The UK is moving closer to a needlestick injury and infection law, in view of a proposed EU Directive. KENNETH STRAUSS provides an insight into the legislative framework and the case for implementing safety solutions ahead of a legal mandate.
Needlestick injury has been increasingly recognised as a major health and safety hazard for healthcare workers in the UK, and healthcare professionals have called for better protection for decades. For some time we have observed the positive effects of the US Needlestick Safety and Prevention Act of 2000,1 but only recently have the wheels of EU legislative activity begun to turn with real momentum. In June 2009, European social partners in the hospital and healthcare sector signed a Europe-wide framework agreement on the prevention of sharps injuries, which has been incorporated into a proposal for an EU Directive. Assuming this Directive is adopted, each member state will be required to bring into force legislation, or legally binding agreements, to ensure the safest possible working environment in the hospital and healthcare sector. However, full compliance for all healthcare employers is unlikely to be imposed until mid to late 2012. This article aims to explain more about the significance of needlestick injury, the proposed EU Directive and presents the case for an early adoption of a safety equipment policy.
Significance of needlestick
Sharps injuries are the most frequent occupational hazard faced by nurses, phlebotomists, doctors and other healthcare workers. Such injuries are particularly dangerous in view of their potential for transmitting life-threatening pathogens. Over 20 dangerous bloodborne pathogens can be transmitted by contaminated needles or other sharp objects, including hepatitis B (HBV), hepatitis C (HCV) and HIV. Most injuries are from hollow-bore needles used in injection syringes, blood-drawing devices and intravenous catheters – the everyday tools of the healthcare worker and the most deadly, as they contain residual blood. On suffering an injury from a contaminated needle, the risk of infection is one in three for hepatitis B, one in 30 for hepatitis C and one in 300 for HIV (see Fig. 1).2 However, the number of needlestick injuries reported may not accurately indicate the size of the problem.4,5 Between 60% and 80% of incidents go unreported.6 Figures from the public service trade union UNISON and the Royal College of Nursing (RCN) estimate that more than 100,000 needlestick injuries occur each year in the UK, and more than one million are estimated to occur in the European Union each year. Under-reporting may be due to several reasons: reporting is considered too time consuming, staff members are too busy, and there may be an underestimation of the risks associated with such an exposure.7 Nurses suffer the majority of such injuries, which occur when drawing blood, administering drugs or in the operating theatre, and account for nearly two out of three needlesticks. Doctors rank second to nurses in absolute numbers of needlesticks, but they rarely report injuries when they happen. Emergency crews, medical and ancillary staff, and paramedics are also at risk. A surprisingly large number of needle injuries occur to persons other than the user of the sharp. Downstream workers, such as housekeeping staff, are also frequently injured (see Fig. 2). An important study on needlestick injuries, published by the RCN in 2008,9 estimated the annual cost of dealing with needlestick injuries at £500,000 per National Health Service (NHS) Trust. The cost associated with each inoculation injury has been estimated to range between ?15,000 to ?1,000,000 for an injury resulting in transfer of a bloodborne virus.10
In the case of hepatitis B an effective protective vaccine is available, but no such protection is available for the other blood borne viruses. These other infections are difficult to treat. The prophylaxis/treatment is unpleasant and may cause significant side effects, nor is there a guarantee that treatment will be successful. Many nurses infected are young women, often in their prime reproductive years, and for them a needlestick can be utterly devastating. Demotivation and potential workforce turnover may also result, as 56% of the RCN 2008 survey’s respondents said they lived and worked in significant fear of needlestick injury and its consequences. Nearly one-half of the 4,700 respondents had been stuck by a needle or sharp at some point in their career and 10% had sustained an injury in the past year. However, 28% of nurses said they had never received advice from their employer about what to do after being injured and only 15% of respondents said they were offered prophylactic treatment after having been stuck or cut.11 The mental and emotional strain placed on healthcare workers when they suffer a needlestick injury is also enormously important, as many months can elapse before they know the health outcome of their injury. The RCN report also concluded that safety-engineered devices are an effective means of reducing needlestick injuries. Their use is also supported by the Health and Safety Executive (HSE).12 Evidence suggests that the majority of needlestick injuries can be prevented by the use of such devices and compliance with guidance.13 However, as the RCN survey showed, nurses’ access to safety-engineered devices is low – 47% have no access to them at all. A recent HSE report indicates that devices with safety mechanisms constitute only 5% of all instruments purchased by the NHS.14 Over a third of incidents occurring between 2000-2007 in the ward or in A&E (43% and 37% respectively), and around 20% in intensive care and in operating theatres (22% and 20% respectively) would have been preventable with proper adherence to universal precautions and safe disposal of clinical waste.15
The US Needle Stick Safety and Prevention Act (2000) requires the mandatory provision of needlestick safetyengineered devices in America’s healthcare institutions. Awareness of the health risks of accidental blood exposure is just as high in the UK and Europe as in the US, but the safety-engineered devices that have been in routine clinical use in the US for nearly a decade, have not been so widely adopted in Europe. At present two countries do have partial legislative coverage. In 2006, the Madrid autonomous region of Spain passed legislation similar to the US law16 and, since then, three more of the 17 Spanish autonomous regions have followed the Madrid example. Regulation has also recently been passed in Germany,17 but this is not enforceable by law. Any European healthcare facility that has adopted a safety equipment policy has done so autonomously. In the UK, the RCN and UNISON raised awareness of sharps injuries and occupational transmission of bloodborne pathogens in 2001.18 A “Safer Needles Network” was subsequently organised, made up of healthcare professionals with an interest in sharps awareness. Moreover, the UK Department of Health recommended a reduction in the use of sharp devices wherever possible and consideration of needle protective devices,19 but specific legislation was not introduced. However, there are now a wide variety of carefully designed safer sharps: spring-loaded retractable needles, guards that shield the dangerous tips, punctureresistant sharps containers, needle destructors, blunt sutures, and needle-free access valves for intravenous sets. Safetyengineered devices have been proven to reduce the rate of needlestick injuries in healthcare workers to nearly zero in some studies.20, 21 Recent focus on the issue by EU institutions has led to a binding agreement by the designated EU representatives of healthcare workers (European Public Service Union, ESPU) and healthcare employers (European Hospital and Healthcare Employers’ Association, HOSPEEM). The purpose of the agreement is “to prevent workers injuries with all medical sharps (including needlestick injuries)”. In October 2009, the European Commission completed a proposal for an EU Council Directive to give legal effect to the Framework Agreement. It will require EU member states to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within two years of adoption at the latest. The Agreement and the Directive will contribute to achieving the safest possible working environment in the UK hospital and healthcare sector. The proposed legislation will include consultation on the choice and use of safe equipment, to prevent needlestick injuries to staff. This agreement is likely to proceed into EU legislation and then, into national legislation over the next two to three years, and is a very welcome step.
Approval of the proposed Directive is by no means a foregone conclusion and transposition into national law is not likely to occur until summer 2012. However, the need for early adoption of safety equipment policies is still pressing. The financial costs of a needlestick injury are significant and there is the obvious risk of life-threatening infection. These injuries have an enormous psychological impact on injured healthcare workers, as they face many months of uncertainty, not knowing whether they will acquire a fatal infection. Healthcare workers deserve the protection currently afforded by the now readily available safety-engineered devices, which have proven to be cost effective. With a compulsory legal deadline moving ever closer, there is now no reason for healthcare workers to continue risking their lives and careers using unprotected devices. Some leading institutions have already recognised the compelling ethical, social and economic arguments put forward by various studies on the subject, and have chosen to implement safety products ahead of a legal mandate. Even if it is not possible to adopt a full safety policy at present, healthcare institutions can make safety-engineered devices more available for use, offer further support and advice for staff who are injured, and encourage better reporting of incidents. • Kenneth Strauss, MD, is the European medical director of BD.
1 Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens: needlesticks and other sharps injuries; final rule. Fed Regist. 2001;66;5317. 2 Eye of the Needle: UK surveillance of significant occupational exposures to bloodborne viruses in healthcare workers. Health Protection Agency, November 2008. 3 Eye of the Needle: UK surveillance of significant occupational exposures to bloodborne viruses in healthcare workers. Health Protection Agency, November 2008. 4 Burke S., Madan I. Contamination incidents among doctors and midwives: reasons for non-reporting and knowledge of risks. Occup Med. 1997:147(6):357-360. 5 Dobie D.K., Worthington T., Farouqui M. et al. Avoiding the point. Lancet. 2002;359:9313. 6 Benitez Rodriguez E., Ruiz Moruno A.J., Cordoba Dona J.A., Escolar Pujolar A., Lopez Fernandez F.J., Servicio de Medicina Pr. Underreporting of percutaneous exposure accidents in a teaching hospital in Spain. Clin Perform Qual Health Care 1999. Apr-Jun; 7(2): 88-91. 7 Adams D., Elliott T. Impact of safety needle devices on occupationally acquired needlestick injuries: a fouryear prospective study. J Hosp Infect. 2006;64:50-55. 8 Eye of the Needle: UK surveillance of significant occupational exposures to bloodborne viruses in healthcare workers. Health Protection Agency, November 2008. 9 Royal College of Nursing, Needlestick Injury in 2008. 10 National Health Service for Scotland (NHS Scotland). Needlestick Injuries: Sharpen Your Awareness. Report of the Short Life Working Group on Needlestick Injuries in the NHS Scotland. Edinburgh: National Health Services for Scotland: 2001. 11 Nursing Times, EU legislation will mean safer needles, June 2009. www.nursingtimes.net/ whats-new-in-nursing/acute-care/ eu-legislation-will-mean-safer-needles/ 5002435.article 12 Health and Safety Executive Board Paper HSE/08/60 “European Commission measures for protecting healthcare workers from infections due to needlestick injuries.” 13 Cullen B.L., Genasi F., Symington I., Bagg J., McCreaddie M., Taylor A. (2006) “Potential for reported Needlestick injury prevention among healthcare workers in NHS Scotland through safety device usage and improvement of guideline adherence: an expert panel assessment” J Hosp Infection 2006, 63:445-451. 14 Memorandum submitted by the Safer Needle Network to Select Committee on Public Accounts 2nd May 2003 15 Eye of the Needle: UK surveillance of significant occupational exposures to bloodborne viruses in healthcare workers. Health Protection Agency, November 2008. 16 Boletín Oficial de la Conunidad de Madrid. Orden 714/2006. Madrid, Spain: Comunidad de Madrid; Jueves, 26 de Febrero del 2006:13-14. 17 German Technical Rules for Biologic Devices (BGR/TRBA 250, Biologische Arbeitsstoffe im Gesundheitswesen und der Wohlfahrtspflege). 2005. www.baua.de 18 Royal College of Nursing. Be sharp, be safe: avoiding the risks of sharps injury. In: Working Well Initiative. www.rcn.org.uk/developments/ publications, London: Royal College of Nursing Publications: 2001. 19 Department of Health. Guidance for Clinical Health Care Workers: Protection Against Infection With Blood-borne Viruses. Recommendations for the Expert Advisory Group on AIDS and the Advisory Group on Hepatitis. London: Department of Health; 1998. 20 Mendelson M.H., Short L.J., Schechter C.B. et al. Study of a needleless intermittent intravenousaccess system for peripheral infusions: analysis of staff, patient, and institutional outcomes. Infect Control Hosp Epidemiol. 1998;19(6):401-406. 21Younger B., Hunt E., Robinson C. et al. Impact of a shielded safety syringe on needlestick injuries among healthcare workers. Infect Control Hosp Epidemiol. 1992;13:349-353.
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