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CASE STUDY FT. MEDOVATE: Patient safety at forefront of two new medical devices for Regional Anesthesia

Jun 6th 2019

Medovate, an innovation development company dedicated to the commercialization of pioneering medical technologies created within the NHS, is developing two new medical devices to improve patient safety and reduce the risk of nerve damage during regional anesthesia procedures. As part of the process they have engaged our services as a leading manufacturer of educational tools for ultrasound guided interventional procedures to complete comprehensive simulated usability testing.

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

The Challenge

Current regional anesthesia procedures require two users, an Anesthetist and assistant. An Anesthetist holds an ultrasound scanner in one hand and a regional anesthetic needle in the other. Using the ultrasound scanner to guide needle tip placement, the Anesthetist instructs the assistant to inject the anesthetic solution. Studies have shown that anesthetic 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 anesthesia 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 specializing 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.