Strategy to secure the neuraxial route in anaesthesia: Risk mapping and feedback from the application of the ISO 80369-6 standard NRFit® connectors

Abstract

In anesthesia, a medication error would occur every 20 to 133anesthesia procedures, and 14% is related to a route administration error. To secure neuraxial route, ISO group published a norm in 2016 to develop specific connectors, the "NRFit® connector". The main objective of this work, is to develop a risk mapping related to neuraxial medication errors therefore prepare the NRFit® implementation in anesthesia units in a French Universitary Hospital. Failure modes, effects and criticality analysis (FMECA) methodology was used for our risk mapping which was divided in 3 anesthesia specialities. For each, the analysis was performed for accidental neuraxial administration of intravenous drugs, and its opposite error. Secondly, NRFit® devices were tested for 1month by 3 experimented anesthetists. The majority of reported errors concerns epidural and intrathecal anesthesia, and more frequently in the field of obstetrics. Opioids and tranexamic acid, administered in neuraxial route, are drugs with the highest criticality. The tests were rather conclusive and made it possible to highlight the additional needs in medical devices. Obstetrics is the riskiest area due to the frequency of epidural anesthesia, the administration of critical drugs in intravenous and neuraxial route. This work increased the awareness of our group, improved the measure of this risk and harmonized practices. This work is the first step of the project to prevent administration route error in anesthesia during patient's drug management. The next step will be the NRFit® implementation for epidural and combined spinal-epidural anesthesia in our hospital.