Sharp safety in healthcare settings
Authors: Dr J. Ford (R&D Officer, SMTL) & Mr P. Phillips (Director, SMTL)
This paper is a general introduction to the issue of sharp safety in health care settings.
Occupational sharps injuries are a common occurrence and the emerging risk of blood borne viruses has increased awareness and concern in health care settings. This has led to the production of safety-engineered devices, designed to protect the user from injury after use. This paper summarises some of the issues surrounding sharps safety and is the first in a series of related articles to be published on the web site.
Health care workers (HCWs) have always been at risk from exposure to blood-borne pathogens, but in the 1980s, the emergence of AIDS made HCWs focus on their practices, and evaluate methods for reducing this risk.
In the UK, it is estimated that approximately 100,000 needlestick injuries occur per year (Unison 2000). Transmission most commonly occurs after percutaneous exposure to a patient's blood by a 'sharps' or 'needlestick' injury. The estimated risk of transmission following such an injury has been shown to be as follows (Brewer, 2001):
Estimated risk of transmission
Type of infection
1 in 3
Hepatitis B virus (HBV)
1 in 30
Hepatitis C virus (HCV)
1 in 300
Human Immunodeficiency virus (HIV)
From 1997 to 2007, the Health Protection Agency received reports of 5 HIV and 14 HCV seroconversions from health care centres throughout the UK (HPA 2008).
Prevalence of sharps injuries
Data collected from 6 Welsh NHS trusts (2003, unpublished) shows very similar trends to UK injury data collected via the EPINet system (Watterson, 2004). The main results are summarised as follows:
- Nurses appear to sustain the most sharps injuries in the workplace, with Doctors being the second largest group.
- The majority of injuries were sustained by the original user of the item.
- Needles with disposable syringes caused the most injuries
- In Wales, butterfly devices (steel needles with butterfly wings) caused the second largest number of injuries which does not correspond with their frequency of use.
- Most injuries occur when the device is being used to perform a procedure or immediately after use but incorrect disposal practices still account for a high proportion of injuries.
Desirable properties of safer devices
Safety engineered devices are designed to protect the user from sharps injuries following use. These include devices with shields or sheaths which are placed over the needle following use or retractable needle systems where the needle retracts into the body of the device. Devices are either 'active' (i.e. require user action to engage safety feature) or passive (i.e. require no additional action to make the device 'safe').
The FDA identified key factors in the design of sharps safety instruments, which are as follows:
- The user should be able to easily tell whether the sharps injury prevention feature is activated. (All safety devices)
- It should be possible to activate the feature with a single- handed technique, allowing the users hands to remain behind the exposed sharp.(Devices with 'active' safety mechanisms)
- The shield should completely enclose the needle and prevent finger access when activated (Devices with needle shields)
- The sharp should be fully retracted within the housing of the device. (Retractable sharps)
- The housing should extend beyond, (i.e., fully cover the sharp) and prevent finger access.(Fixed recessed sharps)
- The use of colour should achieve a specific purpose, (e.g., differentiate device models or sizes) and conform with user conventions, (e.g., orange hubs and needle covers for insulin syringes).(All devices)
(Taken from section 5, FDA 2005)
Factors to consider when using safety-engineered devices include the following:
- user safety
- patient experience
- ease of use
- compatibility with other devices
- compatibility with current procedures
- availability of training and support (Ford and Phillips 2008)
An EU directive (2010/32/EU) was passed in May 2010 aimed at preventing occupational sharps injuries. It includes measures that have to be taken in order to protect workers. These include 'on the basis of the results of the risk assessment, providing medical devices incorporating safety-engineered protection mechanisms' (Clause 6 of Directive). Healthcare organisations are to implement the requirements of the Directive by May 2013. At the date of writing (Aug 2012), the Health & Safety Executive (H&SE) are consulting on proposed UK regulations to implement the Council Directive. The consultation period ends on 8th Nov 2012.
Are safety devices always better?
There is evidence suggesting that sharps safety devices can lower rates of sharps injuries, and this is thought to be enhanced by sharp safety training and education (Health and Safety Executive, 2012). However, other evidence shows that safer devices do not always prevent sharps injuries, and there are reports that some 'safer' devices have actually caused needlestick injuries while in use (Letter from US General accounting office 2000, Paterson and Elder 2005).
In some cases, users may not realise that a device requires activation to be made safe, whilst others may not bother to carry out the additional 'activation' step. Other studies which inspected sharps disposal boxes during clinical evaluations revealed that high numbers of devices had not been activated - percentages of non-activated devices ranged from 2-44% (PHL 1997, Mendleson et al., 2003 and Mulherin et al., 1996 ). Only a few published studies have investigated user acceptability and this is thought to be an important aspect of introducing sharp safety devices (Health and Safety Executive, 2012).
Tackling sharp safety in the workplace requires a holistic approach. This should include raising awareness, providing training and carrying out risk assessments as well as evaluating 'safety-engineered' devices prior to possible introduction.
NOTE: Other sharps safety articles will be available on Medidex soon.
- Brewer S 2001. Needlestick awareness; working well campaign. Infection Control The Medical Book; 163-164
- EU directive (2010/32/EU) 'Implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU' Journal of the European Union, 1.6.2010
- FDA. 2005. Guidance for Industry and FDA Staff, Medical Devices with Sharps
- Injury Prevention Features (web site http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071755.pdf) (last accessed May 2012)
- Ford J and Phillips P 2008. How to evaluate safety-engineered devices. Nursing Times; 104 (36) :42-45
- Health and Safety executive 2012. An evaluation of the efficacy of sharp safety devices : systematic review. Web site http://www.hse.gov.uk/research/rrpdf/rr914.pdf
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- Unison 2000. The Union Campaign for an end to the deadly needlestick risk. Web site www.hazards.org/Hazards70needlesticks.pdf(last accessed June 2011)
- United States General Accounting Office. 2000. GA0-01-60R - Occupational safety: selected cost and benefit implications of needlestick prevention devices for hospitals. Letter dated 17/11/2000
- Watterson L (2004) Monitoring Sharps injuries: EPINet surveillance results. Nursing Standard; 19 (3) : 33-38