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Healthcare failure mode effect analysis of a miniaturized extracorporeal bypass circuit

Background: The introduction of new and more advanced technology in healthcare occurs with an increasing speed. Therefore, more attention is needed for safety evaluation of new devices or techniques from an end-user perspective, especially when (inter-) national perfusion safety standards are lacking. A recently increased awareness of the safety risks as a consequence of technical or human error has provoked interest in optimisation of perfusion methodology and devices. To prevent or reduce the severity or likelihood of failures of new technology, ‘failure mode effect analysis’ is a proven proactive technique. When it is used as a qualitative analysis for possible hazards in patient treatment associated with the use of medical devices, it’s called healthcare failure mode effect analysis (hFMEA). Methods: To evaluate the safety of the Extra Corporeal Circulation Optimized (ECCO, Sorin Group, Mirandola, Italy) miniaturized bypass circuit, hFMEA was used. A multi disciplinary team that consisted of two clinical perfusionists, a clinical physicist, a clinical physicist trainee and a technician has performed this analysis. Results: The hFMEA demonstrated that failure of the bubble sensor for the electric remote clamping system on the arterial line (Figure 1), activated by air passing the venous bubble trap, had the highest risk score of all failure modes. This has led to the implementation of an extra low-level sensor in the system to prevent air passing through into the centrifugal pump. The hFMEA has also indicated that extra individual simulation training is needed for handling critical failures during the use of the miniature bypass system. Conclusion: Early identification of possible technology failures in any process or device can avoid adverse patient outcomes. The technique of hFMEA is a valuable tool in evaluating the use of high-risk apparatus, such as an extracorporeal bypass system, in patient treatment in order to increase patient safety.