A Call to Safety: Why Current Safety Devices Are Not Solving the Needlestick Issue

Bill Clinton signed the Needlestick Safety and Prevention Act (NSPA) in 2000, requiring health care facilities to evaluate and provide safety devices for their workers. The legislation broadened the opportunity for the adoption of safety needles and other devices designed to prevent needlestick injuries, and manufacturers stepped up their development of safety sharps. But current safety sharps technology has not eliminated sharps-related injuries. More than a decade later, sharps injuries still occur frequently, creating risk for bloodborne disease transmission and a tremendous financial burden on our health care system.

The Centers for Disease Control and Prevention estimates hospital-based health care workers in the United States suffer more than 384,000 sharps injuries each year, or more than 1,000 sharps injuries every day.¹ These accidents rarely result in serious outcomes, but when they do, the outcomes are costly and potentially life-threatening. Sharps injuries can transmit such bloodborne pathogens as hepatitis B virus, hepatitis C virus, and HIV. Even when a sharps-related injury does not result in life-threatening illness, the administrative costs of complying with testing and documentation requirements are substantial.

Why has the NSPA failed to achieve its goal? Clinicians and other caregivers receive training in safety needle technology, and they certainly don’t want to hurt their patients or themselves. There is inadequate foolproof safety needle technology on the market, resulting in a persistently high rate of needlestick injury. This is clear even with a brief review of safety sharps technology.

The Earliest Safety Sharps
Safety-engineered needles and sharps devices first appeared in the United States in response to a 1987 OSHA Advisory Notice that described engineering controls as the preferred method for reducing the risk of exposing health care workers to bloodborne pathogens. By 1996, there were more than 1,000 patents issued in the United States for medical devices with sharps safety features, but adoption of safety sharps by health care facilities began slowly.² The devices were significantly more costly than traditional sharps, and all of them required technique modification. Adoption started to take off as state legislatures began to require that employers provide safety features in all relevant sharps device categories. California became the first state to pass such a law.³ Before the Federal Needlestick Safety and Prevention Act (FNSPA) established a nationwide mandate, 16 states followed California's example within two years.⁴

What Impact Did This Have?
Even in the wake of FNSPA, U.S. health care facilities introduced safety sharps gradually, which made the technology's impact difficult to measure. One early, unusual example of the impact of safety sharps comes from Memorial Sloan-Kettering Cancer Center, which implemented an "all at once," facility-wide transition to safety sharps. This immediate adoption resulted in an overall reduction in sharps injuries of 58 percent and a 71 percent reduction in injuries associated with hollow-bore needles.⁵

A more recent paper by Laramie, et al., studied the sharps injuries that occurred among employees in acute care hospitals in Massachusetts from 2002-2007, where the type of device most frequently associated with a sharps injury was hypodermic needles and syringes. The rate of sharps injuries decreased at a steady rate with the transition to safety sharps, decreasing 3.5 percent per year -- from 7.0 to 5.8 injuries per 1,000 FTEs.⁶

How Safe Are Safety Needles?
Despite these significant improvements, the problem remains. Interestingly, as the adoption of safety sharps improves, so does the relative incidence of injuries associated with these devices. This begs the question, how safe are safety needles?

Laramie, et al. indicated that at the same time their overall sharps injury rate declined, the proportion of injuries involving hypodermic needles and syringes with sharps injury prevention features steadily increased from 36 percent to 71.1 percent. The proportion of sharps injuries involving hypodermic needles and syringes with safety features doubled between 2002 and 2007.⁶. A New York City tertiary care facility reported that 27 percent of sharps injuries were associated with safety sharps during the two-year post-intervention period.⁵.

Sharps injury prevention features do not necessarily or automatically render the sharp safe. The many reasons for this have a common theme: In most cases, the safety device requires the user to engage the safety feature, and it can add complexity to an already delicate and critical procedure.

• Active design rather than passive. Active devices require one- or two-handed activation by the user after use. Technically, the term "passive" implies that the activation of the safety feature is automatic. There are different interpretations of the term "passive" as it relates to design of sharps devices, making interpretation of published sharps injury data difficult. Currently, there are devices on the market that are marketed and labeled as "passive" and still require additional pressure or other activity that requires a change in technique. By requiring additional activity, for example at the completion of dose administration, the safety features are active in nature. Comparing active versus semi-passive devices, a recent study by Tosini, et al. reported that safety-engineered devices (SEDs) with manually activated safety features were associated with 10.7 times more sharps injuries than SEDs with semiautomatic or automatic safety features.⁷
• Training issues and failure to activate the device. The majority of safety sharps require moderate amounts of training, which is time consuming and labor intensive. For facilities that lack education departments for new-product training, typically these types of devices are introduced to the health care worker by "see-one-do-one-teach-one." This method often will not allow the health care worker to fully grasp the design and its required function. With improper training comes improper use of the device. An audit of sharps containers at three Ontario hospitals found 13 percent of the safety syringes had not been activated. Of note, the brand of syringes utilized by these facilities was described as having "automated retraction."⁸
• Perception. Perception is a key player in human error. We see what we expect to see and hear what we expect to hear. If a nurse perceives the activation of a safety device to cause pain in the patient or extend the length of time it takes to perform the procedure, it is unlikely the device will be activated. If a nurse is required to move his/her hands toward an exposed needle in order to activate the safety feature, perception of danger may interfere with this action. In the very early days of safety sharps, it was not uncommon to see the safety features broken off the devices because the perception was the feature interfered with the success of the procedure or was otherwise perceived to be a danger to either the user or the patient.
• Resistance to change. Improvement requires change and while we appreciate improvement, we are also usually resistant to change. With safety devices designed to increase the level of safety for the health care worker, there is normally a high level of change in the method of use or normal routine. This can be uncomfortable for a nurse who is dealing with such a dangerous hazard as a sharp.

It is clear that the current "safety" needle options have eliminated neither sharps injuries in health care providers nor the potential for accidental reuse. All of the current syringes currently on the market require some kind of alteration in technique. The modification of technique may be perceived as minor, but devices that require the user to apply additional pressure on the plunger or to manipulate the device in a manner that is different from what is natural will never eliminate sharps injuries.

The Voice of the Customer
MedPro Safety Products, Inc., a leading developer of transformational technologies that enable safer medication delivery and blood collection, surveyed 262 health care professionals at the APIC 2011 Annual Educational Conference held in June 2011. The survey's key findings include:

• 68 percent of health care workers reported needlestick injuries have not been eliminated at their institutions despite FDA, CDC, and OSHA requirements in place for more than a decade.
• 43 percent do not believe the safety features that prevent needlestick injury are always activated after use and prior to disposal at their institutions, and fewer than 40 percent check for activation.
• 43 percent are not happy or are ambivalent with the current syringes used at their institutions.

Clearly, current sharps technology is not solving the problem. Even the syringe products that are being touted as "passive" are not eliminating sharps injuries or reuse because of the human factors involved. Sharps devices that are truly passive and require absolutely no extra push, pull, twist, or other activation must be designed and brought to market.

A Call to Action
There needs to be a sense of urgency on the part of sharps device manufacturers. Despite the evolution of safety syringe design over the past two decades, sharps-related injuries remain a serious and present danger to health care providers everywhere. The goal should be truly passive sharps safety, every needle, every time.

References
1. Panlilio AL, Orelien JG, Srivastava PU, Jagger J, Cohn RD, Cardo DM. Estimate of the annual number of percutaneous injuries among hospital-based healthcare workers in the United States, 1997-1998. Infect Control Hosp Epidemiol 2004; 25(7):556-562.
2. Kelly D. Trends in US patents for needlestick prevention technology. AEP 1996; 2(4):7-8.
3. Perry J. California leads the way with healthcare worker safety law. AEP 1998; 4(1):4-5.
4. Pugliese G, Perry J. The Needlestick Safety and Prevention Act (H.R. 5178): what does it require? AEP 2000; 5(4):41-42.
5. Sohn S, Eagan J, Sepkowitz KA, Zuccotti G. Effect of implementing safety-engineered devices on percutaneous injury epidemiology. Infect Control Hosp Epidemiol 2004; 25(7):536-542.
6. Laramie, AK, Pun VC, Fang SC, Kriebel D, Davis L. Sharps injuries among employees of acute care hospitals in Massachusetts, 2002-2007. Infect Control Hosp Epidemiol 2011; 32(6):538-544.
7. Tosini W, Ciotti C, Goyer F, et al. Needlestick injury rates according to different types of safety-engineered devices; results of a French multicenter study. Infect Control Hosp Epidemiol 2010; 31(4):402-407.
8. Stringer B, Haines T. Ongoing use of conventional devices and safety device activation rates in hospitals in Ontario, Canada. J Occup Environ Hyg 2011 Mar; 8 (3):154-60.

Posted by Barbara DeBaun on Mar 28, 2012