Estimation of the performance stability of the newly developed topical haemostatic agents based on the chitosan/alginate fibrids

Abstract

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.

Design of New-Generation Usable Forms of Topical Haemostatic Agents Containing Chitosan

“…The chitosan/alginate micro- and nano-fibrids composition was used for the fabrication of the usable forms of the topical haemostatic agents, prepared according to [ 18 , 25 , 26 ].…”

“…The lyophilized powder made of an aqueous suspension of the chitosan/alginate micro- and nano-fibrids [ 18 , 27 ] was used as a reference.…”

“…The risk analysis was performed using the Failure Mode and Effects Analysis (FMEA) technique [ 18 ], taking into the account the guide given in EN ISO 14971:2012 and EN ISO 22442-1:2007 Standards, as described in [ 12 , 13 ]. During the test, the stability of the designed functionalities in usable forms of the tested topical haemostatic agents for the simulated one year was estimated.…”

“…The topical haemostatic agents are medical devices that are used mostly in case of an intense haemorrhage [ 5 , 14 , 15 , 16 , 17 ]. Several usable forms are applied in practice, such as impregnated gauze, tampon, foam, and powders [ 18 ].…”

Preparation and characterization of calcium carboxymethyl cellulose/chitosan blend nonwovens for hemostatic agents

“…5 While hemostatic agents exist in a variety of compositions and dosage forms, they can incorporate collagen, chitosan, oxidized cellulose, kaolin, or thrombin. [6][7][8][9] Moreover, they can be formulated as a powder, hydrogel, foam, knit, or nonwoven sheet. Powder-and hydrogel-type hemostatic agents can cover irregular surfaces.…”