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Sharps injury prevention

 

Premier’s commitment

Premier has a longstanding commitment to worker safety, including prevention of occupational needlestick injuries. This Web site assembles a wide array of resources to assist healthcare organizations eliminate sharps-related injuries. Many of these resources were developed by the Safety Institute and include:

The summary that follows provides an overview of the issue, as well as links to Safety Institute's resources and many more.

 

Introduction to sharps injuries

Exposure to blood and body fluids of patients infected with bloodborne pathogens, like HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV), poses a risk of occupationally-acquired infection. The greatest risk is posed by percutaneous injuries (e.g., needlesticks and injuries from other sharp devices).

The new federal and state laws and recent OSHA mandates have moved needlestick prevention to the top of the safety agenda. Selecting, evaluating, and adopting safety devices requires collaboration among many individuals in the healthcare setting. To ensure a successful program, each healthcare facility and setting will need to tailor its approach to the specific risks and characteristics of the clinical environment and the needs and preferences of the workers.

Summary of regulatory and legislative requirements

November 2000 - Federal needlestick safety and prevention act

On November 6, 2000 President Clinton signed into law the Needlestick Safety and Prevention Act. This law authorized OSHA to revise the 1991 Bloodborne Pathogen Standard to require the use of devices with engineered sharps injury protection and a log with details of sharps-related injuries. Among the revisions, the Act specified that the definition of engineering control be expanded to include safety devices and that safety device use be mandated. 

January 2001- OSHA: revised bloodborne pathogen standard

On January 18, 2001, OSHA published its revision to the bloodborne pathogen standard in the Federal Register, with an effective date of April 18, 2001. The 23 states with state-level OSHA plans had an additional six months to implement a similar standard. The new requirements include:

  1. An expanded definition of engineering control to include devices with engineered sharps injury protection and needleless systems;
  2. Exposure control plans that reflect changes in technology which reduce exposure to bloodborne pathogens and document the consideration, at least annually, of devices to minimize occupational exposure;
  3. Input solicited from non-managerial (i.e. frontline) workers for identification, evaluation, and selection of devices and other controls. This process must be documented in the exposure control plan; and
  4. A sharps injury log of percutaneous injuries with information on the type and brand of device involved, the department where the incident occurred, and an explanation of how the injury occurred.

OSHA has explained that the 2001 revision of the bloodborne pathogen standard does not change anything related to the mandate and enforcement of the use of devices with engineering sharps injury protection, which has been enforced since the compliance directive was issued in November 1999. It does, however, expand requirements related to the use of front-line workers in the selection and evaluation of these devices and maintenance of the sharps injury log.

State-level OSHA plans and federal legislation.

State-level OSHA plans must incorporate regulations that are "at least as effective" (that is, at least as strict) as those set forth by OSHA at the federal level. As with all revisions in federal OSHA standards, the 23 states with state-approved OSHA plans were permitted an additional six months from the federal implementation date (April 18, 2001) to review/revise their state OSHA regulations to include, at a minimum, the new federal OSHA requirements, but they may adopt stricter requirements. In the interim period, state plans follow their current requirements. States with state-approved OSHA plans include: AK, AZ, CA,CT, HI, IA, IN, KY, MD, MI, MN, NV, NC, NM, NY, OR, SC, TN, UT, VA, VT, WA, and WY.

State laws

California’s groundbreaking law, enacted in September 1998, mandated that the state OSHA program revise its bloodborne pathogen standard to require employers to implement sharps injury prevention technology, including needleless systems when applicable, for IV access and needles with engineered sharps injury protection. The law also requires employers to record all exposure incidents, including the type and brand of the device involved in the injury, and to maintain a sharps injury log.

By December 2001, a total of 21 states had passed needle safety legislation; the bulk of the bills are patterned after California’s. Many of these state laws have requirements similar to those in the revised OSHA standard as mandated by the new Federal Needlestick Safety and Prevention Act. If a state needle safety law has requirements above and beyond what the federal law requires, then the additional state requirements must be followed. For instance, some states require healthcare facilities to report needlestick injury data to a state agency. If a state needle safety law is less stringent than the federal law, the federal law’s requirements must be followed. States with state laws include: AR, AL, CA, CT, GA, IA, ME, MD, MA, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN TX, WV. See the State Legislative Grid for a status summary of current state activity.

November 2001: On November 27, 2001, OSHA revised its Enforcement Procedures for Occupational Exposure to Bloodborne Pathogens (CPL 2-2 69) and incorporated the new sharps injury prevention requirements. This provides uniform procedures for enforcement of the standard. See Key Documents or download full text here.

Summary

All employers are required to provide sharps injury prevention devices now, and OSHA has enforced this since November 1999. Some states may have stricter requirements set forth in state law; in that case, the stricter requirements apply. If applicable, consult your individual state laws and state OSHA Bloodborne Pathogen Requirements. An abbreviated summary of compliance dates may be downloaded.

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OSHA Implementation strategies

OSHA's position is that the revised OSHA standard does not change anything regarding the use of safety devices, and that hospitals already should be using sharps safety devices. Hospitals are currently being cited for lack of safety devices. What is new is that frontline workers need to be involved in the evaluation and selection process, and a detailed sharps injury log must be maintained. Regarding the use of safety devices, OSHA may be flexible in issuing citations if there is evidence of safety devices already being used in some clinical applications, and a written plan with a realistic timeline that outlines the process for completion of the selection, evaluation and adoption of safety devices in all areas where sharps are used. The bloodborne exposure control plan should be revised to reflect the process that will be used to accomplish this.

Involvement of frontline workers

OSHA wants to ensure that management does not select devices without input from non-managerial workers -- those responsible for direct patient care or potentially exposed to injuries from contaminated sharps. Input may be obtained from these frontline workers in any manner appropriate to the circumstances of the workplace. This input will be needed for identifying devices to consider, performing some type of assessment or evaluation of the devices, and selecting devices for implementation. Such input may be formal or informal; OSHA has explained that it does not prescribe any specific procedures for obtaining worker input. Frontline worker involvement in the evaluation and selection of safety devices can help promote acceptance of these devices when they are implemented. Although it may not be feasible to involve every worker who will use a device in the selection and evaluation of every device, a representative sample of workers should always be included.

Device evaluation

The evaluation process can be formal or informal. A formal evaluation might include a pilot study on a particular unit, with written evaluation forms completed by each worker. An informal evaluation might include bringing sample devices to the department or setting for a representative sample of frontline workers to evaluate them and provide informal feedback.

Nor are there exact formulas for the number of workers needed to evaluate a device, the number of devices to be evaluated, or the length of time an evaluation should be conducted. What is important: having a mechanism in place to solicit input from workers on an ongoing basis regarding their needs and preferences for safety devices. This input will be combined with data from exposure incidents and the sharps injury log and employee feedback, and will guide future decisions on selection and implementation of safety devices. In some cases, it may be necessary to replace the device that was originally selected with a more suitable device. This determination can only be made by the individual facility or work site based on its own data and experiences.

The final selection will be based on the preferences of the workers as they perform their duties and procedures using the safety devices. Preferences may vary for a single device, depending on the department and workers evaluating the device. The preferences are influenced by a number of factors -- for example, prior experience with safety devices, type of clinical procedures being performed, noise or lighting in the clinical setting, or even the size of the workers' hands.

Other factors that might be considered in the final selection include:

Sharps injury log

OSHA intends the sharps injury log to be used as a tool for identifying high-risk areas and providing information that may be helpful in evaluating devices. The confidential sharps injury log must include, at a minimum, the following information:

OSHA explains that the sharps injury log may be kept in any format, such as electronic or paper. Employers may also use existing mechanisms for data collection, such as incident reports, provided that the necessary data is collected. OSHA permits use of the 300 Log to meet the requirements of the sharps injury log provided the type and brand of the device causing the sharps injury is entered on the Log, and records are maintained in a way that segregates sharps injuries from other types of work-related injuries and illnesses, or allows sharps injuries to be easily separated. (Key document OSHA Recording Criteria for Needlestick and Sharps Injuries Section 1904.8 CPL2-0.131.) The information from this sharps injury log can be used to guide the selection and evaluation of safety devices. The data from the sharps log is only one source of information for assessing the effectiveness of engineering controls. Employee interviews and informal feedback are other examples of input that should be considered. Trends in the data may be helpful in making a general assessment of the effectiveness of the sharps injury prevention program; however, calculation of rates of injury by device or brand is often inaccurate and misleading for a number of reasons: (1) Injuries are significantly underreported (up to 70 percent in some studies), which can influence the rates; and (2) individual facilities usually do not have enough data to calculate rates that are statistically significant and could not have occurred by chance, so in many cases it is impossible to compare the relative ability of devices to reduce needlestick injuries.

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OSHA Implementation tools


Sharp safety tool kit – OSHA Bloodborne pathogen program

A series of forms and tools is provided to assist in assessing current bloodborne pathogen programs, selecting and/or evaluating safer sharps devices and evaluate safe work practices.

Additional device evaluation tools can be downloaded from the Training for Development of Innovative Control Technology (TDICT) Project at http://www.tdict.org.

Sharps injury data collection tools

Two exposure/injury data collection forms that capture the information OSHA requires in the sharps injury prevention log:

This information is also described under Resources; see Surveillance software and data collection tools.

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Safety devices from Premier

Many safety devices designed to prevent sharps injuries -- including syringes, phlebotomy devices, lancets, vascular access devices, suture needles, and sharps disposal containers -- are available through Premier's contracts with more than 24 suppliers. Additional information is provided in Premier’s electronic catalog.

A list of Premier sharps injury prevention devices under contract is also available.

These contracts offer a cost-effective selection of devices for evaluation. Please note, however, that all safety devices the organization's staff considers appropriate should be evaluated, whether or not they are covered by a group contract.

    Related Premier press releases on sharps safety devices(Microsoft Word files)

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Risks of occupational bloodborne infection

Following a needlestick or other percutaneous injury from a sharp object (e.g., lancet, scalpel, broken glass), the risk of developing an infection will depend on the infectious status of the patient, the immune status of the worker, the severity of the needlestick injury, and the availability and use of appropriate post-exposure prophylaxis.

HIV: Sharps injuries expose workers not only to HIV and hepatitis B but also to hepatitis C, against which there is no vaccine and limited treatment. The CDC reports that as of December 2001, there were 57 documented and as many as 138 possible cases of occupational HIV transmission to healthcare workers. Most involved nurses and laboratory technicians. Percutaneous injury (e.g., needlestick) was associated with 48 (84 percent) of total documented transmissions. Of these, 44 involved devices considered to be at a high risk for transmission of a bloodborne pathogen -- that is, hollow-bore needles, most of which were used for blood collection or insertion of an IV catheter.

The CDC has reported that the average risk of HIV infection transmission from percutaneous (e.g., needlestick) exposures to HIV-infected blood is 0.3 percent. However, we know that individual exposures vary in their probability of transmission of HIV; for some exposures, that risk may exceed 0.3 percent. Data from a retrospective case-control study showed that the risk of HIV transmission was increased when the worker was exposed to a larger quantity of blood from a patient as indicated by a visibly bloody device, a procedure that involved a needle used in an artery or vein, or a deep injury. Combined data from a number of studies indicate that post-exposure prophylaxis with antiretroviral agents may reduce the risk of HIV transmission and is recommended for occupational exposures under certain circumstances. Currently there is no vaccine to prevent HIV infection and no treatment exists to cure it.

HBV: The number of occupationally acquired hepatitis B cases has declined dramatically over the past 10 years, with the use of hepatitis B vaccination mandated by OSHA’s bloodborne pathogen standard. However, the CDC estimates that each year, several hundred healthcare workers are still infected with HBV, and many of these will die from their infection.

The risk of HBV transmission from a needlestick exposure to an HBV-infected patient ranges from 6 percent to 30 percent for workers who are not immune and thus susceptible to HBV infection. Workers who have antibodies to HBV are immune and not at risk. If a susceptible worker is exposed to HBV, post-exposure prophylaxis with hepatitis B immune globulin and initiation of hepatitis B vaccine is more than 90 percent effective in preventing HBV infection.

HCV: The greatest threat to healthcare workers may well be from hepatitis C virus infection, the most common bloodborne infection in the United States, affecting approximately 4 million people. Healthcare workers clearly have an increased occupational risk for HCV infection. Chronic infection develops in up to 85 percent of patients, of whom 70 percent develop active liver disease that often leads to cirrhosis, one of the most common reasons for a liver transplant.

The average risk of HCV transmission following needlestick exposure to an HCV infected patient is 1.8 percent. Currently no vaccine exists to prevent HCV infection, and neither immunoglobulin nor antiviral therapy is recommended as post-exposure prophylaxis. Healthcare workers with known exposure should be monitored for seroconversion and referred for medical follow-up if seroconversion occurs.

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Nature of sharps injuries

All healthcare workers handling "sharps" are at risk for injury and subsequent exposure to and infection with a bloodborne pathogen (in most cases HIV, HCV, or HBV). As recently as March 2000 it was estimated that more than 385,000 percutaneous injuries occur among healthcare workers from needles and other sharps used in the healthcare setting. [The CDC's estimate was derived from combined databases from the CDC National Surveillance System for Hospital Healthcare Workers (NaSH) and the EPINet database at University of Virginia’s International Healthcare Worker Safety Center (EPINet), and adjusted for underreporting.] Published studies have noted that up to 70 percent of such injuries are never reported. Data collected by hospitals that participate in EPINet indicate that in the average hospital, approximately 30 needlestick and sharp-object injuries per 100 beds occur each year.

timing of needlestick injuriesInformation on the type of devices that cause percutaneous injuries in the U.S. is available from data from hospitals that participate in NaSH and from hospitals included in the EPINet database. These data show that disposable syringes are the most common device causing injury, followed by suture needles and devices used to access veins, including winged-steel needles, phlebotomy needles, and IV catheter insertion devices. Approximately 40 percent of percutaneous injuries occur during use, another 40 percent occur after use and before disposal, and approximately 10 to 15 percent are disposal-related.

The circumstances leading to a needlestick injury depend partly on the type of the device and how it is used. For example, devices that must be disassembled after use (e.g., prefilled cartridge syringes) pose a risk during this manipulation. Recapping of needles by hand poses a known risk of needlestick injury, yet five percent of needlesticks are reported to be related to recapping. Injuries also occur during disposal from improper disposal or use of overfilled sharps disposal containers.

Data show that certain devices pose an increased risk of transmission of a bloodborne infection. For example, although syringes cause the greatest number of sharps injuries, only a fraction are in the high risk category of injuries (caused by hollow, blood-filled needles) because they are used for injections rather than access into a vein or artery. In contrast, a disproportionately high number of injuries from IV catheter stylets and phlebotomy needles are high risk and can result in transmission of a bloodborne infection because most of these devices are hollow and blood-filled.

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Overview of current technology

More than 1,000 U.S. patents have been issued since 1984 for needles and other medical devices that incorporate injury prevention features. All major medical device companies in the United States have marketed devices with safety features as alternatives to conventional devices. It is estimated that 85 percent of injuries are preventable with currently available technology.

Safety devices shown to decrease risk: Devices with safety features have been shown in numerous studies to reduce the frequency of needlestick injuries, but for many reasons they do not completely eliminate it. In some cases, the safety feature cannot be activated until the needle is removed from the patient. Some healthcare workers may fail to activate the safety feature; users can bypass the safety feature; or the safety feature may fail. It is important to understand the factors that influence the safety of a device in order to plan effective needlestick prevention programs. Devices with safety features can reduce needlestick injuries when used in combination with a comprehensive prevention program.

Improvements in technology: Technology continues to emerge, and many of the sharps injury prevention devices have moved into second- or third-generation technology with continuous improvements in design and performance.

Safety device conversion - progress report: The Needlestick Safety and Prevention Act of 2000 and subsequent revisions in OSHA's enforcement procedures have led to a dramatic increase in the use of safety peripheral IV catheters (95 percent) and blood collection devices (83 percent) in acute care settings from 2000 to 2005. Some gaps still remain in the use of scalpels and blades in acute care and in all devices used in non-acute settings. More details on safety conversion (.doc) (30 KB) are available, from the December 2005 issue of Safety Share.

Time investment for product evaluation: Proper evaluation of these sharps injury prevention devices is an important part of the process. Numerous tools are available for conducting evaluations, educating staff on proper use, collecting and analyzing data on effectiveness, and implementing a device facility-wide in all applicable care delivery sites. Front-line workers need to be included in the identification, evaluation and selection of the safety devices. There is no formula for how many devices need to be evaluated or for what length of time. Each facility must determine this based on its own needs and the preferences of the workers.

Conventional needles may still be needed: Safety needles may not be needed for all applications. It is estimated that only 30 percent 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 pharmacy. It will be important to document those situations where conventional needles and devices may still be appropriate.

Cost effectiveness of safety devices: The precise cost of needlestick injuries cannot be quantified in terms of dollars but represent pain and suffering for the worker and the potential for significant losses for an institution. The emotional trauma for the worker, family and friends following a needlestick injury can be devastating. Direct and indirect costs for the facility include post-exposure medical follow-up, lost worker time or replacement costs, disability, and OSHA citations and fines. The organization must also consider the negative impact the event can have on the morale of the workers.

The goal of implementing safety devices is to protect workers from exposure to bloodborne pathogens. It has been suggested that the cost of safety devices may be offset by a reduction in the direct costs associated with post-exposure medical follow-up and treatment of needlestick injuries. However, it is important to note that it is extremely difficult to show direct cost savings. Cost-effectiveness of safety devices was recently addressed in a GAO Report to Congress. (Adobe Acrobat file).

In this GAO report the incremental cost of implementing safety devices was not offset by the direct costs associated with avoiding treatment for needlesticks. The exception to this was for moderate- to high-risk exposure follow-up costs (>$1500), when the incremental cost of the safety device was no greater than two times the cost of a conventional device. See summary table below:

Follow-up being offset by incremental cost for safety devices
Cost of safety device compared to conventional Low-Risk Exposure ($500 ) Medium-Risk Exposure ($1,500) High-Risk Exposure ($2,500)
1.5 times more costly No YES YES
2.0 times more costly No No YES
3.5 times more costly No No No

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