Access Site and Hub Disinfection: In Vitro Testing of a Novel Device

Transcription

1 Access Site and Hub Disinfection: In Vitro Testing of a Novel Device Marcia A. Ryder, PhD MS RN, George Szorenyi, BS, Martin A. Hamilton, PhD, Gordon C. Hamilton, BS, Paul D. Holtom, MD University of Southern California, Los Angeles, CA, USA, LGGS Inc., Anaheim, CA, USA, Big Sky Statistical Analysts, Bozeman, MT, USA Marcia A. Ryder, PhD MS RN 87 Bottlebrush Dr., Los Angeles, CA Tel: (0) ryder@aol.com Background Experiment : Access Site Disinfection Intraluminal biofilm is a significant source of catheter-related bloodstream infection (CRBSI) in both short term and long-term catheters,. Microorganisms gain access to the internal surface of the catheter hub and endolumen during injection through contaminated needleless connectors and injection ports, and with stopcock and catheter hub manipulation. The needleless connector is an integral patient safety component of vascular access systems. However, all luer-activated needleless connectors and split septum devices have the capacity to transfer bacteria, some significantly more than others, if not disinfected,. Many institutions have reported increased infection risks with certain needleless connectors despite the institutions stated use of alcohol prep pad disinfection protocols -7. The Joint Commission 009 National Patient Safety Goals require the use of injection site and hub disinfection protocols before accessing. Complete eradication of microorganisms on the port is dependent on the ) microbial burden on the access site surface, ) antimicrobial agent,) concentration of the antimicrobial agent, ) contact time of the agent, ) method of application, and 6) frequency of application. National/international guidelines and recommendations are not instructive to most of these criteria (see Table ). The 008 SHEA/IDSA Central line Bloodstream Infections Prevention strategies recommend disinfection of injection sites, needleless connectors and catheter hubs with an alcoholic chlorhexidine (CHG) preparation or 70% isopropyl alcohol (IPA). Chlorhexidine/alcohol combinations for needleless connector and hub disinfection have been shown to be superior to alcohol alone even in low concentrations 8-0. Currently the IPA prep pad is mostly used in clinical practice, but with highly variable results -7. The use of a prep pad, designed for skin antisepsis, is a questionable method to disinfect access sites due to the ) lack of established methodology for effective application on the variety of connector configurations, ) inability to clean internal hub surfaces, ) inconsistent application among clinicians, ) application time required (at least sec. application ) and ) touch contamination with use. A novel device, the Site-Scrub TM is designed to disinfect all access devices by scrubbing with a foam-pad saturated with a % CHG / 70% IPA formulation contained within a plastic housing. The device is placed over and onto a needleless connector, injection site, stopcock, or catheter hub and rotated for 8 complete turns over 0 sec. Objective The purpose of this experiment is to compare the effectiveness of the Site-Scrub (PFM Medical Inc., Oceanside, CA) to an IPA prep pad by ) quantification of the number of microorganisms remaining after septum disinfection and ) to quantify the number of bacteria transferred through the connector on injection. Methods The Alaris SmartSite Plus and B. Braun UltraSite needleless connectors were chosen for study based on prior data that demonstrated a high rate of bacterial transfer without disinfection. The connector septa were inoculated with x0 Staphylococcus epidermidis, and then allowed to dry. Connectors were then treated in one of three ways, disinfection with the Site-Scrub (8 complete rotation 0 sec), disinfection with an IPA prep pad (scrub, sec), or no disinfection (control). Each connector was immediately flushed with ml sterile fluid, which was then cultured to quantify the number of microorganisms passing through the connector. Three connectors of each type were observed for each response (surface count and flush count) for each of the treatments in each of independent experiments, counts (CFU per connector) in all.

2 Results Experiment : Access Site Disinfection The results of the surface counts and flush counts (Table ) were each statistically analyzed for log density (log 0 CFU per connector) (Table ). Figure graphically displays the log density for each of the results. The difference in mean log reduction values was highly statistically significant. Geometric Mean of Surface Counts Connector type Alcohol prep. Control Site-Scrub SmartSite Plus 7 0 < 0. UltraSite < 0. (0 on of connectors) SURFACE Geometric Mean of Flush Counts Connector type Alcohol prep. Control Site-Scrub SmartSite Plus UltraSite 6 00 < 0. (0 on of connectors) FLUSH Table. Summary showing the geometric mean of CFU per connector for each combination of count location, treatment, and connector type. Mean of Log Reduction Values SmartSite Plus UltraSite Alcohol prep Site-Scrub Alcohol prep Site-Scrub Mean p-value <0.00 <0.00 SURFACE Mean of Log Reduction Values SmartSite Plus UltraSite Alcohol prep Site-Scrub Alcohol prep Site-Scrub Mean p-value FLUSH Table. Mean of log reduction values, averaged over experiments. The -tailed p-value is based on a paired t-test for comparing Alcohol prep to Site-Scrub.

3 Experiment : Access Site Disinfection 6 Alcohol prep. Control Site-Scrub SURFACE Surface log density 0 Experiment Connector Type Smart Site Ultra Site Smart Site Ultra Site Smart Site Ultra Site Figure. Surface log density. Each point is the surface log density for one of the 7 connectors tested...0 Alcohol prep. Control Site-Scrub FLUSH Flush log density Experiment Connector Type Smart Site Ultra Site Smart Site Ultra Site Smart Site Ultra Site Figure. Flush log density. Each point is the flush log density for one of the 7 connectors tested.

4 Experiment : Stopcock / Hub Disinfection Background Microorganisms gain access to the internal surface of the catheter hub and endolumen with stopcock and catheter hub manipulation and by injection through contaminated access sites. Colonization of the catheter hub has been found to be a significant independent risk factor for CRBSI in as many as 67% of cases (RR 7.9-.). Stopcocks were recognized to be a significant source of contamination (8%) as early as 97. A recent study in operating suites identified contamination in % of stopcocks used during the operative procedure. Subsequent contamination of the intravenous tubing was associated with an increased risk of nosocomial infection (OR,.08: 9% CI, ; p=0.) and mortality (OR.- : 9% CI, p=0.09) after surgery. Despite a strong association of stopcock use with CRBSI (OR.98) neither stopcock or hub disinfection methodology is addressed in any national guideline, perhaps because there is no existing device available for this purpose. The 008 SHEA / IDSA CRBSI prevention strategies include disinfection of catheter hubs with an alcoholic chlorhexidine (CHG) preparation or 70% isopropyl alcohol (IPA). Chlorhexidine/alcohol combinations used for needleless connector and hub disinfection has been has shown to be superior to alcohol alone even in low concentrations 8-0. Hub and stopcock colonization throughout the literature is determined by culture of the internal lumen of the catheter and should be the site targeted for disinfection. However, disinfection of the internal portion of the hub with a prep pad is virtually impossible and may result in further contamination by touch contamination. Complete eradication of hub colonization is dependent on ) microbial burden in the hub lumen, ) the antimicrobial agent, ) the concentration of the antimicrobial agent, ) contact time of the agent, ) the method of application, and 6) the frequency of application. The Site-Scrub TM is a novel device designed to disinfect catheter hubs, stopcocks, or any female luer system. Site-Scrub disinfects by scrubbing with a foam-padded device saturated with a % CHG / 70% IPA formulation within a plastic housing. The device is placed over a stopcock, or catheter hub and rotated for 8 complete turns over 0 sec. 8 Objective The purpose of this experiment is to compare the effectiveness of a novel disinfection device Site-Scrub (PFM Medical Inc., Oceanside, CA) to an IPA prep pad by quantification of the number of microorganisms transferred through a stopcock on injection. Methods The internal surface of -way stopcock hubs were inoculated with x0 Staphylococcus epidermidis, and then allowed to dry. Stopcock hubs were then treated in one of three ways, disinfection with the Site-Scrub (8 complete rotations, 0 sec), disinfection with an IPA prep pad (scrub, sec), or no disinfection (control). Each hub was immediately flushed with ml sterile fluid, which was then cultured to quantify the number of microorganisms (CFU per hub) passing through the stopcock. Three hubs were observed for each treatment in each of multiple (-) tests conducted within each of independent experiments, tests and 7 counts in all.

5 Experiment : Stopcock / Hub Disinfection Results The Site-Scrub counts ranged from 0 ( of 9 hubs) to CFU. The IPA prep pad counts on 9 hubs ranged from.x0 to 7.9x0 CFU, barely less than control (see Figure ). A flush count of zero CFU per hub was observed only for the Site-Scrub treatment (see Figure ). The geometric means of flush CFU counts per carrier, averaged across all tests were.98 0 for control,. 0 for alcohol prep, and less than 0.7 for Site-Scrub. Site-Scrub was statistically significantly better than alcohol prep (p < 0.00). Geometric Mean of Flush Counts Alcohol prep. Control Site-Scrub < 0.7 (0 on of the 9 hubs) Table. Summary showing the geometric mean of CFU per hub for each treatment. Mean of Log Reduction Values Alcohol prep Site-Scrub Mean..87 p-value < 0.00 Table. Mean of log reduction values, averaged over tests. The -tailed p-value is based on a paired t-test for comparing alcohol prep to Site-Scrub.

6 Experiment : Stopcock / Hub Disinfection Alcohol prep. Control Site-Scrub Flush log density 0 Test Experiment Figure. Each point is the flush log density for one of the 7 hubs. The hubs of the specified treatment in an experiment are aligned vertically. p = > Alcohol prep. Control.0 Flush log density Figure. Each point is the flush log density for one of the 78 hubs. The hubs of the specified treatment in an experiment are aligned vertically. The alcohol prep pad was no better than the control with no disinfection... Test Experiment 6

7 Conclusion This study demonstrates the repeatability and reliability of the Site-Scrub to disinfect needleless connectors and catheter hubs compared to the alcohol prep pad. Site-Scrub was statistically significantly better than the prep pad at eradication of bacteria from the needleless connector surfaces and at preventing viable bacteria from being flushed through the disinfected connectors as well as the hubs. Use of the Site-Scrub may significantly reduce intraluminal catheter colonization and CRBSI. REFERENCES. Garland JS, et. al. Cohort study of the pathogenesis and molecular epidemiology of catheter-related bloodstream infection in neonates with peripherally inserted central venous catheters. ICHE. 008;9():. Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med. 00;0:6. Ryder M, Fisher S, Hamilton M, James G. Bacterial transfer through needlefree connectors: Comparison of nine different devices. The Society for Healthcare Epidemiology of America. Baltimore, MD. Abstract #9, April Ryder M, Schaudinn C, Gorur A, Costerton JW. Microscopic examination of microbial colonization of needleless connectors. Publication Number -6, APIC Annual Education Conference, Denver, CO. June Rupp ME, et al. Outbreak of bloodstream infection temporally associated with the use of an intravascular needleless valve. Clin Infect Dis. 007;:08 6. Salgado CD, et al. Increased rate of catheter-related bloodstream infection associated with use of a needleless mechanical valve device at a long-term acute care hospital. ICHE. 007;8(6):68 7. Maragakis LL, et al. Increased catheter-related bloodstream infection rates after the introduction of a new mechanical valve intravenous access port. ICHE. 007;7():67 8. Jarrell NM, Maher KO. Minimizing risk of catheter related blood stream infections from multiple line accesses in a pediatric cardiac intensive care unit. APIC Annual Conference, San Jose, CA. June 007. Publication number Casey AL, et al. A randomized,prospective clinical trial to assess the potential infection risk associated with the PosiFlow TM needleless connector. J Hosp Infection. 00;:88 0. Salzman MB, et al. Use of disinfectants to reduce microbial contamination of hubs of vascular catheters. J Clin Microbiol. 99;():7. Kaler W, Chinn R. Successful disinfection of needleless access ports: a matter of time and friction. JAVA. 007;():0. Safdar N, Kluger DM, Maki DG. A review of risk factors for catheter-related bloodstream infection caused by percutaneously inserted, noncuffed central venous catheters: Implications for preventative strategies. Medicine. 00;8(6):66. McArthur BJ, Hargiss C, Schoenknecht FD. Stopcock contamination in an ICU. Am J Nursing. 97;7():96. Loftus RW, et al. Transmission of pathogenic bacterial organisms in the anesthesia work area. Anesthesiology. 008;09:99. Yebenes JC, et al. Prevention of catheter-related bloodstream infection in critically ill patients using a disinfectable, needlefree connector: a randomized controlled trial. AJIC. 00;():9. Funding for these studies was provided by PFM Medical, Inc. 7

8 TABLE : Connection Without Infection Strategies! Practice Recommendations Guidelines Standards 009 The Joint Commission: National Patient Safety Goals Accreditation Program for: Hospitals Long Term Care Home Care Critical Access Hospitals Ambulatory Health Care NPSG Implement best practices or evidence-based guidelines to prevent central line-associated bloodstream infections. As of April, 009, the hospital s leadership has assigned responsibility for oversight and coordination of the development, testing, and implementation of NPSG As of July, 009, an implementation work plan is in place that identifies adequate resources, assigned accountabilities, and a time line for full implementation of NPSG by January, 00. As of October, 009, pilot testing in at least one clinical unit is under way, for the requirements in NPSG As of January, 00, the elements of performance in NPSG are fully implemented across the hospital. 6 As of January, 00: Use a standardized protocol to disinfect catheter hubs and injection ports before accessing the ports. 008 SHEA/IDSA Practice Recommendations Section I. C. After insertion. Disinfect catheter hubs, needleless connectors, and injection ports before accessing the catheter (B-II). 7-9 a. Before accessing catheter hubs or injection ports, clean them with an alcoholic chlorhexidine preparation or 70% alcohol to reduce contamination. Section A.. Compliance with cleaning of catheter hubs and injection ports before they are accessed a. Assess compliance through observations of practice. i. Numerator: number of times that a catheter hub or port is observed to be cleaned before being accessed. ii. Denominator: number of times a catheter hub or port is observed to be accessed. iii. Multiply by 00 so that the measure is expressed as a percentage. 007 Institute for Safe Medical Practices Safe Practice Recommendations: disinfect the port before connecting tubing or a syringe to the port. 006 Infusion Nursing Standards of Practice. Injection and Access Caps Standard. Protocols for disinfection, accessing, and changing of injection and access caps shall be established in organizational policies and procedures and practice guidelines, and shall be in accordance with manufacturer s labeled use(s) and directions. Practice Criteria A. To prevent the entry of microorganisms into the vascular system, the injection or access port should be aseptically cleansed with an approved antiseptic solution immediately prior to use; antiseptic solution containers in a single-use package should be used. 00 CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections Recommendations for placement of intravenous catheters in adults and children IX. Replacement of administration sets, needleless systems, and parenteral fluids B. Needleless intravascular devices. Minimize contamination risk by wiping the access port with an appropriate antiseptic and accessing the port only with sterile devices 007 epic : National Evidence-Based Guidelines for Preventing Healthcare-Associated Infections in NHS Hospitals in England CVAD A single use application of alcoholic chlorhexidine gluconate solution (preferably % chlorhexidine gluconate in 70% isopropyl alcohol) should be used and allowed to dry when decontaminating the injection port or catheter hub (and needle-free devices CVAD ) before and after it has been used to access the system, unless contraindicated by the manufacturer s recommendations, in which case either aqueous chlorhexidine gluconate or aqueous povidone iodine should be used. Safer Healthcare Now! Quebec Campaign: Central Line Maintenance Bundle 7. Accessing the lumens aseptically - Accessing the lumens aseptically has also been shown, through the work of The Canadian ICU Collaborative, to desrease the risk of infection. A number of centers have found it helpful to reduce choice and thus reduce possible error by making only chlorhexidine antiseptic swabs available. This includes the practice of using chlorhexidine antiseptic to swab ports. 8