HCWs have always been at risk of needlestick injuries, but quantifying the actual number of percutaneous needlestick injuries (NSIs) sustained by U.S. HCWs is difficult. Panlilio et al. combined data for 1997 and 1998 from the National Surveillance System for Healthcare Workers (NaSH) and the Exposure Prevention Information Network (EPINet). The EPINet was developed in 1991 to provide standardized methods for recording and tracking percutaneous injuries, and blood and body fluid contacts. The EPINet system consists of a needlestick and sharp object injury report and a blood and body fluid exposure report and software for entering and analyzing data. Since its introduction in 1992, EPINet has been acquired by >1,500 hospitals in the United States; EPINet has also been adopted in other countries including Canada, Italy, Spain, Japan, and the United Kingdom.

The Needlestick Safety and Prevention Act (NSPA) of 2000, and the 2001 revised Bloodborne Pathogens Standard require healthcare facilities to maintain a sharps injury log. The log must include, at a minimum, the type and brand of device involved in the exposure incident, the department where the exposure occurred, and an explanation of how the injury occurred. EPINet has adjusted the data for underreporting. Panlillio et al. estimated that the number of percutaneous NSIs sustained annually by U.S. HCWs is 304,325 (4). This is in contrast to the 1,728 percutaneous NSIs reported in 2003 by 48 U.S. healthcare facilities to the EPINet surveillance program (5). The overall annual percutaneous NSI rate for all network hospitals (29 facilities) in 2007 was 27.97 per 100 occupied beds (33.49 injuries per 100 occupied beds for teaching hospitals; 16.16 for nonteaching facilities). A safety-designed device was used only 37.4%, and was activated fully only 11.9%, of the time (6). Clearly, the risk of transmission of bloodborne pathogens, such as HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV), still exists. Although much work has been done to decrease NSIs, we must continue to develop and implement devices that will be used consistently and that are not too costly.

The Bloodborne Pathogens Standard promulgated by the Occupational Safety and Health Administration (OSHA) (7) in 2001, in addition to mandating reporting, also requires that engineering controls and work practices eliminate or minimize HCW exposure to blood. One means of accomplishing this goal is to use needleless systems. Phillips et al. set out to determine whether the NSPA itself had an effect on the rate of percutaneous injuries among hospital employees. By analyzing data from a multihospital sharps injury database, the investigators found evidence that the NSPA did contribute to the decline in percutaneous injuries among U.S. hospital workers (8). Conversely, Jagger et al. found, despite the NSPA, that surgical injuries continued to increase during the same period that nonsurgical injuries decreased, suggesting that attention to safer surgical devices and practice is needed. The EPINet data (suture needles comprising much of sharps injuries) support this view (9).

A retrospective review of 3,297 percutaneous injuries from hollow-bore safety-engineered devices occurring between 2001 and 2009 was conducted, using the EPINet needlestick surveillance data. Nurses sustained 64.6% of all injuries from safety-engineered sharps devices (SESD); 42.9% of SESD injuries occurred after device use and may be preventable through consistent use of safety-engineered technology. Excluding injuries that occurred during device use or between procedural steps, 71.8% (28/39) of physician injuries, 58.2% (645/1,109) of injuries to nurses, and 45.8% (88/192) of injuries to phlebotomists occurred when an available SESD was not fully activated. Passive devices that do not require action on the part of the user to engage the safety feature currently represent a small portion of the SESD market. The use of innovative passive SESDs coupled with continual education of end users is necessary for an effective sharps injury prevention program (10).

Still, since the introduction of needleless systems, decreased rates of occupational needlestick exposures have been documented (11,12,13,14,15,16,17). Protected-needle intravenous (IV) systems also have decreased NSIs due to IV connectors by 62% to 88% (18,19). Again, unfortunately, the devices are not routinely activated, which appears to be related to inadequate training (13).

The association between needleless devices and patient infection seems to relate to HCWs’ lack of familiarity with the device and/or its mechanics. Some have investigated the mechanics of needleless devices to determine whether new technology added to the device could reduce infection risk. Menyhay and Maki reported on a simulation study that compared the efficacy of conventional alcohol disinfection of the membranous septum of needleless Luer-activated valved connectors before access with the use of a novel antiseptic-barrier cap that, when threaded onto the connector, places a chlorhexidine-impregnated sponge in continuous contact with the membranous surface (20). After removal of the cap, there is no need to disinfect the surface with alcohol before accessing it. After contaminating, disinfecting, and then culturing the connectors, the authors demonstrated that if the membranous septum of a needleless Luer-activated connector is heavily contaminated, conventional (5 to 7 seconds) disinfection with 70% alcohol did not reliably prevent entry of microorganisms. In contrast, the antiseptic-barrier cap provided a high level of protection. Another study considered a recently developed needleless closed Luer access device (CLAD) (Q-Syte, Becton Dickinson, Sandy, Utah). The devices were contaminated with bacteria and then disinfected with 70% isopropyl alcohol followed by flushing with 0.9% saline. Although the devices had been accessed up to 70 times, no microorganisms were found even when challenge microorganisms were detected on the syringe tip after activation and on the compression seals before decontamination, suggesting that the Q-Syte CLAD can be activated up to 70 times with no increased risk of microbial contamination within the fluid pathway (21). The Luer-activated valved connector, which allows a chlorhexidine-impregnated (or alcohol) sponge to do the work, could be particularly helpful because it does not depend on the action of an HCW for disinfection.

Needleless systems are now almost universally used; the benefit to the HCW and the risk to the patient have been demonstrated. Education is a key intervention to prevent patient infections with devices new to an institution. Novel interventions will need to be studied further to assess their benefit and cost. A study to determine the risk factors for bloodstream infections (BSIs) in patients receiving home intravenous infusion therapy (22) revealed that receipt of total parenteral nutrition and intralipid therapy through a needleless system was a BSI risk factor. The results of a survey on the subject of injection caps demonstrated that positive cultures were significantly more common from needleless devices than from protected-needle devices. It was concluded that when injection caps are manipulated, nutrient-rich solutions can remain in the caps of the needleless devices and become contaminated. Another study that assessed needleless systems used with Hickman catheters suggested that such systems can be associated with increased rates of catheter-related (CR) BSI (23). The investigators cultured luminal fluid from Hickman catheters of hematology patients and found that these catheters with the needleless system were twice as likely to show luminal contamination compared with catheters without the system. Four BSIs in patients with the needleless device had peripheral blood and luminal fluid cultures that yielded concordant bacterial strains based on the results of pulsed-field electrophoresis (PFGE) and restriction fragment polymorphism studies. Do et al. described an increased BSI rate with the use of a needleless intravenous system in a home-care setting when caps were changed every 7 days and a subsequent decrease in BSIs when the needle-less device end cap was changed every 2 days, suggesting that the mechanism for BSI could involve contamination from the end cap (24). Kellerman et al. reported an 80% increase in BSIs related to central venous catheters (CVC) in pediatric hematology-oncology patients receiving home healthcare after introduction of a needleless device for CVC access (25). At another institution, a significant increase in the BSI rate in a surgical intensive care unit (ICU) and an organ transplant unit was associated with the introduction of a needleless intravenous system. This was attributed to nurses’ lack of familiarity with the device and deviation from the manufacturers’ recommended practices (26). Finally, another study that investigated the risk factors associated with an increased rate of BSIs in pediatric ICU found that exposure to the IVAC first-generation needle-less device (IVAC, San Diego, California) was an independent BSI risk factor. The BSI rate returned to baseline after institution of a policy to replace the entire IVAC device, valve, and end cap every 24 hours (27).

Although the needleless systems have evolved, risks for the patient still exist. Before the 1980s, access to an intravenous system was accomplished by inserting a hollow-bore needle
into a latex cap, placed on the administration set. The first safety systems were needle devices with shielding or retracting mechanisms, then came split septum needleless connectors in which a blunt cannula was used to access the connector instead of a needle. The first rendition of this device created negative pressure when the blunt cannula was removed. This made it more likely for the catheter to occlude. The next generation of such connectors incorporated an antireflux, Luer-activated valve, which helped neutralize any negative pressure when the syringe was disconnected. Eventually, the mechanical valve needleless connectors that generate negative, positive, or neutral pressure during disconnect, using Luer lock connectors, became available. The third generation of connectors combined the existing Luer-activated valve concept with a displacement action, which expels a small amount of solution used to flush the catheter when the flush syringe is disconnected from the Luer. The displacement is a passive feature; once this has occurred, the remaining solution is retained within the catheter and no further positive pressure exists. The positive-pressure Luer connector is designed to reduce retrograde flow into the catheter more effectively than can the slit septum or standard Luer connectors, without the use of heparin flushes, by preventing backflow and reducing the amount of blood, and hence clot, in the catheter.

One institution, however, found a 60% increase in the rate of CR-BSIs in their ICUs associated with the introduction of a positive-pressure mechanical valve (MV) port. The institution reverted back to using their previously used mechanical valve (28). Others additionally found an increase rate of BSIs associated with positive-pressure mechanical valve needleless connectors, even after educational sessions regarding proper use of the MV (29,30,31,32). Jarvis et al. compared healthcare-associated CVC-BSI (HA-BSIs) rates at five hospitals that introduced MV needleless connectors (MV-NCs) after using split septum (SS) connectors. All hospitals performed HA-BSI surveillance using Centers for Disease Control and Prevention (CDC) definitions during use of both types of connectors. The authors found that the HA-BSI rate increased significantly in all ICUs and wards when SS-NCs were replaced by MV-NCs and decreased significantly when SS connectors were reintroduced (33).

These outbreaks led to the Society for Hospital Epidemiology of America (SHEA)-Infectious Disease Society of America (IDSA) recommendation against routine use of positive-pressure MV-NCs (34). In August 2010, the U.S. Food and Drug Administration (FDA) sent out a medical device safety alert and a letter to infection control practitioners summarizing the concerns regarding the safety of positive-displacement needleless connectors and required nine companies to conduct postmarket surveillance studies on positive-displacement needleless connectors to assess whether they are associated with higher rates of HA-BSIs. Of note, FDA has received three reports of death associated with BSI and positive-displacement needleless connectors (35).

Of course, understanding how to efficiently and conveniently disinfect a valve is important. Rupp et al. found that a 5-second scrub with a 70% isopropyl alcohol pledget adequately disinfected SS intravascular catheter connector valves under clinical and laboratory conditions (36).

Finally, the tourniquet could function as a possible vehicle for cross-contamination of pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). Leitch et al. examined the contamination rate of phlebotomy tourniquets with MRSA. The investigators found that the tourniquets were contaminated with MRSA 25% of the time; they believed that the contamination occurred via the phlebotomists’ hands, not the patients’ skin (37). The practice for tourniquet use varies widely from single-patient use to disposal upon the discretion of the phlebotomist. Given that multidrug-resistant organisms, such as community-acquired MRSA, now are ubiquitous, the need for practices such as discarding or disinfecting tourniquets with alcohol wipe between uses to prevent tourniquets from harboring pathogens must be considered and evaluated.