Risk Management Plan For the Hospital Environment

A risk management plan is placed in ISO 14971:2019 standard for mitigating different kinds of risk related to the use of medical electrical equipment including the electromagnetic interference (EMI) risk in the hospital environment. However, EMI accidents in the hospital are still happening indicating that further improvement in the risk management plan is required. Currently, the risk management plan in the standard does not factor in the hospital environment realistically, leading to incomplete risk analysis, evaluation, estimation, and control methods. Due to the dynamic environment of hospitals, the rule-based EMC approach is insufficient and the risk-based EMC approach should be utilized in improving risk management plans. In this paper, we utilized several risk-based EMC approach techniques and measurements such as the foot-printing technique, for properly examining the hospital environment, source-victim matrix tool, to categorize the severity of EMI issue, statistical tools like
probability density function, cumulative density function, etc., to calculate probability and predict any future EMI risk. These techniques assist in the zoning of the hospital environment into low-risk, medium-risk, and high-risk for which risk control methods can be established. Overall, we hinted toward improving the risk management plan, in terms of flexibility, accuracy, and reliability, using risk-based EMC approach techniques.