I have been thinking a lot (a good cup of coffee always comes in handy) lately about ways of achieving electromagnetic compatibility (EMC) in medical scenarios from a risk-based perspective.
But what is EMC anyway? Well, it is defined as the “ability of (an) equipment or a system to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to anything in that environment” [1].
There are several key words in the above definition, which are: equipment, environment, and disturbance. From this, one can infer that any medical electrical equipment has the potential to be a source or a victim of electromagnetic interference (disturbance) in an environment in which it is being used.
Traditionally, experts adhere to and implement guidelines written in EMC standards to ensure the safe operation of equipment in their environments of intended use. However, standards do not evolve as fast as the rate of technological developments. For instance, one of the most relevant standards for medical EMC (IEC 60601-1-2:2014) was released more than 8 years ago [2].
Over the years, medical equipment and systems have become more complex while operating in environments whose electromagnetic characteristics keep evolving. Furthermore, a growing number of these safety-critical equipment and systems can now communicate wirelessly which heightens the need to ensure that they keep functioning correctly. With this increasing complexity, following a rule-based EMC approach will not guarantee that an equipment or system will operate safely in its environment of intended use, even if it complies with existing standards.
Therefore, a risk-based EMC approach is one in which effort is focused on reducing the inherent risks that medical equipment and systems face in their immediate environment to the lowest possible level. In practice, it would involve three main steps:
- Electromagnetic Risk Identification which entails characterising the risks stemming from the operating electromagnetic environment
- Electromagnetic Risk-Reduction which implies effectively mitigating the risks to acceptable safety levels by applying appropriate techniques and measures
- Validation and Verification which provides confirmation that the applied risk reduction techniques and measures effectively address the identified risks
In conclusion, this approach is at the heart of the ETERNITY Project. The end goal is to formalise it by providing a clear risk assessment methodology that would be beneficial to European companies in the medical-technology industry and, as a result, enhancing Europe’s leadership role in this sector.
References
[1] International Electrotechnical Commission, “Electromagnetic compatibility,” IEC 60050-161:1990 – International Electrotechnical Vocabulary – Chapter 161: Electromagnetic compatibility, 1990. https://www.electropedia.org/iev/iev.nsf/display?openform&ievref=161-01-07 (accessed Feb. 28, 2022).
[2] International Electrotechnical Commission, “IEC 60601-1-2:2014 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests,” 2014. Accessed: Feb. 28, 2022. [Online]. Available: https://webstore.iec.ch/publication/2590