Estimation of the performance stability of the newly developed topical haemostatic agents based on the chitosan/alginate fibrids
Designing medical devices requires a wide range of verification steps for estimation of the performance and safety. Designing the research program needs a rational selection of appropriate testing methods (in preclinical and clinical studies) for determination of the risk of potential incompatibilities resulting in adverse events. The significance of the appropriate selection of the testing method is increased in advanced medical devices. The presented research considers the verification of the functional properties of recently developed topical haemostatic agents with the use of the chitosan/alginate fibrids, based on the previously elaborated risk analysis made according to the guidelines of the PN-EN-ISO 14971:2012 and PN-EN ISO 22442-1:2008 standards. The aim of this research was to verify the stability of the performance of the newly developed haemostatic agents during storage. The defined aim of the study arose from the thesis that the appropriate selection of raw materials and a new manner of reprocessing them enabled keeping the usability of the final product for at least two years.