Importance of Product Design on Effective Bacterial Removal by Fluid Convection in Y Set and Twinbag Systems

Kubey, W.; Straka, P; Holmes, C. J.

doi:10.1159/000014329

Cited by 7 publications

(5 citation statements)

References 17 publications

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“…For instance, early reports of the flush-before-fill concept using quantitative microbiology was followed by clinical demonstration of reduced peritonitis rates [8]. Furthermore, we have shown a superiority of Twinbag systems over Y-set systems in microbiological challenge studies, which again parallels the clinical experience in terms of peritonitis rates [20,21].…”

Section: Resultssupporting

confidence: 64%

An in vitro Bacterial Touch Contamination Risk Assessment of Two CAPD Twinbag Systems

Kubey

Straka²,

Holmes³

2000

Blood Purif

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The objective of this study was to compare, using in vitro quantitative microbiology, the ability of two commercially available peritoneal dialysis solution delivery systems to prevent and remove, via convective fluid flow, intralumenal fluid path bacterial contamination. The two systems (A and B) differed in both the configuration of their flow control, or Y-junction and the method of fluid flow control and also in the design of their Luer tubing connectors. System A had a tubing type Y-junction that requires clamps to control fluid flow and uses a connector with a male Luer that is deeply recessed within a shroud. System B has a dial-type rigid Y-junction with in-line flow control and a connector with a male Luer that is shrouded but not recessed. System A connectors allowed significantly (p < 0.0001) fewer bacteria to be transferred into the fluid path than System B after simulated touch contamination. Also, when an equivalent number of bacteria were deliberately placed into the fluid paths of both systems, System A was more effective in removal of the bacterial contamination by convective fluid flow than System B (p < 0.0001), resulting in fewer organisms infused into the simulated peritoneum. Specific design features of System A, such as a recessed male Luer, and a Y-junction fluid flow path with low turbulence were likely explanations for its superior results. This study emphasizes the importance of connector and fluid path flow design in the aseptic performance of peritoneal dialysis delivery systems.

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Section: Resultssupporting

confidence: 64%

An in vitro Bacterial Touch Contamination Risk Assessment of Two CAPD Twinbag Systems

Kubey

Straka²,

Holmes³

2000

Blood Purif

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“…disposable dialysate containers and the Y connector as a single set) [18][19][20][21][22] and routine use of the 'flush before fill' technique. 21,[23][24][25][26][27] This is most likely responsible for improvements in the 1990s and 2000s. [28][29][30][31][32][33][34][35][36] The reasons for the continuing improvement are less obvious.…”

Section: Discussionmentioning

confidence: 99%

A systematic review of peritoneal dialysis-related peritonitis rates over time from national or regional population-based registries and databases

Marshall

2021

Perit Dial Int

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Peritoneal dialysis (PD)-related peritonitis is one of the top priorities for care and research among PD stakeholders. This study summarizes PD peritonitis rates from available population-based national or regional registries around the world, examining trends over time. This is a systematic review of PD peritonitis rates in patients treated with PD for kidney failure, from census-based national or provincial/statewide/provider registries or databases. MEDLINE (via PubMed) was searched from inception to August 2020, and inquiries made to national registry personnel using the International Comparisons section of the 2018 United States Renal Data System Annual Data Report as a contact list. Quantitative synthesis was done using weighted random-effects Poisson regression. Of 81 countries that reported utilization of PD, 19 did not have a traditional dialysis registry (governed by either professional societies or government entities), and only 33 monitored PD peritonitis rates correctly and accessibly. There is wide variation in PD peritonitis rates between countries, although the global average has been decreasing over time, from 0.600 episodes/patient-year in 1992 to 0.303 in 2019. Other sources of variability include the continent in which the country is nested and the size of its PD population. PD peritonitis, despite its importance for PD stakeholders, is under-monitored. While the global rate is decreasing over time, the presence and extent of this improvement varies from country to country. There is an opportunity for better monitoring, research into underachieving and overachieving nations and development of international clinical support networks.

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“…Our results show that none of the bacteria contaminating the pin were transferred to the fluid path, ruling out the possibility of bacteria gaining access to the peritoneum during PD fluid exchanges. These results are all the more impressive considering the level of contamination generated by the challenge procedures (1.6x10 5 CFU), which is considerably higher than might be expected in the clinical setting—from 10 2 CFU by unprepared hands, up to 4.5x10 3 CFU if hands are washed but not dried (22)—or than has been reported as the worst-case touch contamination scenario in previous studies (23-25) evaluating the ability of several commercially available PD connectors to prevent fluid path contamination (Table 1).…”

Section: Discussionmentioning

confidence: 58%

“…32, NO. 5 PDI (22)-or than has been reported as the worst-case touch contamination scenario in previous studies (23)(24)(25) evaluating the ability of several commercially available PD connectors to prevent fluid path contamination (Table 1).…”

Section: Discussionmentioning

confidence: 99%

“…It is important to note that, although the CRM device can also operate the flush-before-fill step, we simulated PD exchange in the present study without including that step. Without such convective removal of bacteria contaminating the fluid path, commercially available connector systems would not be very efficient in reducing bacterial contamination (23,25).…”

Section: Discussionmentioning

confidence: 99%

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In Vitro Microbiology Studies on a New Peritoneal Dialysis Connector

Bonaventura

Cerasoli²,

Pompilio

et al. 2012

Perit Dial Int

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ObjectiveWe evaluated the ability of a recently developed peritoneal dialysis (PD) connector to prevent the risk of bacterial transfer to the fluid path after simulated touch and airborne contamination.MethodsStaphylococcus epidermidis ATCC1228 and Pseudomonas aeruginosa ATCC27853 strains were used. For touch contamination, 2 μL of a standardized inoculum [1x108colony-forming units (CFU) per milliliter] were deposited on top of the pin closing the fluid path of the patient connector. For airborne contamination, the patient connector was exposed for 15 seconds to a nebulized standardized inoculum. To simulate the patient peritoneum and effluent, the patient connector was pre-attached to a 2-L bag of sterile PD solution. After contamination, the patient connector was attached to the transfer set, the pin was captured, flow control was turned to simulate “patient drain” into the empty bag, and then “patient fill” using the bag pre-attached to the connector. Finally, a new pin was recaptured. The PD solution collected in the bag pre-attached to the connector was run through a 0.20-μm filter for colony counts.ResultsNo infected connector transferred bacteria to the fluid path, regardless of the challenge procedure or the strain used.ConclusionsOur results show that the new PD connector may fully obviate the risk of bacterial infection, even in the presence of heavy contamination. Further studies are in progress to test our PD connector in a clinical setting.

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Importance of Product Design on Effective Bacterial Removal by Fluid Convection in Y Set and Twinbag Systems

Cited by 7 publications

References 17 publications

An in vitro Bacterial Touch Contamination Risk Assessment of Two CAPD Twinbag Systems

An in vitro Bacterial Touch Contamination Risk Assessment of Two CAPD Twinbag Systems

A systematic review of peritoneal dialysis-related peritonitis rates over time from national or regional population-based registries and databases

In Vitro Microbiology Studies on a New Peritoneal Dialysis Connector

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