OBJECTIVES : For many medical devices the evidence on efficacy and safety profile is limited compared to pharmaceuticals. This can be overcome by real-world data collected during device use. Here we evaluate the lessons learned from a data collection during sedation monitoring in major European and Canadian hospitals.

METHODS : As art of a quality improvement initiative (QII) hospitals collected data on current practice and also after introduction of capnography. The world SIVA tool was used to define adverse events and interventions of interest. To register and store events simple tools were developed to be deployed in proximity to the operation rooms. Tools captured ASA risk, sedative, depth of sedation, escalation of care and patient death along with the identified adverse events and interventions. Proof-of-principle used an offline Excel tool that was later developed into an iPad app. The results were aggregated and provided to the hospital.

RESULTS : Three sites have completed and 5 are currently undertaking a QII using the developed tools. User reception to and uptake of the data collection tools was positive. To date, data on over 5,000 patients has been collected; far larger than any published clinical study. The uptake of capnography decreased the cumulative incidence of adverse events by at least 20% at each completed site. Overall, a 41.9% reduction was observed. A positive effect on the awareness on respiratory compromise was evident. Success was dependent on the cooperation and buy-in of the medical staff. Making the tools simple and easy-to-use was of paramount importance.

CONCLUSIONS : Digital technology may lower the barrier for real-world data collection. For medical devices, real-world data collection may both increase their evidence base and help hospitals understand the incremental benefits provided by new health technologies.