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OBJECTIVE: To compare relative risk (RR) of central line-associated bloodstream infection (CLABSI) between hospitals using Clave needleless connector technologies (NCT) and comparator hospitals using non-Clave NCT. And, to estimate avoided CLABSIs, mortality, and cost savings. BACKGROUND: Needleless connectors, while protective against needlestick injury, have long been implicated as a potential risk for CLABSI. Significant RR reduction of CLABSI among the many NCT has not been clinically demonstrated. METHODS: The U.S. Healthcare-Associated Infections database was accessed for CLABSI data for calendar year 2019 via the Centers for Medicare and Medicaid Services website. This dataset was merged with the Clave NCT manufacturer's 2019 database to identify hospitals purchasing Clave NCT (MicroClave™, NanoClave™, Clave Neutron™, Clave™, Microclave™ Clear) and non-Clave NCT comparator hospitals. Sub-analysis of Clave NCT hospitals included: (1) Clave NCT mixed-use and (2) Clave high-volume use hospitals. The standardized infection ratio (SIR) was generated to estimate CLABSI RR after adjusting for intern/resident-to-bed-ratio (IRB), care location, and hospital demographics. Using the RR, avoided CLABSIs, mortality, and cost savings were calculated. RESULTS: A total of 2987 eligible hospitals (1288 Clave NCT, 1699 non-Clave NCT) with 17,452,575 central line-days were evaluated. All three Clave NCT hospital groups showed a statistically significant reduction in RR compared to the non-Clave NCT hospitals. The RR in Clave NCT hospitals was 0.93, a 7% decrease in CLABSI risk (p = 0.02). In the Clave NCT subgroups, mixed-use hospitals RR was 0.93, a 7% reduction (p = 0.04), while the Clave NCT high-volume hospitals experienced a 19% reduction, RR 0.81 (p = 0.04). An estimated 563 CLABSIs and 84 related deaths were avoided with use of Clave NCT and $27,095,231 in cost savings. CONCLUSION: The use of the Clave NCT, in and of itself, is an effective risk reduction strategy for CLABSI prevention, reduced mortality, and substantial cost savings.

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OBJECTIVE: Although needleless connectors (NCs) are widely used in clinical practice, they carry significant risk of bloodstream infection (BSI). In this study, we quantified differences in bacterial transfer and biofilm formation between various NCs. DESIGN: Prospective, clinically simulated in vitro experimental study. METHODS: We tested 20 NCs in a 5-day clinical simulation of Staphylococcus aureus inoculations onto NC septum surfaces, which were then flushed with saline and cultured for bacterial transfer. Biofilm formation was measured through destructive sampling of the connector-catheter system. Moreover, 8 NC design factors were evaluated for their influence on bacterial transfer and biofilm formation. This study was designed without a disinfection protocol to ascertain the intrinsic risk of each NC. RESULTS: Clave Neutron and MicroClave had the lowest overall mean log density of bacteria in the flush compared to other NCs (P < .05), except there were no statistically significant differences between Clave Neutron, Microclave, SafeTouch, and SafeAccess (P ≥ .05). The amount of biofilm in the NC was positively associated with bacteria in the flush (P < .0005). Among 8 design factors, flow path was most important, with the internal cannula associated with a statistically significant 1 log reduction (LR) in bacteria in the flush (R2 = 49%) and 0.5-2 LR in the connector (R2 = 34%). All factors together best explained bacteria in the flush (R2 = 65%) and biofilm in the connector (R2 = 48%). CONCLUSIONS: Bacterial transfer and biofilm formation in the connector-catheter system varied statistically significantly between the 20 NCs, suggesting that NC choice can lower the risk of developing catheter-related BSIs.

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The need for filtering intravenous infusions has long been recognized in the field of venous access, though hard scientific evidence about the actual indications for in-line filters has been scarce. In the last few years, several papers and a few clinical studies have raised again this issue, suggesting that the time has come for a proper definition of the type of filtration, of its potential benefit, and of its proper indications in clinical practice. The WoCoVA Foundation, whose goal is to increase the global awareness on the risk of intravenous access and on patients' safety, developed the project of a consensus on intravenous filtration. A panel of experts in different aspects of intravenous infusion was chosen to express the current state of knowledge about filtration and to indicate the direction of future research in this field. The present document reports the final conclusions of the panel.

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PURPOSE: Infusate osmolarity, pH, and cytotoxicity were investigated as risk factors for midline catheter failure. METHODS: An experimental, randomized, controlled, blinded trial was conducted using an ovine model. Two 10-cm, 18-gauge single-lumen midline catheters were inserted into the cephalic veins of sheep. The animals were divided into 6 study arms and were administered solutions of vancomycin 4 mg/mL (a low-cytotoxicity infusate) or 10 mg/mL (a high-cytotoxicity infusate), doxycycline 1 mg/mL (an acidic infusate), or acyclovir 3.5 mg/mL (an alkaline infusate) and 0.9% sodium chloride injection; or 1 of 2 premixed Clinimix (amino acids in dextrose; Baxter International) products with respective osmolarities of 675 mOsm/L (a low-osmolarity infusate) and 930 mOsm/L (a mid-osmolarity infusate). Contralateral legs were infused with 0.9% sodium chloride injection for control purposes. Catheter failure was evaluated by assessment of adverse clinical symptoms (swelling, pain, leakage, and occlusion). A quantitative vessel injury score (VIS) was calculated by grading 4 histopathological features: inflammation, mural thrombus, necrosis, and perivascular reaction. RESULTS: Among 20 sheep included in the study, the overall catheter failure rate was 95% for test catheters (median time to failure, 7.5 days; range, 3-14 days), while 60% of the control catheters failed before or concurrently (median time to failure, 7 days; range, 4.5-14 days). Four of the 6 study arms (all but the Clinimix 675-mOsm/L and acyclovir 3.5-mg/mL arms) demonstrated an increase in mean VIS of ≥77% in test vs control legs (P ≤ 0.034). Both pain and swelling occurred at higher rates in test vs control legs: 65% vs 10% and 70% vs 50%, respectively. The mean difference in rates of occlusive pericatheter mural thrombus between the test and control arms was statistically significant for the vancomycin 10-mg/mL (P = 0.0476), Clinimix 930-mOsm/L (P = 0.0406), and doxycycline 1-mg/mL (P = 0.032) arms. CONCLUSION: Administration of infusates of varied pH, osmolarity, and cytotoxicity via midline catheter resulted in severe vascular injury and premature catheter failure; therefore, the tested infusates should not be infused via midline catheters.

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BACKGROUND: Subcutaneous ureteral bypass (SUB) device placement is an increasingly popular treatment option for decompression of ureteral obstruction in cats. Mineralization occlusion of the device occurs in a minority of cases but is the most common complication. OBJECTIVE: To evaluate a 2% tetrasodium ethylenediaminetetraacetic acid (tEDTA) solution for treatment of mineralization occlusion in cats with SUBs. ANIMALS: Six client-owned cats (8 obstructed devices). METHODS: Case series. Each cat was found to have device occlusion based on a combination of ultrasound examination, SUB irrigation, and failure to identify another cause of device obstruction. Each SUB was drained, irrigated using sterile saline, and infused with 1-2 mL of 2% tEDTA solution. Success was defined as normalization of flow during subsequent ultrasound visualization while irrigating. The volume and frequency of tEDTA instillations, time to achieve device patency, follow-up biochemical and ultrasound findings, and future reobstruction events were recorded. RESULTS: Resolution of mineralization was documented in all 8 SUBs. Reobstruction events occurred in 2 cats, all of which resolved after additional tEDTA infusions, but 1 cat ultimately required device exchange at 356 days from the first tEDTA infusion. In 1 cat, a single infusion was prematurely discontinued because of persistent pelvic dilatation after 1.25 mL of tEDTA had been instilled. No complications were observed. CONCLUSIONS AND CLINICAL IMPORTANCE: Tetrasodium EDTA infusions can be safely considered as a treatment option for mineralized SUB devices in cats. This solution was easily infused, well tolerated, and avoided the need for SUB device exchange in the majority of cats in which it was used.

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This work explains the motivation, advantages, and novel approach of using velocity magnetic resonance imaging (MRI) for studying the hydrodynamics in a complicated structural biomedical device such as an intravenous catheter needleless connector (NC). MRI was applied as a non-invasive and non-destructive technique to evaluate the fluid dynamics associated with various internal designs of the NC. Spatial velocity maps of fluid flow at specific locations within these medical devices were acquired. Dynamic MRI is demonstrated as an effective method to quantify flow patterns and fluid dynamic dependence on structural features of NCs. These spatial velocity maps could be used as a basis for groundtruthing computational fluid dynamics (CFD) methods that could impact the design of NCs.

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The compatibility of a 2% chlorhexidine gluconate/70% isopropyl alcohol (CHG/IPA) skin preparation with a gum mastic liquid adhesive (GMLA) and liquid adhesive remover (LAR) was assessed in healthy volunteers. Twenty subjects completed test material combination with microbial sampling at 3- and 7-day time points. Mean log10 reductions from baseline for normal flora were assessed. There was no significant difference in reduction of normal flora on skin prepped with CHG/IPA versus skin prepped with CHG/IPA followed by GMLA or LAR. The conclusion of the study was that the use of GMLA or LAR with CHG/IPA does not affect the antiseptic effectiveness of CHG/IPA.

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Catheter-related bloodstream infection and catheter occlusion are potential significant complications of parenteral nutrition therapy. The increased incidence and associated morbidity, mortality, increased costs, and quality-of-life issues experienced with these adverse events necessitate specialized management of vascular access devices. The host coagulation response to biomaterials and the associated development of biofilm on vascular devices are complex phenomena. Multiple interventions are required to prevent access of bacteria to both intraluminal and extraluminal catheter surfaces, and the occurrence of catheter occlusion. The discovery of the biofilm form of microbial life and the associated recalcitrance of biofilm bacteria to antimicrobials has provided insight into the failure of current prevention, diagnostic, and treatment protocols. Critical interventions are presented correlating current evidence with new discoveries in pathogenesis.

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