Needles and needleless devices for infusion of anti‐haemophilic factor concentrate: impact on protein structure and function

Abstract

A poor response to the infusion of anti-haemophilic factor (AHF) concentrates used to control acute bleeding or prevent haemorrhage during surgery may have many causes, including the lack of functional activity of the infused protein concentrate. It is generally recommended to follow the manufacturers' instructions when administering the factor intravenously. For convenience, infusion sets with 23 gauge butterfly needles are packaged with the major brands of AHF concentrate. In hospitals, blunt connectors for i.v. infusion are becoming more prevalent to reduce the risk of needle stick injuries to both patients and hospital staff. The integrity of AHF infused using such devices has not been examined. We examined the possibility that passage of complex proteins such as AHF through such devices may result in alteration of the protein, rendering it inactive. The results presented here suggest that this is not the case; neither the structure nor the function of AHF protein products was adversely affected by the use of the needleless transfer device (NTD) or the needle types and sizes commonly used in clinical practice. Samples of factor VIII and factor IX AHF concentrate were passed through the B-D Blunt Plastic Cannula or 23, 27 and 30 gauge needles. No significant changes in electrophoretic mobility or coagulation activity were detected. Samples generally showed slightly increased coagulation activity when compared with the control in which the sample was passed directly out of the syringe with no device attached. These data indicate that the NTD and various needle gauges are acceptable for the infusion of AHF concentrate in a clinical setting. Furthermore, the use of small gauge needles has advantages that may improve adherence to rigorous factor replacement programmes.