Patient safety at forefront of two new medical devices for Regional Anaesthesia

6th June, 2019

The challenge

Current regional anaesthesia procedures require two users, an Anaesthetist and assistant. An Anaesthetist holds an ultrasound scanner in one hand and a regional anaesthetic needle in the other. Using the ultrasound scanner to guide needle tip placement, the Anaesthetist instructs the assistant to inject the anaesthetic solution. Studies have shown that anaesthetic solutions injected at high pressure causing damage to nerve fascicles, with serious nerve damage occurring in up to 1% of procedures and transient nerve damage in up to 8% of cases.

Two new devices, SAFIRA®(SAFer Injection for Regional Anaesthesia) and RADS (Regional Anaesthesia Delivery System), both invented by NHS clinicians, have been designed to increase patient safety when carrying out regional anaesthesia procedures by controlling the injection pressures.

Comprehensive usability studies promote patient safety

A key part of the product development process for any new medical device is comprehensive usability studies.

Medovate selected MedXpress.Pro, a company specialising in education and patient safety for ultrasound-guided interventional procedures, to supply simulators for use during usability studies for RADS and SAFIRA®.

Through this working partnership, both new systems are undergoing comprehensive tests, using tools that effectively replicate real life clinical settings, before the next stage of product testing involving clinical trials with patients, keeping patient safety at the forefront of the development process.

Medovate procured two MedXpress.Pro NYSORA SIMULATORS™ as part of conducting usability studies for the RADS and SAFIRA® projects. The training mannequins have been used by NHS clinicians to test new device key features: the injection system and injection pressure measurements.

"We are keenly focused on bringing devices to market that improve patient safety. Part of this commitment is ensuring the device testing stage of the development process is adequately robust. Using these anatomically representative simulators with practising regional anaesthetists in during our usability studies enables greater understanding of the clinical procedure and device operation, ensuring we thoroughly evaluate safety and performance of RADS and SAFIRA® prior to progressing to clinical studies in patients."

Stuart Thomson, Managing Director, Medovate

"MedXpress.Pro have been delighted to be involved in the testing of two such important new devices for regional anaesthesia procedures. Our company is focused on using real life clinical practice and educational challenges to develop products that improve patient safety and as such being a part of supporting the development process for two such devices to promote patient safety fits perfectly with our company values and mission."

Katherine Hughey, Managing Director, MedXpress