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Table 4 Summary Simulated-use evaluation

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

  Average of residuals:*
Scope Site: Protein μg/cm2 Bioburden Log10/cm2**
  Average (STD) Average (STD)
  Pos control Post-clean % Reduction Pos control Post-clean RF***
Bronchoscopes: [N = 3]
S1 1229.6 (133.9) 4.8 (1.5) 99.6% 7.08 (0.23) < LD ≥ 7.08
S2 887.6 (388.6) 2.5 (2.2) 99.7% 7.01 (0.21) < LD ≥ 7.01
L1 517.6 (221.3) 1.4 (1.7) 99.7% 6.71 (0.45) 1.19 (1.10) 5.52
Colonoscopes: [N = 3]
S1 1663.6 (246.2) 1.13 (2.4) 99.9% 6.35 (0.37) < LD ≥ 6.35
S2 1677.9 (178.3) 2.01 (0.92) 99.9% 6.99 (0.25) 0.31 (0.25) 6.69
L1 437.4 (118.4) 0.23 (0.14) 99.9% 6.54 (0.21) 0.61 (0.69) 5.93
L2 458.2 (111.1) 0.17 (0.11) 99.9% 6.46 (0.31) 1.56 (1.14) 4.90
Duodenoscopes: [N = 3]
S1 1703.3 (231.8) < LD ≥ 99.99% 5.95 (0.45) 0.05 (0.08) 5.90
S2 1287.9 (115.5) < LD ≥ 99.99% 6.52 (0.19) 0.01 (0.02) 6.51
L1 378.0 (89.6) 0.02 (0.10) > 99.99% 6.44 (0.19) 0.09 (0.16) 6.35
L2 368.9 (71.5) 0.02 (0.04) > 99.99% 6.59 (0.07) 1.05 (1.24) 5.54
L4 136.1 (17.6) < LD ≥ 99.99% 5.88 (0.65) 1.87 (0.65) 4.01
  1. * Note: The residuals for protein and bioburden for all sites tested met the benchmark for cleaning of < 6.4 ug/cm2 protein and < 4 Log10 cfu/cm2 bioburden. Each value represents the average of triplicate tests. 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 that the sample concentration was below the limit of detection. The LD for the protein assay was 0.5 μg/mL and for the bioburden assay the LD was 10 cfu/mL.
  2. **Average of all three microorganisms together
  3. *** RF; Log10 Reduction factor