Optimisation of Cleaning Processes for Medical Instruments Used in Minimally Invasive Surgery (MIS)
AiF 15 ZN
The just-in-time provision of complex instruments like endoscopes, especially for minimally invasive surgery (MIS) techniques, is mainly asking for appropriate cleaning processes as a precondition for effective sterilisation or high-level disinfecting: Residual soil found on surfaces after inadequate cleaning and insufficiently removed contaminants lead to impaired operation and loss of function of these instruments. The failure of sterilisation procedures because of inadequate cleaning lead to the demand for validation of reliable cleaning, disinfecting and sterilisation processes. Just as the complexity of the instruments grows, e.g. from the field of MIS, the requirements addressed to reprocessing do also.
The enormous range of variation of possible contaminants and the difficulty associated with quantification of cleaning quality led to the demand of establishing new parameters of cleanliness. Visual inspection, not the best method, can only be conducted on the outside of instruments, but is not possible to check highly complex or lumen instruments. Detection of difficult to remove contamination like proteins are one possible solution to increase the hygiene safety and of instruments before reuse and the well-being of patients and staff. It has to be guaranteed that transmission of pathogens from patient to patient or patient to personal can be prevented. Quantitative and qualitative methods have to be validated to ensure not only the disinfecting efficacy, according to the guidelines of the Robert Koch Institute in Germany. A new approach for quality assurance is necessary. Literature and reports about insufficient cleaning results show that central disinfection units in hospitals often are overcharged with these problems. A possible alternative is the reprocessing of medical instruments by external rental companies as in the field of operating theatre textiles. Many hospitals are already supplied by such companies with high quality, safely sterilised articles just in time and at an improved quality compared to traditional solutions. An important pre-condition, however, was the development of high-tech articles together with efficient cleaning, disinfecting and sterilisation processes.
Within the project, possibilities to develop cleaning, disinfecting and sterilising techniques for filigree medical instruments are investigated which can be the basis for novel services and new jobs. This will include a concept of disassembling, storing and transportation of soiled and cleaned instruments as well as processes to clean efficiently at low costs and highest safety during use. Proper disinfection and sterilisation following the cleaning step shall be optimised, too. The officially permitted processes will be investigated in comparison to the novel process concepts.
The analytical methods described in the draft prEN ISO 15883-1 “Cleaning and Disinfection Apparatus – General Requirements, Definitions, Test Procedures” were checked and compared with other procedures. The applicability of CO2-cleaning, plasma-technology, ozone, enzymes and further methods for the reprocessing of medical instruments is investigated within the project.
We would like to thank the Arbeitsgemeinschaft Industrieller Forschungsvereinigungen “Otto von Guericke” e.V. (AiF) (Association of Industrial Research Organisations) for the financial support of the reasearch project (AiF 15 ZN) funded by the budget of the Federal Ministry of Economic Affairs.
The research report is available on request from FRT.