OSHA Compliance:

OSHA Compliance:
Needlestick Prevention Requires Planning, Products, and People

By Enid K. Eck, RN, MPH; Barbara DeBaun, RN, BSN, CIC; and Gina Pugliese, RN, MS

The landmark Needlestick Safety and Prevention Act, signed by President Clinton Nov. 6, 2001, authorized the federal Occupational Safety and Health Administration (OSHA) to revise the 1991 Bloodborne Pathogens Standard (29 CFR 1919.1030) to mandate the use of sharps injury prevention devices. OSHA's revised standard took effect April 18, 2001 and includes four major components: 1) adoption of sharps injury prevention devices, 2) maintenance of a log of all contaminated needlesticks injuries, 3) inclusion of frontline workers in the identification, evaluation, and selection of safety devices, and 4) annual revision of the exposure control to outline all the steps taken to select and adopt safety devices. As written, the standard applies to all worksites under federal OSHA mandate where employees may be exposed to blood or other potentially infectious material. The standard does not cover public (state and municipal) facilities unless they are specifically covered by a separate state-run OSHA plan or have a state law that applies. Of 27 states that are under federal OSHA--Georgia, Maine, Massachusetts, New Hampshire, Ohio, Texas, and West Virginia--have passed needle safety laws covering public healthcare settings. States with state OSHA plans (there are 23) have 6 months from the effective date of the federal standard (by October 18, 2001) to adopt a standard that is "at least as effective" as the federal standard.

If a state has a specific needle safety law with requirements above and beyond what the federal OSHA standard requires, then the additional state requirements must be followed. As of May 2001, 18 states have passed needle safety laws (figure 1). For example, some states laws may require heathcare facilities to report needlestick injury data to a state agency. If a state needle safety law is less protective than the federal law, the federal law's requirements must be followed.

Effective sharps safety programs are those that address the complex, dynamic priorities of planning, product identification, and connections with people along the continuum of care and the product supply chain. Although measurable progress can be achieved, a successful program requires ongoing review of each component of the program.

Creating an effective plan

Figure 1: State Needlestick Legislation as of May 2001August 2001

It is important to note that the bloodborne pathogen standard is a performance-oriented standard. This gives employers the flexibility to meet the intent of the standard based on the unique characteristics of the worksite and what is determined to be "appropriate." Thus, the type of work practices, protective barriers and engineering controls (e.g., sharps safety devices) will likely vary in each facility and depend on the types of procedures being performed, the risks involved, the preferences of the workers, and any other unique factors or experiences of that facility. There may be some variation in the specific interpretations of the standard in compliance documents prepared for the OSHA field staff. However, what will be important is the detailed written exposure control plan that outlines what each facility is doing to protect its workers based on their own unique characteristics. OSHA published the revised bloodborne pathogen standard in the January 18, 2001 issue of the Federal Register. In this published revision, OSHA included many suggestions and ideas on how to comply. What will be important is the plan reflects what is actually being done and that it is reviewed and updated annually to reflect any changes that are made.

OSHA requires that the plan include consideration and implementation of appropriate commercially available and effective safer medical devices. OSHA does note that employers should account for innovations in procedure and technological developments that reduce the risk of exposure incidents. This does not mean that we need to continually change or replace our devices as a new one comes along. It does mean that there should be a consideration of both trends in the injuries and exposures and a consideration of new devices if it is determined that a change is needed to reduce risk. OSHA also requires that the plan include the methods used for identification of devices as "candidates" for adoption, the methods used to evaluate them, and justification for final decisions. Special notations in the plan need to include situations where conventional devices are still needed; for example, if safety devices are not available or a clinician judges that they interfere with the procedure and jeopardize the safety of the patient or worker.

BBP exposure prevention: Based on your experiences

OSHA requires that a sharps injury log be kept of injuries from contaminated needles. The log must include information on the type and brand of device involved, the department where the incident occurred, and an explanation of how the injury occurred. Information from the log is just one source of information to help guide the sharps injury prevention program to determine where interventions are needed, that is, administrative, work practices, or engineering control (e.g., safety devices). This log will provide trends in injuries and may identify situations that need further investigation. For example, if there is an increase in needlestick injuries associated with disposal of devices in one location, it might indicate that the disposal units are not being replaced when they are filled or it might mean there is a defect in the box. Further investigation is needed to determine the potential cause and preventive action required. There might be a trend in the data indicating that there may be an increase in the needlestick injuries for a particular type of device in one group of workers. Further investigation may reveal that the workers in a particular department have had a shortage in staff and increase in patient load and admitted that they are not always activating the safety mechanism.

How useful are device-specific injury rates?

It is important to point out that rarely will there be enough data from a single facility to calculate rates of injury for specific devices that are statistically significant and can be used to determine the efficacy of one safety device over another. So, caution must be used in interpretation of rates. For example, in a Centers for Disease Control and Prevention (CDC) study of the efficacy of phlebotomy devices compared to conventional devices, the rate of injury for a conventional device was 3-4 injuries per 100,000 devices used. The rate of injury for the safety devices ranged between 0.9 and 3.1 per 100,000 devices. So, if you wanted to show a statistically significant reduction in the rate of injury when comparing a conventional phlebotomy device to a safety device, you would need between 500,000 and 1.6 million devices in each group to have statistically significant data and rule out the possibility that the difference occurred by chance alone (alpha 0.05 and statistical power of 90 using X2 Fishers exact test) If you wanted to compare the efficacy of one safety phlebotomy device over another the number of devices in your sample would need to be even larger. Further complicating the issue of using rates to compare devices is the inconsistency in reporting injuries, the profound degree of underreporting, and the variations in reporting, all of which impact the accuracy of the data collected. For example, the underreporting of needlestick injuries has been as high as 70% in some facilities. This makes the establishment of a non-judgmental, "no-fault" reporting system essential to encourage reporting. If employees are fearful of being criticized for being careless, they often will choose not to report injuries thus rendering the sharps injury data incomplete and less useful.

So, although the OSHA standard requires that the brand and type of device be included in the log, the data should be used to look for trends and not for calculation of injury rates by type or brand of device. So use all your injury and exposure data as only one piece of information to guide your sharps injury prevention program. Avoid calculation of rates to compare devices because unless you have huge numbers, they will rarely be able to provide an accurate picture of what is really happening. There is also no national consensus on the denominator to use to calculate rates for comparison purposes--some facilities have used the number of full time staff, number of occupied beds, or number of devices used.

Frontline worker input

Other sources of information to guide the identification, selection and evaluation of safety devices are interviews with frontline workers. There are many different performance criteria and preferences of individual workers. It will be important to get the workers' input and gain consensus on what they believe will protect them from injury. You may not have agreement by all the staff regarding the perceived safety of one particular device. The type of procedures being performed in a particular department or care setting will also guide the selection process. So you may need to provide more than one device in a particular category.

Selecting appropriate and effective devices

OSHA's revised standard calls for implementation of safer medical devices that are commercially available, appropriate, and effective. Each facility and worksite must determine what is an appropriate device based on the clinical environment, procedures being performed, the patient population, and the needs and preferences of the frontline workers.

The effectiveness of a device is a subjective view by the workers and not an evaluation to determine efficacy of one device compared to another. OSHA has stated that an effective safer medical device is "a device that, based on reasonable judgment, will make an exposure incident involving a contaminated sharp less likely to occur." This "reasonable judgment" is the judgment of the frontline workers that will be using the device. That is why the frontline worker input into the selection process is so important. Other considerations in determining the appropriateness and effectiveness of a safety device are summarized in Table 1.

Prevent infections with immunizations

Although the revised standard does not change the requirements for the administration of hepatitis B vaccinations, it still remains the primary means of preventing transmission of hepatitis B in the workplace. As such, a periodic review of new employee health records is a prudent way to assure that immunization is being offered and encouraged among employees at potential risk of exposure to blood.

Establish, monitor, continually improve PEP mechanisms

Equally important is the establishment of a comprehensive post-exposure management program. Healthcare workers must have immediate access to a practitioner who is capable of providing state-of-the-art, post-exposure prophylaxis (PEP) in addition to the emotional or psychological support required at a moment when the worker needs it most.

Development of an internal needlestick hotline or establishment of a system where a core group of individuals such as nursing supervisors are trained to provide PEP has been successfully instituted in many institutions across the country. PEP drug choices must be appropriate based on the risk assessment of the injury and source patient. Time is of the essence so it is critical that the established system allows for the worker, with a high-risk exposure, immediate access to the appropriate prophylaxis.

The exposure control plan should also include the most recent recommendations from the US Public Health Services/CDC; for example, the post-exposure follow-up and tests for HCV and post HBV vaccination testing of workers at ongoing risk of occupational bloodborne pathogen exposures.

Exposure control: Administrative, work practice, and engineering

Administrative exposure controls can take many forms. An important initial strategy is to educate senior management/administration about the program's overall effectiveness, financial impact, and barriers to success. Soliciting support for the program initiatives is critical, particularly because of the many innate challenges in today's healthcare system.

Education of staff is one of the most challenging and potentially frustrating components of the plan. We all recognize that the nationwide nursing shortage has impacted who and how we teach them. A nursing staff of mostly full-time nurses is a thing of the past in many parts of the US. Many facilities rely on part-timers, per diems, and travelers who work very infrequently or for short periods of time to provide adequate staffing. Effective education requires creativity and flexibility that may include the development of a train-the-trainer program (i.e., unit-based nurses that can provide just-in-time training to individuals that may have missed the opportunity to receive orientation prior to placement or assignment).

Optimal training on devices with engineered sharps injury protection requires actual handling of the product. Although viewing a video or observing a demonstration of a device may be somewhat useful, this approach has limited effectiveness as it does not afford the nurse the ability to actually experience the safety feature. Adequate skill development requires time and practice.

Work practice controls remain the cornerstone of a sharps injury prevention program, therefore it is critical to continuously evaluate your staff to assure safe practices are taking place. This can be accomplished formally during safety/infection control rounds where observations are recorded and reported back to the specific area's clinical and/or administrative manager. Specifically, workers should be observed to determine placement and utilization of sharps containers, utilization of safety devices as intended (e.g., activation of safety feature), evidence of two-handed recapping, and creation of a safe work environment. This important documentation will provide evidence that a surveillance system is in place to monitor compliance with recommended practices.

Product evaluation process

Several authors have described effective mechanisms for assuring sharps safety product availability. Key recommendations include:

  • Include frontline workers in all stages of identification, evaluation, and final selection of safety devices
  • Establish a product evaluation oversight committee
  • Determine essential product criteria to assure product acceptability
  • Coordinate product evaluations using objective process
  • Select products that meet end-user needs
  • Assess the appropriateness and effectiveness of the safety device

The product evaluation oversight committee

The market availability of sharps safety devices is rapidly expanding with major advances in technology design and for this reason, OSHA modified its definition of "engineering controls" to include as examples "safer medical devices such as sharps with engineered sharps injury protections and needleless systems."

This change clarified that safer medical devices are considered to be engineering controls under the standard. Sources of information on sharps safety devices on the market include:

Frontline worker input

The revised standard requires employers to solicit input from frontline (non-managerial) healthcare workers when identifying, evaluating, and selecting safety-engineered sharp devices. A product evaluation oversight committee can facilitate sharps injury reduction by identifying, evaluating, and expediting the implementation of clinically acceptable safety products. Staff with clinical, purchasing, materials management, safety, and education expertise are helpful to include on such a committee. As well, including administration stakeholders within the committee addresses any financial adjustments or budgetary considerations.

Table 1. Factors to Consider in the Selection of Safety Devices
  • Functional reliability of safety feature
  • Suitability--range of uses across patient populations and procedures
  • Intuitiveness/ease of use
  • Active versus passive
  • Single or two handed use
  • Hands remain behind sharp
  • Amount of change in technique required
  • Indication of activation
  • Undefeatable safety feature
  • Packaging
  • Sharp covered permanently
  • Interference with procedure
  • Right or left handed use
  • Size hands needed to manipulate device
  • Breadth of the product line

Although a formal committee may have oversight in the process, the actual input can be obtained from frontline workers in any manner that is appropriate to the circumstances of the workplace. This frontline worker input will be needed for identifying devices to consider, performing some type of assessment or evaluation of the devices, and then for the final selection of device for implementation. This input can be formal or informal and OSHA has explained it does not prescribe any specific procedures for obtaining worker input. Examples that OSHA has provided for soliciting frontline worker input are summarized in Table 2.

Regardless of the method used to solicit input from frontline workers, the method must be documented in the exposure control plan. This should include which employees were involved and the process used to solicit input. The evidence that frontline worker input was solicited could include, for example, meeting minutes, copies of documents used to request employee participation, records of responses from employees such as reports or evaluation forms, or even environmental rounds forms.

Assuring product availability

Now that there is a federal mandate requiring safety-engineered sharps devices, product availability problems may occur. If a safety device is not available, for example on extended backorder for purchase, there needs to be a potential "runner-up." You should not wait to replace a conventional device with a safety device until a specific product is available but rather implement a different safety device in the interim.

Creating the people connections

If effective people connections are not solidly in place, the best possible plan and the most effective sharps safety products will not achieve the desired outcome of injury reduction. Creating effective people connections requires consistency, collaboration, commitment, and intensive communication.

Table 2. Methods to Solicit Input from Frontline Workers for Evaluation and Selection of Safety Devices
  • Informal problem solving groups
  • Participation in safety audits
  • Worksite inspections
  • Exposure incident investigations
  • Analysis of exposure incident data or hazard analysis
  • Participation in evaluation of device through pilot testing
  • Involvement in safety and health committee


The most important component of creating effective "people connections" is establishing consistency in every part of the sharps safety program. Although it would seem to be obvious, consistency of purpose assures that competing interests are addressed effectively. Everyone involved in the sharps injury reduction program must stay focused on the same targeted outcome reducing risks of exposure to workers by implementing devices that they prefer and that they believe will protect them. There may be variety of ways to achieve this but the purpose remains the same.

Once the program purpose has been negotiated and can be consistently supported, consistent messages must be established so that everyone in the healthcare setting understands the goals of the program. Clarifying each person's role in achieving the program goals and assuring that everyone is informed as the program unfolds greatly facilitates program compliance and ultimately injury reduction. As with any marketing strategy, creating slogans or mottoes that capture the essence of the injury reduction effort help participants to remember the goal and actively engage in the effort to reduce injuries.

Report the outcomes and successes of the injury reduction program consistently to maintain enthusiasm and facilitate identification of potential barriers. Create user-friendly data displays or "storyboards" that include charts, graphs, and information on successful work practice interventions and/or administrative controls. These tools will be an effective way to demonstrate to JCAHO surveyors that your facility has taken a proactive approach to needlestick injury prevention.

As issues or questions about the program, products or procedures are identified it is essential that the designated sharps safety staff follow through on whatever the issues are, reporting back to the department or individuals that raised the concern initially. Staff tend to fill in the gaps if they can't count on a consistent response from the leadership of an important program like sharps safety.

The revised standard requires solicitation of input from frontline employees; evidence that employee input has been sought and obtained can include minutes from meetings, completed evaluation forms, or copies of documents (e.g., hospital newsletter) requesting employee participation.


Although collaboration is frequently touted as an important element of any successful program, it is easier to talk about than do. Some strategies that enhance collaboration include:

  • Maintain respect for everyone involved in the program
  • Identify common goals/interests to achieve success
  • Recognize every specialty has expertise to contribute
  • Assure input and participation from all frontline workers that are at risk for exposures
  • Spend time together as colleagues to gain comfort and build trust

Programs as comprehensive and complex as sharps injury reduction require input from a wide variety of disciplines and individuals who may have historically been excluded or even disenfranchised. A history of exclusion isn't easily overcome without establishing new patterns of interaction. Respect is essential to soliciting input and opinions from everyone involved.

Use interest-based negotiation strategies to assure that all stakeholders are adequately heard. Work to reach consensus, especially on areas of initial disagreement, by identifying common goals, shared responsibility, and ownership of the ultimate outcome(s). Although the same device may be the source of injuries in many different areas of clinical care, each setting has unique factors that contribute to such injuries e.g., patient acuity on an ICU, pace or activity in an ER, types of procedures in an OR, etc.

Provide a variety of mechanisms such as hotlines, suggestion boxes, newsletters, interactive open forums in department staff meetings to solicit suggestions, injury reduction strategies, and successes. New employee orientation may be an additional opportunity to emphasize the value of forwarding suggestions to individuals charged with the responsibility of initiating product trials. Each specialty has valuable information and expertise that should be incorporated into injury reduction strategies. Creatively capture all the ideas possible.

The process of sharps injury reduction can be long and frustrating and maintaining interest and commitment in the face of competing needs can be particularly challenging. By spending time together as colleagues, the staff involved in the injury reduction program can gain comfort and build trust with each other. Trusting relationships are essential when facing the challenges of injury reduction in the "real world."


There is no perfect product or "silver bullet" available to solve all the multifaceted challenges of reducing sharps injuries. Persistence and an unwavering commitment to resolving each and every problem as it is identified are critical. Problems with staff resistance to using safety products or changes in practice, product backorders, limitations in current technology, delays in product evaluations, and implementation all necessitate long-term commitment, and a willingness to persevere.

To assure ultimate success with injury reduction, thoughtful strategies for continuous improvement should be developed. Use objective measures built on reliable and readily available data. Verify the validity of all data sources to enhance stakeholder "buy-in."

Creative thinking or brainstorming potential solutions can often identify new strategies or approaches to problems that are particularly challenging. No ideas should be discarded until thoroughly explored and possibly piloted in limited locations.

Communicate with internal and external audiences

The slogan "location, location, location" conveys the primary message for anyone interested in selling a home or business property. In injury reduction programs the corresponding slogan is "communication, communication, communication."

Ultimately, the success of a sharps injury prevention program depends on the implementation of an effective communication plan. There are internal and external audiences that must be successfully addressed.

The internal audience includes: clinical staff and end users, administration stakeholders, purchasing, materials managers, safety and employee health experts. Each member of the internal audience should be fully informed regarding injury reduction strategies, available safety products, resource and technology gaps, and any current program challenges. Information should be conveyed in an understandable, focused way so that the "language" of each discipline is incorporated into key messages. Provide mechanisms for staff to have questions answered and problems reported.

External audiences are equally important and may include; regulatory agencies, state and/or county departments of health services, product suppliers and distributors, labor union representatives, and the media. Each external audience is apt to have a different area of concern. Identify appropriate spokespersons to address each audience and assure accuracy of all information being provided.


Although there are many priorities in reducing sharps injuries, there are three elements that, if effectively addressed, can greatly enhance the success of an injury reduction program. Think of them as the three "Ps," an effective Exposure Control Plan, assuring the availability and appropriate use of safer products and developing a team of people committed to working together to reduce sharps injuries. If any of these elements becomes the "weakest link" then the whole program is in jeopardy and rather than getting "voted off," that component should be strengthened to more fully contribute to everyone's success.

Gina Pugliese is the director of the Safety Institution, Premier Inc. based in Chicago, Ill. She holds faculty appointments at the University of Illinois School of Public Health and Rush University of Nursing. Barbara DeBaun is the director of infection control for California Pacific Medical Center in San Francisco. Enid. Eck is the senior consultant for HIV and infectious disease for Kaiser Permanente, California.

For a complete list of references, log onto www.infectioncontroltoday.com

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