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Needleless Connectors and CRBSI
B. Braun Statement and Frequently Asked Questions
B. Braun positioning statement about Needleless Connectors and CRBSI:
B. Braun Medical Inc. (B. Braun) is developing a plan in response to the FDA's request for nine medical device companies to conduct a post-market surveillance on positive displacement needleless connectors in connection with catheter-related bloodstream infection (CRBSI) rates. Not all positive displacement needleless connectors are created equal as each differs in design, flow paths and function. CRBSIs are a multi-factorial issue which can be reduced through awareness, education and training combined with good practice interventions. With this in mind B. Braun will continue to educate the industry through its Sharing Expertise® programs about CRBSIs and best practices related to needleless connector usage.
Some Frequently Asked Questions regarding needleless connectors and catheter-related bloodstream infections are addressed in the following discussion.
What is the FDA request all about?
FDA is requiring companies that manufacture positive displacement needleless connectors to conduct postmarket surveillance studies. The studies will help clarify the infection risk associated with these devices and define more precisely their risks and benefits. Manufacturers will be required to collect data on bloodstream infections in patients who received their devices compared to patients who received other types of needleless connectors. More details can be found in
FDA’s letter to infection control professionals.
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What is involved in post market surveillance?
Post market surveillance incorporates evaluating the performance of a device after it has been on the market for some time. It may involve any one or combination of the following: investigation into literature reports, retrospective studies, laboratory studies, prospective studies, FDA reports, customer complaint history, and individual facility feedback and data tracking.
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How will B. Braun be responding to the FDA inquiry for post market surveillance?
In response to these actions a team comprising of Regulatory, Medical Affairs, Engineering, Quality, Marketing, and external medical consultants has been formulated and is developing a comprehensive response to address the FDA inquiry which may incorporate any one or more of the following: investigation into literature reports, retrospective studies, laboratory studies, prospective studies, FDA reports, customer complaint history, and individual facility feedback and data tracking.
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What is the infection rate associated with the ULTRASITE® needleless connector?
A specific infection rate value cannot be assigned to a needleless connector. The device itself does not have an infection rate. CRBSI rates are a multi-factorial concern and vary greatly by hospital. CRBSI rates can be reduced through awareness, education, and training combined with good practice interventions. 1,2,3,4,5
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What types of needleless connector devices does B. Braun offer?
B. Braun offers a variety of needleless connector devices to meet the desired need of individual facilities. These include SafeLine® Split Septum devices, Safsite® Capped Luer Access device, ULTRASITE® Capless Luer Access device, and CARESITE™ Luer Access device.
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Has the B. Braun ULTRASITE needleless connector been related to any deaths associated with bloodstream infections?
Based on both B. Braun and FDA records none of the B. Braun needleless connector systems have been directly associated with any patient deaths.
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Has the B. Braun ULTRASITE needleless connector been associated with an increase in infection rates?
There is no evidence to support that the ULTRASITE valve has increased infections independent of other significant variables. CRBSI rates are a multi-factorial issue which has been demonstrated to be reduced through awareness, education, and training combined with good practice interventions. 1,2,3,4,5
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How does the B. Braun ULTRASITE needleless connector differ from others on the market?
All needleless connectors are designed differently. The ULTRASITE LAD is designed with an open fluid pathway with no gaps around the external seal and no "interstitial spaces" or hidden fluid entrapment areas inside the device.
Many needleless connectors are designed with internal fluid transitional areas that incorporate a plunger over a pin. These internal transition areas have been shown in several studies to have the ability to harbor bacteria. 6,7 The devices used in the citations referenced by the FDA in their letter to Infection Preventionists primarily incorporate designs with these transitional areas, gaps, and interstitial spaces. ULTRASITE is designed significantly differently from these devices and remains safe for clinical use.
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How does Positive Displacement influence infection rates?
The action of Positive Displacement itself does not influence infection rates. Increased infection rates anecdotally reported include all mechanical valves (Positive and Negative displacement), not just positive displacement.
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If positive displacement is not the cause of increased infection rates, why are positive displacement devices typically associated with an apparent increase in infections?
Positive Displacement needleless connectors have increased in use on Central Lines (CL) to help reduce catheter occlusions thus minimizing additional costs / risks with catheter clearing or possible catheter replacement if the catheter becomes clotted. 8,9 Patients with CLs are also a higher risk population for infection. Tracking and measuring of infection rates is often focused on Central Lines. Since Positive Displacement needleless connectors are used with higher risk patients and used on CLs more frequently than negative displacement devices there has been a perceived higher awareness of infections around these devices.
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Why are mechanical valves coming under scrutiny?
Mechanical valves were introduced in the late 1980s and were introduced along with blunt cannula split septum (BCSS) devices to help reduce needle-sticks - the first being the B. Braun capped system SAFSITE® luer access device. These devices required extra pieces (plastic cannula and caps) to use the system and were cumbersome and more complicated. Newer needleless connectors were introduced to eliminate the caps and cannula and simply required swabbing of the top prior to accessing with a syringe or luer connector. Since the introduction of these devices, the understanding of how these devices are to be used and the benefits they provide have become unclear. Many clinicians have thought these devices to be safety device and thus not requiring disinfection prior to accessing. In one clinician survey 31% of nurses admitted to not disinfecting NCs prior to access.7
As a leading manufacturer of safe infusion therapy products, B. Braun, with its Sharing Expertise® philosophy as its driving force, championed an awareness campaign, "The Vein Starts Here," in conjunction with INS, APIC, AVA and several key opinion leaders to help communicate the proper use of needleless connectors, best practices, and help educate on bacteria and infection.
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What defines a needleless connector as a mechanical valve?
A valve is defined by Webster’s dictionary as: A mechanical device that regulates the flow of gases, liquids, or loose materials by blocking and uncovering openings.
As it relates to needleless connectors, a mechanical valve is considered a needleless connector that has an internal moving part in the fluid pathway. By this definition all needleless connector devices can be considered a mechanical valve with the exception of a blunt-cannula-split-septum device. All other devices have septums / plungers that move into the fluid pathway.
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Is the ULTRASITE® valve considered a mechanical valve?
Yes, ULTRASITE is considered to be a mechanical valve.
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Does B. Braun offer any supplemental materials in support of training on needleless connectors?
Understanding needleless connectors and how to use them is important in minimizing potential increases in infection.
This goes hand-in-hand with hand washing and other bundled infection prevention practices.
B. Braun offers various support materials (free of charge) to help educate clinicians on B. Braun products
and on the use of needleless connectors. A poster series on infection prevention along with:
- a product video
- pocket cards
- in-service training and materials
They are available on our websites and through specific requests to our sales force.
Visit http://tinyurl.com/safeinfusiontherapy.
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- Provonost P, Needham D, et al. An Intervention to Decrease Catheter-Related Bloodstream Infection in the ICU. N Engl J Med 2006 Vol. 355, No. 26
- McGuire A. Zero infections, zero lost: Killeen’s Metroplex Health System implements John Hopkins initiative. Advance for Nurses, February 2009; Vol. 7, No. 2.
- Cantrell S. Striving for Excellence: Infection Prevention Success Stories. Healthcare Purchasing News, February 2008
- Harnage S. Achieving Zero Catheter Related Blood Stream Infections: 15 Months Success in Community Based Medical Center. The Journal of the Association for Vascular Access 2007 Vol. 12, No. 14
- Muto C. Reduction in Central Line-Associated Bloodstream Infections Among Patients in Intensive Care Units - Pennsylvania, April 2001-March 2005. JAMA 2006 Vol. 295, No 3
- Ryder M. Microscopic Evaluation of Microbial Colonization on Needleless Connectors poster, APIC 2008; Vol. 31, No. 2
- T. Karchmer study, 2005 SHEA Conference
- Leone M. Dillon R. Catheter Outcomes in Home Infusion - JIN March/April 2008; Vol. 31, No. 2
- Berger L. Effects of Positive Pressure Devices on Catheter Outcomes, JVAD 2000
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NEW! Perifix® Catheter Connector
