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16
May 2009MANAGING INFECTION CONTROL
Sharps
Safety
Advances in
Many changes have occurred since I started my careerin the medical device industry almost 29 years ago. One of the major changes has been in the products used to accom-plish intravascular infusion. Let's look at how IV infusionsystems have changed over time.
Needle Access Injection Port
Almost every catheter that was used 29 years ago hadan injection port placed on the proximal end. The injectionport consisted of a small piece of plastic covered with latexrubber that was constricted with a small band around it.(See Figure 1.)Injections were made by inserting a sharpconventional needle into the latex dam and injectingmedication. The purpose of the injection cap was to providean avenue into the patient's venous system without havingto stick another needle into the patient. The needle accessinjection port was easy to disinfect. The commission wouldsimply wipe the top of the latex dam with an appropriatealcohol pad. Since only a small needle was being withdrawnfrom the injection port there was a minimal negativedisplacement of blood in the catheter. Needles were often“secured” with tape. Unfortunately, as we all know, tape didnot provide very good securement and disconnection often
D
ecember 1991, OSHA published the BloodbornePathogens Standard to protect workers from therisk of bloodborne pathogen exposure. The standardbecame effective in March 1992. The Bloodborne PathogenStandard applied to all employers that had employees withreasonably anticipated occupational exposure to blood or otherpotentially infectious materials or OPIM. The BloodbornePathogen Standard was applied to healthcare workers and somegeneral industries as well, e.g., first aiders. In September, 1998California passed the first needlestick safety law requiring the useof safety products. A number of other states have passed similarlegislation mandating the use of safety products.In September 1998, following the adoption of the Californialaw, Federal OSHA issued a Request for Information (RFI) onavailable safety products. The information that was gathered fromthe RFI indicated the feasibility and availability of a number of safer medical devices. It also showed the importance of work practicecontrols and training when new safety products were introduced.In May of 1999, the Stark-Boxer Healthcare Worker NeedlestickPrevention Act was introduced to Congress. A modified NeedlestickSafety and Prevention Act was introduced by Congressman CassBallenger of North Carolina. The Act was passed unanimously inthe House and Senate. President Bill Clinton signed the Act intolaw in November 6, 2000.The Act required OSHA to revise the Bloodborne PathogenStandard to mandate the use of safer products and to reduce theexposure 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 doesnot use a needle for the collection of bodily fluids, administrationof medications, administration of fluids, and any other procedurewith potential percutaneous exposures to a contaminated sharp.By using a needleless system fewer needles would be used andneedlestick injuries could be avoided.A needleless connector is still one of the best ways to preventneedlestick injuries—by eliminating as many needles as possible.By eliminating the needles and replacing them with a non-needleddevice means that you can't be stuck by needle that is not there.No needle—no risk!
Needleless Connectors
Technologiesassist in prevention of bloodstream infections
by Ron Stoker
Figure 1.
 
Medications would be administered inserting the bluntcannula into the pre-pierced septum. This type of systemeliminates the use of a sharp needle but it also has some draw-backs. Right beneath the split septum is located an area thataccommodates the introduction of the cannula. If the clinicianfails to properly use a positive-pressure flush technique ora clamp on the system connection, blood can flow back up intothe patient's infusion catheter. This can create a risk of clottingof the catheter and can elevate the risk of infection. Anotherdrawback of this type of system is that conventional hypodermicneedles can mistakenly be used with this system, circumventingthe advantage of the blunt cannula. The split-septum productsdid not address the problem of catheter occlusion. Split-septumconnectors created negative pressure when the blunt cannula waswithdrawn. Any negative pressure at the time of disconnectioncan jeopardize device patency by allowing retrograde flow intothe lumen of the catheter.
Luer-Activated Ports—Negative Displacement
Following the adoption of the Needlestick Safety andPrevention Act, Luer-activated mechanical valves began to beused on a more frequent basis. When the male luer is inserted intothe connector a valve opens and fluid can be infused or aspirated.Once the luer is removed the valve closes automatically. Thisprovides intermittent access to the vasculature and removes theneed for either a conventional sharp needle or a blunt needle.These were both positive steps in patient and healthcare workersafety. Needlestick injuries were reduced because the needle hadbeen removed from the system. (See Figure 3.)
18
May 2009MANAGING INFECTION CONTROL
occurred. In addition, many healthcare workers receiveneedlestick injuries using this type of product. Many needleswere also recapped following injection and additional needle-stick injuries occurred. As we are all aware, there were nogovernmental or regulatory requirements to use any type of safety device at this time period.Although needleless IV systems were available atthe time, only about 50 percent of hospitals were usingneedleless IV systems by 1995. Many healthcare organiza-tions were slow to adopt or did not adopt needlelesssystems. One of the excuses used for this was the increasedcost of the devices even though the benefits were proven tosave lives.However, following the 2001 revised BloodbornePathogen Standard; healthcare facilities began to adoptneedleless connectors in much greater numbers. Needlelesssystems used on IV tubing have made one of the greatestimpacts in reducing needlestick injuries. The needles thatwere used on injection ports in IV tubing accounted for thehighest rate of sharps injuries.
Pre-pierced Septum and Blunt Cannula
Injection caps began to be replaced with pre-piercedseptum and blunt cannula. These consisted of a re-sealableport that attached to the hub of the patient's access device.A blunt needleor cannula could be used to repeatedlypenetrate the septum. This blunt needle eliminated the needfor a sharp needle and would provide intermittent access tothe vascular system. (See Figure 2.)
Sharps
Safety
Figure 2.Figure 2.Figure 3.
Needleless systems used on IV tubing have made one ofthe greatest impacts in reducing needlestick injuries.
 
An additional connector has been designed with a positivepush feature that gives an overall negative fluid displacement andtherefore no retrograde blood movement into the catheter lumen.
Latest Advances
Luer-Activated Ports—Clear with Anti-Microbial Technology
In the latest advance in luer-activated ports, MaximusMedical, a division of Medegen, has recently introduced theMaxGuard™ Advanced Luer Activated Device featuring Agion
®
antimicrobial technology. (See Figure 5.)Many hospitalized patients receive medicationsand nutritionalsupport intravenously. During the process of administeringintravenous medication, environmental contaminants can beintroduced into the bloodstream. This is of particular concern if proper infection prevention techniques are not followed. MaxGuardwith antimicrobial technology helps prevent contamination andgrowth of microorganisms at the point of entry into the catheter, andsubsequently in the bloodstream. MaxGuard is new technologyintroduced to assist hospitals in reducing catheter-relatedHowever the luer- activated design posed some otherrisks. One of the problems created by the luer-activateddesign is the inadvertent negative fluid displacement thatoccurrs when the male luer is removedfrom the connector.This negative fluid displacement pulls blood into thecatheter lumen and intraluminal thrombotic catheter block-ages can occur. Not only does this create occlusions butincreases the potential for growth of microorganisms whichcould flow into the patient's bloodstream. When a catheterocclusion occurs, clinicians administer anti-thrombolyticagents to de-clot the line. This increase in manipulation of the line costs the hospital time and money. It also increasesthe patient's risk of infection due to contamination. Thecatheters often have to be replaced because the blood clotcould not be removed. This is both difficult for the patientand expensive. It became very important for clinicians tomaintain the patency of the catheters.Many clinicians started to note an increase in blood-stream infections with the use of these products. It has beentheorized that this is due to the inability of disinfecting thesurface of the device. The theory is that the lack of a flat,smooth surface where the male luer connector would beinserted could be a problem. The newer products hadcrevices and recesses that were supposedly difficult todisinfect on the top of the valve. Some luer-activatedconnectors were found to cause an increase in bloodstreaminfections in several studies.
Luer-activated Ports—Positive Displacement
A number of companies started to design luer-activatedvalves that displace fluids as the male luer was removed.The concept is that after the syringe is removed from theconnector, the needleless connector pushes a smallamount of solution out of the connector distally. Thiswould then push fluid out of the distal end of the catheterand would totally fill the catheter with solution thus mini-mizing occlusion. This positive pulse of fluid clears thecatheter tip from blood, thus making occlusions less likelyto form because blood is not sitting in a catheter for anextended period of time. (See Figure 4.)
20
May 2009MANAGING INFECTION CONTROL
Sharps
Safety
Figure 5.Figure 4.
A needleless connector isstill one of the best ways toprevent needlestick injuries—by eliminating as many needlesas possible.
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