UK-based medical device development company Medovate announces that it has secured additional CE mark regulatory approvals for its SAFIRA® (SAFer Injection for Regional Anaesthesia) technology to include an NRFit syringe and a palm operator.
Within the last year, Medovate has achieved CE mark regulatory approval covering five devices in its SAFIRA range: an infusion driver, a foot pedal, a luer syringe, the NRFit syringe, and a palm operator. These latest product range additions are intended to further improve patient safety and offer greater control to anaesthetists.
The NRFit syringe provides a second option to the universal Luer connection syringes with which the system was originally introduced. It is recognized that Luer connectors carry the potential for medical tubing misconnections, which can lead to incidences of wrong route administration of medicines and gases. The UK-based National Health Service 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 new palm operator, Medovate hopes to offer anaesthetists more versatility and choice, company officials say. 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 fit under a surgical glove, within the palm of a hand. The addition of a hand operator product to the SAFIRA range offers regional anaesthetists’ greater choice when using SAFIRA.
According to Medovate’s technology director of Alan Finnerty, “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.”
So far, SAFIRA has been launched in the United States, Australia, and New Zealand. And, in June, it became available across Europe via Medovate’s distributor partner Vygon with both syringe options, Luer and the new NRFit. Further regulatory approvals for the palm operator are expected throughout 2021, which will enable the full SAFIRA product range to be made available in the United States and additional key markets as further distributors are appointed.