Disinfection
Scrubbing the hub has never been easier.
Purpose and study design
The goal of this engineering study(1) was to evaluate the optical disinfectability of the K-Zero and competitor products.
This study is intended to illustrate visually the disinfectability of the product.
The proof of functional disinfection was carried out and documented within a separate microbial ingress study(2).
Within this study four different products from different manufacturers were tested. The products are listed in the table below.
Product | Batch | Manufacturer |
|---|---|---|
SmartSite | (10)20046621 | BD |
MicroClave | 5116463 | ICU Medical |
Ultrasite | 0061760814 | B.Braun |
K-Zero | SO-01389 | Fresenius Kabi |
One drop of a fluorescent solution(3) was applied to the surface of each product.
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After 30 seconds, the fluorescent solution was removed with a disinfection cloth (B.Braun Softa Cloth CHX 2%) by swiping over the surface for 15 seconds according to the manufacturer's instructions(4).
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After drying, UV light was used to show the remaining fluorescent solution on the surface.
This procedure was repeated for three samples of each type of needlefree connectors.
Before
After
K-Zero
Fresenius Kabi
SmartSite
BD
MicroClave
ICU Medical
Ultrasite
B.Braun
This engineering study shows that the fluorescent solution did not enter any gaps or openings in the K-Zero.
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Compared to tested competitors, there is noticeably less residual fluorescent solution on the surface of K-Zero.
References
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(1) Performance data on file at Fresenius Kabi internal study (DHF-EPB-006627)
(2) Microbial ingress study conducted by Nelson Laboratories (Salt Lake City, UT 84123 USA). Study number 981949-S01B.2
(3) UV-solution contains 99.6 mass-% MCT oil and 0.4 mass-% fluorescent Tinopal OB (C31592)
(4) Exact disinfection technique is not described by manufacturer B.Braun. Therefore, guidance by INS [Infusion Therapy Standards of Practice, 8th edition (2021): Gorski et al.] was referred for the disinfection technique. Disinfection shall be done by a vigorous mechanical scrub using a flat swab pad containing 70% isopropyl alcohol or alcohol-based chlorhexidine suitable for use with medical devices. During the 15 seconds disinfection time, the needlefree connectors were scrubbed by pressing the cloth to the membrane side with a thumb and performing 5 rotational movements for ~180° each. This procedure was repeated 3 times, each time using a noncontaminated area of the disinfection cloth.