P40 The simulation test: can medical devices pass?

Background Simulation-based education can enhance healthcare professional’s knowledge, skills and attitudes in safe environments. Traditionally, simulators are utilised to train or measure procedural-based skills and teamwork behaviours.¹ The ASSERT Centre, UCC use a Human Patient Simulator (HPS CAE®) and intensive care ventilator (Hamiliton G5®) in pre-clinical testing of a continuous respiratory sensing monitor (RespiraSense PMD Solutions®). Project description The RespiraSense sensor measures chest and abdomen deflection during breathing to directly measure respiratory rate (RR). The device was attached to the HPS in the appropriate position. In order to accurately control RR, a G5 Hamilton Medical intensive care ventilator was used to ventilate the mannequin. The HPS was intubated with a size 8.5 ETT and ventilated on pressured controlled mandatory ventilation (P-CMV). Ventilation settings were; Pressure Control of 15 cmsH2O and Positive End Expiratory Pressure of 5 cmsH2O with an Inspiratory: Expiratory Ratio of 1:2. These parameters were chosen as they are physiologically representative of a normal ventilated healthy patient, and achieved normal ventilation and pressure values throughout the study. Summary of results The devices dynamic response measurements were observed following changes in ventilation RR, ranging from 6–60 breaths/min. The breaths were increased in increments of 1, every 2 minutes. The device measurements and the ventilators CMV rate were plotted and analysed using the Bland Altmann’s method, revealing both measures within 95% limits of agreement for the difference of the means (±2 SD). Secondly, stability over time was measured, where the ventilation rate was set for a period of 4 hours and measured against the devices performance. This was repeated 3 separate times, for 4 hour periods, of 10, 20 and 30 breaths/min. The device allows for historical and real-time plotted graphs of RR, which were measured against the set CMV rate over the periods. The device provided accurate and stable measurement of RR, including RR extremes in a controlled environment, using a human patient simulator under mandatory controlled ventilation. Connection problems were identified between the sensor and hardware device during the trial, which were communicated to the product engineers. Discussion The utilisation of simulation centre expertise and technologies by engineers, clinicians and others in the medical device field may expedite product design, identify design errors, increase end-user satisfaction and reduce patient harm.² Conclusion Evaluating medical devices utilising simulation offers the opportunity to discover and correct design errors which may not become apparent until later, during clinical trials or post-market surveillance. References Aggarwal R., Mytton O., Derbrew M., Hananel D., Heydenburg M., Issenburg B., MacAulay C., Mancini M., Morimoto T., Soper N., Ziv A., Reznick R. Trainingand Simulation for Patient Safety. BMJ Quality and Safety in Health Care 2010. 19 (Suppl 2): i34-i43. Underdahl L., Nelson F. Improving medical device safety and performance: From passive reporting to active surveillance and beyond. Management in Healthcare 2019. 3(3). pp 250–261.