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Literature review of Safety-Engineered Devices on the Incidence of ...

Executive Summary

Objective and main findings

Objective: to review the literature from 2005 to 2010.

What is the incidence of sharp object injuries among health care workers? What are recognized risk factors for the occurrence of sharp object injury among health care workers.

Is there evidence that safety-engineered devices are effective in reducing the incidence of sharp object injury among health care workers? If so, in what settings?


Definition-what is a sharp object injury

The risk of health care workers sustaining harm form sharp object injuries was first described in 1981 by McCormick and Maki. [1] A sharp object injury is a percutaneous piecing wound typically caused by a hollow-borne needle or sharp instrument, including, but not limited to, needles, lancets, scalpels, and contaminated broken glass. This type of injury can occur at the time people use, disassemble, or dispose of needles or sharp instruments. In the healthcare work place, sharp object injuries pose a recognized occupational hazard to health care workers in recent decades. Nowadays, it is estimated that approximately 600,000 to one million needlstick injuries occur annually in the United States (CDC). World Health Organization (WHO) estimates suggest that 1 in 10 health care workers worldwide sustain a sharp object injury.[2] However, the actual number of sharp object injuries remains unknown due under-reporting. CDC estimated that about half of the sharp object injuries go unreported.

Add something about burden of injury/disease in Canada/rest of the world-confirm it is an important issue

There are more than 20 species of bloodborne pathogens including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) related to sharp object injury. Such injuries also cause considerable anxiety and distress for affected individuals.

Frequency and Description of Sharp Object Injuries

Job, Age, Location, Reasons, Devices, PEP, Vaccination, Under-report, Working hours, Others

Epidemiology of Percutaneous Exposures

The International Care Worker Safety Centre at the University of Virginia estimated an annual incidence of 295,082 percutaneous injuries in hospital-based health care workers, using 1996 Exposure Prevention Information Network (EPINet) data and a 39% under-reporting rate. [3]

Risk factors-usually divided

Donor-high viral load, drug addict, etc


Syringes are normally reported as the device responsible for the greatest number of injuries but when the rate is calculated per device usage analysis of injury rates reveals that syringes account for the lowest rate of sharp object injuries and IV catheter stylets accounted for the highest rate.[4-6]


Up to fifth of all healthcare associated sharp injuries occur in the operation theatre. [7] Orthopaedic surgeons may be more prone to sharp object injury due to the prevalence of bone spikes in the operative field and the use of sharp orthopaedic instruments such as drills, saws and wires, according to Pa McCann’s study. [8]

Personal affected-comorbidity, training, job type, work area , vaccination, PEP etc

It is usually been found that residents, medical and dental students, and nursing staff were among the highest risk groups for sustaining a sharp object injury.[9]

The groups of healthcare workers to whom needlestick injuries most commonly occur may vary by location or department within a hospital.

Workload pressures and time constraints are likely to cause both sharp object injuries and under-reporting.[10-12]


The non-reporting of sharp object injuries was first identified by Hamory (1983) who commented that as many as 40% were not reported. [1983 Hamory, under-reporting]

Alvarado-Ramy et al. found that 46% of sharp object injuries were not reported by health care workers.[13] Under-reporting rates were highest for residents (69%), medical students (65%), nurses (32%), and phlebotomists (9%).[13] In a study by Patterson et al., 41% of sharp object injuries were not reported by third- and fourth-year medical students.[14]


Non-compliance with sharp object injury protocols is commonest among senior surgical staff. [2010 Adams] A revision of the protocol to reduce the time it takes to complete it may improve compliance.

Impact of Sharps Object injuries on Health Care Workers


The pathogens most commonly transmitted by sharp object to health-care workers in hospitals are HBV, HCV and HIV.[15] The risk of transmission of hepatitis C (3%), hepatitis B (30%), and HIV (0.3%) from the patient to the health care worker depends on viral load of the patient and the amount of blood that passes from one to the other.[16-18] Pa McCann found in a survey among surgeons that the estimated transmission rate for HIV, hepatitis B and hepatitis C were inaccurately perceived to be 40%, 16% and 24%. [8] A survey of patients admitted to a German University Hospital estimated that the HBV, HCV and HIV prevalence among patients were 5.3%, 5.8% and 4.1%. [19] Since the blood-borne viral diseases are becoming increasingly prevalent, health care workers should regard all patients as high-risk, regardless of known viral status. [8]

Sharp injuries are a major source of HCV infection among health care workers, accounting for almost 40% of HCV infections.[2] Sharps object injuries are a major source of HCV infection among health care workers, causing approximately 39% of the HCV infections globally every year.[20]

Global incidence of HBV infection is higher than that of HCV.[2] Health care workers infected with HBV through occupational exposures during adulthood may have a more favorable prognosis than those infected with HCV, however, unlike HCV, HBV can be efficiently prevented and at low cost thought immunization.


Tremendous efforts are made to prevent sharp object injuries, but the psychological aspects of these injuries have received little attention.[21] Sohn et al. used the Beck Depression Inventory, Hamilton Anxiety Scale and Perceived Stress Scale to measure the stress and mental health among health care workers with or without experiencing sharp object injury and they found out that health care workers with experiences of sharps injury exhibited significantly higher levels of anxiety and depression than those without such experiences, and they reported that their stress and depression levels were significantly elevated after being injured.[21] Also, health care workers who had not been vaccinated against HBV exhibited significantly higher levels of anxiety.[21] Fisman et al. reported that distraction, anger and rushing were associated with highest risk of sharp object injuries.[22]

Interventions to Decrease incidence of Sharp Object Injuries

Safety-engineered devices are medical sharps that have been designed to include safety features or mechanisms, including design features to eliminate or minimize the risk of injury to the user or others.[23]

Strategies are available to prevent infections due to sharp object injuries including education of health care workers on the risks and precautions, reduction of invasive procedures, use of safer devices, and procedures and management of exposures.[2]

Active safety feature-requires a voluntary action by the user to engage the safety device.

Passive safety feature-safety feature is automatic, or requires no additional action on the part of the user.[23]

Why current situation unsatisfactory

Sharp Products and Sharp Objective Injuries

Throughout the 1990s, devices with sharps injury protection were gradually and voluntarily adopted in US hospitals, until the Needlestick Safety and Prevention Act of 2000 was passed.[24] Safety sharps and needle-free technology is available to prevent sharps-related injury and can include:[25]

1) Hollow-bore needles with integral sharps protection, which are available to replace traditional hollow-bore needles used for a range of procedures including intramuscular and subcutaneous injections and venesection. These devices can be activated automatically or manually by the user, thereby ensuring the needle is rendered blunt at the earliest opportunity and consequently minimising the potential for a needlestick or

sharps-related injury.

2) Cannulae are also available from a range of manufacturers with integral sharps protection, which again can be manually or automatically activated to render the introduction stylet blunt at the earliest opportunity.

3) Self-adhesive anchoring devices can be used as an alternative to suturing both midline and central venous access devices. They can also be used on peripheral IV devices and to secure wound drains and urinary catheters. These self-adhesive devices dispense with the need for suturing and therefore are associated with a lower risk of infection (RCN 2005).

4) Needle-free IV systems can be achieved by connecting a specific needle-free connector to the hub of a cannulae or catheter. Infusions or injections are then administered by connecting the blunt syringe or IV administration set to the needle-free connector. Such devices are available from a range of manufacturers.

5) Scalpel with retractable blade and safety sheath.

A reduction in injury rate of ~50–60% might be possible with phlebotomy devices and safety butterflies[13, 26, 27] and~80% for cannulae [28]. Cannulation devices, especially those with passive safety controls, have good evidence of injury reduction.[4] One study of a shielded safety syringe suggested an 86% reduction in injuries[29], while another controlled study found a 50–61% reduction, but with similar findings in areas which did not use safety devices.[30] A study of safety syringes in a dental setting reportedly reduced the injury rate to zero.[31] An extrapolation from the similar shielding technologies used for phlebotomy devices would suggest up to 50% of injuries associated with intramuscular injections drawn up with needle-and-syringe might be preventable.[4]

Safety-engineered Devices and Compliance Issues

non-compliance report and compliance report

Regulatory and Legal Issues

The World, USA

Canada (Federal, Province), Alberta


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