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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Page 15

 

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GUIDE TO INSPECTIONS OF ELECTROMAGNETIC

COMPATIBILITY ASPECTS OF MEDICAL DEVICE

QUALITY SYSTEMS

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APPENDIX C - PRIORITIZATION OF RISK


Device Function

 

Life supporting or sustaining (high)
Patient monitor with alarm (possibly high)
Used for drug delivery (possibly high)
Automated diagnosis function (possibly high)
Interconnected with other critical devices (medium to low)

 

Failure or Malfunction Consequences

 

Lead to patient death (high)
Serious injury (possibly high)
Minor injury (medium)
Possible EMI, but no direct patient/user injury (medium)

 

EMI Events History

 

EMI-related incidents associated with death or serious injury (high)
Numbers or types of reports of concern (high to medium)
EMI-related incident reports, other (medium)

 

Intended Use Environment

 

Intended use in operating rooms, intensive or critical care units, or other critical care area (high)
Many sources of EMD: radio transmitters, cellular telephones, high power transmission lines (possibly high)
Intended or typically used in transport vehicles (possibly high)
Few sources or low power EMD sources (medium to low)

 

EM Emissions

 

Device or accessory intentionally emits electromagnetic energy or radiation (high)
Device has pumps, motors, large power supplies or digital components that may emit electromagnetic energy (high to medium)
Device is AC (alternating electrical current) or mains powered (medium)

 

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