A risk assessment method based on the failure analysis of medical devices in the adult Intensive Care Unit

Backgrounds and Objective: The Intensive Care Unit (ICU) receives patients whose situation demands high complexity tasks. Their recovery depends on medical care, their response to medications and clinical procedures, and the optimal functioning of the medical devices devoted to them. Adverse events in ICU due to failures in the facilities, particularly medical devices, have an important impact not only on the patients but also on the operators and all those involved in their care. The origins of the technological failures seem to be more oriented to the interaction between the equipment and the operator: once the medical equipment is functioning, we must guarantee its correct execution to meet both the clinical service's objectives and the expectations of those involved in care, including the patients themselves. We present an approach to quality management based on failure analysis as the source of risk for medical devices' functioning and operation in the ICU. We decided to address it through a systematic approach by using the Failure Mode and Effects Analysis (FMEA) method and the Ishikawa diagrams' support to obtain the causes graphically. Material and Methods: We used the risk analysis framework as a basis of the methodology. By obtaining the causes and sub causes of technological failures in the ICU for adult patients, we applied the FMEA method and the Ishikawa diagrams to analyze the relationship between cause and failure. The ICU devices came from the Official Mexican Standard and WHO information related to the ICU operation and facilities. The data from the causes of failure came from specialized consultation and discussion forums on medical devices where these topics were addressed; we searched for over five years in Spanish forums. We proposed a calculation of the Risk Priority Number based on the information subtracted from the forums. Then, we defined an indicator showing the priority level that can be used to address the issue. Results: In general, the results showed that most of the medical equipment failure causes have medium and high-risk priority levels and, in some cases, the cause presented as the most prevalent didn't match with the reported in official documents such as technical or operation manuals. The most frequent causes found are related to electrical system issues and operation skills. We presented three study cases: defibrillator, vital sign monitor, and volumetric ventilator, to show the risk level designation. The conclusions inferred from these cases are oriented to training strategies and the development of support material in Spanish. Conclusion: The development of risk management methodologies that aim to monitor and solve potential hazard situations in critical areas is valuable to the health technology management program. The FMEA method showed to be a strong basis for the risk assessment processes, and its application to the ICU medical technology allowed the creation of the evidence supporting the decision-making process concerning strategic solutions to guarantee patient safety