Reiniging, desinfectie en sterilisatie (herbruikbare) medische hulpmiddelen - Module 5 Evidence-tabel

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison /control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Gold, 2013

Type of study: observational study

Setting and country: United states

Funding and conflicts of interest:

The authors have no conflicts of interest and received funding though the

US Department of Energy and the US Food and Drug Administration.

Inclusion criteria:

Liquid aliquots of the coagulated blood or bacteria were dried onto the surface of the device and removed with the wipes. There are no specific inclusion criteria.

Exclusion criteria:

None

N total at baseline:

N= 60 (10 trials using six different wipes)

Important prognostic factors²:

Not applicable

Groups comparable at baseline?

yes

Describe intervention (treatment/procedure/test):

Six commercially available disinfectant cleaning wipes were evaluated for their effectiveness to remove a coagulated blood test soil from the surface of a reusable medical device.

Describe control (treatment/procedure/test):

Six commercially available disinfectant cleaning wipes were evaluated for their effectiveness to remove Streptococcus pneumoniae bacteria from the surface of a reusable medical device.

Length of follow-up:

Not applicable

Loss-to-follow-up:

Not applicable

Incomplete outcome data:

Not described. Unclear if there was incomplete outcome data due to failed experiments.

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

Wipe 1

RLU Relative Light Unit (Relative Light Unit): 4.11 + 2.00

CFU: 1.21%

Wipe 2

RLU: 1.56 + 1.09

CFU: 0.98%

Wipe 3

RLU: 5.22 + 2.72

CFU: 1.31%

Wipe 4

RLU: 12.00 + 2.59

CFU: 1.92%

Wipe 5

RLU: 9.44 + 3.19

CFU: 1.69%

Wipe 6

RLU: 12.00 + 3.02

CFU: 1.92%

The authors conclude that the active ingredient, wipe design, and wipe wetness are important factors to consider when selecting a disinfectant cleaning wipe.

Gonzales, 2015

Type of study: observational study

Setting and country: United states

Funding and conflicts of interest:

The authors have no conflicts of interest and received funding through the US Department of Energy and the US Food and Drug Administration.

Inclusion criteria:

An anesthesia machine and objects representative of smooth and ridged machine knobs were contaminated with Staphylococcus aureus, Bacillus atrophaeus spores, and Clostridium sporogenes spores. There are no specific inclusion criteria

Exclusion criteria:

None

N total at baseline:

N= 45

Important prognostic factors²:

Not applicable

Groups comparable at baseline?

yes

Describe intervention (treatment/procedure/test):

The ability of 5 commercially available cleaning-disinfecting wipes to remove bacteria

Describe control

The ability of with gauze soaked with water or bleach to remove bacteria.

Length of follow-up:

Not applicable

Loss-to-follow-up:

Not applicable

Incomplete outcome data:

Not described. Unclear if there was incomplete outcome data due to failed experiments.

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

Authors reported that commercial wipes performed equally well as a gauze with water but do not report comparative data to a gauze with bleach. Due to an absence of data published, it was impossible to quantify the difference in performance between commercial wipes and a gauze with bleach. No raw data was reported

The authors conclude that physically removing bacteria from device surfaces with water was often as effective as the cleaning-disinfecting wipes. Of the wipe active ingredients evaluated, sodium hypochlorite was the most effective overall. The wetness of the wipes may also play a role in their effectiveness.