Independent* Microbial Integrity Testing Study objectives were established to test the integrity of INTEGRITY® Needlefree IV Access Ports with a single 10cm Extension Tube (Ref: 12011000) following the application of a micobial challenge. Each of 20 devices was inocculated with Staphylococcus Aureus ATC6538 (S. aureus). They were then swabbed with Sterile 0.2 micron filtered 70% Isopropanol alcohol blended with 30% Water for Injection and allowed to dry. The devices were then flushed with 10ml of fluid and the injectate tested for contamination. This was carried out 20 times per day per device over a 7-day period. The study included two positive, two negative and three sterility control samples.
No trace of S. aureus was detected on the 20 devices tested, during or following 140 activations over 168 hours.
On both of the positive control samples, S. aureus was isolated at each time point (140 activations over 168 hours).
Neither the negative control samples nor the sterility control samples tested positive for S. aureus during or following 140 activations over 168 hours.
The INTEGRITY® Needlefree IV Access Port with a single 10cm Extension Tube (Ref: 12011000), when used with adequate disinfection procedure, maintains its microbial barrier properties after 140 activations, over a 7-day period.
*Testing carried out by Microbiological Validation Services Ltd., Sheffield, UK (Nov 2016).