- Email: [email protected]
Optimal Disinfection Times for Needleless Intravenous Connectors
O R I G I N A L
A R T I C L E
Optimal Disinfection Times for Needleless Intravenous Connectors Judy S. Smith, MSN, RN, CRNI Clinical Nurse Expert, Venous Access, Seton Healthcare Family, Austin, TX Gwen Irwin, RN, CRNI, VA-BC Clinical Manager, Venous Access, Seton Healthcare Family, Austin, TX Mary Viney, MSN, RN, CPHQ, NEA-BC Vice President Nursing Practice, Seton Healthcare Family, Austin, TX Lynda Watkins, MPH, BSN, RN, CIC Infection Preventionist, University Medical Center at Brackenridge, Austin, TX Shonnie Pinno Morris, BSMT, ASCP, SM Manager, Microbiology Labs, Seton Healthcare Family, Austin, TX Kenn M. Kirksey, PhD, RN, ACNS-BC Director, Nursing Strategic Initiatives, Lyndon B. Johnson General Hospital, Houston, TX Adama Brown, PhD Research Scientist, University of Texas at Austin School of Nursing, Austin, TX
Abstract Background: Elimination of catheter-related bloodstream infections is a major focus in health care. According to the Centers for Disease Control and Prevention and the Infusion Nurses Society, the optimal time for needleless connector disinfection has not yet been empirically established. Methods: Using experimental design and established lab procedure, a 0.5 MacFarland suspension was used to inoculate 172 needleless connectors with bacteria (Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa) and allowed to dry for 18 hours. Five groups of connectors (n ¼ 27 per group) were disinfected using 70% isopropyl alcohol with friction for 5, 8, 10, 12, and 15 seconds, and flushed with 0.5 mL nonbacteriostatic sterile normal saline onto sheep-blood agar plates for incubation at 35 C for 48 hours. Bacterial growth (1 colony) was noted on 2 negative controls; therefore, a second sample (n ¼ 172) was tested as above using additional precautions of masking, gloving, and gowning. A third group of connectors was tested using a 0.5 MacFarland suspension containing yeast (Candida albicans). Results: Group 1 showed significant (c24 ¼ 37.93; P ¼ .00) and strong (Cramér’s V ¼ 0.53; P ¼ .00) associations between scrub time and growth status. Although not statistically significant, Groups 2 and 3 demonstrated clinically significant associations between these factors. Conclusions: Although additional research is warranted, our study showed that disinfection times of 5 and 8 seconds were inadequate for reducing bacterial transfer. However, disinfection times of 10, 12, and 15 seconds resulted in comparable, decreased rates of bacterial migration. Keywords: disinfection of needleless connectors, CRBSI prevention, patient safety, time requirement for disinfection of needleless connectors
Correspondence concerning this article should be addressed to [email protected] http://dx.doi.org/10.1016/j.java.2012.07.008 Copyright Ó 2012, ASSOCIATION FOR VASCULAR ACCESS. Published by Elsevier Inc. All rights reserved.
Background and Literature Review he American health care system is under intense scrutiny as national reform efforts are directed toward decreasing costs and improving accessibility to services for all citizens. Quality and efficiency are crucial to the sustainability of
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both the profit margin and the mission of organizations, with the elimination of preventable hospital-acquired conditions being a major focus. Avoidable infections are a source of increased morbidity and inflated costs, causing longer lengths of stay and needless human suffering.1 In 2009, The Centers for Medicare and Medicaid Services stopped reimbursing facilities for the treatment of certain preventable infections, urging greater accountability to higher standards of patient safety.2 Catheter-related bloodstream infections (CRBSIs) are among these largely preventable conditions. According to the Centers for Disease Control and Prevention, a total of 80,000 cases of CRBSI occur annually in the United States in intensive care units alone. If entire hospitals are assessed, the number increases to 250,000. O’Grady et al1 reported an approximate cost of $25,000 per episode and an attributable mortality rate of 12% to 25%. These alarming statistics call for the concerted and sustained effort of health care providers to prioritize and maximize patient safety through the reduction or elimination of CRBSI. The Bloodborne Pathogens Act of the Occupational Safety and Health Administration requires health care facilities to use needle-free systems whenever possible for “the collection or withdrawal of bodily fluids after initial venous or arterial access is established, the administration of medication, or any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps.”3 However, with the advent of needleless intravenous systems, particularly those with mechanical valves, CRBSI rates began to rise. This was especially problematic when manufacturers’ recommendations for use were not closely followed.4,5 Organizations must continue to use needleless intravenous systems for the protection of health care workers. Therefore, it is crucial to the safety and wellbeing of patients that those who work with these needleless systems be educated and motivated to use them properly. The Guidelines for the Prevention of Intravascular CatheterRelated Infections1 recommend that clinicians scrub needleless connectors with an appropriate antiseptic before access.1 This critical step, according to the Infusion Nurses Society Standards of Practice,6 is essential, yet the optimal scrub time required to prevent migration of bacteria through the connector and into the bloodstream has not yet been established through scientific inquiry. Menyhay and Maki7 reported that a 5-second scrub was inadequate for this purpose. Kaler8 found that a 15-second scrub was sufficient to prevent migration of pathogens through the connector into the bloodstream. However, Simmons et al9 noted bacterial transfer even with a 15-second scrub. A 15-second scrub time has been touted as the unofficial gold standard within the vascular access specialty. However, empiric evidence for this widely held belief is inadequate. Furthermore, expert reports and observations indicate that a 15-second scrub is difficult to achieve in the clinical setting.10 A bedside nurse experiences many time-sensitive demands and is required to perform important patient care activities in a fast-paced and ever-changing environment. Ongoing investigation is needed to further clarify
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the precise scrub time required for prevention of bacterial migration through needleless connectors. In response to this lack of clarity and difficulty with compliance, we designed an experiment to test the sufficiency of different disinfection times for the prevention of pathogen migration through needleless connectors into the bloodstream. The goal was to build upon the work of Kaler8 and to add to the body of scientific nursing knowledge in this area. Methods, Design, Data Collection, and Analysis This research was exempted from review by the organization’s institutional review board and approved for implementation by the Clinical Research Steering Committee. A prospective experimental design without randomization was selected. Microclave needleless connectors (Hospira, Lake Forest, IL) were selected for this study based on the low rate of bacterial transfer reported with the split septum, straight fluid path design.11 Due to space constraints in the organization’s microbiology lab, the experiment was performed in a simulated operating room area, with airflow similar to that used in actual operating rooms. Standard microbiology procedures were used, including the use of clean gloves for all procedures. Microclaves were divided into 6 groups of 27 connectors each (Figure 1). Each group received varying disinfection
Figure 1. Preparation of needleless connector groups.
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times and techniques (ie, 5, 8, 10, 12, and 15 seconds of scrubbing with an alcohol swab, and 5 minutes contact with an alcohol antiseptic barrier cap (EffectIV, Hospira, Lake Forest, IL). Positive and negative controls were used. A standard 0.5 McFarland suspension broth of Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa was used to inoculate the membranes of 172 (sample size determined by power analysis) Microclave needleless connectors using a 50 mL pipette (Figure 2). This suspension was selected for the purpose of replication of previous research8 and because these organisms are commonly implicated in CRBSI. The organisms were mixed in a single solution rather than separated because this most closely reflects actual patient experiences with polymicrobial contamination from normal flora and organisms in the environment. The inoculated connectors were allowed to air dry for 18 hours. Then, 27 connectors inoculated with the bacterial suspension were disinfected with 70% isopropyl alcohol for 5 seconds using friction (twisting motion) (Figure 3). The same procedure was repeated for each 27-unit group of connectors using differing amounts of time: 8, 10, 12, and 15 seconds. The alcohol antiseptic barrier cap was applied to another 27 Microclaves and left in place for 5 minutes according to manufacturer’s recommendations. All scrubbing of needleless connectors was performed by 1 experienced, nationally certified vascular access registered nurse to ensure consistency of
Figure 3. Scrubbing needleless connectors. technique. After disinfection was complete, each connector was flushed with 0.5 mL nonbacteriostatic sterile normal saline solution. The flushes were collected downstream onto sheepblood agar plates and incubated at 35 C for 48 hours (Figure 4). Clean gloves were changed between each flush. Negative Controls Five sterile Microclaves were flushed with 0.5 mL nonbacteriostatic sterile normal saline solution, collected downstream onto sheep-blood agar plates, and incubated at 35 C for 48 hours.
Figure 2. Inoculation of needleless connectors.
Positive Controls Five Microclaves were inoculated with the bacterial broth suspension and air dried overnight. No disinfection was performed before flushing with 0.5 mL nonbacteriostatic sterile normal saline solution that was collected onto sheep-blood agar plates and incubated at 35 C for 48 hours. All agar plates were examined by licensed microbiology lab personnel after 48 hours of incubation (Table 1). Of note, 2 negative controls had growth of 1 colony of S. epidermidis at the edge of the plate. In view of this unexpected anomaly, the experiment was repeated with heightened awareness of potential contamination by personnel. All persons in the room during the Phase 2 of the experiment were required to wear bouffant caps, surgical masks, clean gloves, and
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minutes (10 minutes total) before flushing. All needleless connectors were then flushed and incubated as described above (Table 2). All positive and negative controls were as expected in the second phase of the experiment. A third phase was undertaken to examine optimal disinfection times for needleless connectors contaminated with C. albicans. Yeast was separated from bacteria in this experiment as recommended by Kaler,8 who postulated that C. albicans could not grow competitively in the presence of the bacterial suspension used. Bouffant caps, surgical masks, clean gloves, and nonsterile isolation gowns were worn by all persons in the room during the experiment. Needleless connectors were inoculated with a 0.5 McFarland suspension of C. albicans and allowed to air dry for 18 hours. These were then disinfected as described above (antiseptic barrier cap in place for 10 minutes), flushed with 0.5 mL nonbacteriostatic sterile normal saline solution onto blood agar plates, and incubated for 48 hours at 35 C (Table 3). Positive and negative controls were as expected.
nonsterile isolation gowns. Microclave needleless connectors were again inoculated and disinfected as above, except that the antiseptic barrier cap was left in place for an additional 5
Statistical Analysis Data were analyzed using SPSS version 19 (IBM, Armonk, NY) and were examined in 2 ways. First, we examined the relationship between scrub time and presence of bacteria or yeast using c2 analysis. Values from the c2 test (which measures association) as well as Cramér’s V test, (a measure of the strength of the association) were examined. Second, because an association was found between scrub time and the presence of bacteria or yeast, we also sought to determine which scrub time was most likely to predict a positive status using logistic regression. Scrub times ranged from 5 to 15 seconds. For both analyses, a particular scrub time was coded “1” and all other times were coded “0.” Similarly, status (ie, the presence or absence of a pathogen) was coded “1” if the pathogen was present and “0” if it was not. For the logistic regression analysis, scrub times were
Table 1. Phase 1 Culture ResultsdBacterial Suspension
Table 2. Phase 2 Culture ResultsdBacterial Suspension
Figure 4. Flushing needleless connectors onto blood agar plates.
Result
Result Method
Positive
Negative
Method
Positive
Negative
Scrub time (sec)
Scrub time (sec) 5
16
11
5
8
19
8
11
16
8
8
19
10
3
24
10
4
23
12
0
27
12
3
24
15
2
25
15
3
24
11
16
Antiseptic barrier cap 10 min
5
22
Positive controls
5
0
Positive controls
5
0
Negative controls
2
3
Negative controls
0
5
Antiseptic barrier cap 5 min
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Table 3. Phase 3 Culture ResultsdYeast Suspension Result Method
Positive
Negative
5
1
26
8
3
24
10
1
26
12
1
26
15
0
27
Antiseptic barrier cap 10 min
0
27
Positive controls
5
0
Negative controls
0
5
Scrub time (sec)
entered into the model as independent variables and the dependent variable was status. Results The results of the c2 analysis suggested that there was a significant association between scrub time and status for the entire sample (both bacterial groups and the yeast group) (c24 ¼ 36.40; P ¼ .00). In addition, the strength of the relationship was moderate (Cramér’s V ¼ 0.300) and significant (P ¼ .00). This finding suggested that longer scrub times are associated with negative status. When the analyses were run separately, only the first group showed a statistically significant association between scrub time and status (c24 ¼ 37.93; P ¼ .00) and the strength of the association was strong (Cramér’s V ¼ 0.53; P ¼ .00). Significant associations were not found for the other groups and the strength of the association between scrub time and status was less than moderate for the other 2 groups. For the logistic regression analysis involving the entire sample, we found that relative to the 10-second scrub time, scrub times of 5 seconds were 4.07 times more likely to result in a positive status (Wald c2 ¼ 10.037; P ¼ .002) and scrub times of 8 seconds were 3.40 times more likely to result in a positive status (Wald c2 ¼ 7.456; P ¼ .006). The data demonstrated that relative to scrub times of 10 seconds, scrub times of 12 seconds (Wald c21 ¼ 1.387; P ¼ .239) and 15 seconds (Wald c21 ¼ 0.702; P ¼ .402) were less likely to be associated with a positive status (Exp B of 0.474 and 0.608, respectively). However, these findings were not statistically significant. Logistic regression analysis conducted on the separate groups showed that scrub time was not a significant predictor of status. This finding is a result of the fact that when the data were analyzed separately, few positive statuses were found in the 3 groups.
Discussion Disinfection of needleless connectors for the prevention of CRBSI continues to be a crucial practice for ensuring patient safety. Technique and timing for optimal cleansing are issues deserving of scientific scrutiny. Phases 1 and 2 of our study suggested that longer scrub times were associated with less bacterial transfer through the needleless connector. Scrub times of 5 and 8 seconds were much more likely to result in transfer of pathogens from the connector to the bloodstream. Although not statistically significant, there was a clinically significant decrease in bacterial transfer with scrub times of 10, 12, and 15 seconds (Figures 5 and 6). In Phase 3 of the study, there was very little transfer of yeast through the needleless connector with any amount of disinfection. Scrub times of 5, 8, 10, and 12 seconds yielded only 1 out of 27 positive cultures, and a disinfection time of 15 seconds resulted in 0 out of 27 positive cultures (Figure 7). As in previous studies, statistical significance is difficult to achieve when there are few positive results in a sample.9 For example, in the second phase of our study, a 5-second alcohol scrub resulted in 8 out of 27 positive cultures, whereas a 10-second alcohol scrub resulted in only 4 out of 27 positive cultures. An extra 5 seconds of disinfection resulted in a 50% reduction in bacterial transfer through the needleless connector. However, because these numbers are small, the finding was not statistically significant. In the bacterial phases of this study the antiseptic barrier cap performed approximately at the level of an 8-second alcohol scrub when applied to a heavily contaminated needleless connector for 5 minutes. However, when left in place for 10 minutes, the performance of the antiseptic barrier cap was improved by approximately 50% (11 of 27 positive cultures when left in place for 5 minutes vs 5 of 27 positive cultures when left in place for 10 minutes) In the yeast phase, the antiseptic barrier cap applied for 10 minutes resulted in no transfer of bacteria through the connector. This finding contradicts other published reports which reported greater efficacy of the antiseptic barrier cap in reducing bacterial load on the septum surface of the needleless connector as well as pathogen transfer through the needleless connector.12,13 An explanation for this discrepancy may be the different disinfectant solutions used in the antiseptic barrier caps. The device used in this study contained 70% isopropyl alcohol alone, whereas the cap used by Menyhay and Maki12 and Oto et al13 contained 2%
Figure 5. Phase 1 culture resultsdbacterial suspension.
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Figure 6. Phase 2 culture resultsdbacterial suspension. chlorhexidine with 70% isopropyl alcohol. We did not examine the usefulness of the antiseptic barrier cap as a physical barrier to contamination when applied to clean needleless connectors, which may also be a significant factor in device efficacy reported elsewhere. Limitations Our findings are limited by the existence of 2 negative controls that had a small amount of target organism growth in Phase 1, and by the lack of statistical significance for the findings in Phases 2 and 3. Future research should focus on larger sample sizes to allow for the achievement of statistical significance despite small percentages of positive results. Only 1 type of needleless connector and 1 type of antiseptic barrier cap were tested in our study. Further work should examine other types of connectors and antiseptic barrier caps for effectiveness in reduction or elimination of pathogen transfer through the needleless connector. Conclusions/Recommendations for Practice Our findings suggest that clinicians accessing needleless connectors play a key role in the elimination of pathogen transfer from a patient’s environment into the bloodstream. Taking time to adequately disinfect needleless connectors before access is critical to prevention of CRBSI and ensuring patient safety. Although today’s health care environment presents challenges to adequate staffing and increasing demands on nurse time, the fact remains that scrubbing the hub is an essential, life-saving measure and should not be neglected in favor of other patient care activities.
Figure 7. Phase suspension.
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To achieve longer scrub times for needleless connectors in a fast-paced clinical environment where many demands are made upon nurses’ time, nurse leaders must seek opportunities to provide education and support about the importance of this practice and the consequences of neglecting to scrub the hub. Smith et al10 suggested teaching in the affective domain of learning and harnessing peer pressure to assist in the achievement of optimal disinfection times for needleless connectors. Other suitable strategies include cognitive and psychomotor education activities with hands-on practice. Real-time measurement of individuals’ disinfection times with followup reporting and counseling may also be appropriate. Our study data suggest that there was a significant drop in rate of bacterial transfer through the needleless connector with a 10-second scrub when compared with scrub times of 5 and 8 seconds. Conversely, there was no statistically significant difference in rate of bacterial transfer among disinfection times of 10, 12, and 15 seconds. In view of the difficulty with attaining consistent, prolonged scrub times in the clinical setting, this finding may support a 10-second disinfection time as an equally effective yet more attainable goal than a 15-second scrub time. If patient safety can be assured with a 10-second scrub rather than a 15-second scrub (a 33% decrease in time required for disinfection of needleless connectors), compliance with organizational connector disinfection policy resulting in lower rates of CRBSI may result. Before practice changes can be recommended, further study is needed to replicate these results, perhaps with a larger sample to ensure statistical as well as clinical significance is achieved. For vascular access experts, the elimination of CRBSI resulting from pathogen migration through the needleless connector is the only acceptable end point. Although clinicians and scientists are exploring strategies to achieve this goal, intermediate findings, such as those reported here, are of potential value in keeping patients safe. Disclosure Microclave needleless connectors and EffectIV alcohol antiseptic barrier caps for this study were provided by Hospira. References 1. O’Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infections. 2011. http://www.cdc.gov/hicpac/BSI/BSI-guidelines-2011. html. Accessed June 26, 2012. 2. Centers for Medicare and Medicaid Services. Hospital acquired conditions. 2009. http://www.cms.hhs.gov/ HospitalAcqCond/06_Hospital-Acquired_Conditions.asp# TopOfPage. Accessed June 26, 2012. 3. US Dept of Labor, Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens, needlestick and other sharps injuries; final rule. 2001. http://www.osha.gov/pls/oshaweb/owadisp. show_document?p_id¼16265&p_table¼federal_register. Accessed June 26, 2012.
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4. New needleless valves leading to spike in BSIs. http://go. galegroup.com/ps/i.do?&id¼GALE%7CA193061646&v¼ 2.1&u¼txshrpub100020&it¼r&p¼HRCA&sw¼w. Accessed September 27, 2011. 5. Rosenthal K. Do needleless connectors increase bloodstream infection risk? Nurs Manage. 2006;37:78-80. 6. Alexander M. Infusion nursing standards of practice. J Infus Nurs. 2011;34(1Suppl):S1-S110. 7. Menyhay S, Maki D. Disinfection of needleless catheter connectors and access ports with alcohol may not prevent microbial entry: the promise of a novel antiseptic-barrier cap. Infect Control Hosp Epidemiol. 2006;27: 23-27. 8. Kaler W. Successful disinfection of needleless mechanical access ports: a matter of time and friction. J Assoc Vasc Access. 2007;12:203-205. 9. Simmons S, Bryson C, Porter S. “Scrub the hub.” Cleaning duration and reduction in bacterial load on
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11.
12.
13.
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central venous catheters. Crit Care Nurs Q. 2011;34: 31-35. Smith JS, Kirksey KM, Becker H, Brown A. Autonomy and self-efficacy as influencing factors in nurses’ behavioral intention to disinfect needleless intravenous systems. J Infus Nurs. 2011;34:193-200. Bouza E, Munoz P, Lopez-Rodriguez J, et al. A needleless closed system device (CLAVE) protects from intravascular catheter tip and hub colonization: a prospective randomized study. J Hosp Infect. 2003;54:279-287. Menyhay S, Maki D. Preventing central venous catheterassociated bloodstream infections: development of an antiseptic barrier cap for needleless connectors. Am J Infect Control. 2008;36(Suppl):S174.e1-e5. Oto J, Imanaka H, Konno M, et al. A prospective clinical trial on prevention of catheter contamination using the hub protection cap for needleless injection device. Am J Infect Control. 2011;39:309-313.
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A R T I C L E
Optimal Disinfection Times for Needleless Intravenous Connectors Judy S. Smith, MSN, RN, CRNI Clinical Nurse Expert, Venous Access, Seton Healthcare Family, Austin, TX Gwen Irwin, RN, CRNI, VA-BC Clinical Manager, Venous Access, Seton Healthcare Family, Austin, TX Mary Viney, MSN, RN, CPHQ, NEA-BC Vice President Nursing Practice, Seton Healthcare Family, Austin, TX Lynda Watkins, MPH, BSN, RN, CIC Infection Preventionist, University Medical Center at Brackenridge, Austin, TX Shonnie Pinno Morris, BSMT, ASCP, SM Manager, Microbiology Labs, Seton Healthcare Family, Austin, TX Kenn M. Kirksey, PhD, RN, ACNS-BC Director, Nursing Strategic Initiatives, Lyndon B. Johnson General Hospital, Houston, TX Adama Brown, PhD Research Scientist, University of Texas at Austin School of Nursing, Austin, TX
Abstract Background: Elimination of catheter-related bloodstream infections is a major focus in health care. According to the Centers for Disease Control and Prevention and the Infusion Nurses Society, the optimal time for needleless connector disinfection has not yet been empirically established. Methods: Using experimental design and established lab procedure, a 0.5 MacFarland suspension was used to inoculate 172 needleless connectors with bacteria (Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa) and allowed to dry for 18 hours. Five groups of connectors (n ¼ 27 per group) were disinfected using 70% isopropyl alcohol with friction for 5, 8, 10, 12, and 15 seconds, and flushed with 0.5 mL nonbacteriostatic sterile normal saline onto sheep-blood agar plates for incubation at 35 C for 48 hours. Bacterial growth (1 colony) was noted on 2 negative controls; therefore, a second sample (n ¼ 172) was tested as above using additional precautions of masking, gloving, and gowning. A third group of connectors was tested using a 0.5 MacFarland suspension containing yeast (Candida albicans). Results: Group 1 showed significant (c24 ¼ 37.93; P ¼ .00) and strong (Cramér’s V ¼ 0.53; P ¼ .00) associations between scrub time and growth status. Although not statistically significant, Groups 2 and 3 demonstrated clinically significant associations between these factors. Conclusions: Although additional research is warranted, our study showed that disinfection times of 5 and 8 seconds were inadequate for reducing bacterial transfer. However, disinfection times of 10, 12, and 15 seconds resulted in comparable, decreased rates of bacterial migration. Keywords: disinfection of needleless connectors, CRBSI prevention, patient safety, time requirement for disinfection of needleless connectors
Correspondence concerning this article should be addressed to [email protected] http://dx.doi.org/10.1016/j.java.2012.07.008 Copyright Ó 2012, ASSOCIATION FOR VASCULAR ACCESS. Published by Elsevier Inc. All rights reserved.
Background and Literature Review he American health care system is under intense scrutiny as national reform efforts are directed toward decreasing costs and improving accessibility to services for all citizens. Quality and efficiency are crucial to the sustainability of
T
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both the profit margin and the mission of organizations, with the elimination of preventable hospital-acquired conditions being a major focus. Avoidable infections are a source of increased morbidity and inflated costs, causing longer lengths of stay and needless human suffering.1 In 2009, The Centers for Medicare and Medicaid Services stopped reimbursing facilities for the treatment of certain preventable infections, urging greater accountability to higher standards of patient safety.2 Catheter-related bloodstream infections (CRBSIs) are among these largely preventable conditions. According to the Centers for Disease Control and Prevention, a total of 80,000 cases of CRBSI occur annually in the United States in intensive care units alone. If entire hospitals are assessed, the number increases to 250,000. O’Grady et al1 reported an approximate cost of $25,000 per episode and an attributable mortality rate of 12% to 25%. These alarming statistics call for the concerted and sustained effort of health care providers to prioritize and maximize patient safety through the reduction or elimination of CRBSI. The Bloodborne Pathogens Act of the Occupational Safety and Health Administration requires health care facilities to use needle-free systems whenever possible for “the collection or withdrawal of bodily fluids after initial venous or arterial access is established, the administration of medication, or any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps.”3 However, with the advent of needleless intravenous systems, particularly those with mechanical valves, CRBSI rates began to rise. This was especially problematic when manufacturers’ recommendations for use were not closely followed.4,5 Organizations must continue to use needleless intravenous systems for the protection of health care workers. Therefore, it is crucial to the safety and wellbeing of patients that those who work with these needleless systems be educated and motivated to use them properly. The Guidelines for the Prevention of Intravascular CatheterRelated Infections1 recommend that clinicians scrub needleless connectors with an appropriate antiseptic before access.1 This critical step, according to the Infusion Nurses Society Standards of Practice,6 is essential, yet the optimal scrub time required to prevent migration of bacteria through the connector and into the bloodstream has not yet been established through scientific inquiry. Menyhay and Maki7 reported that a 5-second scrub was inadequate for this purpose. Kaler8 found that a 15-second scrub was sufficient to prevent migration of pathogens through the connector into the bloodstream. However, Simmons et al9 noted bacterial transfer even with a 15-second scrub. A 15-second scrub time has been touted as the unofficial gold standard within the vascular access specialty. However, empiric evidence for this widely held belief is inadequate. Furthermore, expert reports and observations indicate that a 15-second scrub is difficult to achieve in the clinical setting.10 A bedside nurse experiences many time-sensitive demands and is required to perform important patient care activities in a fast-paced and ever-changing environment. Ongoing investigation is needed to further clarify
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the precise scrub time required for prevention of bacterial migration through needleless connectors. In response to this lack of clarity and difficulty with compliance, we designed an experiment to test the sufficiency of different disinfection times for the prevention of pathogen migration through needleless connectors into the bloodstream. The goal was to build upon the work of Kaler8 and to add to the body of scientific nursing knowledge in this area. Methods, Design, Data Collection, and Analysis This research was exempted from review by the organization’s institutional review board and approved for implementation by the Clinical Research Steering Committee. A prospective experimental design without randomization was selected. Microclave needleless connectors (Hospira, Lake Forest, IL) were selected for this study based on the low rate of bacterial transfer reported with the split septum, straight fluid path design.11 Due to space constraints in the organization’s microbiology lab, the experiment was performed in a simulated operating room area, with airflow similar to that used in actual operating rooms. Standard microbiology procedures were used, including the use of clean gloves for all procedures. Microclaves were divided into 6 groups of 27 connectors each (Figure 1). Each group received varying disinfection
Figure 1. Preparation of needleless connector groups.
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times and techniques (ie, 5, 8, 10, 12, and 15 seconds of scrubbing with an alcohol swab, and 5 minutes contact with an alcohol antiseptic barrier cap (EffectIV, Hospira, Lake Forest, IL). Positive and negative controls were used. A standard 0.5 McFarland suspension broth of Staphylococcus aureus, Staphylococcus epidermidis, and Pseudomonas aeruginosa was used to inoculate the membranes of 172 (sample size determined by power analysis) Microclave needleless connectors using a 50 mL pipette (Figure 2). This suspension was selected for the purpose of replication of previous research8 and because these organisms are commonly implicated in CRBSI. The organisms were mixed in a single solution rather than separated because this most closely reflects actual patient experiences with polymicrobial contamination from normal flora and organisms in the environment. The inoculated connectors were allowed to air dry for 18 hours. Then, 27 connectors inoculated with the bacterial suspension were disinfected with 70% isopropyl alcohol for 5 seconds using friction (twisting motion) (Figure 3). The same procedure was repeated for each 27-unit group of connectors using differing amounts of time: 8, 10, 12, and 15 seconds. The alcohol antiseptic barrier cap was applied to another 27 Microclaves and left in place for 5 minutes according to manufacturer’s recommendations. All scrubbing of needleless connectors was performed by 1 experienced, nationally certified vascular access registered nurse to ensure consistency of
Figure 3. Scrubbing needleless connectors. technique. After disinfection was complete, each connector was flushed with 0.5 mL nonbacteriostatic sterile normal saline solution. The flushes were collected downstream onto sheepblood agar plates and incubated at 35 C for 48 hours (Figure 4). Clean gloves were changed between each flush. Negative Controls Five sterile Microclaves were flushed with 0.5 mL nonbacteriostatic sterile normal saline solution, collected downstream onto sheep-blood agar plates, and incubated at 35 C for 48 hours.
Figure 2. Inoculation of needleless connectors.
Positive Controls Five Microclaves were inoculated with the bacterial broth suspension and air dried overnight. No disinfection was performed before flushing with 0.5 mL nonbacteriostatic sterile normal saline solution that was collected onto sheep-blood agar plates and incubated at 35 C for 48 hours. All agar plates were examined by licensed microbiology lab personnel after 48 hours of incubation (Table 1). Of note, 2 negative controls had growth of 1 colony of S. epidermidis at the edge of the plate. In view of this unexpected anomaly, the experiment was repeated with heightened awareness of potential contamination by personnel. All persons in the room during the Phase 2 of the experiment were required to wear bouffant caps, surgical masks, clean gloves, and
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minutes (10 minutes total) before flushing. All needleless connectors were then flushed and incubated as described above (Table 2). All positive and negative controls were as expected in the second phase of the experiment. A third phase was undertaken to examine optimal disinfection times for needleless connectors contaminated with C. albicans. Yeast was separated from bacteria in this experiment as recommended by Kaler,8 who postulated that C. albicans could not grow competitively in the presence of the bacterial suspension used. Bouffant caps, surgical masks, clean gloves, and nonsterile isolation gowns were worn by all persons in the room during the experiment. Needleless connectors were inoculated with a 0.5 McFarland suspension of C. albicans and allowed to air dry for 18 hours. These were then disinfected as described above (antiseptic barrier cap in place for 10 minutes), flushed with 0.5 mL nonbacteriostatic sterile normal saline solution onto blood agar plates, and incubated for 48 hours at 35 C (Table 3). Positive and negative controls were as expected.
nonsterile isolation gowns. Microclave needleless connectors were again inoculated and disinfected as above, except that the antiseptic barrier cap was left in place for an additional 5
Statistical Analysis Data were analyzed using SPSS version 19 (IBM, Armonk, NY) and were examined in 2 ways. First, we examined the relationship between scrub time and presence of bacteria or yeast using c2 analysis. Values from the c2 test (which measures association) as well as Cramér’s V test, (a measure of the strength of the association) were examined. Second, because an association was found between scrub time and the presence of bacteria or yeast, we also sought to determine which scrub time was most likely to predict a positive status using logistic regression. Scrub times ranged from 5 to 15 seconds. For both analyses, a particular scrub time was coded “1” and all other times were coded “0.” Similarly, status (ie, the presence or absence of a pathogen) was coded “1” if the pathogen was present and “0” if it was not. For the logistic regression analysis, scrub times were
Table 1. Phase 1 Culture ResultsdBacterial Suspension
Table 2. Phase 2 Culture ResultsdBacterial Suspension
Figure 4. Flushing needleless connectors onto blood agar plates.
Result
Result Method
Positive
Negative
Method
Positive
Negative
Scrub time (sec)
Scrub time (sec) 5
16
11
5
8
19
8
11
16
8
8
19
10
3
24
10
4
23
12
0
27
12
3
24
15
2
25
15
3
24
11
16
Antiseptic barrier cap 10 min
5
22
Positive controls
5
0
Positive controls
5
0
Negative controls
2
3
Negative controls
0
5
Antiseptic barrier cap 5 min
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Table 3. Phase 3 Culture ResultsdYeast Suspension Result Method
Positive
Negative
5
1
26
8
3
24
10
1
26
12
1
26
15
0
27
Antiseptic barrier cap 10 min
0
27
Positive controls
5
0
Negative controls
0
5
Scrub time (sec)
entered into the model as independent variables and the dependent variable was status. Results The results of the c2 analysis suggested that there was a significant association between scrub time and status for the entire sample (both bacterial groups and the yeast group) (c24 ¼ 36.40; P ¼ .00). In addition, the strength of the relationship was moderate (Cramér’s V ¼ 0.300) and significant (P ¼ .00). This finding suggested that longer scrub times are associated with negative status. When the analyses were run separately, only the first group showed a statistically significant association between scrub time and status (c24 ¼ 37.93; P ¼ .00) and the strength of the association was strong (Cramér’s V ¼ 0.53; P ¼ .00). Significant associations were not found for the other groups and the strength of the association between scrub time and status was less than moderate for the other 2 groups. For the logistic regression analysis involving the entire sample, we found that relative to the 10-second scrub time, scrub times of 5 seconds were 4.07 times more likely to result in a positive status (Wald c2 ¼ 10.037; P ¼ .002) and scrub times of 8 seconds were 3.40 times more likely to result in a positive status (Wald c2 ¼ 7.456; P ¼ .006). The data demonstrated that relative to scrub times of 10 seconds, scrub times of 12 seconds (Wald c21 ¼ 1.387; P ¼ .239) and 15 seconds (Wald c21 ¼ 0.702; P ¼ .402) were less likely to be associated with a positive status (Exp B of 0.474 and 0.608, respectively). However, these findings were not statistically significant. Logistic regression analysis conducted on the separate groups showed that scrub time was not a significant predictor of status. This finding is a result of the fact that when the data were analyzed separately, few positive statuses were found in the 3 groups.
Discussion Disinfection of needleless connectors for the prevention of CRBSI continues to be a crucial practice for ensuring patient safety. Technique and timing for optimal cleansing are issues deserving of scientific scrutiny. Phases 1 and 2 of our study suggested that longer scrub times were associated with less bacterial transfer through the needleless connector. Scrub times of 5 and 8 seconds were much more likely to result in transfer of pathogens from the connector to the bloodstream. Although not statistically significant, there was a clinically significant decrease in bacterial transfer with scrub times of 10, 12, and 15 seconds (Figures 5 and 6). In Phase 3 of the study, there was very little transfer of yeast through the needleless connector with any amount of disinfection. Scrub times of 5, 8, 10, and 12 seconds yielded only 1 out of 27 positive cultures, and a disinfection time of 15 seconds resulted in 0 out of 27 positive cultures (Figure 7). As in previous studies, statistical significance is difficult to achieve when there are few positive results in a sample.9 For example, in the second phase of our study, a 5-second alcohol scrub resulted in 8 out of 27 positive cultures, whereas a 10-second alcohol scrub resulted in only 4 out of 27 positive cultures. An extra 5 seconds of disinfection resulted in a 50% reduction in bacterial transfer through the needleless connector. However, because these numbers are small, the finding was not statistically significant. In the bacterial phases of this study the antiseptic barrier cap performed approximately at the level of an 8-second alcohol scrub when applied to a heavily contaminated needleless connector for 5 minutes. However, when left in place for 10 minutes, the performance of the antiseptic barrier cap was improved by approximately 50% (11 of 27 positive cultures when left in place for 5 minutes vs 5 of 27 positive cultures when left in place for 10 minutes) In the yeast phase, the antiseptic barrier cap applied for 10 minutes resulted in no transfer of bacteria through the connector. This finding contradicts other published reports which reported greater efficacy of the antiseptic barrier cap in reducing bacterial load on the septum surface of the needleless connector as well as pathogen transfer through the needleless connector.12,13 An explanation for this discrepancy may be the different disinfectant solutions used in the antiseptic barrier caps. The device used in this study contained 70% isopropyl alcohol alone, whereas the cap used by Menyhay and Maki12 and Oto et al13 contained 2%
Figure 5. Phase 1 culture resultsdbacterial suspension.
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Figure 6. Phase 2 culture resultsdbacterial suspension. chlorhexidine with 70% isopropyl alcohol. We did not examine the usefulness of the antiseptic barrier cap as a physical barrier to contamination when applied to clean needleless connectors, which may also be a significant factor in device efficacy reported elsewhere. Limitations Our findings are limited by the existence of 2 negative controls that had a small amount of target organism growth in Phase 1, and by the lack of statistical significance for the findings in Phases 2 and 3. Future research should focus on larger sample sizes to allow for the achievement of statistical significance despite small percentages of positive results. Only 1 type of needleless connector and 1 type of antiseptic barrier cap were tested in our study. Further work should examine other types of connectors and antiseptic barrier caps for effectiveness in reduction or elimination of pathogen transfer through the needleless connector. Conclusions/Recommendations for Practice Our findings suggest that clinicians accessing needleless connectors play a key role in the elimination of pathogen transfer from a patient’s environment into the bloodstream. Taking time to adequately disinfect needleless connectors before access is critical to prevention of CRBSI and ensuring patient safety. Although today’s health care environment presents challenges to adequate staffing and increasing demands on nurse time, the fact remains that scrubbing the hub is an essential, life-saving measure and should not be neglected in favor of other patient care activities.
Figure 7. Phase suspension.
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To achieve longer scrub times for needleless connectors in a fast-paced clinical environment where many demands are made upon nurses’ time, nurse leaders must seek opportunities to provide education and support about the importance of this practice and the consequences of neglecting to scrub the hub. Smith et al10 suggested teaching in the affective domain of learning and harnessing peer pressure to assist in the achievement of optimal disinfection times for needleless connectors. Other suitable strategies include cognitive and psychomotor education activities with hands-on practice. Real-time measurement of individuals’ disinfection times with followup reporting and counseling may also be appropriate. Our study data suggest that there was a significant drop in rate of bacterial transfer through the needleless connector with a 10-second scrub when compared with scrub times of 5 and 8 seconds. Conversely, there was no statistically significant difference in rate of bacterial transfer among disinfection times of 10, 12, and 15 seconds. In view of the difficulty with attaining consistent, prolonged scrub times in the clinical setting, this finding may support a 10-second disinfection time as an equally effective yet more attainable goal than a 15-second scrub time. If patient safety can be assured with a 10-second scrub rather than a 15-second scrub (a 33% decrease in time required for disinfection of needleless connectors), compliance with organizational connector disinfection policy resulting in lower rates of CRBSI may result. Before practice changes can be recommended, further study is needed to replicate these results, perhaps with a larger sample to ensure statistical as well as clinical significance is achieved. For vascular access experts, the elimination of CRBSI resulting from pathogen migration through the needleless connector is the only acceptable end point. Although clinicians and scientists are exploring strategies to achieve this goal, intermediate findings, such as those reported here, are of potential value in keeping patients safe. Disclosure Microclave needleless connectors and EffectIV alcohol antiseptic barrier caps for this study were provided by Hospira. References 1. O’Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infections. 2011. http://www.cdc.gov/hicpac/BSI/BSI-guidelines-2011. html. Accessed June 26, 2012. 2. Centers for Medicare and Medicaid Services. Hospital acquired conditions. 2009. http://www.cms.hhs.gov/ HospitalAcqCond/06_Hospital-Acquired_Conditions.asp# TopOfPage. Accessed June 26, 2012. 3. US Dept of Labor, Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens, needlestick and other sharps injuries; final rule. 2001. http://www.osha.gov/pls/oshaweb/owadisp. show_document?p_id¼16265&p_table¼federal_register. Accessed June 26, 2012.
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4. New needleless valves leading to spike in BSIs. http://go. galegroup.com/ps/i.do?&id¼GALE%7CA193061646&v¼ 2.1&u¼txshrpub100020&it¼r&p¼HRCA&sw¼w. Accessed September 27, 2011. 5. Rosenthal K. Do needleless connectors increase bloodstream infection risk? Nurs Manage. 2006;37:78-80. 6. Alexander M. Infusion nursing standards of practice. J Infus Nurs. 2011;34(1Suppl):S1-S110. 7. Menyhay S, Maki D. Disinfection of needleless catheter connectors and access ports with alcohol may not prevent microbial entry: the promise of a novel antiseptic-barrier cap. Infect Control Hosp Epidemiol. 2006;27: 23-27. 8. Kaler W. Successful disinfection of needleless mechanical access ports: a matter of time and friction. J Assoc Vasc Access. 2007;12:203-205. 9. Simmons S, Bryson C, Porter S. “Scrub the hub.” Cleaning duration and reduction in bacterial load on
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central venous catheters. Crit Care Nurs Q. 2011;34: 31-35. Smith JS, Kirksey KM, Becker H, Brown A. Autonomy and self-efficacy as influencing factors in nurses’ behavioral intention to disinfect needleless intravenous systems. J Infus Nurs. 2011;34:193-200. Bouza E, Munoz P, Lopez-Rodriguez J, et al. A needleless closed system device (CLAVE) protects from intravascular catheter tip and hub colonization: a prospective randomized study. J Hosp Infect. 2003;54:279-287. Menyhay S, Maki D. Preventing central venous catheterassociated bloodstream infections: development of an antiseptic barrier cap for needleless connectors. Am J Infect Control. 2008;36(Suppl):S174.e1-e5. Oto J, Imanaka H, Konno M, et al. A prospective clinical trial on prevention of catheter contamination using the hub protection cap for needleless injection device. Am J Infect Control. 2011;39:309-313.
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