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Table 2 Summary Clinical Use Evaluation

From: EVOTECH® endoscope cleaner and reprocessor (ECR) simulated-use and clinical-use evaluation of cleaning efficacy

Scope Site: Average of residuals remaining post-cleaning*Average (Standard Deviation) [Range]
  Protein μg/cm2 Hemoglobin μg/cm2 Bioburden Log10 cfu/cm2
Bronchoscopes: [N = 10]
S1 < LD < LD < LD
S2 0.32 (0.83) < LD 0.12 (0.26)
  [0 - 2.62]   [0 - 0.67]
L1 < LD < LD 0.03 (0.09)
    [0-0.29]
Colonoscopes: [N = 15]
S1 0.26 (0.79) < LD 0.12 (0.20)
  [0-2.94]   [0 - 0.67]
S2 1.04 (2.47) < LD 0.02 (0.08)
  [0-9.41]   [0-0.33]
L1 0.12 (0.12) < LD 0.04 (0.07)
  [0-0.32]   [0-0.25]
L2 < LD < LD 0.0007 (0.022)
    [0-0.008]
L3 < LD < LD 0.007 (0.023)
    [0-0.09]
Duodenoscopes: [N = 15]
S1 0.03 (0.11) < LD 0.37 (0.94)
  [0-0.44]   [0-3.34]
S2 1.28 (3.80) < LD 0.14 (0.53)
  [0-14.   [0-2.04]
L1 0.21 (0.67) < LD 0.26 (0.97)
  [0-2.60]   [0-3.78]
L2 0.043 (0.09) < LD 0.11 (0.41)
  [0-0.33]   [0-1.58]
L4 0.06 (0.11) < LD 0.81 (1.35)
  [0-0.31]   [0-4.47]
Gastroscopes: [N = 15]
S1 1.14 (1.77) < LD 0.10 (0.30)
  [0-6.44]   [0-1.13]
S2 0.63(1.80) < LD 0.03 (0.06)
  [0-6.99]   [0-0.15]
L1 0.07 (0.20) < LD 0.04 (0.06)
  [0-0.75]   [0-0.24]
L2 0.03 (0.10) < LD 0.11 (0.35)
  [0-0.38]   [0-1.22]
  1. * All values have been "normalized" against the baseline (negative) controls (i.e. the average for the negative controls was subtracted for all test values). The term "LD" indicates the sample concentration was below the limit of detection. The LD for the protein assay was 0.5 μg/mL, for the haemoglobin assay the LD was 5 μg/mL, and for bioburden assay the LD was 10 cfu/mL.