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GUIDE TO INSPECTIONS OF ELECTROMAGNETIC COMPATIBILITY ASPECTS OF MEDICAL DEVICE QUALITY SYSTEMS | 8 |
at the facility during this time period or a power outage); additional diagnostic procedures that necessitated use of other devices which may have contributed to the EMI (e.g., a portable x-ray machine was being used at the other end of the room on another patient at the same time the event occurred); 2. additional equipment used in conjunction with the subject device (e.g., radiant heater used over a neonate's crib); 3. environmental conditions which may have contributed to the event (e.g., static charge was high because of dry climate that day, the adverse event occurred during a thunderstorm). 4. repeatability of the event and comparison to similar events at the same facility or other geographic areas (e.g., radio transmissions of delivery vehicles at the loading dock in a hospital caused ECG monitors to malfunction on that side of the building). 21 CFR 820.198(b) Determining Whether An Investigation Is Necessary Any complaint involving EMI should be evaluated and investigated by the firm, unless such investigation has already been performed for a similar complaint and another investigation is not necessary. Documentation should justify why another investigation is not necessary. The firm may need to determine if a complaint is EMI-related, aided by the following types of questions:
If the answers to the above questions do not indicate that EMI was a causative factor, then that information should be documented as the reason for not investigating EMI and the name of the individual responsible for the decision not to investigate for EMI aspects. 21 CFR 820.198(d) Determination of MDR Events Complaints should be evaluated by the firm for:
21 CFR 820.200(a)&(b) Analyzing Reports and Establishing and Maintaining Procedures For Performing and Verifying That Servicing Meets Specified Requirements Manufacturers should thoroughly analyze service reports associated with EMI, and document corrective and preventive action in accordance with 21 CFR 820.100. Failure trends by grouping failures by location, user application, repeat component failures, etc., can yield evidence or potential EMC problems. |
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