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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.

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.

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.

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.

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.

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.

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.

The use of vascular access devices in hospitalized and home care patients has expanded rapidly in the past decade. New designs, materials, insertion techniques, and protocols for care related to vascular access devices have emerged. Complications associated with them, however, have remained a persistent problem. Septicemia, thrombosis, and occlusion are three of the more serious complications that can lead to the need for removal of the device. These complications are reviewed and areas for future research are identified.

Medical science has made dramatic strides in the use of innovative drug therapies to improve the lives of patients with life-threatening and chronic illnesses. As new therapies have evolved, so has the way in which they are administered. The transition of care from hospital to home and cost competition forced the home infusion industry to find safe, cost-effective methods to deliver parenteral therapy. Medical device technology has met the challenge with several new devices alternatives. Almost at the same time, three new peripheral device options were introduced: the midline catheter, the peripherally inserted central venous catheter (PICC) , and the peripheral port. While these devices are proving to be safe, cost-effective methods for delivery of parenteral therapy, confusion exists regarding the appropriate use, care and management among the various access devices. Traditionally, device selection was based primarily on the need for short-term or long-term access. Peripheral intravenous catheters were used until venipuncture was no longer possible. Central venous catheters were used only for hemodynamic monitoring in the critically ill, when parenteral nutrition or chemotherapy required prolonged access, or when peripheral veins were exhausted. Now the issues are different; multiple drug regimens are administered in alternate care settings with variable lengths and frequencies of drug administration, multiple device options are available each with variable risks, non-medical caregivers provide care and administer parenteral drugs

Cost reduction is a major focus of healthcare in the United States (US) and throughout the world. US hospitals are merging and downsizing staff as a major effort in cost containment. Specialty care teams such as nutrition support, IV therapy, and infection control, have been early prey to downsizing or elimination by administrators who perceive these programs as dispensible amenities. This will most likely prove to be counterproductive and excessively costly. In 1994, the US Agency for Healthcare Policy and Research published The National Bill for Diseases Treated in the U. S. Hospitals, which listed medical complications from the use of a device or procedure for diagnosis or treatment among the top ten most costly health-related problems in the US, at an annual cost of $3.1 billion. An extraordinary number of medical devices are used in the delivery of parenteral and enteral nutrition. Both modalities carry significant risk for costly complications related to the associated medical device. The incidence of central venous catheter (CVC) complications alone is estimated at well over 10%. The consequences of adverse events with vascular catheters and enteral feeding devices can be life-threatening. Patients may survive elaborate, high-tech surgical procedures after trauma or lifethreatening illnesses only to later suffer or die as a result of insufficient knowledge of prevention or treatment of medical device-related complications, or failure of the device itself. Patients surviving such adverse events may be left with profound abnormalities such as neurological impairment, disfigurement, loss of limb, or permanent loss of venous access sites; all negative outcomes which result in extended length of hospital stay and inordinate costs. Another costly and unfortunate outcome of device-related adverse events is malpractice litigation, not typically a line-item in a hospital’s or agency’s budget. Following are examples of recent legal cases where large sums were awarded for patients who suffered or died from such events.

Home infusion therapy is the fastest growing segment of home care, yet little is known about the utilization of various venous access devices in the home. This study reports pioneering data from thirty seven hospital-based, community-based and home infusion pharmacy agencies across the country which provide home infusion therapy services. Venous access device utilization data for adults and children are compared and differences among agency types of home care providers are analyzed. Significant patient device utilization differences among different provider types and age groups are discussed in terms of their implications for clinicians, educators, policy makers and researchers.

Catherer-related sepsis is a problem with many variables. A process of elimination may eventually identify the actual cause(s) of this phenomenon. We began our problem-solving approach by observing personnel inserting and caring for central lines, which showed a lack of compliance with existing protocols. A program was designed to provide the correct procedural activities. This study plans to test whether ongoing educational programs and an infection control department that maintains a high degree of visibility are effective in reducing nosocomial line-related infections.

All hospitalized patients except infants (a total of 1,647 patients) who received central venous TPN solutions at UCDMC from 1981 through 1985 were studied to determine the incidence of complications from the use of TPN. A complication was considered to have occurred if the patient experienced obvious morbidity, mortality, or both; an event known to be deleterious, despite a lack of demonstrable morbidity; or premature loss of the central venous catheter. Complications related to catheter placement occurred in 5.7 percent of patients, sepsis in 6.5 percent, mechanical complications in 9 percent, and metabolic complications in 7.7 percent. The incidence of induction of sepsis increased during 1984 to 1985 due to the introduction of multilumen central venous catheters. The most frequent catheter placement complications were hemorrhage and pneumothorax. Major venous thrombosis and nursing mishaps were the most common mechanical complications. Metabolic complications were infrequent and were generally not severe after adjustment of the protocol in late 1981. Four patients (0.2 percent) died from TPN-associated complications: a child on home TPN who underwent a catheter change and in whom hyperosmolar hyperglycemic coma developed, a patient with end-stage chronic obstructive pulmonary disease in whom tension pneumothorax occurred, a patient who died from complications of subclavian artery laceration, and a patient who died from Candida septicemia. Complications of TPN are frequent and may be severe. Quality assurance mechanisms for identification of these complications are necessary and should form the basis for the establishment of appropriate protocols.