The goal of this Reduced Touch Contamination Connector project is to develop a new safer style of medical connectors that is less prone to mishandling and touch contamination.  By reducing touch contamination of medical connector tips entering the intravascular fluid path, the risk of bloodstream infections is expected to be reduced.  In the case intravenous access, human error is a frequent source of contamination.  Recently, major CDC1, CMS2, Joint Commission and CHOA quality initiatives have targeted reduction of hospital acquired infections (HAI), including blood stream infections (BSI) and central line associated blood stream infections (CLABSI). In general steps towards quality improvement frequently focus on organizational issues, provider education and technique during insertion and maintenance of vascular access, rather than on device design improvements.

Luer devices, have been in existence for about a century with modifications to designs as medical materials science advanced from glass and metal to plastic. The original Luer product was a two part glass syringe invented by Hermann W. Luer at the turn of the twentieth century.4  The standard “Luer” connector has the original 6% taper which continues today.   Advances in the Luer syringe included the luer lock design which was developed and popularized by Becton Dickenson in the early 1900’s.  The current ISO standard was developed as modification to an ANSI standard from the early 1990’s.  Plastic materials had taken over from glass and metal as the preferred manufacturing material and these new standard were needed to harmonize devices.5

As specified in the ISO standard for luer locks, the male tip with a 6% taper extends 2.1 mm beyond the locking collar as shown in the first diagram.  This enables engagement of the tip within a female connector to stabilize the device prior to engagement of the locking collar.   Unfortunately, this protruding tip is prone to contamination.  This can happen in many ways.

The focus of this project is to develop an improvement over the billions of standard luer lock devices used.   The improvements are expected to be a significant improvement in safety for patients.  Due to the huge volume of parts used, even if only a modest reduction in contamination risk is attained, there will be a major effect on patient safety.

With the new technology there will be an expected reduction in:

• Blood stream and soft tissue infection from fluid paths that become contaminated during the provider assembly process prior to the infusion.
   
• Deaths related to sepsis and organ failure as result of blood stream contamination.
   
• Healthcare costs associated with prolonged hospitalization to treat BSIs and CLABSIs.
   
• Contamination of laboratory specimens which are costly, confusing and lead to unnecessary follow up procedures and antibiotic usage.
   
• Luer lock medical connectors are ubiquitously found throughout medical and healthcare facilities.  These small bore connectors are convenient and simple.  The design is currently governed by a specific ISO standard, 594-2.