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By Enid K. Eck, RN, MPH; Barbara DeBaun, RN, BSN, CIC; and GinaPugliese, RN, MS
It has beentwo years since California became the first state to pass the landmark legislationmandating the use of devices to reduce the risks of sharps-related injuries. This lawrequired a revision of the state's bloodborne pathogen standard to include implementationof sharps injury prevention technology, a written exposure control plan that describes aneffective procedure for identifying and selecting sharps injury prevention technology, andmaintaining a sharps injury log.
In November 1999, OSHA clarified its position and stepped up enforcement on the use ofsharps injury prevention devices under the bloodborne pathogen standard. (OSHADirective:CPL 2-2.44D). The use of sharps injury prevention devices was required in OSHA'sbloodborne pathogen standard issued in 1991, but this requirement was not strictlyenforced until now. The complete 70-page Federal OSHA directive and additional complianceinformation 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 enforcementprocedures 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 bydate 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 arevision of the state OSHA's bloodborne pathogen requirements and include a requirementfor 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 draftingsome type of legislation.
We have seen a tremendous increase in the pace of adopting safety devices over the pastfew years. However, there is still much to be done and an urgent need to speed up the paceof adoption of safety devices to protect all workers from sharps-related injuries and riskof bloodborne pathogen infections.
There is not one absolute approach to sharps injury prevention. Components of such aprogram include leadership and support of senior management; device evaluation, selection,training, and implementation; frontline worker feedback and involvement, injury datacollection and analysis, and continued monitoring for effectiveness, availability, andcompliance. It is important to recognize that the path ahead will be a challenge.
Although we are seeing a steady increase in the purchase and use of safety devices, notall conventional devices with needles and sharps features have been replaced by safetydevices. The issue is complex, and multiple factors need to be considered when developinga successful program.
Issues to consider include the following:
A written exposure control plan is the framework of the program to reduce risks ofbloodborne pathogen exposures to workers. It is required to contain all essential elementsin a carefully and meticulously constructed plan. Although the OSHA regulation describesthe elements that must be included in your plan, it does not define how therequirements are to be met. Your plan must include the use of sharps injury preventiondevices to eliminate or reduce risks of exposure. Each facility will need to documenttheir timelines and status/progress in the implementation of safety devices. If your planis reviewed by an OSHA inspector, you can expect the document to be evaluated word forword, line by line to ascertain how you have met the intent of the standard and yourprocess for modifying your written exposure control plan if things go astray (and theywill).
The written exposure control plan must describe an effective procedure for obtainingthe active involvement of key employees in reviewing, implementing, and updating theexposure control plan with respect to the procedures the employees perform in theirrespective work areas.
The sharps injury prevention program is often led by a multidisciplinary team or teamsthat may consist of infection control, risk management, quality improvement, nursing,medical staff, laboratory, employee health, safety, and materials management. It isessential to include frontline workers that are actually using the devices in the earlystages of selection, evaluation, and implementation of devices for their expertise and togain support of staff who will use these devices.
The challenge will be how to recruit employees with an interest and commitment toworker safety and also a desire to be actively involved in product selection andevaluation. 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 theymight be aware of, problems with existing products, compliance issues, and additionalstrategies 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 duringproduct evaluations), and requests for information during new employee orientation orannual bloodborne pathogen training.
To develop a comprehensive, objective evaluation process a multidisciplinary team ofclinical management, frontline workers, and supply chain management experts should beconvened to coordinate the safety product evaluation, selection, and implementationprocess. After soliciting broad-based support from administrative stakeholders, theevaluation team should conduct a preliminary review of all available needle/sharps safetyproducts by incorporating input from Product Procurement, Materials Services, andfrontline departmental staff who use the various sharps/needle product(s).
The evaluation coordinating team should establish general criteria regarding productperformance, product availability, and procurement. Product selection can be completedmore effectively if the evaluation process incorporates frontline worker input at manylevels in the selection and evaluation of sharps safety products. This comprehensiveselection process greatly facilitates a successful product implementation.
Inclusion of frontline staff, with characteristics described above, on the coordinatingcommittee, the development of general and device-specific criteria, and the planning ofdevice-related and injury-reduction strategies will facilitate quality decisions andpromote user acceptance. If you are part of a group purchasing organization, you shouldalso consult your materials management department to determine which safety devices areavailable and include these in your process for selection and evaluation. Group purchasingcontracts provide opportunities for competitive pricing, but no contract requires 100%compliance.
The process for product selection must be structured around general and device-specificcriteria that promote objectivity and validation of product efficacy in injury reduction.Maintaining objectivity throughout the product evaluation process helps to assure that theinitial product evaluation findings will be replicated throughout full implementation. Byestablishing device-specific criteria and carefully selecting an appropriate number ofdepartments in which to evaluate each product, post-implementation surprises will be keptto a minimum, and the learning curve associated with all new technology will be moremanageable.
A recognized resource for objective evaluation tools is the Training for theDevelopment of Innovative Control Technology Project (TDICT). Sample forms are availableon their Web site, http://members.aol.com/tdictproj. Sample evaluation tools arealso available from the manufacturers. However, it will be essential to review and revisethese tools to meet the specific applications in your facility and to assure that they areobjective.
General performance and selection considerations that are often applied to sharpssafety 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 ofproduct 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, andproduct distribution, inventory management, disposal volume, compatibility with relatedequipment, and availability of manufacturer support for device-specific training.
Once a potential sharps safety device has successfully met all the general performanceconsiderations, more device-specific criteria should be developed. Device-specificcriteria 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 thatallows frontline workers to provide direct feedback on each specific product as well asidentification of the most important product features.
Device-specific criteria can be divided into at least three general categories: beforeuse, during use, and after use. Examples of "before use" device-specificcriteria include: 1) clear labeling (i.e., color coding, instructions, etc.); 2)size, shape, and type of packaging; 3) needle interchangeability; 4) suitability for therange 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 thatmay deter staff from selecting the safety device in specific settings.
"During use" criteria may include: 1) impact on flow rates, specimencollection, etc.; 2) simplicity or intuitiveness of use; 3) functional reliability; 4)compatibility with other products; 5) patient comfort or safety; 6) utility across patientpopulations, including pediatrics; 7) single-handed use. These "during use"criteria help to determine any barriers to implementation or product characteristics thatcould 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 potentialchanges in disposal process. The "after use" criteria assist in determining any"downstream" impact the safety device may produce. The reliability of the safetyfeature in preventing sharps injuries "after use" is critical to the ultimateimpact 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 distributioncarts? Will disposal create any problems (i.e., will the device fit into theopening of the sharps container or will its packaging increase waste volume?)
Once the product evaluation and selection process has been completed, it is importantto identify all the potential challenges to successful implementation of the safetydevice(s). Challenges frequently relate to product availability and procurement, staffeducation and training, and the overall economic impact. Availability and procurementchallenges 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 productvolumes that can result in back orders.
Over the past two years, California healthcare facilities have experienced frequentsupply interruptions and "back orders" that significantly interfered withconsistent program implementation. As the mandate for sharps safety devices sweeps acrossthe country and healthcare facilities step up their speed of adoption, productavailability will likely continue to be affected. It will be important to document anyinterruptions or backorders in product availability as part of your exposure control plan.
Periodically, an unanticipated incompatibility of the safety device with other patientcare equipment or procedures necessitates the provision of a mix of sharps safety andconventional products. Such a mix of products can be confusing to staff and may delayskill development with the new safety product because staff tend to revert to theconventional product for all uses rather than just those required by product/procedureincompatibility.
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 ofsafety feature, there may be other features that have an impact on selection andpreference. For example, the length of the tubing and location of the clamps and accessports must meet all clinical procedures.
Staff education and training is essential to ensure competency with each new sharpssafety device. To activate the safety feature of most safety devices, some type oftechnique change is frequently required. Although devices may be fairly intuitive,understanding how a safety feature works and any limitations the device may havefacilitates compliance with implementation and correct product use. Educating and trainingstaff can enhance product implementation by identifying the core elements and essentialskills needed to use any safety device effectively, providing an opportunity to practicewith each new product and have their skill development validated through a returndemonstration.
If education and training departments have limited resources, consider atrain-the-trainer program that incorporates and optimizes the skills and accessibility offrontline staff. Use education resources, which are typically provided by manufacturers,including videos, posters, brochures, and clinical staff.
There are limited published data on efficacy of safety devices. Only a few large-scalestudies have been done to show effectiveness of specific devices in reducing risk ofinjury. Unless involved in research studies, individual hospitals can rarely collectenough data to show statistical significance in a device reducing injuries. The difficultyin analyzing this data is compounded by the significant degree of underreporting, up to70%, which must be accounted for in the final analysis. Some facilities have seen anincrease in injuries with the use of a safety device only to find out it is related to asudden increase in reporting injuries. In the absence of statistically significant data,there is still much to gain from looking at individual incident reports, device-specificinjury data, and trends in a hospital.
It is also important to evaluate each safety product independently to determine itsspecific impact over time. Other potentially confounding variables in the analysis ofinjury data are the impact of education, policy or procedure changes, and product backorders that require the use of conventional products.
Some hospitals calculate injury rates for specific devices, departments, or types ofstaff. There is no general agreement on the method to calculate rates and include a widevariety of denominators (e.g., occupied beds, number of staff, or number of devicesused). Factors that complicate the choice of denominators and calculation of rates includechanges in patient census, overtime shifts, patient acuity, and a specific device'sfrequency of use. What will be more important than calculating rates for comparison iswhat actions are taken as a result of data collected or the trends noted. For example, ifa follow-up investigation is conducted, what are the results and what action is takenbased on those results to reduce risks to workers? The trend in the data rather than thespecific 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 ofinjuries, device causing the injury, and to identify strategies for prevention. In somestates, like California, a sharps injury log is required that includes identification ofthe specific devices (type, brand, and model) involved in the injury, and workerdescription 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, somefacilities have developed a "product board" for the Employee Health/OccupationalHealth department to enable the employee to identify the product involved in the sharpsinjury. The product board will need to be updated frequently to include all new devicesthat are being used.
Although the implementation of sharps safety devices is driven predominately by a focuson healthcare worker safety, patient safety considerations cannot be ignored. Concernsabout infection control, the appropriateness of home-care use, and different patienteducation strategies begin to emerge as more and different devices become available.Needleless systems with access port caps or valves, retracting or blunting needles, and/orstylets may require specific changes in practice and patient education.
The limitations of current technology in types of devices, gauges, lengths, etc., maynecessitate changes in clinical practices or the need for conventional products tocontinue to be used. Procedures such as orthopaedic joint taps or injections andintravenous infusions on extremely low-birth-weight babies cannot be done easily withcurrent safety technology. As technology options change, each patient care procedureshould 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 proceduresthat 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 arecurrently no safety devices, the establishment of safer work practices and administrativecontrols is extremely important. Enlisting the insight, creativity, and support of allfrontline staff will greatly enhance the identification of alternative methods andpractices that may eliminate the need for a sharp device.
By creating safe "zones" within the operative field where better control ofhand-offs or instrument transfers may be done will substantially reduce the risk forsharps injuries. Magnetic sheets that capture and hold loose sharps, easily accessibledisposal 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 eachother 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 ofsharps safety products, never lose sight of the value of simple interventions. Encouragestaff to keep sharps disposal boxes close at hand and not overfilled. Ensure adequatelighting, reduce clutter, and other distractions.
No simple solution exists for addressing the challenge of sharps injury prevention. Ifyou are just getting started, it is imperative that you focus on devices most likely to behollow-bore and blood-filled. If your program is well-developed, don't become complacentbecause holding the gains is often more challenging than achieving them in the firstplace. If utilized, the well-established network within the Infection Control community isan invaluable resource that will greatly facilitate implementation of a successfulprogram.
Use all your lifelines, ask the audience (especially frontline workers), eliminate someoptions (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 atKaiser Permanente Medical Care Program (Pasadena, Calif). Barbara DeBaun, RN, BSN, CIC, isthe Infection Control Manager at California Pacific Medical Center (San Francisco, Calif).Gina Pugliese, RN, MS, is the Director of Premier Safety Institute and Associate Facultyat Rush University College of Nursing and at the University School of Public Health(Chicago, Ill).
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