Sharps Safety

Advances in
Needleless Connectors
Technologies assist in prevention of bloodstream infections by Ron Stoker

D
ecember 1991, OSHA published the Bloodborne Many changes have occurred since I started my career
Pathogens Standard to protect workers from the in the medical device industry almost 29 years ago. One of
risk of bloodborne pathogen exposure. The standard the major changes has been in the products used to accom-
became effective in March 1992. The Bloodborne Pathogen plish intravascular infusion. Let's look at how IV infusion
Standard applied to all employers that had employees with systems have changed over time.
reasonably anticipated occupational exposure to blood or other
potentially infectious materials or OPIM. The Bloodborne Needle Access Injection Port
Pathogen Standard was applied to healthcare workers and some Almost every catheter that was used 29 years ago had
general industries as well, e.g., first aiders. In September, 1998 an injection port placed on the proximal end. The injection
California passed the first needlestick safety law requiring the use port consisted of a small piece of plastic covered with latex
of safety products. A number of other states have passed similar rubber that was constricted with a small band around it.
legislation mandating the use of safety products. (See Figure 1.) Injections were made by inserting a sharp
In September 1998, following the adoption of the California conventional needle into the latex dam and injecting
law, Federal OSHA issued a Request for Information (RFI) on medication. The purpose of the injection cap was to provide
available safety products. The information that was gathered from an avenue into the patient's venous system without having
the RFI indicated the feasibility and availability of a number of to stick another needle into the patient. The needle access
safer medical devices. It also showed the importance of work practice injection port was easy to disinfect. The commission would
controls and training when new safety products were introduced. simply wipe the top of the latex dam with an appropriate
In May of 1999, the Stark-Boxer Healthcare Worker Needlestick alcohol pad. Since only a small needle was being withdrawn
Prevention Act was introduced to Congress. A modified Needlestick from the injection port there was a minimal negative
Safety and Prevention Act was introduced by Congressman Cass displacement of blood in the catheter. Needles were often
Ballenger of North Carolina. The Act was passed unanimously in “secured” with tape. Unfortunately, as we all know, tape did
the House and Senate. President Bill Clinton signed the Act into not provide very good securement and disconnection often
law in November 6, 2000.
The Act required OSHA to revise the Bloodborne Pathogen Figure 1.
Standard to mandate the use of safer products and to reduce the
exposure of clinicians to bloodborne pathogens. A new definition of
a needleless system was provided in this revised standard.
A needleless system was defined as a medical device that does
not use a needle for the collection of bodily fluids, administration
of medications, administration of fluids, and any other procedure
with potential percutaneous exposures to a contaminated sharp.
By using a needleless system fewer needles would be used and
needlestick injuries could be avoided.
A needleless connector is still one of the best ways to prevent
needlestick injuries—by eliminating as many needles as possible.
By eliminating the needles and replacing them with a non-needled
device means that you can't be stuck by needle that is not there.
No needle—no risk!

16 MANAGING INFECTION CONTROL May 2009

 Sharps Safety

Needleless systems used on IV tubing have made one of

the greatest impacts in reducing needlestick injuries.

occurred. In addition, many healthcare workers receive Medications would be administered inserting the blunt
needlestick injuries using this type of product. Many needles cannula into the pre-pierced septum. This type of system
were also recapped following injection and additional needle- eliminates the use of a sharp needle but it also has some draw-
stick injuries occurred. As we are all aware, there were no backs. Right beneath the split septum is located an area that
governmental or regulatory requirements to use any type of accommodates the introduction of the cannula. If the clinician
safety device at this time period. fails to properly use a positive-pressure flush technique or
Although needleless IV systems were available at a clamp on the system connection, blood can flow back up into
the time, only about 50 percent of hospitals were using the patient's infusion catheter. This can create a risk of clotting
needleless IV systems by 1995. Many healthcare organiza- of the catheter and can elevate the risk of infection. Another
tions were slow to adopt or did not adopt needleless drawback of this type of system is that conventional hypodermic
systems. One of the excuses used for this was the increased needles can mistakenly be used with this system, circumventing
cost of the devices even though the benefits were proven to the advantage of the blunt cannula. The split-septum products
save lives. did not address the problem of catheter occlusion. Split-septum
However, following the 2001 revised Bloodborne connectors created negative pressure when the blunt cannula was
Pathogen Standard; healthcare facilities began to adopt withdrawn. Any negative pressure at the time of disconnection
needleless connectors in much greater numbers. Needleless can jeopardize device patency by allowing retrograde flow into
systems used on IV tubing have made one of the greatest the lumen of the catheter.
impacts in reducing needlestick injuries. The needles that
were used on injection ports in IV tubing accounted for the Luer-Activated Ports—Negative Displacement
highest rate of sharps injuries. Following the adoption of the Needlestick Safety and
Prevention Act, Luer-activated mechanical valves began to be
Pre-pierced Septum and Blunt Cannula used on a more frequent basis. When the male luer is inserted into
Injection caps began to be replaced with pre-pierced the connector a valve opens and fluid can be infused or aspirated.
septum and blunt cannula. These consisted of a re-sealable Once the luer is removed the valve closes automatically. This
port that attached to the hub of the patient's access device. provides intermittent access to the vasculature and removes the
A blunt needle or cannula could be used to repeatedly need for either a conventional sharp needle or a blunt needle.
penetrate the septum. This blunt needle eliminated the need These were both positive steps in patient and healthcare worker
for a sharp needle and would provide intermittent access to safety. Needlestick injuries were reduced because the needle had
the vascular system. (See Figure 2.) been removed from the system. (See Figure 3.)

Figure 2. Figure 3.

18 MANAGING INFECTION CONTROL May 2009

 Sharps Safety

Figure 4.

A needleless connector is
still one of the best ways to
prevent needlestick injuries—
by eliminating as many needles
as possible.

However the luer- activated design posed some other

risks. One of the problems created by the luer-activated
design is the inadvertent negative fluid displacement that
occurrs when the male luer is removed from the connector.
This negative fluid displacement pulls blood into the An additional connector has been designed with a positive
catheter lumen and intraluminal thrombotic catheter block- push feature that gives an overall negative fluid displacement and
ages can occur. Not only does this create occlusions but therefore no retrograde blood movement into the catheter lumen.
increases the potential for growth of microorganisms which
could flow into the patient's bloodstream. When a catheter Latest Advances
occlusion occurs, clinicians administer anti-thrombolytic Luer-Activated Ports—
agents to de-clot the line. This increase in manipulation of Clear with Anti-Microbial Technology
the line costs the hospital time and money. It also increases In the latest advance in luer-activated ports, Maximus
the patient's risk of infection due to contamination. The Medical, a division of Medegen, has recently introduced the
catheters often have to be replaced because the blood clot MaxGuard™ Advanced Luer Activated Device featuring Agion®
could not be removed. This is both difficult for the patient antimicrobial technology. (See Figure 5.)
and expensive. It became very important for clinicians to
maintain the patency of the catheters.
Figure 5.
Many clinicians started to note an increase in blood-
stream infections with the use of these products. It has been
theorized that this is due to the inability of disinfecting the
surface of the device. The theory is that the lack of a flat,
smooth surface where the male luer connector would be
inserted could be a problem. The newer products had
crevices and recesses that were supposedly difficult to
disinfect on the top of the valve. Some luer-activated
connectors were found to cause an increase in bloodstream
infections in several studies.

Luer-activated Ports—Positive Displacement

A number of companies started to design luer-activated
valves that displace fluids as the male luer was removed.
The concept is that after the syringe is removed from the Many hospitalized patients receive medications and nutritional
connector, the needleless connector pushes a small support intravenously. During the process of administering
amount of solution out of the connector distally. This intravenous medication, environmental contaminants can be
would then push fluid out of the distal end of the catheter introduced into the bloodstream. This is of particular concern if
and would totally fill the catheter with solution thus mini- proper infection prevention techniques are not followed. MaxGuard
mizing occlusion. This positive pulse of fluid clears the with antimicrobial technology helps prevent contamination and
catheter tip from blood, thus making occlusions less likely growth of microorganisms at the point of entry into the catheter, and
to form because blood is not sitting in a catheter for an subsequently in the bloodstream. MaxGuard is new technology
extended period of time. (See Figure 4.) introduced to assist hospitals in reducing catheter-related

20 MANAGING INFECTION CONTROL May 2009

 Sharps Safety

bloodstream infections. This latest advance in luer-activated for healthcare-associated infections (HAIs), healthcare
needleless connectors helps clinicians prevent bloodstream professionals are seeking techniques and technologies to
infections. This will help to provide clients with a product that assist in their bloodstream infection prevention efforts. ✛
significantly improves their efforts to enhance patient care and
positive outcomes.
The MaxGuard positive displacement connector not only
contains antimicrobial technology but it is clear which provides Ron Stoker is the founder and executive director of
a visualization of the fluid path. It features a positive displace- the International Sharps Injury Prevention Society (ISIPS)
ment technology that provides a bolus of fluid to clear the and is a frequent contributor to Managing Infection Control
catheter tip upon disconnection from the device. It also features magazine. He speaks frequently at national and international
Medegen’s patented Tru-Swab® top which acts as a double seal meetings on sharps safety, hand hygiene and infection
barrier to contamination and allows for true disinfection during control issues. He is co-author of the “Compendium of
pre-access swabbing. The translucent housing provides for Infection Control Technologies.” For more information on
visualization of the fluid path allowing for complete flushing the Compendium, go to http://kunaki.com/Sales.asp?PID=
of the device. PX00OLESG1. Mr. Stoker is providing a number of webinars
The introduction of MaxGuard comes at a time when blood- focusing on a variety of sharps injury prevention safety
stream infection rates continue to be a major concern among products. For more information on the webinars, go to
hospitals. With the new federal policy restricting reimbursement www.isips.org/seminars.html.

Reader Service No. 63

May 2009 MANAGING INFECTION CONTROL 21