Compodock, a new device for sterile docking.

BACKGROUND A new device for sterile docking, the Compodock (Fresenius NPBI Transfusion Technology), was developed for connecting PVC tubing for medical use while maintaining sterility. STUDY DESIGN AND METHODS Sterility of the connections was assessed by welding tubing with a heavy exterior contamination with Bacillus subtilis spores and also by welding in an environment contaminated with aerosols of B. subtilis. Tubing was either dry or liquid-filled ("wet") and had various diameters. Bacterial culture medium was flushed through the welded area and subsequently cultured. Tensile strength was measured, and, under semi-routine conditions, Compodock was tested for user friendliness and speed. RESULTS None of the cultures of welded tubing with exterior contamination showed growth, neither the dry-dry (n = 434) nor the wet-wet connections (n = 622). Cultures were also negative for welds made in the contaminated environment (dry-dry, 67; wet-wet, 55). Tensile strength complied fully with ISO 3826 standards (that is, a force of 20 newtons [N] for 15 sec), with a mean maximal strength ranging from 73 to 100 N, depending on diameter and content of the tubing. The semi-routine handling was regarded as good: welds were easily opened; there were clear instructions and error warnings; and the processing time averaged 52 seconds. CONCLUSION The Compodock is able to maintain a functionally closed system, with maintenance of sterility, despite heavy exterior bacterial contamination; tensile strength conformed to ISO standards. Compodock is suitable for routine implementation in the blood bank.