No discussion of needlestick injury trends would be complete without considering the impact of the U.S. Needlestick Safety and Prevention Act of 2000 that mandated the use of safety-engineered sharp devices. The legislation also prompted the Occupational Safety and Health Administration (OSHA) to revise its Bloodborne Pathogens Standard in 2001, strengthening requirements for employers to identify and make use of effective and safer medical devices.
Nearly a decade later, a study published in the December 8, 2008 issue of the Journal of Infection and Public Health1 examined the effectiveness of federal legislation and regulations in reducing healthcare workers’ (HCWs) risk of exposure to bloodborne pathogens. Analyzing needlestick injury data over a 12-year period (1993-2004) from a large network of U.S. hospitals using the Exposure Prevention Information Network (EPINet) sharps injury surveillance program, the researchers found a 34 percent decline in needlestick injury rates for U.S. healthcare workers overall, and a 51 percent decline in needlestick injuries for nurses.
While this is certainly welcome news, and proof-positive of the value of safety devices, further examination shows that there’s still much work to be done. Study co-author Jane Perry, associate director of the University of Virginia Health System’s International Healthcare Worker Safety Center, observed, "Overall, we’re not seeing much change in the data over the last few years. In the year or two after the legislation was passed, from 2001 to 2002, we saw a sharp drop in injury rates for most device categories. However, the overall pattern we’ve seen in the last five years is a stabilization or plateauing of rates," she said, adding, "we did achieve a significant reduction in injury rates, which we attribute to the law."
The JIPH study found that the largest reductions in injury rates were for two device categories with the highest risk of transmitting infections. These two high-risk device categories – phlebotomy needles and I.V. catheter needles – showed reductions of 59 percent and 53 percent respectively. Perry noted that adoption of safety devices for these applications has been particularly high, with market penetration of 90 percent or more. "In the categories where we’ve seen the highest adoption of safety devices, we’ve also seen the most reduction in injury rates," she noted.
Marilyn Hanchett, R.N., infection control practitioner with the Sinai Hospital Baltimore, Lifebridge Health in Baltimore, MD, highlighted examples of sharps safety technology innovations. "There are two very significant success stories historically that I’ve had the opportunity to experience. Both changed the way I and many others approached specific high-risk procedures. The first was Baxter’s introduction of the Interlink needleless system, which changed the way healthcare professionals intermittently accessed IV systems. It was ground-breaking technology and although needle-free systems have continued to evolve, that product remains in use. I was a bedside RN when that technology was introduced and intermittent IV access has never reverted to the previous methods of using unprotected needles. Today many manufacturers offer needle-free products, but historically I think it’s important to acknowledge Baxter’s role in changing not only products but also our vision of what better sharps safety practice could – and should - be."
Another noteworthy success story in sharps safety technology development, described Hanchett, was the introduction of the StatLock Stabilization Device, now available from Bard. With the goal of eliminating the use of sutures and suture needles for securing central lines, this unique catheter securement technology "really changed the way we looked at securing our IV catheters, especially PICCs," she said.
B. Braun Introcan Safety IV Catheter
Recently, Baxter launched its VITAL-HOLD catheter stabilization device as part of a convenience kit combined with its V-LINK luer-activated device. Vital-Hold locks catheters and lines securely in place, helping to reduce unscheduled restarts compared to tape, thus resulting in reduced risk of lost lines and associated needlestick injuries. Baxter’s V-Link antimicrobial IV connector is coated both inside and out with a proprietary VitalShield antimicrobial coating that is designed to help prevent microbial contamination and growth of pathogens in the device. This needleless IV access device features a flat, swabable surface, translucent housing, and double-seal protection - promoting standardized technique.
In 1992, ICU Medical Inc. introduced the CLAVE – a one-piece, closed, needle-free connector. The unique design of the Clave ensures compliance with needle-free policies because of its passive technology which cannot accept a needle. The Clave requires no additional components or adapters to access and requires no end cap for sterility. This microbiologically closed system helps protect the patient’s catheter from contamination that can otherwise lead to bloodstream infections.
The MicroCLAVE Neutral Displacement Connector from ICU Medical helps maintain catheter patency with virtually no reflux of blood into the catheter lumen either when connected or disconnected from an administration device. The dedicated internal fluid path technology provides a built in barrier to bacterial ingress.
Building on the successful design of the original Clave product, ICU Medical recently launched the Antimicrobial CLAVE, the only antimicrobial needle-free connector with dedicated internal fluid path technology. Ionic silver has been infused into all fluid path contact components which includes the internal cannula and split septum seal.
Also from ICU Medical, the Spiros (Closed Male Connector) is a needle-free closed system for the transfer and mixing of hazardous drugs. Upon disconnect the Spiros automatically self seals and closes the system. The Spiros prevents drips or spills in the event of a disconnection from a transfer device or IV set and protects against environmental contamination.
Earlier this year, Medegen Inc. announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new MaxGuard Advanced Luer Activated needleless connector featuring Agion Antimicrobial Technology. Medegen’s positive displacement technology provides a bolus of fluid to clear the catheter tip upon disconnection from the device. A translucent housing provides for visualization of the fluid path allowing for complete flushing of the device.
Safety systems from B. Braun Medical Inc. include the ULTRASITE Needle-Free IV System with positive displacement, designed to reduce accidental needlesticks when injecting, aspirating, or infusing fluids and medications; as well as the new Introcan Safety IV Catheter.
Even amidst such huge advancements, there’s always room for improvement, suggested Chris Trauger, product manager, IV catheters for B. Braun Medical Inc. For example, "with 90 to 95 percent of the U.S. IV catheter market converted to a safety device, it looks like we’re in compliance. And the statistics show that needlestick injuries have gone down. The question is, can they go down even further?" he challenged. "The goal should always be zero. Is that realistic? Maybe not, but that should always be our goal to reach."
Accentuating the need for continuous awareness, in October 2008 the California Division of Occupational Safety and Health (Cal/OSHA) alerted employers in the healthcare industry about pre-filled syringes containing one of the 2008-09 seasonal influenza vaccines, which were packaged with conventional needles that lacked a safety feature to protect users from needlesticks.
Gina Pugliese, vice president, Premier Safety Institute, commented, "Although OSHA issued a revision [to the Bloodborne Pathogens standard] in 2001, it only impacts on workers in the U.S. and not manufacturers. So healthcare workers must rely on manufacturers to provide the needed safety devices."
Baxter's The VITAL-HOLD catheter stabilization device
is used to lock catheters and lines securely in place.
VITAL-HOLD is latex free, packaged sterile, and the soft, flexible design enhances patient comfort
"An issue that still remains is ‘user preference’," said Pugliese. "OSHA specifies that the front line workers have to be involved in the selection and evaluation of devices. So for pre-filled syringes, if the safety device is incorporated into the device, the worker needs to become familiar with activation of the safety feature after use. Field evaluations conducted by the Premier Safety Institute of a number of different types of safety syringes found that workers become familiar with activation of safety features of syringes with less than five uses. However, workers still have specific preferences on the type of syringes that they prefer and many factors guide this preference, including ease of use, active versus passive activation, right or left-handed use, indication of activation, and suitability for a range of uses across patient populations and procedures. It is preferred that the safety feature be incorporated into the pre-filled syringe, rather than as an ‘add-on’ to ensure use."
"User preference may also impact on selection of syringes used for specific procedures," continued Pugliese. "In the situation where syringes are included as a component of a procedure tray, some trays are still available without safety syringes. Hospitals have the choice to purchase trays without syringes and add their own safety syringe based on user preference, purchase trays with standard devices (which are often less expensive) and replace them with their own safety syringes, or select trays that incorporate the safety syringe that they are familiar with."
Inviro Medical’s InviroSNAP! Safety Syringe Flu Trays enable easy influenza vaccine administration and are designed for convenient access. Each sealed tray includes 25 unwrapped sterile syringes, rather than 25 individually packaged, unopened syringes, reducing waste and increasing labor efficiency in the administration of influenza treatment. The InviroSNAP! Safety Syringes bridge the gap between bulky retro-fitted designs and more expensive automatic retractables. They function like a traditional syringe and are easy to use while administering flu shots, but the devices are engineered with a safety feature integral to the design. After using standard technique to administer a medication dose, the clinician pulls the plunger back, causing the needle to retract inside the barrel. The plunger is then snapped off, permanently disabling the device.
Citing a recent agreement in which leading pharmaceutical company sanofi-aventis will package its vaccine product with Unilife Medical Solutions’ Ready-To-Fill retractable safety syringe, Perry commented, "pre-filled syringes are increasingly in demand in medicine because they eliminate the possibility of administering the wrong dosage to patients and in many cases they’re more time efficient. It’s good news that the industry is beginning to recognize the need to package pre-filled syringes with safety needles. I would expect to see an increasing array of sharps safety technology developed for this market."
Sandel sharps safety products include Neutral Zone instrument drape, Hands Free passing tray, safety scalpel and safety scalpel handle.
"Overall there’s been a lot of success in implementing safety devices in the U.S., with a high level of adoption in most healthcare facilities. But one area where safety device implementation has lagged is surgery," said Perry. "When you look at our overall data, it’s clear that a large proportion of injuries occur in the surgical setting. If 30 percent of needlesticks and percutaneous injuries come from one clinical area, and that area has not shown much inclination to adopt safety devices and practices, it’s going to effect the degree to which rates can continue to decline. Thus, in our view, the major factor in the plateau of sharps injury rates over the last five years has been the lack of progress in the OR."
"As with many professionals, surgeons can be resistant to change," commented Lucy Reday, product manager, Sandel Medical Industries. She outlined several challenges in getting surgeons to adopt safety devices.
"First, the vast majority of surgeons were never trained in the use of sharps safety products (safety scalpels/handles and/or blunt suture needles) and have been clinically successful for years without them.
"Second, the vast majority of injuries involve the staff and not the actual surgeon. In addition, the historical belief has been that such incidences are a ‘part of surgery’ and therefore should be simply accepted (and potentially not reported).
"Third, many surgeons believe that changing to an engineered safety device may compromise their clinical outcomes. Historically, safety scalpels have been poorly designed relative to the surgeon’s needs and requirements – [with the] wrong weight and feel, inability to utilize their preferred choice of surgical blade, impaired visibility, etc.," said Reday.
The Change-A-Blade Safety Scalpel Handle from Sandel features a metal neck that is identical to a standard reusable scalpel. This frees healthcare facilities to utilize any #10, #11 and #15 standard blade, enabling each surgeon to keep their tool of choice. A fully retractable safety shield gives the surgeons uninterrupted puncturability and unobstructed field of vision. Change-A-Blade is weighted similar to a traditional #3 Scalpel Handle. An audible-click indicates that the safety shield is fully engaged.
The BD Beaver Safety Cataract Knife, featuring a specially designed, integrated retractable shield, is designed to minimize the risk of accidental surgical blade injuries that could occur during all phases of a surgical procedure: before use, during passing, between steps of the procedure, after use or during disposal. The integrated safety shield is easily activated by the user with just one finger, through a spring-assisted slider that provides tactile and audible feedback in both the shielded and unshielded positions. The single-use knives are essentially the same size and weight as conventional ophthalmic knives.
Suture needles are the second leading cause of needlestick injury in the U.S., accounting for 22 percent of incidents. The use of blunt suture needles, which Perry described as "sharp enough to get through internal tissue, but not sharp enough to penetrate the skin and cause a needlestick," has been endorsed by both the American College of Surgeons and OSHA. Yet resistance remains high, in part due to pre-conceptions about the devices by older surgeons who may have tried first generation blunt suture needles years ago.
"One of the reasons for the relatively low adoption of blunt suture needles has been lack of availability," said Ethicon Products Company Spokesperson Kristen Wallace. "Surgeons were looking for a greater variety of suture/needle combinations. In April 2009, ETHICON expanded the ETHIGUARD Blunt Point Needle product line by launching 30 new product codes to address this issue."
Ethicon’s Ethiguard Blunt Point Needles are made from a heat-treated, stainless steel alloy that delivers optimal strength and ductility to resist bending and breaking. The blunt point geometry allows for easy soft-tissue penetration with no more additional bleeding or patient trauma than with a conventional taper needle. Additional attributes include a ribbed and flattened body that affords stability in the needle holder for improved protection against slipping. Ethicon has also combined its Plus Antibacterial Sutures (which kill bacteria and inhibit bacterial colonization of the suture) with Ethiguard Needles to provide additional protection for both surgeons and their patients.
Also from Ethicon, DERMABOND Topical Skin Adhesive is a liquid bonding agent that holds many cuts, wounds and incisions together as effectively as stitches do. The adhesive material in Dermabond also forms a strong microbial shield to help protect wounds from bacteria that may lead to infection as they heal.
ICU Medical’s Antimicrobial Clave and MicroClave
"Another potential cause for low adoption is physician education," continued Wallace. "The practice of using sharp needles starts during residency training. Exposing surgeons to the benefits of blunt suture needles early on may impact adoption. The recommendation of universal adoption from industry advocates such as the American College of Surgeons (ACS) can help to lead the discussion."
Having a "champion" surgeon to lead sharps safety efforts can also be a big help, said Pugliese. "There are many new safety scalpels that perform equally to the reusable scalpels and samples from a variety of different suppliers need to be evaluated by the surgeons. Regarding blunt suture needles, the elegant research done by the CDC on their efficacy was published in 1997 and surgeons reported no interference with surgical procedures. I believe this is a matter of re-introduction of these devices in the OR and again, a champion surgeon."
Perry noted that along with safer devices, work practices that can reduce either the use of sharps or the risks associated with them must also be implemented. For example, employing a "no-hands passing" or "neutral zone" technique for transferring scalpel blades among members of the surgical team is an important practice that’s currently being heavily promoted to help reduce the risk of injury.
According to David Skinner, vice president, Daniels Sharpsmart Inc., "OR teams are acutely aware of the ‘neutral zone’ and instrument hand-off risk, yet transfer injuries are still too frequently reported. Daniels’ Bladesmart receiving device was designed by OR staff and develops further the neutral zone principle enabling safer transfer of scalpels, suture [needles] and other sharp objects."
The Z-Friction Instrument Drape from Sandel is a flexile non-skid bright orange material that serves as a noticeable neutral zone on the sterile field, the Mayo stand or back table. Sandel’s Hands Free Transfer Tray facilitates non-hands passing of scalpels and instruments on the sterile field. Sandel’s Stretch-A-Tray expands to accommodate instruments in a variety of shapes and sizes.
Disposing of risk
The final risk for injury during the lifecycle use of a needle or other sharps occurs during, and after, disposal of the device. Well-designed sharps containers placed in strategic locations, when combined with best practices, can help protect healthcare workers, patients and visitors from accidental needlesticks.
"The challenge is incorporating engineered passive safety features in a user-friendly design, in a compact wall space at an affordable cost point," said Skinner. "Even with extensive use of sharps safety devices, 6-9 percent of sharps injuries are container-related, i.e. via deposition, protrusion, bounce-out or penetration. These are caused primarily by sharps containers with small openings, point-first deposition, insensitive trays, and thin walls or closures."
Sharpsmart’s larger access, sensitivity, passive overfill protection, pre-assembly, tamper-proof closure, strength, and bracketry are the product of five years of engineered clinical research. These passive safety features work 24/7 to protect staff, are independent of contractor intervention, and have significantly reduced sharps injuries (SI) in peer-reviewed studies, according to Skinner.
Debra Gillmeister, director of healthcare services marketing for Stericycle Inc., described how the "vertical drop" design of Stericycle Bio Systems containers allows for simple, single-handed disposal of a wide variety of sharps, even including winged-steel "butterfly" needles that are often hard to get fully inside of a container due to their attached flexible tubing.
Stericycle’s Sharps Disposal Management Service, in which service technicians provide regularly scheduled, pro-active change-out of the Bio Systems reusable containers, can help alleviate challenges associated with in-house management of disposable sharps containers. "If you’ve got a disposable container, those containers [often] don’t get changed out until they’re full, and that really creates an opportunity for needlesticks," explained Gillmeister. "I’ve been in facilities where I’ve walked into the soiled utility room and twelve disposable containers are lined up against the wall – they’re not even in the receptacle that they’re supposed to go into – with needles sticking out of the tops of them, because nobody wanted to change the containers out. So that is a real issue."
The Stericycle program helps ensure best practice for sharps disposal, from making sure the right sized containers are installed in the most appropriate locations at the proper height according to NIOSH guidelines, to selecting the most suitable style of container for a particular area. For example a "hamper top" lid that accommodates larger sharps and medical devices may be preferable in the OR, suggested Gillmeister.
In an independent study of 52 Stericycle customer facilities, 100 percent of respondents indicated a significant decline in disposal needlesticks, with 77 percent averaging 0 to 1 per year, which Gillmeister attributes to the proactive change-out of containers by Stericycle employees as well as user-friendly container designs.
"In a recent study involving 28 U.S. hospitals, Daniels Sharpsmarts, when compared to non-user hospitals, were associated with significantly less Total SI; an 81 percent reduction in Container-associated SI; and a 23 percent reduction in Inappropriate-disposal SI," said Skinner.
Not to be overlooked is the positive environmental impact achieved with reusable containers.
Stericycle's Sharps Management Service includes pro-active change-out of containers.
"Disposable sharps containers add plastic and cardboard to a hospital’s sharps waste stream," said Skinner. "In two recent U.S. studies, one of 11 hospitals and another of 103 hospitals, reusable Sharpsmarts reduced the sharps waste stream by 4-6 tons per 100 occupied beds. In addition, Sharpsmart efficiency resulted in staff having to exchange 30-50 percent less containers."
A Carbon Footprint Calculator posted on the Stericycle website, www.stericycle.com, helps facilities gauge the impact of their activities on the environment. Because the Stericycle containers can be reused up to 600 times, a significant amount of plastic and cardboard is diverted from landfills, thus reducing carbon dioxide emissions.
"An average 200-bed hospital using our system would have diverted 13,180 pounds of CO2 from the atmosphere per year," Gillmeister illustrated. Using the calculator we learn that’s the equivalent of 679 gallons of gasoline, or 249 propane tanks. According to a running total on the Stericycle website, "overall since the Bio Systems container has been in existence we’ve kept more than 69 million containers out of landfills," she said.
Just because a facility provides healthcare workers with sharps safety devices does not ensure that the safety mechanisms will always be activated. The clinician may be rushed and either forget or for some reason consciously choose not to activate the safety feature, or they might think the safety mechanism was activated when it wasn’t.
Trauger emphasized the role that "passive" safety devices such as B. Braun’s Introcan Safety IV catheter can play in improving sharps safety compliance. Whereas "active" sharps safety devices require the user to do something to engage the safety mechanism in order to protect the needle, passive devices provide automatic needlestick protection without a change in technique.
For example, with B. Braun’s Introcan Safety IV Catheter, described Trauger, "the needle tip is always protected, from the time it’s removed from the catheter hub to the time it’s disposed."
Because truly passive devices cannot be bypassed, they not only serve to protect caregivers administering treatment, but also employees, patients and visitors who could potentially come in contact with an exposed needle downstream after the procedure is completed.
Passive safety devices continue to grow in popularity as hospitals grapple with ways to improve compliance and reduce needlestick injury rates, acknowledged Pugliese. "Hospitals that have adopted safety devices in all situations where there is a potential exposure to blood and still experience needlestick injuries often see the injuries as a result of non-activation of the device. So compliance with activation is still an issue and what is influencing many hospitals to select devices with a ‘passive’ activation feature where the needle is covered automatically as part of the use of the device, such as retractable needles."
While Trauger estimated that 70 to 80 percent of the IV catheter market is currently using an active safety device, "the passive safety market is growing faster than any other segment within the IV catheter market."
The use of passive safety devices may indeed provide an added safeguard, but Perry provided this caveat, "there are applications where HCWs need to control the activation of the safety feature. The most common example is giving incremental doses, as is done in anesthesia. A device with a safety feature that automatically engages when it is withdrawn from a patient would not be appropriate for this type of procedure. We think there’s a need for choice in the marketplace; no one kind of safety feature will fit all clinical applications."
"Also, it’s important to note that very few safety devices are truly passive – that is, the safety feature engages after use without requiring any additional action on the part of the user. Devices are sometimes marketed as ‘automatic’, but in fact usually require that the user do something to engage the safety mechanism," she said.
Cautioned Trauger, "some products are marketed as passive, however if the safety mechanism can be bypassed, the product is not a truly passive safety device."
Another benefit of the B. Braun Introcan Safety IV Catheter is its ease of use. Featuring a Universal Bevel design that accommodates a variety of insertion angles, the B. Braun Introcan Safety allows for easy, comfortable catheter insertion resulting in improved outcomes as well as reduced risk. "The other way to reduce needlestick injuries is to reduce the number of IV catheters being used or reduce the number of insertion attempts a clinician performs on a patient," Trauger explained. "Ultimately, it’s a best practice model consisting of safer products, informed caregivers and consistent processes that will help drive down needlestick injuries and reduce IV complications."
"Safety products are part of the solution but we cannot rely on them to eliminate our exposure risk," said Hanchett. "You’ve got to make sure that you have reinforcement and education programs in place to combat the resistance of clinicians to changing habits and behaviors. And you also have to strive hard for front of mind awareness relative to protecting yourself. We need to be more careful. The technology will certainly protect us up to a certain point, but we have to be cognizant of our own safety."
"It really requires a vigilance that I think is very hard to maintain when people are super busy and beset by so many other competing and valid priorities," added Hanchett. "Which is more important? Sharps safety, falls, medication errors, throughput issues to relieve congestion in the ED and move patients through the system? The list goes on and on. If sharps safety doesn’t remain a priority, you will inevitably start to see an increase in exposure events."
"If we have learned nothing else since 1990, it is that with change there has to be a top-down mandate," she emphasized. "We knew about emerging sharps safety products before the OSHA Bloodborne Pathogens Standard was implemented, but it took the federal government to require it before the products were widely adopted. The same model applies to individual institutions. Executive leaders and the senior management must insist on the change. In fact, research shows us that they must be champions of change. If they don’t believe in it, no one else will."
Perry recommends that hospitals provide annual retraining on safety devices used in the facility. "When it comes to safety devices, training is key – and then retraining, to ensure that clinicians are using the devices properly and to find out if any issues or problems have arisen. Problems do arise with safety devices; a particular brand may not be the most appropriate for a particular clinical application. Also, certain clinical areas, such as nuclear medicine, may require a safety device that is unique to that setting – what we call a ‘niche’ application. In some cases, a safety device may not yet be available for a particular procedure, in which case the emphasis should be on safe work practices to reduce risk."
Also, "collecting needlestick injury data is essential for monitoring safety device usage and to ensure they are being used properly. The data can be used to analyze how and where injuries occur, and design evidence-based strategies to prevent them," offered Perry.
Reporting of injuries and subsequent root cause analysis is key to the ongoing success of any sharps safety program, stressed Pugliese. "Hospitals need to do an analysis of every needlestick injury to determine the cause and target prevention accordingly. For example, is it failure to use a safety device when available, non-activation of the safety feature, or a special situation that needs addressing, or sharps container-related injuries?"
Hanchett suggested that eliminating non-safety products is critical to reinforcing change. "When you replace a product, there is usually some objection. But if you remove the opportunity to revert to non-safety products, the objections typically decrease as staff modify their habits to adopt the new technology. It is important to remember that change is difficult. It is essential to provide on-going feedback and reinforcement to support a sustainable, incremental change in our awareness, attitudes and practice."