Protection against needlestick injuries: active or passive safety?

Since phlebotomy procedures can affect patient satisfaction and pose a risk for needlestick injuries (NSIs) that could lead to serious or even fatal bloodborne infections, appropriate product selection is critical. Data analysis by the International Healthcare Worker Safety Center from 90 facilities from 1993 through 2001 showed that 94% of injuries from phlebotomy needles involved a blood-filled needle, which presented the highest risk of bloodborne pathogen transmission.¹ This injury prevalence led to the Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogens Standard in the early 1990s and passage of the Needlestick Safety and Prevention Act (the Act) in 2000. This national law, which mandated the use of safety-engineered devices (SEDs), has largely succeeded in reducing NSIs during blood collection.²

ne study that assessed percutaneous injuries (PIs) to healthcare workers in 87 hospitals from 1993 through 2000 (prior to the Act) and from 2001 through 2004 (after the Act’s passage) showed a significant 59.9% reduction in PIs for phlebotomy needles.³ Another hospital recorded a 70% reduction in reported NSIs from 20 in 2003 to 6 per 100,000 devices in 2004 following implementation of SEDs.⁴

Safety-engineered blood-collection devices can be classified into two broad categories: active and passive, as defined by the safety-feature activation method. By design, passive technology devices do not require additional steps to initiate the safety mechanism since it activates automatically during device use. Active devices require one- or two-handed activation by the healthcare professional after use. These products can be subdivided further into manual shielding (those with a protective sliding shield or a protective needle shield over the needle) and semi-automatic safety features that require one-handed activation by pushing a button, a plunger, or a final push/click to engage the safety mechanism. Healthcare workers can only activate the manual shielding safety device after withdrawing the needle fully from the vein. In contrast, users can activate semi-automatic devices while the needle is still in the vein. The safety feature may not always be part of the device; it can also be part of the holder to which the device is attached for blood collection.

In a French multicenter study conducted in 61 hospitals from 2005 through 2006, the passive safety devices evaluated were associated with lower NSI incidence rates. Study researchers noted a mean frequency of 2.05 injuries per 100,000 safety-engineered devices purchased. Specifically, self-retracting lancets (for capillary blood collection) showed the lowest incidence of NSI among the product types included in the study, which prompted the authors to conclude that passive devices achieve the highest level of safety against NSIs.⁵ The study did not evaluate passive venous blood-collection devices. Thus, one must be cautious not to generalize findings obtained from just one type of blood-collection device.

When choosing the optimal device for a particular clinical setting, it is important not only to consider the type of safety mechanism but also its ease of use. Many clinicians prefer the flexibility of active devices, which allow the user to activate the safety mechanism manually at the most appropriate time during the blood-collection procedure. The ability to manipulate the device is critical to attaining the best possible venous access and reducing the potential for premature activation of the safety device — both of which may necessitate a second needlestick. As such, passive devices may present challenges for the user, since they may offer less control than active devices and may not be desirable for procedures that warrant more command of the instruments. The input of HCWs who use these products is critical to these decisions. In fact, OSHA requires that frontline workers be engaged in an annual review and evaluation of available safety devices.⁶ This evaluation must take into consideration all procedures that may be performed with each device. No single safety device is suitable for every procedure that requires needles or sharps.

Healthcare providers should opt for products that have safety features that correspond to the clinical environment (e.g., patient’s condition) and complexity (e.g., procedure type, difficulty). To satisfy a variety of clinical needs, vendors are inventing a portfolio of both passive and semi-automatic safety devices to reduce needle exposure time. In-vein activation devices reduce the risk of exposure to a contaminated needle. Such a device reduced NSIs by 88% with zero NSIs in the last 21 months of a recent study.⁷ Also being manufactured are passive self-retracting lancets which activate only when positioned and pressed against the skin surface, as well as passive blood-collection needles with a safety feature that activates when the user inserts the first tube into the holder.

With current economic challenges, the higher purchase cost for safety-engineered devices and lack of awareness of the OSHA regulation may tempt healthcare institutions to use conventional devices. In non-hospital environments (e.g., clinics, private physicians’ offices, long-term care facilities), SED-adoption levels lag behind those of hospitals.⁸ It is imperative that purchasers of medical equipment in these facilities review the OSHA regulation⁶ and fully engage healthcare workers in these decisions.

The cost of protecting healthcare workers from needlestick injuries extends beyond the initial purchase price. The total cost related to just one NSI often fails to incorporate the psychological toll on the injured healthcare worker and his family. It also is difficult to capture the expenses associated with staffing interruptions while the healthcare worker is being treated. OSHA can also fine facilities for failing to comply with the Needlestick Safety and Prevention Act, and NSIs often raise the potential for labor union action and litigation.

Even with the availability of SEDs, exposure to bloodborne pathogens still presents a risk to healthcare workers. Safety devices are most effective when used in the context of a comprehensive, management-supported safety program that considers all aspects of the workplace. Staff involvement in device selection and evaluation, as well as training on both new and in-use devices, are key to reducing sharps injuries.

What can laboratory professionals do to advance this cause? Familiarize themselves with the OSHA regulation and take action to make sure their facilities are in compliance. We all can play a role to ensure the safety of our most valuable assets — our healthcare professionals.

Ana Stankovic, MD, PhD, MSPH, is the Worldwide Vice President, Medical Affairs, BD Diagnostics – Preanalytical Systems, headquartered in Franklin Lakes, NJ.

References

1. Perry J, Jagger J. EPINet data report: Injuries from phlebotomy needles. Advances in Exposure Prevention. 2003;6:43-45.
2. Needlestick Safety and Prevention Act of 2000. Public Law 106-430, US Statutes at Large 1901 (2000):114.
3. Jagger J. Caring for healthcare workers: A global perspective. Infect Control Hosp Epidemiol. 2007;28:1-4.
4. Adams D, Elliott TSJ. Impact of safety needle devices on occupationally acquired needlestick injuries: a four-year prospective study. J Hosp Infect. 2006;64:50-55.
5. Tosini W, Ciotti C, Goyer F, Lolom I, et al. Needlestick injury rates according to different types of safety-engineered devices: Results of a French multicenter study. Infect Control Hosp Epidemiol. 2010; 31:402-407.
6. Occupational Safety and Health Administration. Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens. Accessed at www.osha.gov/needlesticks/needlefaq.html.
7. Hotaling M. A retractable winged steel (butterfl y) needle performance improvement project. Jt Comm J Qual Patient Saf. 2009;35:100-105.
8. Jagger J, Perry J, Gomaa A, Kornblatt Phillips E. The impact of U.S. policies to protect healthcare workers from bloodborne pathogens: The critical role of safety-engineered devices. J Infect Public Health. 2008;1:62-71.