A modern hospital has a wide range of medical devices that can be technologically very advanced and complex in terms of electromagnetic emissions and susceptibility. It is a public environment where people carry communication equipment and/or medical active implants. Therefore, electromagnetic interference among the devices in the hospital environment is not an unfamiliar topic. There is a misconception among engineers that if all medical devices comply with harmonized standards, then the installation of a large number of medical devices altogether would work absolutely fine. However, this is not always true, and so for complex systems, a smarter approach is necessary to assess and control the risks of electromagnetic interference. This paper emphasizes the importance of using the risk-based approach to deal with the often unpredictable factors causing electromagnetic interference in a complex hospital environment.

This paper emphasizes the need for a risk-based EMC approach in the hospital environment. A modern hospital with various kinds of wireless medical electronic equipment especially in the intensive care, operation theatre, neonatology, etc., pollutes the environment by creating electromagnetic interference with other equipment in the vicinity or even implanted equipment inside the patient. Even following the IEC 60601-1-2 product standard for medical equipment which is based on a rule-based approach, suppressing electromagnetic interference effectively is an arduous task. In the upcoming years, the number of wireless devices in a modern hospital will significantly increase and might cause EMC instability in this highly complex system. Hence, an urgent requirement for an advanced and smarter approach leads to the use of a risk-based EMC approach. The detrimental effect of intentional sources causing electromagnetic interference in the hospital environment is briefly discussed. The risk-based EMC approach has been applied in the Medisch Spectrum Twente hospital, where it was discovered that wireless devices such as digital mobile radio, cell phone, and radio frequency identification equipment critically affect equipment pumps and patient monitors.

Various studies have been conducted to monitor the electromagnetic (EM) environment of the hospital, where an emitter is mounted near medical devices. They placed their antenna in a specific area to test the maximum amplitude of power obtained by the antenna as well as explore the environment without identifying the time-variance behavior. The main goal of this paper is to observe the time-variance behavior of the emitters over the course of a 24-hour period when a receiving antenna is installed in a room and the effect they have on the EM environment. It will provide the probability of EMI from the perspective of the emitters, which will help to use it further for the risk-based EMC approach. In this paper, the discussion about the different types of time-variance behavior is done with examples, statistically explained the results.

Hospitals are one of the most critical and sensitive environments where possible EMI issue may have life-threatening effects. Although the electronic equipment placed within satisfies various EMC standards, a risk of EMI still exists. Due to the high complexity and dynamics of this system, the electromagnetic environment substantially differs from the one of an EMC laboratory. A full risk-based EMC analysis can significantly help mitigate this problem but requires plenty of effort, time, and careful management. In this paper, we present a simplified but robust, time efficient method of evaluating the electromagnetic risks, as an intermediate step before implementing a full riskanalysis campaign. Such an analysis allows to get the first impression about the environment and its influence on the medical device within.

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