A Compliance Improvement Project to Reduce Central Line Associated Blood Stream Infection (CLABSI) Using a Passive Disinfection Device in an Adult Oncological Hospital in Brazil
Phase: NA
Conditions: Infection, Hospital
Sponsor: Solventum US LLC

 
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3M Confidential 
Document Name: CLIN-PROT-ICH-US-05-319980 
Clinical and Non-Clinical: CLIN-INDEX-3M-SPON-US-05-014137 
 
 
 
 
 
 
Quality Improvement Project 
 
 
Project Title 
 
 
 
Use of a passive disinfection device to 
improve the disinfection compliance of 
connectors and to reduce Blood Stream 
Primary Infection associated with central 
catheters (CLABSI) in an adult oncology 
hospital. 
 
Principal Investigator 
 
 
 
Facility  
 
 
 
 
 
 
 
 
 
 
Ethics Committee 
 
 
 
 
 
 
 
 
Sponsor 
3M Brazil 
Rod Anhanguera 
Km 110 - Jd. Manchester Sumaré 
São Paulo - SP, 13181-900, Brazil 
 

 
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Clinical and Non-Clinical: CLIN-INDEX-3M-SPON-US-05-014137 
 
Contract Research Organization: 
 
 
 
 
 
 
 
 
 
 
Approver List (3M Approvers Only): 
Signer 
Role Date Signed 
  
 
 
 
 
 
 
 
 
 
3M Confidential 
This document contains confidential information that is the property of 3M and is subject 
to all of the restrictions on use and disclosure contained in the study contract to which this 
is appended. Do not copy, disclose, circulate or use for benefit for any third party without 
written authorization from 3M.  
 
 
 

 
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Table of Contents 
 
1. 
INTRODUCTION ................................................................................................................................. 4 
2. 
PROJECT OBJECTIVES AND PURPOSE ........................................................................................... 5 
3. 
PROJECT DESIGN ............................................................................................................................... 5 
3.1 Primary and Secondary Endpoints ................................................................................... 8 
3.2 Subjects ............................................................................................................................ 8 
4. 
DISINFECTING BARRIER CAP INFORMATION ............................................................................ 10 
4.1 Name, Description and Intended Use ............................................................................ 10 
4.2 Risk/Benefit Summary ................................................................................................... 10 
4.3 Product Use .................................................................................................................... 11 
4.4 Adverse Events or Misuse ............................................................................................. 12 
5. 
STATISTICS ....................................................................................................................................... 13 
5.1 Data Sets Analyzed ........................................................................................................ 13 
5.2 Assessment Methods ...................................................................................................... 13 
5.3 Statistical Methods ......................................................................................................... 14 
6. 
DATA HANDLING AND RECORD KEEPING .................................................................................. 15 
6.1 Study Personnel ............................................................................................................. 15 
6.2 Completion and Return of Case Report Forms .............................................................. 15 
6.3 Final Report ................................................................................................................... 15 
7. 
REFERENCES .................................................................................................................................... 16 
8. 
APPENDICES ..................................................................................................................................... 17 
 
 

 
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1. Introduction 
A compliance improvement study to reduce Central Line Associated Blood Stream Infection 
(CLABSI) using a passive disinfection device in an oncological population in Brazil. 
 
Although many efforts have been focused on reducing the level of hospital-acquired 
infections, central line associated bloodstream infections (CLABSIs) remain a serious 
complication in hospitalized patients, leading to significantly longer hospital stays, 
morbidity, and mortality for affected patients.  In a case-control study in Brazil, for example, 
the incremental length of stay for adult ICU patients with CLABSI compared to those without 
CLABSI averaged 19.6 days, while incremental costs for one CLABSI infection totaled US 
$89,886 (Dal Forno, et al. 2012.) 
 
An emerging issue in Brazil is the shifting etiology of CLABSI infections.  A significantly 
higher percentage is attributed to Gram-negative bacilli compared to the US and other 
northern countries (Marra et al, 2011.)  Even so, coagulase-negative Staphylococci have 
traditionally been the most prevalent causative organisms for this type of infection.  
However, 2015 surveillance data from the Brazilian National Health Surveillance Agency 
(ANVISA) showed for the first time that Klebsiella pneumoniae, a Gram-negative organism, 
caused the highest percentage of CLABSIs in adults.  K. pneumoniae was identified in 16.9% 
of infections, while coagulase-negative Staphylococcus was ranked second at 16.5%.   
Acinetobacter species and Pseudomonas aeruginosa, two other Gram-negative organisms, 
caused the 4th and 5th highest number of CLABSIs, respectively (ANVISA, 2016.)  A 
predominance of Gram-negative organisms causing catheter-related blood stream infections 
was also noted from a multi-site study in Sao Paulo, Brazil.  The top three causative 
organisms for CR-BSIs were A. baumannii (19%), P. aeruginosa (15.2%), and K. 
pneumoniae (15.24%) (Bicudo et al, 2011.) 
 
The increase in Gram-negative organism CLABSI infections is concerning, as several are 
already highly resistant to specific classes of antibiotics.  2015 ANVISA surveillance data 
showed that 77.4% of the Acinetobacter strains and 39.1% of P. aeruginosa strains from 
CLABSI infections were resistant to carbapenems, while 43.3% of K. pneumoniae strains 
were resistant to both carbapenems and to 3rd and 4th generation cephalosporins (ANVISA, 
2016.)    
 
Implementation of a set of evidence-based practices, or bundles, both for insertion of Central 
Venous Catheters (CVC) and for CVC maintenance, is recommended to combat CLABSI 
infection rates.  The CLABSI Maintenance Bundle includes appropriate hub disinfection in 
addition to administration set changes and daily review of line necessity with timely removal 
(Marshall et al., 2014.)  Implementation of the bundles has lowered CLABSI infection rates 
(Grigonis et al, 2016.)  However, compliance to traditional “scrub the hub” disinfection 
methods are low (Cameron-Watson, 2016.)   The disinfecting barrier cap was developed to 
remove operator variability with scrub the hub and improve compliance to disinfection 

 
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procedures.  Increased compliance can lead to reductions in CLABSI rates (Danielson et al, 
2014; Merrill et al, 2014, Morneau et al, 2015; Ramirez et al, 2012; Sweet et al, 2012.)  
 
The objective of this quality improvement project is to replicate hub disinfection compliance 
studies in a Brazilian model, where etiology of infections differ from many northern 
countries.  Completing this quality improvement project will help determine if there is a 
corresponding drop in CLABSI when using disinfecting barrier caps as in seen in the studies 
referenced above, given the differences in causative organisms for CLABSI. 
 
2. 
Project Objectives and Purpose 
(1) To examine healthcare professionals’ compliance to needleless connector antisepsis 
with the barrier cap protocol compared to the previous “scrub the hub” protocol;  
(2) To establish the effect of the disinfecting barrier cap on the rate of CLABSI per 1,000 
intravenous line days among the designated patient population.  
 
Catheter-associated urinary tract infection (CAUTI) rates and ventilator-associated 
pneumonia (VAP) rates during the intervention period will also be reviewed to control 
for possible seasonal or environmental effects that may also influence CLABSI and 
hospital infection rates overall.   
 
Data for CAUTI and VAP will be available for intensive care units (ICUs), as collection 
is only mandatory for ICUs in Brazil.   For this study, the definition of CLABSI is that 
used by the National Healthcare Safety Network (NHSN).  The definitions of CAUTI 
and VAP are those used by The Brazilian National Health Surveillance Agency 
(ANVISA.)   
 
During the project, changes to the insertion and maintenance infection reduction bundles 
for CLABSI prevention in designated intervention units will be limited to the 
implementation of the disinfecting barrier cap in the place of current method, and cap 
training/feedback procedures. These procedures include, but are not limited to, visual aids 
designed to increase adherence to the new procedure, and feedback after compliance 
audits – which is required since uncapped ports may present a risk to the patient. 
 
Additionally, any changes to infection reduction bundles for CAUTI and VAP will be 
avoided during the study to allow these measurements to be used as controls.  If any 
changes to infection reduction practices for CAUTI and VAP are made during the duration 
of the project, these will be noted and a determination will need to be if those infection 
rates are still appropriate to use as controls. 
 
3. 
Project Design  
A quasi-experimental before-and-after project with a seven -month intervention phase.  

 
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Overview 
Project Initiation (Month #1) 
• Give consent form (Responsibility Term) to healthcare professionals participating 
in retroactive compliance survey (PI, site staff)  
• Complete retroactive scrub-the-hub compliance survey (care givers) 
• Multiple teaching sessions on project objectives, use of the disinfecting barrier 
caps (PI, study staff) 
• Begin recording monthly CLABSI, CAUTI, & VAP data for designated wards 
from the 6-month pre-intervention period 
• Stock caps in designated locations in assigned intervention wards to prepare for 
introduction (PI, study staff) 
 
Introduce Intervention (Month #2, Day 1) 
• Place disinfecting cap strips on IV poles near ICU beds containing patients with 
central IVs (PI/study staff/care assistants) 
• Introduce individual disinfecting caps in non-ICU intervention wards in 
appropriate areas to be utilized for other patients that meet acceptance criteria for 
the study. 
• Begin use of caps in assigned units (care givers) 
 
Cap Implementation and Reinforcement (Month #2) 
• Daily stocking of cap strips and individual caps, as appropriate, in intervention 
wards (care assistants) 
• Measure compliance with observation form for disinfecting cap use 3 times per 
week.  Document number of ports being used for continuous infusion, and any 
misuse of disinfecting caps as listed in Section 4.4.2.  Notify the Nurse Assistance 
Unit after the end of the audit about any uncapped needleless connectors or 
misused caps for any necessary corrections (PI, study staff)  
• 2 weeks after intervention:  team training and compliance improvement 
brainstorming 
•  Implement suggestions to improve compliance, which could include placement of 
disinfecting cap use posters, re-training, sharing updates on disinfecting cap 
compliance data, and/or other interventions deemed appropriate arising from the 
brainstorming process (PI, study staff).  
 
Recording Period (Months 3-8) 
• Daily stocking of cap strips or individual caps in intervention units, as appropriate 
(care assistants) 
• Continue use of disinfecting caps (care givers) 
• Measure compliance with disinfecting cap use weekly, with observation form.  
Document number of ports being used for continuous infusion, and any misuse of 
disinfecting caps as listed in Section 4.4.2.  Notify the Nurse Assistance Unit after 

 
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the end of the audit about any uncapped needleless connectors or misused caps for 
any necessary corrections (PI, study staff)  
• Enter weekly compliance observations into electronic database 
• Complete documentation of pre-intervention CLABSI, CAUTI, & VAP data  
• Document monthly post-intervention CLABSI, CAUTI, & VAP data by ward  
 
End of Study (After Month-8) 
• Remove disinfecting barrier cap stock from assigned wards 
• Complete documentation of post-intervention CLABSI, CAUTI, & VAP data  
• Complete entry of weekly compliance observations into electronic database 
• Data analysis by designated group 
 
 
3.1 Primary and Secondary Endpoints 
3.1.1 Primary Endpoint:  The rate of compliance to hub disinfection protocol.   
3.1.2 Secondary endpoints (all collected from aggregate hospital surveillance data): 
3.1.2.1 Rate of central line associated bloodstream infections (CLABSIs) 
per 1,000 central line days   
3.1.2.2 Catheter-Associated Urinary Tract Infection (CAUTI) per 1,000 
catheter days and Ventilator-Associated Pneumonia (VAP) per 
1,000 ventilator days (controls) 
 
 
3.2 Subjects 
Note:  During the project, no individual patient health information will be collected. 
3.2.1 Subject Inclusion Criteria 
• Adult patients admitted to the participant oncologic hospital  
• Adult patients in the assigned intervention units during the seven- 
month intervention period who require needleless connectors for CVC 
IV tubing access.   
 
The types of central venous catheters accessed by needleless 
connectors in this study include: 
• Non-tunneled CVCs percutaneously inserted into the internal 
jugular, subclavian, or femoral veins 
• Tunneled CVCs implanted in the internal jugular, subclavian, 
or femoral veins 
• Peripherally inserted central catheters (PICCs) inserted 
percutaneously into the basilic, brachial, or cephalic vein and 
entering the superior vena cava 

 
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• Patients without CVC IV access who are using a three-lumen dialysis 
catheter with a needleless connector on the third lumen. If a patient with a 
dialysis catheter but without CVC IV access presents an infection, the 
infection will be counted nonetheless due to the impossibility of separating 
it from the other infections.  Dialysis catheters will only receive the 
disinfecting cap if the dialysis catheter contains a third lumen with a 
needleless connector attached. 
• Patients meeting inclusion criteria and who are subsequently transferred 
out to a unit of the hospital not covered by the study will have disinfecting 
caps removed immediately before transfer and will not be included in the 
compliance audits during their period out of the study unit.  They will 
continue to be evaluated when they return to the study unit if that ever 
occurs.  Therefore, if these patients are then transferred back from those 
units (includes HSR units such as: Surgical Center, Nuclear Medicine, 
Radiotherapy, Center of Diagnosis and Imaging, and Chemotherapy; and 
other hospitals of the complex: 
 
 
), disinfecting caps will be re-introduced upon patient transfer, and 
patients will again be included in the study. 
 
3.2.2 Subject Exclusion Criteria 
• Adult patients admitted to the participant oncologic hospital during the 
seven-month intervention period that do not require needleless connectors 
for CVC IV access during their hospital stay. 
• Patients without CVC IV access who are using two-lumen dialysis 
catheters. If such a patient presents an infection, it will be counted 
nonetheless due to the impossibility of separating it from the other 
infections. Dialysis catheters will only receive the caps if the dialysis 
catheter contains a third lumen, with a needleless connector. 
• Patients may be excluded from the study at the investigator’s discretion in 
case of unforeseen circumstances. 
• Additionally, patients who require needleless connectors for CVC IV 
access, who are subsequently transferred to a different institution or to a 
different ward/unit that has not been trained in the use of disinfecting 
barrier caps, will be excluded from the study beginning at the time of 
transfer.  For these patients, the disinfecting caps will be removed 
immediately before the patient is transferred to a unit of the hospital not 
covered by the study (includes HSR units such as: Surgical Center, 
Nuclear Medicine, radiotherapy, diagnostic center and imaging, and 
chemotherapy); and other hospitals of the complex: 
 
 
).  In the hospital units (wards) not covered 

 
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by the study, the procedure used for the disinfection of the catheters will 
be the standard procedure of the hospital (scrub-the-hub) instead of the 
disinfecting caps.  
 
3.2.3 Study Approval 
As the study utilizes commercialized product, and is being implemented as a quality 
improvement 
procedure 
throughout 
the 
patient 
population, 
approval 
for 
implementation will be requested from the institution’s Ethics Committee.  During the 
project, no individual patient protected health information will be collected.   
 
4. Disinfecting Barrier Cap Information 
 
4.1 Name, Description and Intended Use  
The 3M™ Curos™ Disinfecting Cap for Needleless Connectors (the “disinfecting 
barrier cap”) is intended for use on swabbable luer-access valves as a disinfecting 
cleaner prior to line access and to act as a physical barrier to contamination between 
line accesses. The disinfecting barrier cap will disinfect the valve one (1) minute after 
application and act as a physical barrier to contamination for up to seven (7) days (168 
hours) if not removed.     
 
The 3M™ Curos™ Disinfecting Cap for Needleless Connectors is commercially 
available and will be used per product labeling.   
 
4.2 Risk/Benefit Summary 
Minimal adverse health effects are anticipated for the participants in this quality 
improvement project.  All required preclinical safety studies (toxicology studies) have 
been completed.   Benefits may include increased compliance with institutional 
disinfection protocols for needleless connectors and reduced risk of patient exposure to 
infection.  In addition, use of disinfecting barrier caps allow for visual, auditable 
confirmation of compliance to disinfection protocols for needleless connectors, which 
is not possible with the scrub-the-hub disinfection method. 
 
Risks identified in the Risk Management Report include: 
• Not sterile (loss of efficacy resulting in possible infection or contamination) 
• Device is not secure (not applying fully) 
• Choking 
• Device is placed on the wrong connection 
• Degradation of associated device/connector (crack and leak) 
• Flammable 
• Toxicologically hazardous material (70% IPA) enters the blood stream 
 

 
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All known risks, both in normal and fault conditions, along with the overall residual 
risk, have either eliminated or adequately mitigated, considering current state of the 
art.  The risk management for Curos™ Disinfecting Port Protectors revealed no 
significant hazards that could endanger the user, if the product is used as intended and 
under recommended conditions.   
 
4.3 Product Use 
The disinfecting barrier caps will be used on needleless connectors for Central 
Venous Catheter IV tubing access in the designated hospital units during the seven 
month intervention period.   
 
Disinfecting barrier cap strips will be used in ICU wards, and individual disinfecting 
barrier caps will be used in other wards for patients that meet inclusion criteria for the 
study. 
 
Application Instructions  
 
 
• If the needleless connector is visibly soiled with blood or body fluids, clean with 
swab before using cap. 
• Do not use cap if seal is broken, torn, punctured, or if sponge appears dry. 
• Cap must remain on needleless connector for a minimum of one (1) minute and 
may remain on for seven (7) days if not removed. 
• The needleless connector can be accessed immediately after removing the Curos 
disinfecting cap that has been in place for a minimum of one (1) minute. 
• Always place a new Curos disinfecting cap on needleless connector after each 
use. 
• Dispose of the Curos disinfecting cap after each use. 
• WARNING:  Use only on needleless connectors. 
• CAUTION:  Potential choking hazard. 

 
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• CAUTION: Use clinical judgment to assess the risks versus benefits of using this 
product on premature infant populations. Safety and consequences related to IPA 
have not been established or determined in the toxicology literature for this 
population.  
 
Access instructions after removal of cap 
• After disinfecting barrier cap is removed, no dry time is required before accessing 
the line.   
• If performing sequential accesses with needleless connectors, additional “scrub-
the-hub” steps (between every catheter access) are not mandatory as per the 
institution’s current standard of practice.  
• Disinfecting barrier caps will be used to disinfect needleless connectors during the 
project intervention period.  Disinfecting barrier caps are one-time use only, and 
should be discarded after being removed from a needleless connector.   
 
4.4 Adverse Events or Misuse 
4.4.1 As this is a quality improvement study focused on the process of the health 
care professional, no individual patient data, including adverse events, will be 
recorded.   However, if the investigator feels that a device-related adverse 
event does occur, he/she is responsible to report it through the existing 3M 
Medical Complaint system described in Section 4.4.3 below. 
4.4.2 In addition, instances of product misuse may also be reported to the 3M 
Medical Complaint system described in Section 4.4.3 below.  Potential 
scenarios of misuse may include: 
4.4.2.1 Use on wrong connector 
• Open system of vein peripheral catheter 
• Open system of arterial peripheral catheter 
• Open infusion system of central catheter 
• Directly on dialysis catheter hub 
• Directly on central catheter hub 
• Inappropriate connector (for instance, Tego for dialysis) 
4.4.2.2 Device not secure (not applied fully) 
4.4.2.3 Other (describe): 
4.4.3 The 3M Medical Complaint System can be reached by dialing the Help Line 
Hospitalar: 0800 13 23 33, or by email via falecoma3m@mmm.com. 
 

 
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5. Statistics 
 
5.1 
Data Sets Analyzed 
Data from all compliance audits within the six-month recording period (after the 
first month of intervention) will be analyzed for protocol compliance.  This will 
be compared to compliance before the intervention, which will be determined by 
the pre-intervention survey.  
 
CLABSI, CAUTI, and VAP data from the six months prior to the intervention 
will be analyzed and compared to data in the 6-month intervention recording 
period to determine product efficacy. 
 
5.2 Assessment Methods 
 
Compliance 
Compliance is defined as following the protocol for disinfection of the needleless 
connector.  In the pre-intervention period, the disinfection protocol will utilize 
existing institution scrub-the-hub method.  Compliance in the pre-intervention period 
will be determined by survey.   
 
In the intervention period, the disinfection protocol consists of using the disinfecting 
barrier cap on every needless connector used for accessing CVC IV lines per 
protocol.   Compliance will be measured using observations by study personnel 
and/or the principal investigator, according to a schedule to ensure the absence of a 
shift bias.  Observations will take place three times per week during the first four 
weeks in all intervention wards with a specially designed report form. After the first 
four weeks, the observations will be scheduled once per week for each intervention 
ward.   
 
Prospective compliance audits will include observations on the number of needleless 
connectors with, and the number of needleless connectors without, disinfecting 
barrier caps attached.  The Nurse Assistance Unit will be notified after the end of the 
audit about any uncapped needleless connectors or misused caps for any necessary 
corrections.  CVCs with connectors that are being used for continuous infusion at the 
time of the observation will be tallied, but will not be included in the compliance rate 
calculation. 
 
 
Infection Rates 
Incidence of CLABSI, CAUTI, and VAP will be noted from existing aggregate 
hospital surveillance system data.  The incidence will be recorded for each assigned 
intervention ward and for intervention ward overall by month, in the six months 
before the intervention and in the six-month intervention recording period.   

 
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CLABSI is defined as an occurrence of a positive blood culture when a central-line 
catheter has been in place two days or longer on the date of the event.  The rate will 
be documented in terms of catheter days. 
 
CAUTI is defined as a urinary tract infection where an indwelling urinary catheter 
was in place for >2 calendar days on the date of event, with day of device placement 
being Day 1, AND an indwelling urinary catheter was in place on the date of event or 
the day before.   The rate will be documented in terms of catheter days. 
 
VAP is defined as a pneumonia that occurs 48 hours after intubation, which was not 
incubated during the period of the patient’s admission, up to 72 hours after 
extubation.  The rate will be documented in terms of ventilator days. 
 
5.3 
Statistical Methods 
 
5.3.1 Compliance Analyses 
Compliance rates to scrub-the-hub disinfection procedures before the 
intervention will be determined by written survey.  The target survey 
response rate on scrub-the-hub compliance is 70% of healthcare 
professionals in the intervention wards that utilize needleless connectors 
for patient IV access.  An overall compliance rate and compliance rates 
per intervention ward will be determined. 
 
Compliance rate for use of the disinfecting barrier cap on needleless 
connectors during the intervention recording period will be determined by 
weekly observations in each assigned intervention ward, which will be 
scheduled to ensure the absence of a shift bias.  Compliance by ward, and 
by format of disinfecting cap (disinfecting cap strips vs. individual 
disinfecting caps) will also be assessed. 
 
5.3.2 Efficacy Analyses 
 
CLABSI 
The statistical analysis for efficacy is a Poisson-regression with outcome 
measure rate of CLABSI per 1,000 central line days and with predictors 
sort of treatment (scrub the hub protocol or the disinfecting barrier cap), 
and variables for the time trend and the unit.  
 
CAUTI/VAP 
The statistical analysis for efficacy is a Poisson-regression with outcome 
measure rate of CLABSI per 1,000 central line days and with predictors 

 
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sort of treatment (scrub the hub protocol or the disinfecting barrier cap), 
and variables for the time trend and the unit.  
 
CLIN-PROT-ICH-US-05-319980, version 8, update to document 
(Protocol Amendment 2):  Protocol amended to document addition of an 
ad-hoc analysis of CLABSI infections both pre- and post-intervention. 
CLABSI infections will be further classified as those associated with 
mucosal barrier injury (MBI), and those that are not MBI-related, using 
the current CDC NHSN definition of mucosal-barrier injury laboratory-
confirmed bloodstream infection (MBI-LCBI). The analysis of the 
classified CLABSI infections (MBI and not MBI related) will be 
conducted separately using the same planned analysis as the overall 
aggregated CLABSI infections. 
 
 
6. Data Handling and Record Keeping 
 
6.1 
Study Personnel 
Prior to study initiation, the Investigator must provide the following 
documents to 3M or its designee:  
6.1.1 Signed copy of project protocol including any amendments in place prior 
to study initiation 
6.1.2 Curriculum vitae for the Investigator  
6.1.3 Ethics Committee project authorization form 
6.1.4 
Ethics Committee name, location and chairperson  
6.1.5 
Signed research agreement  
 
6.2 
Completion and Return of Case Report Forms 
3M intends to use electronic data capture (eDC) software for this study. The site 
will be trained on the eDC software prior to study enrollment. The site will be 
provided with a manual, including instructions on how to complete the CRFs and 
how to make CRF corrections.  Data may be recorded onto data collection sheets 
prior to data entry or may be entered directly into the eDC system.  Once the 
forms are completed, the monitor will review the CRFs to assure accuracy and 
completeness.  The Investigator must review and sign the CRFs for each subject 
in a timely fashion following completion. 
 
6.3 
Final Report 
The Investigator will prepare a Final Report and submit to the Ethics 
Committee if required.  
 
 

 
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7. References 
7.1 
Dal Forno CB, Correa L, Scatena PD, et al. Bloodstream infection in the intensive care unit: 
Preventable adverse events and cost savings. Value Health Reg Issues. 2012; 1(2): 136-141. 
7.2 
Marra, AR et al.  Nosocomial Bloodstream Infections in Brazilian Hospitals: Analysis of 
2,563 Cases from a Prospective Nationwide Surveillance Study. Journal of Clinical 
Microbiology.  2011; 49(5): 1866–1871. 
7.3 
ANVISA.  Boletim de Seguranca do Paciente e Qualidade em Servicos de Saude n 14:  
Avaliacao dos indicadores naciounais das Infeccoes Relacionadas a Assistencia a Saude 
(IRAS) e Resistencia microbiana do ano de 2015.  Gerencia de Vigilancia e Monitoramento 
em Servicos de Saude.  Dezembro 2016. 
7.4 
Daniela Bicudo D et al.  Risk factors for catheter-related bloodstream infection: a 
prospective multicenter study in Brazilian intensive care units.  Brazilian Journal of 
Infectious Disease 2011; 15(4):328-331. 
7.5 
Marshall J, et al. Strategies to prevent central line-associated bloodstream infections in acute 
care hospitals: 2014 update. Infect Control Hosp Epidemiol 2014; 29(7):753-771.   
7.6 
Grigonis, A., et. al. Use of a Central Catheter Maintenance Bundle in Long-term Care 
Hospitals. American Journal of Critical Care.  2016; 25(2), 165-172. 
7.7 
Cameron-Watson C, Barking Havering, and Redbridge NHS Trust.   Port Protectors in 
Clinical Practice: An Audit.  British Journal of Nursing: (IV Therapy Supplement).  2016; 
25 (8). 
7.8 
Danielson B, et al.  Significant Decline in Central Line-Associated Bloodstream Infections 
Using Alcohol-Impregnated Port Protectors at a Large Non-Profit Acute Care Hospital.  
American Journal of Infection Control.  2014; 42(6), 16. 
7.9 
Merrill K. C., Sumner S., Linford L., Taylor C., and Macintosh C.  Impact of Universal 
Disinfectant Cap Implementation on Central Line-Associated Bloodstream Infections. 
American Journal of Infection Control. 2014; 42(12), 1274-1277.  
7.10 
Moreau, N. and Flynn, J. Disinfection of Needleless Connector Hubs: Clinical Evidence 
Systematic Review. Nursing Research and Practice. 2015, 796762 
7.11 
Ramirez, C., Lee, A., Welch, K. Central Venous Catheter Protective Connector Caps Reduce 
Intraluminal Catheter-Related Infection. The Journal of the Association for Vascular Access.  
2012; 17(4), 210-213. 
7.12 
Sweet, M. A., et al. Impact of Alcohol-Impregnated Port Protectors and Needleless Neutral 
Pressure Connectors on Central Line–Associated Bloodstream Infections and Contamination 
of Blood Cultures in an Inpatient Oncology Unit. American Journal of Infection Control.  
2012; 40(10), 931-934. 
 
 

 
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8. Appendices 
 
8.1 
Retrospective Compliance Survey  
 
 

 
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3M Confidential 
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