Inspections, Compliance, Enforcement, and Criminal Investigations
GUIDE TO INSPECTIONS OF ELECTROMAGNETIC
COMPATIBILITY ASPECTS OF MEDICAL DEVICE
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:
- Based on the information at hand, is EMI a possible or probable cause for the malfunction? (See the possible keywords for EMI in Appendix D.)
- Could the erratic behavior or the intermittent malfunctioning of the device be related to a hardware problem, user error, deficiency in the manufacturing process, or a possible EMDsource? What is the basis for the conclusion?
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:
- circumstances leading to the event (e.g., ESD occurred in the winter and humidity was not controlled in the hospital);
- consequences or risk of the event to the patient or the caregiver (e.g., ESD from the side rails of the bed caused arcing to affect a ventilator) (Appendix C may be helpful in determining the risk of an EMI event.); and
- criticality of the event if it should recur (e.g., infusion pump stopped pumping and alarmed due to a cellular telephone).
The firm should determine if the complaint is a true positive (correctly attributed to EMI by the reporter), false positive (incorrectly attributed to EMI by the reporter), or false negative (not attributed to EMI by the reporter yet probably was EMI). Questioning should demonstrate correct categorization so that appropriate follow-up at the user and manufacturer facilities can occur and appropriate complaints will be submitted to FDA under the Medical Device Reporting regulation, 21 CFR, Parts 803 or 804. Any EMI-related MDR reportable event should be maintained in a separate portion of the complaint files or otherwise clearly identified. Records should follow the Quality System regulations.
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.