We, as the members of The Electronic Medical Equipment Study Group of the Electromagnetic Compatibility (EMC) Conference in Japan, have performed experimental tests on electromagnetic interference (EMI) of medical devices (MDs) by hand-held radiocommunication equipment at EMC test sites and four hospitals. Test results showed occurrence of EMI in 66% of MDs (242of 366) within 4 m at EMC test sites, and in 53% of MDs (57 of 108) in hospital tests with cellular phones (maximum output 0.6 W to 0.8 W). However, about 80% of EMI effects were low-risk, based on the risk level categorization. The occurrence of EMI from Personal HandyPhone System (PHS) terminals (maximum output power 0.08 W) was 8% (28 of 352) at EMC site tests and 4% in hospital tests. The interference effects were categorized into six risk levels from the clinical point of view: category 6 (irreversible interference and urgent clinical measures necessary to avoid fatal injury to patient); category 5 (reversible but could cause fatal injury if continued); category 4 (irreversible, could cause wrong diagnosis or treatment, emergency actions should be taken) etc. By using this categorization, the risk analysis was carried out on serious (categories 6, 5 and 4) EMI, estimating risk in the worst clinical care case scenarios. The EMI effects on several types of life support equipment were classified into categories more severe than 3; therefore, special precautions against EMI must be taken in ICUs, CCUs and operating rooms, and also wards where such life support equipment is used. Based on the results of the EMI tests and the risk analysis, the Study Croup set and published the Guideline on the Use of Radiocommunication Equipment Safeguards for Electronic Medical Equipment in March, 1997.
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Baba et al. (1998) studied this question.