Kit for detecting residual contaminations on medical devices

A kit for inspecting cleaning quality of a sample, the kit comprising:

• a staining solution by soaking said sample, said staining solution comprising a colorant in a dilution phase;
• and
• a developing solution by soaking said sample, said developing solution comprising said dilution phase;
• wherein said dilution phase is a dilution phase compatible with requirements of the medical environment, from which said sample comes, containing one or more medical devices, potentially soiled by protein compounds and/or organic materials and/or biofilms present on said medical devices;
• the kit having a protein detection limit lower than 100 μg/cm2.

A method of checking quality of cleaning of medical devices, by using a kit comprising:

• a staining solution by soaking said sample, said staining solution comprising a colorant in a dilution phase, and
• a developing solution by soaking said sample, said developing solution comprising said dilution phase,
• wherein said dilution phase is a dilution phase compatible with requirements of the medical environment, from which said sample comes, containing one or more medical devices, potentially soiled by protein compounds and/or organic materials and/or biofilms present on said medical devices;
• the method comprising the following steps:
• providing a sample taken randomly from medical devices, previously cleaned in view of sterilisation, or previously cleaned and sterilised in view of quality control,
• bringing said sample into contact with a staining solution which comprises a colorant in a dilution phase compatible with the requirements of the medical environment,
• checking the quality of cleaning of a sample by a potential identification by staining,
• wherein said sample comprises one or more randomly selected medical devices of low porosity and/or low roughness and is placed in a perforated bucket, said bringing into contact being carried out by a first soaking by immersing said perforated bucket containing the sample into a staining solution, and by a second soaking after staining, by immersing said perforated bucket containing the sample in a developing solution comprising said dilution phase, and wherein said identification by staining is visible staining of protein compounds and/or organic materials and/or biofilms;
• and
• wherein said first and second soakings by immersing said perforated bucket containing the sample consist of completely immersing said medical devices in the solutions.