Achieving Sharps Injury Reduction:
Moving from Theory to Implementation
By Enid K. Eck, RN, MPH; Barbara DeBaun, RN, BSN, CIC; and Gina Pugliese, RN, MS
It has been two years since California became the first state to pass the landmark legislation mandating the use of devices to reduce the risks of sharps-related injuries. This law required a revision of the state's bloodborne pathogen standard to include implementation of sharps injury prevention technology, a written exposure control plan that describes an effective procedure for identifying and selecting sharps injury prevention technology, and maintaining a sharps injury log.
In November 1999, OSHA clarified its position and stepped up enforcement on the use of sharps injury prevention devices under the bloodborne pathogen standard. (OSHA Directive:CPL 2-2.44D). The use of sharps injury prevention devices was required in OSHA's bloodborne pathogen standard issued in 1991, but this requirement was not strictly enforced until now. The complete 70-page Federal OSHA directive and additional compliance information and training resources are available on OSHA's Web site, www.osha.gov. Approximately half the states have state OSHA plans and are required to have enforcement procedures in place that are at least as effective as those of Federal OSHA.
In addition to California, 14 states have passed needle-safety legislation. In order by date of passage, these include Tennessee, Maryland, Texas, New Jersey, West Virginia, Minnesota, Maine, Georgia, Iowa, New Hampshire, Alaska, Connecticut, Oklahoma, and Ohio. Some of these laws in those states with state OSHA plans, like California, require a revision of the state OSHA's bloodborne pathogen requirements and include a requirement for the use of safety devices and many go beyond the requirements set by Federal OSHA. Another 17 states (including the District of Columbia) have introduced or are drafting some type of legislation.
We have seen a tremendous increase in the pace of adopting safety devices over the past few years. However, there is still much to be done and an urgent need to speed up the pace of adoption of safety devices to protect all workers from sharps-related injuries and risk of bloodborne pathogen infections.
There is not one absolute approach to sharps injury prevention. Components of such a program include leadership and support of senior management; device evaluation, selection, training, and implementation; frontline worker feedback and involvement, injury data collection and analysis, and continued monitoring for effectiveness, availability, and compliance. It is important to recognize that the path ahead will be a challenge.
The Issue Is Complex
Although we are seeing a steady increase in the purchase and use of safety devices, not all conventional devices with needles and sharps features have been replaced by safety devices. The issue is complex, and multiple factors need to be considered when developing a successful program.
Issues to consider include the following:
- Risk of infection varies by type of device. Not all devices carry the same degree of risk; hollow-bore devices that are blood-filled (e.g., phlebotomy needles) are more likely to result in transmission of disease than one that is either solid (e.g., suture needle) or not contaminated with blood (i.e., a needle used to administer a subcutaneous injection).
- Risk of injury varies by type of device. Injuries occur at different times during the use of a device, such as before, during, or after use or during disposal. These differences in timing of injuries also vary by the type of device used. Thus, different strategies and types of safety features may be needed for specific procedures to reduce risk.
- Evaluation of each type of safety device needed. Many different types of devices cause sharps-related injuries, such as needle-bearing devices, lancets, glass tubes, and instruments. Replacement of these devices cannot be done simultaneously. The evaluation process has to be repeated for each device. The length of time for implementation will depend on the specific device with some being easier to evaluate and implement because staff resistance to change is minimal and the safety devices require little change in technique. For devices with features requiring more manipulation, the time investment is greater because using the safety devices often requires a significant change in technique, and thus, staff resistance is high.
- Safety devices may limit scope of use. Some devices have multiple purposes and some safety features (e.g., needles that are not detachable from syringe) may limit scope of use.
- Not all injuries are preventable. Data from CDC's NaSH (National Surveillance System for Hospital Healthcare Workers) estimates that 64% of sharps injuries are preventable with current technology.
- Injuries may still occur with safety devices. Even devices with engineered sharps protection have been shown to be responsible for sharps injuries that occur before, during, or even after activation of the mechanism. CDC data from NaSH indicate that 41% of injuries with safety devices occur before activation was appropriate; 21% because device was not activated; and 19% during activation.
- Efficacy data are limited. Limited data on efficacy of safety devices (only three large-scale studies published to date); individual hospitals often do not have enough numbers to show statistically significant results for efficacy of a specific device. Underreporting of injuries also complicates the issue and prevents accurate assessment of a device's impact.
- Safety devices do not guarantee use. Implementation of a device does not guarantee acceptability and use by a worker even when compliance is mandatory. Some devices often require a major change in technique. Resistance to change was cited by OSHA as one of the most common reasons for lack of adopting safety devices in OSHA's response to a Call for Information about sharps injury prevention.
- Gaps in technology. Sharps safety technology is not currently available for all devices used in healthcare settings (e.g., spinal needles for anesthesia, catheter insertion devices for low birth-weight neonates, catheters for central venous insertions).
- Need for designated leader. Because sharps injuries are associated with bloodborne pathogen infections, ICPs have been expected to lead the charge in assuring compliance. This expectation is not necessarily related to their clinical experience, project management skills, available resources, or level of interest. Thus, resources and tools are needed to assist them. In addition, contingency planning will be needed to address staffing changes to minimize interruptions in implementation.
- Management commitment is needed. Senior management may not recognize the urgency of the issue or be constrained by financial considerations and competition in the use of the healthcare dollar for other safety priorities for workers and patients.
- Conventional needles may still be needed. Safety needles may not be needed for all applications. It is estimated that only 30% of syringes, for example, are ever used to puncture the skin of a patient. Some of the syringe/needle combinations are used without the needle for other procedures, such as entry into an IV line or for wound or body site irrigation. Syringes with or without needles are frequently used for sterile mixing of medications in pharmacies. It will be important to document those situations where conventional needles and devices may still be appropriate. The challenge is the need to have conventional needles stored in locations where safety needles are used and getting staff to comply with the use of safety needles in all situations where their use is appropriate.
- Safety devices are used in a variety of settings. Selection and adoption of safety devices will need to take into consideration the variety of acute, long-term, and home-care settings where these devices will be used. Implementation and training needs will vary for each setting.
Written Exposure Control Plan
A written exposure control plan is the framework of the program to reduce risks of bloodborne pathogen exposures to workers. It is required to contain all essential elements in a carefully and meticulously constructed plan. Although the OSHA regulation describes the elements that must be included in your plan, it does not define how the requirements are to be met. Your plan must include the use of sharps injury prevention devices to eliminate or reduce risks of exposure. Each facility will need to document their timelines and status/progress in the implementation of safety devices. If your plan is reviewed by an OSHA inspector, you can expect the document to be evaluated word for word, line by line to ascertain how you have met the intent of the standard and your process for modifying your written exposure control plan if things go astray (and they will).
The written exposure control plan must describe an effective procedure for obtaining the active involvement of key employees in reviewing, implementing, and updating the exposure control plan with respect to the procedures the employees perform in their respective work areas.
The sharps injury prevention program is often led by a multidisciplinary team or teams that may consist of infection control, risk management, quality improvement, nursing, medical staff, laboratory, employee health, safety, and materials management. It is essential to include frontline workers that are actually using the devices in the early stages of selection, evaluation, and implementation of devices for their expertise and to gain support of staff who will use these devices.
The challenge will be how to recruit employees with an interest and commitment to worker safety and also a desire to be actively involved in product selection and evaluation. Helpful qualities include: positive energy; objective, critical thinkers; respected by peers; good educators; and clinical experts.
Information can be gathered informally from frontline workers about new products they might be aware of, problems with existing products, compliance issues, and additional strategies and suggestions to reduce risk. This might include staff interviews on rounds, comment boards located on each unit for staff to write their concerns (especially during product evaluations), and requests for information during new employee orientation or annual bloodborne pathogen training.
Objective Evaluation Process
To develop a comprehensive, objective evaluation process a multidisciplinary team of clinical management, frontline workers, and supply chain management experts should be convened to coordinate the safety product evaluation, selection, and implementation process. After soliciting broad-based support from administrative stakeholders, the evaluation team should conduct a preliminary review of all available needle/sharps safety products by incorporating input from Product Procurement, Materials Services, and frontline departmental staff who use the various sharps/needle product(s).
The evaluation coordinating team should establish general criteria regarding product performance, product availability, and procurement. Product selection can be completed more effectively if the evaluation process incorporates frontline worker input at many levels in the selection and evaluation of sharps safety products. This comprehensive selection process greatly facilitates a successful product implementation.
Inclusion of frontline staff, with characteristics described above, on the coordinating committee, the development of general and device-specific criteria, and the planning of device-related and injury-reduction strategies will facilitate quality decisions and promote user acceptance. If you are part of a group purchasing organization, you should also consult your materials management department to determine which safety devices are available and include these in your process for selection and evaluation. Group purchasing contracts provide opportunities for competitive pricing, but no contract requires 100% compliance.
The process for product selection must be structured around general and device-specific criteria that promote objectivity and validation of product efficacy in injury reduction. Maintaining objectivity throughout the product evaluation process helps to assure that the initial product evaluation findings will be replicated throughout full implementation. By establishing device-specific criteria and carefully selecting an appropriate number of departments in which to evaluate each product, post-implementation surprises will be kept to a minimum, and the learning curve associated with all new technology will be more manageable.
A recognized resource for objective evaluation tools is the Training for the Development of Innovative Control Technology Project (TDICT). Sample forms are available on their Web site, http://members.aol.com/tdictproj. Sample evaluation tools are also available from the manufacturers. However, it will be essential to review and revise these tools to meet the specific applications in your facility and to assure that they are objective.
General performance and selection considerations that are often applied to sharps safety devices include: 1) simple and self-evident to use; 2) reliable safety feature; 3) consistent with patient care requirements; 4) minimal interference with procedure; 5) suitability for range of uses; 6) compatibility with related equipment; 7) breadth of product line; 8) compliance with regulatory and clinical practice standards; and 9) current market availability of product.
Other considerations include unit costs, availability under purchasing contracts, and product distribution, inventory management, disposal volume, compatibility with related equipment, and availability of manufacturer support for device-specific training.
Once a potential sharps safety device has successfully met all the general performance considerations, more device-specific criteria should be developed. Device-specific criteria should be objective, measurable, inclusive of all applicable uses of the product, and ensure adequate assessment of functionality and patient care issues. Additionally, device-specific criteria should be incorporated into an easy-to-use evaluation tool that allows frontline workers to provide direct feedback on each specific product as well as identification of the most important product features.
Device-specific criteria can be divided into at least three general categories: before use, during use, and after use. Examples of "before use" device-specific criteria include: 1) clear labeling (i.e., color coding, instructions, etc.); 2) size, shape, and type of packaging; 3) needle interchangeability; 4) suitability for the range of product uses; 5) ease of assembly or prepackaged product components; 6) medication dose visibility and delivery; 7) latex free. The "before use" criteria should assess the general ease of preparation and specific considerations that may deter staff from selecting the safety device in specific settings.
"During use" criteria may include: 1) impact on flow rates, specimen collection, etc.; 2) simplicity or intuitiveness of use; 3) functional reliability; 4) compatibility with other products; 5) patient comfort or safety; 6) utility across patient populations, including pediatrics; 7) single-handed use. These "during use" criteria help to determine any barriers to implementation or product characteristics that could impact patient care delivery.
"After use" criteria may include: 1) time for safety feature activation; 2) type of feature activation (active vs. passive); 3) undefeatable safety feature; 4) reliability of safety feature; 5) confirmation of safety feature activation; 6) activation-associated risk of aerosol or spray; 7) storage for disposal or potential changes in disposal process. The "after use" criteria assist in determining any "downstream" impact the safety device may produce. The reliability of the safety feature in preventing sharps injuries "after use" is critical to the ultimate impact on reducing injuries and the total effectiveness of safety device implementation.
When a decision is made to adopt a new product, review the "cradle-to-grave" procedure. How is the product packaged? Will the device fit into supply distribution carts? Will disposal create any problems (i.e., will the device fit into the opening of the sharps container or will its packaging increase waste volume?)
Implemenation of Sharps Safety Products
Once the product evaluation and selection process has been completed, it is important to identify all the potential challenges to successful implementation of the safety device(s). Challenges frequently relate to product availability and procurement, staff education and training, and the overall economic impact. Availability and procurement challenges include: 1) supplier viability; 2) incomplete product lines (e.g., breadth of sizes or gauges); 3) general speed of procurement including distribution, materials management, and tracking; and 4) any inconsistency in availability of product volumes that can result in back orders.
Over the past two years, California healthcare facilities have experienced frequent supply interruptions and "back orders" that significantly interfered with consistent program implementation. As the mandate for sharps safety devices sweeps across the country and healthcare facilities step up their speed of adoption, product availability will likely continue to be affected. It will be important to document any interruptions or backorders in product availability as part of your exposure control plan.
Periodically, an unanticipated incompatibility of the safety device with other patient care equipment or procedures necessitates the provision of a mix of sharps safety and conventional products. Such a mix of products can be confusing to staff and may delay skill development with the new safety product because staff tend to revert to the conventional product for all uses rather than just those required by product/procedure incompatibility.
If a product is to replace a current similar device, perform a side-by-side analysis. For example, if you are evaluating a new needleless IV system in addition to the type of safety feature, there may be other features that have an impact on selection and preference. For example, the length of the tubing and location of the clamps and access ports must meet all clinical procedures.
Staff education and training is essential to ensure competency with each new sharps safety device. To activate the safety feature of most safety devices, some type of technique change is frequently required. Although devices may be fairly intuitive, understanding how a safety feature works and any limitations the device may have facilitates compliance with implementation and correct product use. Educating and training staff can enhance product implementation by identifying the core elements and essential skills needed to use any safety device effectively, providing an opportunity to practice with each new product and have their skill development validated through a return demonstration.
If education and training departments have limited resources, consider a train-the-trainer program that incorporates and optimizes the skills and accessibility of frontline staff. Use education resources, which are typically provided by manufacturers, including videos, posters, brochures, and clinical staff.
Assessment of Safety Device Efficacy in Reducing Injuries
There are limited published data on efficacy of safety devices. Only a few large-scale studies have been done to show effectiveness of specific devices in reducing risk of injury. Unless involved in research studies, individual hospitals can rarely collect enough data to show statistical significance in a device reducing injuries. The difficulty in analyzing this data is compounded by the significant degree of underreporting, up to 70%, which must be accounted for in the final analysis. Some facilities have seen an increase in injuries with the use of a safety device only to find out it is related to a sudden increase in reporting injuries. In the absence of statistically significant data, there is still much to gain from looking at individual incident reports, device-specific injury data, and trends in a hospital.
It is also important to evaluate each safety product independently to determine its specific impact over time. Other potentially confounding variables in the analysis of injury data are the impact of education, policy or procedure changes, and product back orders that require the use of conventional products.
Some hospitals calculate injury rates for specific devices, departments, or types of staff. There is no general agreement on the method to calculate rates and include a wide variety of denominators (e.g., occupied beds, number of staff, or number of devices used). Factors that complicate the choice of denominators and calculation of rates include changes in patient census, overtime shifts, patient acuity, and a specific device's frequency of use. What will be more important than calculating rates for comparison is what actions are taken as a result of data collected or the trends noted. For example, if a follow-up investigation is conducted, what are the results and what action is taken based on those results to reduce risks to workers? The trend in the data rather than the specific rates and the investigation results and follow-up actions must be documented. Underreporting must also be considered in all data collection and evaluation.
Sharps injury logs can be one source of information to determine types and frequency of injuries, device causing the injury, and to identify strategies for prevention. In some states, like California, a sharps injury log is required that includes identification of the specific devices (type, brand, and model) involved in the injury, and worker description of how the injury occurred and how it could be prevented.
To collect accurate data on the type and brand of device involved in the injury, some facilities have developed a "product board" for the Employee Health/Occupational Health department to enable the employee to identify the product involved in the sharps injury. The product board will need to be updated frequently to include all new devices that are being used.
Although the implementation of sharps safety devices is driven predominately by a focus on healthcare worker safety, patient safety considerations cannot be ignored. Concerns about infection control, the appropriateness of home-care use, and different patient education strategies begin to emerge as more and different devices become available. Needleless systems with access port caps or valves, retracting or blunting needles, and/or stylets may require specific changes in practice and patient education.
The limitations of current technology in types of devices, gauges, lengths, etc., may necessitate changes in clinical practices or the need for conventional products to continue to be used. Procedures such as orthopaedic joint taps or injections and intravenous infusions on extremely low-birth-weight babies cannot be done easily with current safety technology. As technology options change, each patient care procedure should be reevaluated to determine if newer safety products can be used effectively.
Be prepared to provide a paper trail that clearly documents any areas or procedures that preclude the use of approved safety devices due to limitation in product performance, patient safety, and/or market availability.
Because most operative procedures involve the use of many devices for which there are currently no safety devices, the establishment of safer work practices and administrative controls is extremely important. Enlisting the insight, creativity, and support of all frontline staff will greatly enhance the identification of alternative methods and practices that may eliminate the need for a sharp device.
By creating safe "zones" within the operative field where better control of hand-offs or instrument transfers may be done will substantially reduce the risk for sharps injuries. Magnetic sheets that capture and hold loose sharps, easily accessible disposal containers, intermediate trays, and needle-free systems (e.g., laser, staplers, etc.) all promote a safer operative field).
Creating an environment in which staff is committed to caring for and protecting each other is extremely important in the overall effort to reduce sharps injuries.
Don't ignore the obvious. Although the major focus currently is on the selection of sharps safety products, never lose sight of the value of simple interventions. Encourage staff to keep sharps disposal boxes close at hand and not overfilled. Ensure adequate lighting, reduce clutter, and other distractions.
No simple solution exists for addressing the challenge of sharps injury prevention. If you are just getting started, it is imperative that you focus on devices most likely to be hollow-bore and blood-filled. If your program is well-developed, don't become complacent because holding the gains is often more challenging than achieving them in the first place. If utilized, the well-established network within the Infection Control community is an invaluable resource that will greatly facilitate implementation of a successful program.
Use all your lifelines, ask the audience (especially frontline workers), eliminate some options (devices that don't work), and most importantly, phone a friend.
Enid K. Eck, RN, MPH, is the Senior Consultant for HIV and Infectious Disease at Kaiser Permanente Medical Care Program (Pasadena, Calif). Barbara DeBaun, RN, BSN, CIC, is the Infection Control Manager at California Pacific Medical Center (San Francisco, Calif). Gina Pugliese, RN, MS, is the Director of Premier Safety Institute and Associate Faculty at Rush University College of Nursing and at the University School of Public Health (Chicago, Ill).
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