Needleless Connectors and the Improvement of Patient and Healthcare Professional Safety

By William R. Jarvis, MD

Introduction
When it comes to improving patient and healthcare safety, many factors are considered: time to treatment, antimicrobials and increased reporting standards to name a few. However, a small device the needleless connector for intravenous systems can have a big impact, particularly on protecting healthcare workers from needlestick injuries and in reducing bacterial contamination.  There are numerous options for these devices, and there may be confusion on current guidelines, as well as protocols for appropriate disinfection and use. With all the variables and increasing time constraints, how can healthcare professionals such as critical care nurses and infection preventionists improve patient care and safety, as well as protect themselves? By understanding the differences between the device options, healthcare professionals can more easily tailor their patient care, improve adherence to clinical best practice and ensure their safety.

History
At the front line of patient interaction, hospital-based healthcare professionals have a great responsibility to provide quality patient care. But when it comes to protecting themselves, these professionals were at one time at a great risk for needlestick injury. A study by Jagger, et al., revealed that devices that required manipulation after use, such as intravenous (IV) tubing needles and disposable syringes, were associated with an increased rate of injury to the healthcare professional.   At a rate of approximately 385,000 per year, sharps injuries posed a great issue to healthcare professionals, including an increased risk for bloodborne pathogen transmission.

To help protect the healthcare professional, the Needlestick Safety and Prevention Act mandated that the Occupational Safety and Health Administration (OSHA) clarify and revise the Bloodborne Pathogens Standard. The subsequent new provisions put forth in the Exposure Control Plan stated that, Where engineering controls will reduce employee exposure either by removing, eliminating or isolating the hazard, they must be used.

A first-line strategy for compliance was to eliminate or reduce the unnecessary use of needles, primarily using a needle-free IV delivery system. While needleless connectors were initially developed to help improve healthcare professional safety, in recent years the use of needleless connectors may have contributed to improved patient care as well.

Guidelines
The Food and Drug Administration (FDA) has regulatory authority over the marketing of needleless connectors. The requirements for marketing have changed over time. In 2005, the FDA recognized that there is a microbial risk with needleless connectors. The guidance released that year said, The testing should demonstrate that disinfection procedures you use are effective for removing microorganisms from the device.

However, in 2008, this guidance changed and became less clear, stating The testing should demonstrate that disinfection procedures you use are effective. Unfortunately, that allowed some laboratory studies to demonstrate the transfer of microorganisms, rather than validating the removal of them. This still leaves a concern of organism transfer, which would have been otherwise avoided if the organism were removed in the first place. FDA requirements should mimic the clinical situation and be straightforward and consistent for manufacturers. 

It is imperative that the healthcare professional develop and adhere to manufacturer recommended disinfection protocols for their needleless connectors and use a sterile end cap on the male luer of the IV tubing during intermittent infusions to help reduce the risk of contamination. This disinfection process should specify the specific disinfecting agent, the method for disinfection (e.g., scrub the access surface) and the duration such disinfection should occur; such requirements may be needleless connector specific.

Characteristics of Needleless Connectors
When identifying a disinfection protocol, it is important to consider the features of the needleless connector in use. Common device deficits include:
Difficulty in disinfecting the gap between the valve and the hub
Intricate access surfaces that are more difficult to disinfect
Needleless connectors that could harbor bacteria within the valve mechanism but outside the fluid path due to the complicated nature of the multi-part device

There are many needleless connector options available to healthcare professionals, and several characteristics, such as those mentioned above, affect how easy or difficult a connector is to disinfect.

Following are a few key features to consider when evaluating a needleless connector:
External access surface: While some needleless connectors may appear to have relatively flat access surfaces at a glance, a closer inspection can reveal different types of surfaces that are important to consider during disinfection. Look to see if the surface is flat, sealed and solid. Additionally, look to see if there are grooves or slits in it, as well as any gaps around the plunger. These areas are often difficult or impossible to adequately clean, and bacteria in these spaces can lead to fluid path contamination. While guidelines for disinfection vary, one needleless connector has shown to support effective bacteria removal in as little as 3 seconds, while others may take 15 seconds or longer to reduce the risk of bacterial transfer. It is important to look at the specific data for the individual connectors because features of each connectors access surface could influence effective disinfection.

Internal mechanisms and access to fluid path: Observe if the internal mechanisms are simple or complex as fluid may unintentionally leak or be flushed into interstitial space the space between the internal mechanisms and the connector housing where fluid and contamination can become trapped. Interstitial space cannot be flushed or disinfected, and contamination can be transferred from the interstitial space to the luer and ultimately the fluid path. The internal design can have an impact on flushing as well, so it is important to tailor the flushing process to ensure that lines are appropriately flushed. The volume of fluid needed to flush each needleless connector and the catheter adequately may differ and clinical practice shows this can range from 5ml-20ml.

Visibility: Clear connectors allow healthcare professionals to more adequately assess if any residual blood or other infusates, such as blood, total parenteral nutrition or lipid emulsion, remains in the connector. On the other hand, opaque connectors or connectors with multiple components which obscure the fluid path can make this more challenging.  A clearly visible fluid path encourages proper flushing of connectors, which, in turn, clears the catheter and helps maintain catheter patency.

Blood reflux: Needleless connectors that exhibit negative fluid displacement, even if it is a small amount, cause a reflux of blood into the catheter upon disconnection of a syringe or IV line. Conversely, if a connector creates no reflux, such as in the case of a theoretically truly neutral displacement connector or a positive displacement connector, the reflux does not occur so there may be no specific clamping sequence required. While positive or truly neutral connectors can help with catheter patency and catheter tip maintenance, a key takeaway about reflux/displacement is that the fluid movement at the tip of the catheter is not associated with microbial ingress at the access surface of the connector.

Taking these features into consideration, a recent survey of expert clinicians found that a smooth external surface, no gap around septum seal and a clear housing were among the most important features of needleless connectors.

With a variety of options available with differing key features, the need for proper training and a standardized protocol for assessing disinfection effectiveness are essential to improving patient care.

Opportunities to Improve Disinfection and Patient Care
There are several features that can help improve disinfecting and flushing techniques such as a flat, smooth, solid external surface, no opening or gap around the septum seal, clear housing, completely fluid filled design with a one piece internal mechanism, to name a few. However, institutions may stock more than one type of needleless connector, which many healthcare professionals dont realize. This means that appropriate infection control practices for one needleless connector could be erroneously applied to another.

It is important to know which type of needleless connector(s) the institution stocks. The healthcare professionals should understand the features and benefits or risks of the connector they are using. In addition, they should be aware of what infection control recommendations/practices to adhere to, including how to disinfect the needleless connector properly and when to clamp.

The open communication of these details combined with proper disinfection and flushing practices during any manipulation of the needleless connector may help improve patient care.

Conclusion
Needleless connectors are an integral piece of the IV therapy delivery system and safety for the healthcare professional. However, it is imperative that needleless connectors be used that have the greatest number of features associated with decreased contamination risk. After selecting a needleless connector for the facility, all healthcare professionals should be trained on how to adequately disinfect and use that connector to help reduce the risk of contamination.

Overall, it is important for all healthcare professionals to know which needleless connector they are using and the proper methods for use, including disinfection techniques for that connector. The institution can also communicate this information and provide resources, such as manufacturer indications/directions for use and contact information, to equip the healthcare professional with the necessary tools. With all pieces working together, the patient and healthcare professional can contribute to improved patient care and greater safety for all.