRA product range.
“We are now able to support healthcare providers with a complete solution to their regional anaesthesia needs with both hand and foot operators, and a SAFIRA syringe – whatever the stage in their transition from Luer to NRFit devices.”
The NRFit syringe provides a second option to the universal Luer connection syringes with which the system was originally introduced. It is recognised that Luer connectors carry the potential for medical tubing misconnections, which can lead to incidences of wrong route administration of medicines and gases. The NHS issued a Patient Safety Alert in 2019 to recommend and support the safe transition from the Luer connector to NRFit for the delivery of regional anaesthesia.
With the provision of a brand-new palm operator, Medovate hopes to offer anaesthetists more versatility and choice. The palm operator uses the same colour coding as the original foot pedal operator, which remains a key part of the product range for the infusion and aspiration of anaesthetics. The palm operator is ergonomically designed to comfortably fit under a surgical glove, within the palm of a hand.
The addition of a hand operator product range offers regional anaesthetists greater choice when using SAFIRA.
Alan Finnerty, Medovate’s technology director, said: “Medovate is dedicated to improving patient care.
“The extension of our CE certification to include these new devices is a significant milestone for the company, and testimony to the focus and commitment of the team.
“It also consolidates our unique offering to patients and anaesthetists across the globe, with safety remaining a top priority.”
More than 20 million regional anaesthetic nerve blocks are performed each year throughout the EU and US. As the use of regional anaesthesia continues to grow globally the option of using an NRFit syringe, together with either a foot or hand operator, with SAFIRA for regional anaesthesia procedures has the potential to make a significant impact on improving patient safety.