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Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
Published on: August 11, 2017
Universal intravenous access cleaning device fails to sterilize stopcocks
Julie L Holroyd1, David A Paulus, Kenneth H Rand
1From the Departments of Anesthesiology and Pathology, Immunology, and Laboratory Medicine, University of Florida College of Medicine, Gainesville, Florida; Deceased.
Background:
Contamination of a central venous catheter may occur through use of conventional open-lumen stopcock devices (COLDs), or disinfectable, needleless, closed connectors (DNCCs). We investigated the effectiveness of a new universal IV access cleaning device (Site-Scrub) compared with 70% isopropyl alcohol prep pads for sanitizing COLDs or DNCCs inoculated with common catheter-associated pathogens.
Methods:
Site-Scrub was compared with 70% alcohol prep pads for sanitizing contaminated female Luer lock COLD or DNCC filled with sterile saline or propofol and 2 common bacterial central venous catheter contaminants (Staphylococcus epidermidis or Pseudomonas aeruginosa). Devices were contaminated using a glove touch (COLD and DNCC) or syringe tip (COLD). The primary end point of the study was colony-forming units (CFU) after 24 hours.
Results:
The use of glove touch contamination, the contaminants, S epidermidis and P aeruginosa, produced CFU in saline-filled COLDs treated with the Site-Scrub, but not in those treated with alcohol pads (P < 0.001). Similar results were observed with propofol-filled COLDs (P < 0.001). For DNCCs filled with saline or propofol, both alcohol and Site-Scrub effectively reduced CFU growth compared with contaminated controls (P < 0.001). When COLDs were contaminated by treated syringe tips, there was no significant evidence of reduction in CFU growth by using either alcohol pads or Site-Scrub compared with contaminated controls.
Conclusions:
These data suggest that when the inner surface of the COLD is contaminated, both alcohol pads and Site-Scrub were not significantly effective in decontaminating the COLD. When the COLD rim is contaminated, however, alcohol pads outperform Site-Scrub. DNCCs were uniformly decontaminated with either treatment. Future work should focus on better access systems because current COLDs are difficult to decontaminate.
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