- Email: [email protected]
Scrubbing technique for needleless connectors to minimize contamination risk
Accepted Manuscript ‘Scrubbing’ technique for needleless connectors to minimize contamination risk Kenichi Satou, Risa Kusanagi, Aya Nishizawa, Satoshi Hori PII:
S0195-6701(18)30166-X
DOI:
10.1016/j.jhin.2018.03.015
Reference:
YJHIN 5375
To appear in:
Journal of Hospital Infection
Received Date: 11 January 2018 Accepted Date: 15 March 2018
Please cite this article as: Satou K, Kusanagi R, Nishizawa A, Hori S, ‘Scrubbing’ technique for needleless connectors to minimize contamination risk, Journal of Hospital Infection (2018), doi: 10.1016/ j.jhin.2018.03.015. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
THE JOURNAL OF HOSPITAL INFECTION ACCEPTED MANUSCRIPT ‐
Article types: Short reports
Title: ‘Scrubbing’ technique for needleless connectors to minimize contamination risk
RI PT
Names of all authors:
Kenichi Satou a), Risa Kusanagi a), Aya Nishizawa b), Satoshi Hori c) * a) Evaluation Centre, R&D Headquarters, Terumo Corporation
1500 Inokuchi Nakai-machi Ashigarakami-gun Kanagawa, 259-0151 Japan
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TEL: +81-46581-4257; E-mail: [email protected], [email protected]
Date: DD/ MM/ YYYY
M AN U
Signature: Signature:
Date: DD/ MM/ YYYY
b) Hospital Company, Terumo Corporation
3-20-2 Nishishinjyuku Shinjyuku-ku Tokyo 163-1499 Japan
Signature:
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TEL: +81-36742-8500; E-mail: [email protected] Date: DD/ MM/ YYYY
Medicine
EP
c) Department of Infection Control Science, Juntendo University, Graduate School of 2-1-1 Hongo Bunkyo-ku Tokyo 113-8421 Japan
AC C
TEL: +81-33813-3111; E-mail: [email protected] Signature:
Date: DD/ MM/ YYYY
*: Corresponding author: Department of Infection Control Science, Juntendo University, Graduate School of Medicine 2-1-1 Hongo Bunkyo-ku Tokyo 113-8421 Japan TEL: +81-33813-3111; E-mail: [email protected]
1 ‐
ACCEPTED MANUSCRIPT Name of the institution or department where the work was done: Evaluation Centre, R&D Headquarters, Terumo Corporation 1500 Inokuchi Nakai-machi Ashigarakami-gun Kanagawa 259-0151 Japan
Running title:
AC C
EP
TE D
M AN U
SC
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Optimum and specific scrubbing technique
2
ACCEPTED MANUSCRIPT Summary: This study aimed to investigate the appropriate ‘scrubbing’ technique for needleless connectors to minimize contamination risk. To demonstrate a highly effective scrubbing technique to physically eliminate bacteria, needleless connectors were contaminated with Geobacillus stearothermophilus spores and then scrubbed. The study showed that the highest bacterial elimination rate was achieved by the
RI PT
following optimum and specific ‘scrubbing’ technique: Scrub an access port in a
straight line with an alcohol cotton swab, applying a force which is almost equal to an arterial compression hemostasis to the access port, and repeat this procedure once using a new alcohol cotton swab.
SC
Keywords:
CDC guidelines, needleless connector, access port, scrubbing, disinfection
M AN U
Introduction:
The ‘2011 Guidelines for the Prevention of Intravascular Catheter-Related Infections’ [1] (hereafter, CDC guidelines) changed the aseptic technique for needleless connectors from ‘wiping’ to ‘scrubbing’ regardless of the degree of contamination of the access port. However, they did not describe a specific ‘scrubbing’ technique. Therefore, in clinical practice, needleless connectors are disinfected using various undefined
TE D
aseptic ‘scrubbing’ techniques, that are influenced by factors such as the shapes of access ports and mechanisms of access to intravascular catheters. In this study, we investigated the most appropriate, efficient, and specific ‘scrubbing’ technique which
Methods:
EP
could be used in clinical practice.
Needleless connectors
AC C
Mechanical valve: SURPLUG® (SmartSiteTM), CLAVE®, SAFIOFLOW® Split septum: SURPLUG®AD, Safe Access®, Planecta®, Q-SyteTM, Interlink®, SafeTouch®
Bacterium
Geobacillus stearothermophilus ATCC 7953, spore suspension (NAMSA) (hereafter, spore) The bacterium was inoculated into the SCD agar medium and was cultured at 57°C ± 2°C for 1 to 2 days.
Investigation of scrubbing techniques to physically eliminate bacteria We aimed to determine the optimum specific ‘scrubbing’ technique. Approximately 103 colony forming units of the spore was applied to each access port (SURPLUG®) and 3
ACCEPTED MANUSCRIPT allowed to dry for two hours at room temperature. The ports were then scrubbed using alcohol cotton swabs. Three elements of the scrubbing technique were investigated: 1) Direction of scrubbing. Rotating the by 180 ° once in one direction (n=80) was compared with swabbing in a straight line once in one direction (n=120). 2) Number of times of scrubbing. Scrubbing once (n=160) was compared with scrubbing twice (n=40).
RI PT
3) Forec applied during scrubbing. Forces of 0.5, 1, 2, and 3 kg (n=50 of each) were investigated by placing a needleless connector on a flat plate weighing scale and scrubbing it with sufficient force to attain the target weight.
After ‘scrubbing,’ spore recovery was attempted from the surface of the access port and
SC
from the inside of the slit using an aqueous solution containing 0.1% (v/v) polysorbate 80 and 0.1% (w/v) meat peptone. Bacterial elimination rates were calculated by the (positive control).
M AN U
remaining bacterial counts and the recovered bacterial counts without the 'scrubbing'
Investigation of the feasibility of the ‘scrubbing’ technique for needleless connectors other than SURPLUG®
Having established the most effective scrubbing technique for the SURPLUG®, we investigated the effectiveness of this technique on eight other types of needleless
TE D
connectors in which the shapes of the access ports and the mechanisms of access to intravascular tubing were different from those of the SURPLUG®. We also considered the needleless connector types as two groups, mechanical valve or split septum to determine whether there was any differences according to the broad structures of the
EP
devices.
Statistical analysis
AC C
The tests employed in this study were the F test for comparisons between 2 groups and the Bartlett’s test (for homogeneity of variances) for comparisons among multiple (≥ 3) groups. For these statistical analyses, EXSUS ver. 7.7 (CAC EXICARE Corporation) was employed.
Results: In this study, we used the SURPLUG® to investigate a highly effective scrubbing technique to physically eliminate the spore. The bacterial elimination rate (mean ± SD) was higher in straight line scrubbing (81% ± 11%) than with rotational scrubbing (23% ± 20%) (p <0.001: F test). The bacterial elimination rates calculated by each replicate test were grouped by the direction of scrubbing regardless the strength of the forces to the access port, and the average of the rates were shown in each group. 4
ACCEPTED MANUSCRIPT The bacterial elimination rate was higher after scrubbing twice (89% ± 5%) than after single scrubbing (50% ± 32%) (p <0.001: F test) The bacterial elimination rates calculated by each replicate test were grouped by number of times of scrubbing regardless the direction of scrubbing and the strength of the forces to the access port, and the average of the rates were shown in each group (Fig. 1). The highest elimination rate (93% ± 2%) was achieved by scrubbing twice in a straight line, using 1
RI PT
kg of force to the access port and new alcohol cotton swab for each scrubbing. When applying forces exceeding 1 kg, bacterial elimination rates inversely decreased. No significant difference was noted in the bacterial elimination rates between applying 0.5 kg and 1 kg forces, while applying 1 kg vs. 2 kg and 1 kg vs. 3 kg forces revealed significant differences (p <0.001, Bartlett’s test for homogeneity of variances).
SC
We also investigated whether the scrubbing technique used for SURPLUG® using
different forces, which was highly effective in physically eliminating the bacterium, could be applied to the eight other types of needleless connectors. The results revealed that
M AN U
bacterial elimination rates ≥ 90% were achieved in all cases of scrubbing twice in a straight line, by applying 0.5 kg or 1 kg force, while <80% elimination rates were found in two
types of needleless connectors when applying a force of 2 kg to the connectors during scrubbing (Fig. 2). There was no significant difference between the bacterial elimination rates achieved with the six split septum type connectors and the three
Discussion:
TE D
mechanical valve type connectors (92% ± 2% and 93% ± 1%, respectively).
We identified a highly effective scrubbing technique to physically eliminate the bacteria. Our study revealed a 58% increase in the bacterial elimination rates in a
EP
straight line scrubbing cases compared with those of circular scrubbing cases, this being the single most effective element evaluated. We also found that the direction of straight line scrubbing (vertical or horizontal) made no difference (data not shown).
AC C
The next greatest effect (39% increase in bacterial elimination) was seen from two scrubs, using a new alcohol cotton swab for each scrubbing. There was not a linear relationship between bacterial elimination rates and pressure applied during scrubbing; both low and high pressures were less effective at removing bacteria. The reasons why forces of >1 kg were less effective may be because the top surface of the access port became resistant to scrubbing when excessive pressure was applied. All the nine types of needleless connectors (split septum connectors and mechanical valve connectors) showed this tendency. In this study, spores, as indicators, not affected by alcohol were used for investigating the bacterial elimination rates. There is a possibility that the elimination rate may be influenced by the difference in adhesion characteristics between spores 5
ACCEPTED MANUSCRIPT and vegetative bacterial cells. However, as many vegetative bacteria cells are able to be sterilized by alcohol, the possibility is minimized.
Conclusion: This study confirmed that the appropriate scrubbing technique for needleless
RI PT
connectors was as follows: Scrub an access port in a straight line using an alcohol cotton swab, by applying a force which is almost equal to an arterial compression hemostasis to the access port, and repeat this procedure once using a new alcohol cotton swab. Based on these findings, we have concluded that this is the optimum and specific ‘scrubbing’ (the same as stated in the CDC guidelines1) technique for
Funding sources:
Conflict of interest statement:
M AN U
This study was funded by Terumo Corporation.
SC
needleless connectors, to minimize contamination risk.
Mr. Kenichi Satou, Ms. Risa Kusanagi, and Ms. Aya Nishizawa are employees of Terumo Corporation. Financial support was not provided to Mr. Satoshi Hori in this hand hygiene.
References:
TE D
study, but he received an appreciation gift from Terumo Corporation for his lecture on
[1] O’Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, et al.
EP
Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011. Centres for Disease Control and Prevention.
AC C
Fig. 1 Number of times of scrubbing and results of bacterial elimination rates
6
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ACCEPTED MANUSCRIPT
N=40
M AN U
SC
N=160
The bacterial elimination rates calculated by each replicate test were grouped by number of times of scrubbing regardless the direction of scrubbing and the strength of the forces to the access port, and the average of the rates were shown in each group.
AC C
EP
TE D
Fig. 2 Results of bacterial elimination rates in all nine types of needleless connectors
N=10 Mean±SD
It is average for each needleless connectors elimination rate when scrubbing twice with a force of 0.5, 1, 2 kg applied in straight line.
7
S0195-6701(18)30166-X
DOI:
10.1016/j.jhin.2018.03.015
Reference:
YJHIN 5375
To appear in:
Journal of Hospital Infection
Received Date: 11 January 2018 Accepted Date: 15 March 2018
Please cite this article as: Satou K, Kusanagi R, Nishizawa A, Hori S, ‘Scrubbing’ technique for needleless connectors to minimize contamination risk, Journal of Hospital Infection (2018), doi: 10.1016/ j.jhin.2018.03.015. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
THE JOURNAL OF HOSPITAL INFECTION ACCEPTED MANUSCRIPT ‐
Article types: Short reports
Title: ‘Scrubbing’ technique for needleless connectors to minimize contamination risk
RI PT
Names of all authors:
Kenichi Satou a), Risa Kusanagi a), Aya Nishizawa b), Satoshi Hori c) * a) Evaluation Centre, R&D Headquarters, Terumo Corporation
1500 Inokuchi Nakai-machi Ashigarakami-gun Kanagawa, 259-0151 Japan
SC
TEL: +81-46581-4257; E-mail: [email protected], [email protected]
Date: DD/ MM/ YYYY
M AN U
Signature: Signature:
Date: DD/ MM/ YYYY
b) Hospital Company, Terumo Corporation
3-20-2 Nishishinjyuku Shinjyuku-ku Tokyo 163-1499 Japan
Signature:
TE D
TEL: +81-36742-8500; E-mail: [email protected] Date: DD/ MM/ YYYY
Medicine
EP
c) Department of Infection Control Science, Juntendo University, Graduate School of 2-1-1 Hongo Bunkyo-ku Tokyo 113-8421 Japan
AC C
TEL: +81-33813-3111; E-mail: [email protected] Signature:
Date: DD/ MM/ YYYY
*: Corresponding author: Department of Infection Control Science, Juntendo University, Graduate School of Medicine 2-1-1 Hongo Bunkyo-ku Tokyo 113-8421 Japan TEL: +81-33813-3111; E-mail: [email protected]
1 ‐
ACCEPTED MANUSCRIPT Name of the institution or department where the work was done: Evaluation Centre, R&D Headquarters, Terumo Corporation 1500 Inokuchi Nakai-machi Ashigarakami-gun Kanagawa 259-0151 Japan
Running title:
AC C
EP
TE D
M AN U
SC
RI PT
Optimum and specific scrubbing technique
2
ACCEPTED MANUSCRIPT Summary: This study aimed to investigate the appropriate ‘scrubbing’ technique for needleless connectors to minimize contamination risk. To demonstrate a highly effective scrubbing technique to physically eliminate bacteria, needleless connectors were contaminated with Geobacillus stearothermophilus spores and then scrubbed. The study showed that the highest bacterial elimination rate was achieved by the
RI PT
following optimum and specific ‘scrubbing’ technique: Scrub an access port in a
straight line with an alcohol cotton swab, applying a force which is almost equal to an arterial compression hemostasis to the access port, and repeat this procedure once using a new alcohol cotton swab.
SC
Keywords:
CDC guidelines, needleless connector, access port, scrubbing, disinfection
M AN U
Introduction:
The ‘2011 Guidelines for the Prevention of Intravascular Catheter-Related Infections’ [1] (hereafter, CDC guidelines) changed the aseptic technique for needleless connectors from ‘wiping’ to ‘scrubbing’ regardless of the degree of contamination of the access port. However, they did not describe a specific ‘scrubbing’ technique. Therefore, in clinical practice, needleless connectors are disinfected using various undefined
TE D
aseptic ‘scrubbing’ techniques, that are influenced by factors such as the shapes of access ports and mechanisms of access to intravascular catheters. In this study, we investigated the most appropriate, efficient, and specific ‘scrubbing’ technique which
Methods:
EP
could be used in clinical practice.
Needleless connectors
AC C
Mechanical valve: SURPLUG® (SmartSiteTM), CLAVE®, SAFIOFLOW® Split septum: SURPLUG®AD, Safe Access®, Planecta®, Q-SyteTM, Interlink®, SafeTouch®
Bacterium
Geobacillus stearothermophilus ATCC 7953, spore suspension (NAMSA) (hereafter, spore) The bacterium was inoculated into the SCD agar medium and was cultured at 57°C ± 2°C for 1 to 2 days.
Investigation of scrubbing techniques to physically eliminate bacteria We aimed to determine the optimum specific ‘scrubbing’ technique. Approximately 103 colony forming units of the spore was applied to each access port (SURPLUG®) and 3
ACCEPTED MANUSCRIPT allowed to dry for two hours at room temperature. The ports were then scrubbed using alcohol cotton swabs. Three elements of the scrubbing technique were investigated: 1) Direction of scrubbing. Rotating the by 180 ° once in one direction (n=80) was compared with swabbing in a straight line once in one direction (n=120). 2) Number of times of scrubbing. Scrubbing once (n=160) was compared with scrubbing twice (n=40).
RI PT
3) Forec applied during scrubbing. Forces of 0.5, 1, 2, and 3 kg (n=50 of each) were investigated by placing a needleless connector on a flat plate weighing scale and scrubbing it with sufficient force to attain the target weight.
After ‘scrubbing,’ spore recovery was attempted from the surface of the access port and
SC
from the inside of the slit using an aqueous solution containing 0.1% (v/v) polysorbate 80 and 0.1% (w/v) meat peptone. Bacterial elimination rates were calculated by the (positive control).
M AN U
remaining bacterial counts and the recovered bacterial counts without the 'scrubbing'
Investigation of the feasibility of the ‘scrubbing’ technique for needleless connectors other than SURPLUG®
Having established the most effective scrubbing technique for the SURPLUG®, we investigated the effectiveness of this technique on eight other types of needleless
TE D
connectors in which the shapes of the access ports and the mechanisms of access to intravascular tubing were different from those of the SURPLUG®. We also considered the needleless connector types as two groups, mechanical valve or split septum to determine whether there was any differences according to the broad structures of the
EP
devices.
Statistical analysis
AC C
The tests employed in this study were the F test for comparisons between 2 groups and the Bartlett’s test (for homogeneity of variances) for comparisons among multiple (≥ 3) groups. For these statistical analyses, EXSUS ver. 7.7 (CAC EXICARE Corporation) was employed.
Results: In this study, we used the SURPLUG® to investigate a highly effective scrubbing technique to physically eliminate the spore. The bacterial elimination rate (mean ± SD) was higher in straight line scrubbing (81% ± 11%) than with rotational scrubbing (23% ± 20%) (p <0.001: F test). The bacterial elimination rates calculated by each replicate test were grouped by the direction of scrubbing regardless the strength of the forces to the access port, and the average of the rates were shown in each group. 4
ACCEPTED MANUSCRIPT The bacterial elimination rate was higher after scrubbing twice (89% ± 5%) than after single scrubbing (50% ± 32%) (p <0.001: F test) The bacterial elimination rates calculated by each replicate test were grouped by number of times of scrubbing regardless the direction of scrubbing and the strength of the forces to the access port, and the average of the rates were shown in each group (Fig. 1). The highest elimination rate (93% ± 2%) was achieved by scrubbing twice in a straight line, using 1
RI PT
kg of force to the access port and new alcohol cotton swab for each scrubbing. When applying forces exceeding 1 kg, bacterial elimination rates inversely decreased. No significant difference was noted in the bacterial elimination rates between applying 0.5 kg and 1 kg forces, while applying 1 kg vs. 2 kg and 1 kg vs. 3 kg forces revealed significant differences (p <0.001, Bartlett’s test for homogeneity of variances).
SC
We also investigated whether the scrubbing technique used for SURPLUG® using
different forces, which was highly effective in physically eliminating the bacterium, could be applied to the eight other types of needleless connectors. The results revealed that
M AN U
bacterial elimination rates ≥ 90% were achieved in all cases of scrubbing twice in a straight line, by applying 0.5 kg or 1 kg force, while <80% elimination rates were found in two
types of needleless connectors when applying a force of 2 kg to the connectors during scrubbing (Fig. 2). There was no significant difference between the bacterial elimination rates achieved with the six split septum type connectors and the three
Discussion:
TE D
mechanical valve type connectors (92% ± 2% and 93% ± 1%, respectively).
We identified a highly effective scrubbing technique to physically eliminate the bacteria. Our study revealed a 58% increase in the bacterial elimination rates in a
EP
straight line scrubbing cases compared with those of circular scrubbing cases, this being the single most effective element evaluated. We also found that the direction of straight line scrubbing (vertical or horizontal) made no difference (data not shown).
AC C
The next greatest effect (39% increase in bacterial elimination) was seen from two scrubs, using a new alcohol cotton swab for each scrubbing. There was not a linear relationship between bacterial elimination rates and pressure applied during scrubbing; both low and high pressures were less effective at removing bacteria. The reasons why forces of >1 kg were less effective may be because the top surface of the access port became resistant to scrubbing when excessive pressure was applied. All the nine types of needleless connectors (split septum connectors and mechanical valve connectors) showed this tendency. In this study, spores, as indicators, not affected by alcohol were used for investigating the bacterial elimination rates. There is a possibility that the elimination rate may be influenced by the difference in adhesion characteristics between spores 5
ACCEPTED MANUSCRIPT and vegetative bacterial cells. However, as many vegetative bacteria cells are able to be sterilized by alcohol, the possibility is minimized.
Conclusion: This study confirmed that the appropriate scrubbing technique for needleless
RI PT
connectors was as follows: Scrub an access port in a straight line using an alcohol cotton swab, by applying a force which is almost equal to an arterial compression hemostasis to the access port, and repeat this procedure once using a new alcohol cotton swab. Based on these findings, we have concluded that this is the optimum and specific ‘scrubbing’ (the same as stated in the CDC guidelines1) technique for
Funding sources:
Conflict of interest statement:
M AN U
This study was funded by Terumo Corporation.
SC
needleless connectors, to minimize contamination risk.
Mr. Kenichi Satou, Ms. Risa Kusanagi, and Ms. Aya Nishizawa are employees of Terumo Corporation. Financial support was not provided to Mr. Satoshi Hori in this hand hygiene.
References:
TE D
study, but he received an appreciation gift from Terumo Corporation for his lecture on
[1] O’Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, et al.
EP
Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011. Centres for Disease Control and Prevention.
AC C
Fig. 1 Number of times of scrubbing and results of bacterial elimination rates
6
RI PT
ACCEPTED MANUSCRIPT
N=40
M AN U
SC
N=160
The bacterial elimination rates calculated by each replicate test were grouped by number of times of scrubbing regardless the direction of scrubbing and the strength of the forces to the access port, and the average of the rates were shown in each group.
AC C
EP
TE D
Fig. 2 Results of bacterial elimination rates in all nine types of needleless connectors
N=10 Mean±SD
It is average for each needleless connectors elimination rate when scrubbing twice with a force of 0.5, 1, 2 kg applied in straight line.
7