To ensure patient safety, this work group is to investigate the product cleanliness, on delivery, of reusable surgical instruments supplied in a non-sterile condition. Their chemical, physical and biological properties are to be investigated, taking into consideration the generally recognized state of the art.
The objective of this validation is to provide documentary evidence for the fact that, with the selected worst-case conditions, a standardized cleaning process is available that meets the applicable requirements, specifications and regulations, and can be used as a future industry standard and guideline for SMEs for the cleaning of surgical instruments.
To this end, a “worst-case” test object is to be developed and manufactured in accordance with generally applicable working methods and incorporating all common instrument features.
The results confirm that efficient cleaning is able to achieve a high degree of cleanliness, even under worst-case conditions.
The requirements on both biological cleanliness (cytotoxicity and bioburden) and chemical cleanliness (TOC and MS/GC) were met with sufficient safety margins. The objective of the project was thus met and manufacturers were provided with standardized processes that can be used as a basis for their own cleaning validation processes.
Further additional information can also be found here: CleanMed
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