ABSTRACT

Pooled fibrinogen-thrombin products are frequently referred to as “fibrin glue” or “fibrin sealant.” The major challenges to producers of pooled fibrin sealant products are product safety, product consistency, regulatory approval, product availability, and ease of use. In regard to the issue of product safety the risk of viral transmission remains the major concern. Ease of use of the final product is largely associated with two procedures: reconstitution and application. Reconstitution of fibrin-sealant products may be difficult owing to the relatively high concentration of fibrinogen in the reconstituted liquid. Ease of application may be maximized by providing delivery devices that are simple to load and operate, and that meet the needs of the practitioner applying the fibrin sealant. A number of delivery systems have been developed for applying the material directly to a site as a small droplet or bead, for delivery through cannulas, and for application as a spray to cover large areas.