Early man fashioned sharp instruments from flint and stone. Today, these implements are obsolete. Is the same thing happening with safety syringes? Following passage of the Needlestick Safety and Prevention Act, manufacturers responded with product modifications to meet regulatory requirements. Seven years later, these retro-fitted devices dominate the market. Yet a closer look at the situation raises questions about whether these early designs offer optimal protection to healthcare employees and patients, and are still the most cost-effective solution. Have the products developed at the turn of the century become outdated?
While institutions are required to evaluate safety devices annually, their representatives may be comparing apples to apples, limiting the review to outmoded technology. The safety syringe market has evolved, providing new choices with multiple benefits and price points.
Today, there are three distinct product categories to consider: retrofitted devices, which are conventional syringes with add-on pieces; automatically retractable syringes; and manually retractable syringes. This article examines technology now available and lays the groundwork for an evaluation process that may further reduce needlestick injuries.
The Evolution of Safety Syringes
When I began practicing as a nurse in the 1970s, blood-spattered clothing was considered a badge of honor. These stains didnt raise eyebrows; they commanded respect. We didnt wear gloves when giving injections and little was known about transmission of bloodborne pathogens. We used conventional needles, manually recapping them. My colleagues and I regarded needlesticks as unpleasant, not life-threatening.
The world has definitely changed. Our eyes opened during the mid-1980s with the first documented case of HIV transmission from a needlestick to a healthcare worker. Even with this frightening news, and later revamped OSHA standards, a careless attitude prevailed in some facilities. During the 1990s, as more needlestick injuries resulted in severe consequences, it was no longer enough to practice safety measures; better devices were needed.
Those most affected by this serious risk demanded changes. Nurses and infection control specialists pressured government and regulatory agencies to mandate the use of safety syringes. Their efforts were successful, first resulting in state regulations, then, ultimately, in passage of the Needlestick Safety and Prevention Act. By 2000, hospitals had access to a variety of new safety syringes, and their usage was required.
Initially, the number of needlesticks plummeted nationwide. According to EPINet, from 1999 to 2001 there was a 35 percent decline in needlesticks. Unfortunately, thats not the end of this story. The number of injuries has either reached a plateau or is going in the wrong direction. During 2006, 20.66 percutaneous injuries per 100 occupied beds were reported at California Pacific Medical Center, San Francisco the 1,044-bed teaching facility where I work as director of patient safety and infection control. Although this is lower than the EPINet 2003 rate, it still reflects an increase from our 2005 rate of percutaneous injuries of 17.1 per 100 occupied beds. During the 19 years Ive worked here, we have never had an occupational HIV seroconversion. But there have been too many close calls and traumatized nurses who waited for months after a needlestick to learn they escaped a dismal fate.
Our facility is among those doing a great job with infection control, but is it as good as it can get? I think not. Twelve months ago, I participated in a roundtable discussion, sponsored by Inviro Medical Devices, with infection control and nursing thought leaders from around the country. We agreed that the industry has achieved a state of complacency. Needlestick injuries still occur, and diseases from bloodborne pathogens still pose a threat to those exposed. It is not acceptable to merely nod our heads and agree that some injuries are unavoidable. We must once again corral our energy to further address this issue.
Heres an interesting conundrum: manufacturers have introduced a variety of safety syringes. Yet, with so many choices, it is difficult to distinguish the benefits that set them apart. Greystone Associates, a medical and healthcare technology consulting firm, was among the first to write about market segmentation and the three product categories now comprising the $1.6 billion safety syringe market: retro-fitted, automatically retractable and manually retractable. While further developments are welcomed, it is vital to understand available technologies so your institution can make wise choices.
Retrofitted syringes dominate the market. Most hospitals use this technology because until recently, it was the most affordable. How do you know if a syringe falls into this category? It operates like a traditional syringe, but offers protection through a feature that appears to be added on. They were the first to emerge when safety syringe use was mandated. To get new products to market fast, some manufacturers created adaptations instead of engineering them from scratch.
There are a wide variety of retro-fitted syringes, many with caps attached to the needle or syringe, as well as sheaths and shields. While most offer distinct improvements over conventional devices, there are a number of detracting factors. Some require the operator to put fingers close to the used needle while placing a cap or clipping a shield over the sharp. That action is dangerous. In addition, sometimes the safety feature interferes with performance, making it more difficult to give the patient an injection. Also, it consumes additional time to manually perform any of these functions, and many syringes require two hands to activate the safety device, again, increasing the risk of injury.
The assortment of retro-fitted syringe choices creates training challenges. Ideally, a hospital would offer an in-service to train personnel how to use the device. However, the days of full-time staff are gone. Employees work part time or at several facilities each using different instruments. If a device is not intuitive or is cumbersome to operate the safety feature may not be activated, thus defeating its purpose.
On the positive side, many manufacturers offer a modular approach to their product line. You can assemble the exact needle and syringe combination needed, and this flexibility is beneficial. Price also is a factor. Retrofitted devices once were the least expensive option, but now manually retractable syringes are available at the same price.
Automatically Retractable Syringes
Automatically retractable syringes do exactly what the name implies: the needle retreats into the barrel after the injection is complete. This should require no action by the operator, which is a distinct advantage. Unfortunately, there is still opportunity for human error, as well as device malfunction. Anecdotes suggest that it requires additional pressure on the plunger to get the needle to retract. When giving an injection, the objective is to get the needle in and out as painlessly as possible. Nurses may be reluctant to press harder due to the concern that it will hurt the patient. Therefore, some pull the needle out and then activate the trigger. If this occurs or the mechanism doesnt work properly, the patient might not get the full dose of medication and the safety feature is useless.
Training is important to ensure effective use. This category of syringes is the most expensive option, often costing twice as much as other products. Many institutions are unable to justify this expense. Despite its drawbacks, the automatically retractable syringe represents a significant technological advancement and is worthy of consideration.
Manually Retractable Syringes
Manually retractable syringes are the relatively new kid on the block. Like their automatically retractable brethren, they offer a completely original approach to syringe design, instead of modifying a traditional syringe to function in a post-Needlestick Safety Act world. These devices function with the ease of a conventional syringe, but once the injection is complete, the operator pulls back the plunger, retracting the needle safely into the barrel, and snaps off the plunger to seal it inside, rendering it harmless. As with retro-fitted devices, it may require two hands to operate, but unlike some models in that category, this product class does not put fingers in close proximity to a used needle.
Compared to other syringe types, this design may pose the least interference with patient care. There are no add-on features to make injections awkward or difficult, and no additional pressure is required to activate the retraction device. Training is necessary and presents the same challenges addressed earlier. A key benefit of manually retractable syringes is the price. These products offer some of the same advantages as automatically retractable devices, yet cost the same as retrofitted syringes.
How to Assess What Works Best for Your Institution
Because infection control personnel are inundated with new product developments, its often difficult to make sense out of the many options. Its time for a fresh, logical approach to the annual review.
At our institution, we start the process with data what circumstances result in problems? We determine the cause of needlestick injuries so we can secure the best products to prevent them. The majority of our incidents occur while withdrawing the needle from the patient or while manipulating the sharp in the process of performing the procedure. Safety devices do not prevent patients from moving or the operator from slipping or falling. We compare our data to EPINet, the voluntary database, to gauge our performance against national benchmarks.
We then marshal a team, including frontline nurses and representatives from materials management, infection control and occupational health. We factor their experiences and opinions into our decision. We examine products and information gathered from advertisements, mailings, manufacturing representatives and product fairs, as well as those presented by frontline workers who have experience with different products in other settings. In the future, we will compare products from each of the three market segments to determine what best meets our needs.
Cost is certainly part of our equation. Devices that are inserted into veins or arteries, such as phlebotomy needles, blood gas needles and IV catheters, are most likely to be associated with transmission of bloodborne pathogens as compared to a syringe that is used primarily to inject medication into a muscle or tissue. It may be easier to justify more expense for a high-risk device due to the risk-benefit.
Looking to the Future
Syringe manufacturers seem to create their best products with input from those who use them and continued innovation is necessary. Even as I write, I am aware of emerging syringe technology designed to protect patients by reducing medication errors, as well as healthcare professionals from needlestick injuries. According to a 2007 survey conducted by the American Nurses Association, 93 percent of responding nurses believe a write-on label integrated onto the syringe barrel would reduce the risk of medication errors. This simple concept also complies with 2007 Joint Commission requirements about syringe labeling, which the organization says should be prepared at the time the medication or solution is prepared for injection, rather than pre-labeled. One manufacturer plans to incorporate many of the beneficial features nurses recommend into its safety and standard luer lock syringe product lines.
Certainly the healthcare industry has made significant strides in needlestick injury prevention and product development. Those of us who work in healthcare facilities should examine the different types of product categories to ensure we provide optimal protection to our employees. However, there is much more territory to cover. We cannot become complacent simply because incidence has plateaued. Instead, we need to consider this signal as a call to action.
Barbara DeBaun, RN, MSN, CIC, has worked in the field of infection control for the past 28 years and serves as the director of patient safety and infection control at California Pacific Medical Center in San Francisco. DeBaun is a member of the Association for Professionals in Infection Control and Epidemiology (APIC) and served as a board member of the San Francisco Bay Area chapter for 11 years. In addition, she is a member of the 2007 APIC Annual Conference Task Force. During 2002, DeBaun received the ISIPS Sharps Injury Prevention Award for her contributions to the reduction of sharps injuries. She has published numerous articles, and has lectured nationally and internationally about infection control issues, including needlestick prevention, healthcare worker and patient safety.