Biomedical Engineering Reference
In-Depth Information
Table 9.3: Example of Root Causes
General Category
Examples of Causes
Inadequate specification of:
- design parameters
- operating parameters
- performance requirements
- in-service requirements (e.g., maintenance, reprocessing)
- end of life
Insufficient control of changes to manufacturing processes
Insufficient control of materials/materials compatibility information
Insufficient control of manufacturing processes
Insufficient control of subcontractors
Transport and storage
Inadequate packaging
Contamination or deterioration
Inappropriate environmental conditions
Environmental factors
Physical (e.g., heat, pressure, time)
Chemical (e.g., corrosions, degradation, contamination)
Electromagnetic fields (e.g., susceptibility to electromagnetic disturbance)
Inadequate supply of power
Inadequate supply of coolant
Cleaning, disinfection,
and sterilization
Lack of, or inadequate specification for, validated procedures for cleaning,
disinfection, and sterilization
Inadequate conduct of cleaning, disinfection, and sterilization
Disposal and scrapping
No or inadequate information provided
Use error
No information or inadequate specification provided
Inadequate warning of hazards associated with incorrect formulations
Use error
Human factors
Potential for use errors triggered by design flaws, such as
- confusing or missing instructions for use
- complex or confusing control system
- ambiguous or unclear device state
- ambiguous or unclear presentation of settings, measurements, or other
- misrepresentation of results
- insufficient visibility, audibility, or tactility
- poor mapping of controls to actions, or of displayed information to actual
- controversial modes or mapping as compared with existing equipment
- use by unskilled/untrained personnel
- insufficient warning of side effects
- inadequate warning of hazards associated with reuse of single use medical
( Continued )
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