Thermolabiele, flexibele endoscopen Module 2c Evidence-tabel

Eichel, 2021

Type of study: observational cohort study

Setting and country: Germany

Funding and conflicts of interest:

The authors have no conflicts of interest and did not receive funding.

Inclusion criteria:

Transparent polytetrafluoroethylene tubes with a length of 200 cm,

an inner diameter of 2 mm, and a wall thickness of 0.5 mm. In addition,

6 bronchoscopes, 6 gastroscopes, and 6 colonoscopes were examined

Exclusion criteria:

None

N total at baseline:

N= 124 tubes

N= 6 bronchoscopes

N= 6 gastroscopes

N= 6 colonoscopes

Important prognostic factors²:

Not applicable

Groups comparable at baseline?

yes

Describe intervention (treatment/procedure/test):

Complete reprocessing of test tubes contaminated with a soiling solution of heparinized sheep blood and protamine in sodium dodecyl sulfate (SDS) with time interval 0-48 hours after pre cleaning

Describe control (treatment/procedure/test):

Complete reprocessing of test tubes contaminated with a soiling solution of heparinized sheep blood and protamine in sodium dodecyl sulfate (SDS) with a different time interval 0-48 hours after pre cleaning

Length of follow-up:

Not applicable

Loss-to-follow-up:

Not described. Unclear if there was loss to follow-up or if only test tubes with complete outcome data were included.

Incomplete outcome data:

Not described. Unclear if there was loss to follow-up or if only test tubes with complete outcome data were included.

Outcome measures and effect size (include 95%CI and p-value if available):

Microbiological contamination (n=62):

All tubes had ≥9 log10/tube reduction for the number of CFUs of E. faecium

All scopes had <10 CFU/10 mL and no growth of Escherichia coli, Enterobacteriaceae, Enterococci, Pseudomonas aeruginosa, Pseudomonas spp., non-fermenters, and greening streptococci. Therefore, the acceptance criteria for disinfection performance were met.

Residual protein content (n=62):

All tubes had residual protein contend <30 μg/test tube

All scopes had residual protein <100 μg/scope

Biofilm (n=3):

Biofilm was present after pre-cleaning (n=1)

Biofilm was absent after manual brushing (n=1)

Biofilm was absent after complete reprocessing (n=1)

The authors conclude that findings may indicate that flexible endoscopes can be stored after pre-cleaning for up to 16 h without any influence on the reprocessing quality according to current test standards.

However, the number of repetitions is too low to conclude sufficient preparation quality,

especially for storage times other than 16 hours. Moreover, not all types of endoscopes were tested. It therefore remains unclear if results are generalizable to other scopes.