Biomedical Engineering Reference
In-Depth Information
Figure 5.5-17 Medical Equipment Risk Classification Profiler.
Medium risk
Low risk
Equipment that scores 15-17 points on the criteria's
evaluation system.
Equipment that scores 12-14 points on the criteria's
evaluation system.
Hazard surveillance (gray)
Table 5.5-1 Equipment function ranking
Equipment that scores 6-11 points on the criteria's
evaluation system are visually inspected on an annual
basis during the hospital hazard-surveillance rounds.
Point score
Risk category I: equipment function (EF)
Function description
10
Therapeutic - Life Support
9
Therapeutic - Surgical or Intensive Care
Table 5.5-2 Physical risk ranking
8
Therapeutic - Physical Therapy or Treatment
Point score
Risk category II: physical risk (PR)
7
Diagnostic - Surgical or Intensive Care Monitoring
Description of use risk
6
Diagnostic - vOther physiological monitoring
5
Analytical - Laboratory analytical
5
Potential patient death
4
Potential patient injury
4
Analytical - Laboratory Accessories
3
Analytical - Computer and related
3
Inappropriate therapy or mis-diagnosis
2
Miscellaneous - Patient-related
2
Equipment damage
1
Miscellaneous - Non-patient related
1
No significant identified risk
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