Needlestick injuries are one of the most frequent occupational hazards faced by nurses, phlebotomists, doctors and other healthcare workers, as well as those working in downstream functions such as cleaning and waste disposal. Over one million needlestick injuries are estimated to occur in the European Union (EU) each year.1 These injuries have been gaining increasing recognition due to their potentially devastating health consequences as they have the potential for transmitting more than 20 life-threatening blood-borne pathogens, including hepatitis B (HBV), hepatitis C (HCV) and HIV.2
In June 2010, a new EU Directive was published in the Official Journal of the EU,3 which must be integrated into national law in all EU member countries by May 2013. The purpose of the directive is “to achieve the safest possible working environment by preventing injuries to workers caused by all medical sharps (including needle-sticks)”. It specifically cites preventative measures to prevent injury and/or transmission of infection such as: “on the basis of the results of the risk assessment, providing medical devices incorporating safety-engineered protection mechanisms”.3
Interestingly, the legislation resulted from a co-ordinated and co-operative joint request from employer and employee organisations in the medical sector. The directive confirms employers have a responsibility to protect their employees from sharps injuries and that compliance will be mandatory.
A wide variety of studies demonstrate that the adoption of safety-engineered devices, such as catheters and syringes and blood collection devices, radically reduce injury rates.4 Despite pressure on health budgets across Europe, many healthcare organisations have already constructed a robust case for the use of safety-engineered devices, and have made the conversion.5 As well as being integral in efforts to provide a safer working environment for staff, adoption of safety-engineered medical devices helps to eliminate the potential cost of treatment and staff absence arising from accidental needlestick injuries, avoiding expensive and damaging legal action.
A number of discussions and studies have focused on the cost of needlestick injury over the past ten years. Most identify needlestick injury costs purely as the cost of treating the injured party. However, these academic papers specifically exclude factors such as: cost of paid leave for the injured party and substitute staff costs, the cost of resignations, wasted training investment when staff leave, or greater recruitment costs because of staff turnover. Even without calculating such “hidden” costs, these studies still see the conversion to safety devices as providing a viable return on investment.6-8 In the UK, the annual cost of dealing with needlestick injuries is estimated at £500,000 per NHS Trust,9 whereas the total cost of introducing safety-engineered devices to prevent needlestick injuries is estimated at £136,000 per NHS Trust per year – a little over a quarter of the cost of treating injuries.10
Now that the EU Directive is in progress, conversion to safety devices is becoming a more urgent consideration. This article reviews relevant reference points for the legal responsibilities and potential consequences of failure to comply in order to help practice managers address the business and legal case for conversion.
The EU Directive at a glance:
1. Risk assessment:
Include an exposure determination, which covers all situations where there is a potential for injury, or exposure to blood or other potentially infectious material.
Risk assessments shall take into account technology, organisation of work, working conditions, level of qualifications, work-related psycho-social factors and the influence of factors related to the working environment. This will:
- Identify how exposure could be eliminated.
- Consider possible alternative systems.
2. Elimination, prevention and protection:
Specifying and implementing safe procedures for using and disposing of sharp medical instruments and contaminated waste.
Eliminating the unnecessary use of sharps by implementing changes in practice and on the basis of the results of the risk assessment, providing medical devices incorporating safety-engineered protection mechanisms.
c. The practice of recapping shall be banned.
Effective disposal procedures and clearly marked and technically safe containers for disposable sharps.
Prevent the risk of infections by implementing safe systems of work, by:
Developing a coherent overall prevention policy, which covers technology, organisation of work, working conditions, work related psycho-social factors and the influence of factors related to the working environment.
- Conducting health surveillance procedures.
3. Information and awareness-raising:
a. To highlight the different risks.
b. To give guidance on existing legislation.
To promote good practices in relation to prevention and recording of incidents.
To raise awareness by developing activities and promotional materials in partnership with representative trade unions and/or workers’ representatives.
To provide information on support programmes available.
The correct use of medical devices incorporating sharps protection and mechanisms.
b. The risk associated with blood and body fluid exposures.
c. Induction for all new and temporary staff.
Preventive measures including standard precautions, safe systems of work, the correct use and disposal procedures, the importance of immunisation, according to the procedures at the workplace.
The reporting, response and monitoring procedures and their importance.
f. Measures to be taken in case of injuries.
This includes the revision of reporting procedures in place with health and safety representatives and/or appropriate employers/workers representatives. Reporting mechanisms should include local, national and European-wide systems.
Workers shall immediately report any incident involving sharps to the employers and/or the person in charge, and/or the person responsible for safety and health at work.
6. Response and follow up:
The employer takes the immediate steps for the care of the injured worker.
The employer investigates the causes and circumstances and records the accident/incident, taking — where appropriate — the necessary action.
The employer shall, in cases of injury, consider counselling of workers where appropriate and guaranteed medical treatment. Rehabilitation, continued employment and access to compensation shall be in accordance with national and/or sectoral agreements or legislation.
The European Biosafety Network has been established to eliminate sharps injuries throughout the EU. It has produced guidance for employers on how to implement the EU Directive which sets out practical steps and considerations.11
Changes to legislation
Many of the underlying principles of the EU Directive are already implied in current UK legislation and practice – but on a much more general level. For example, employers are already required to undertake risk assessments to assess the risks to the health and safety of their employees. However, the directive goes further and requires a risk assessment specifically for sharps injuries and requiring certain elements to be considered. The directive will have a similar impact in relation to safe practices, information sharing, training and reporting.
The starkest change in UK law will be the immediate banning of the practice of recapping or re-sheathing needles. While this is already considered poor practice in the healthcare sector, it is not yet specifically outlawed.
The directive will harmonise standards and requirements across the EU. It is anticipated that national guidance, including the NHS Handbook and Department of Health Guidance will be updated to reflect the more specific standards set out in the directive.
All healthcare providers should consider the policies they currently have in place in relation to risk assessment, safe procedures and training to ensure that they meet the standards required under the directive.
The directive requires national legislation to provide for “effective, proportionate and dissuasive penalties in the event of any breach of the obligations”.12 It is likely that the UK will transpose the directive by updating or adding to the existing health and safety legislation in force. That would mean that by failing to prevent needlestick injuries, employers could be found to be in breach of health and safety regulations.13
In the UK, there are publications of successful compensation claims, usually prosecuted by the relevant trade union. In 2010, in an important case, damages were awarded for a needlestick injury which took account of the emotional distress that resulted from it.14 In another case in 2008, the courts awarded £465,000 to a doctor who developed a needle phobia after a needlestick injury.15
Needlestick injuries can also be sustained by those who provide disposal and other downstream handling of sharps. In 2008, the main representative union commented, “At the start of our campaign, compensation for a ‘straightforward ‘downstream injury (no resulting infection) was around £1,000; it is now up to £3-5,000”.15 If a worker were to become infected with HIV or HCV as a result of a needlestick, the compensation could be dramatically higher.
The care quality commission (CQC) will have the remit to consider whether healthcare organisations are adhering to the new legislation, brought into force as a consequence of the directive. Failure to comply with such legislation may render an organisation subject to a wide range of enforcement powers. These powers range from fines, public warnings and compliance notices, to closures of services if standards are not met.
The health and safety executive (HSE) inspects NHS organisations to determine how they manage their employees’ risks of exposure to sharps injuries. In recognition of the importance of management and prevention of sharps injuries, the HSE has accelerated its programme of inspections for 2010-2011. No doubt, once the directive is implemented into UK law, the HSE will be holding organisations to these higher standards.
In addition to inspections, the HSE has the ability to prosecute organisations that do not comply with the requisite standards. As well as prosecution, the HSE wields a number of enforcement powers including the issuing of improvement notices, the withdrawal of approvals, revocation of licences or issuing cautions. All of these tools result in heightened scrutiny on the organisation and increase the administrative burdens for staff.
The new directive will serve to increase the obligations on healthcare organisations and the scrutiny that they are placed under. It is clear that the wording of the EU directive, and the implementation guidance provided by independent bodies, emphasise the importance of adopting effective safety measures, including safety-engineered medical devices, wherever the risk of injury occurs. These same bodies advise that planning for compliance with the EU directive is an urgent matter, not one to be left until 2013.
It is therefore important that healthcare organisations respond to the new standards imposed by the directives now in anticipation of the national legislation, so that they are ready when the new standards are enforced. An increasing number of healthcare organisations across Europe have decided to comply well before the legislative deadline, which avoids damaging legal action, costly compensation claims and adverse publicity, all of which divert attention from their core objectives of delivering high-quality healthcare. Leading healthcare organisations want to create an environment for staff and clinicians
that provides proper protection against injuries that are
at best, distressing, and at worst, can ruin careers and destroy lives.
Simon Lindsay is partner in the clinical risk team at Bevan Brittan public services law firm. He specialises in clinical negligence and general healthcare law, with a special interest in healthcare-associated infection.
1. EU Commission for Employment. Social Affairs and Inclusion. New legislation to reduce injuries for 3.5 million healthcare workers in Europe. 8th March 2010.
2. European Parliament. Preventing needle-stick injuries in the health sector. 11th February 2010. Available at: www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+IM-PRESS+20100210IPR68824+0+DOC+XML+V0//EN
3. Council of the European Union. Proposal for a Council Directive implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU. 24 February 2010.
4. International Council of Nurses. Nursing Matters Fact Sheet, ICN on selecting safer needle devices. 2009.
5. Examples include, Winchester and Eastleigh Healthcare NHS Trust, Harrogate and District NHS Foundation Trust, St Vincent’s University Hospital Dubin, The Galway Clinic, Blackrock Clinic Dublin,
6. Armadans Gil L, Fernandez Cano MI, Albero Andres I et al. Safety-engineered devices to prevent percutaneous injuries: cost-effectiveness analysis on prevention of high-risk exposure. Gac Sanit 2006;20(5):374-81.
7. Glenngard AL, Persson U. Costs associated with sharps injuries in the Swedish health care setting and potential cost savings from needle-stick prevention devices with needle and syringe. Scandinavian Journal of Infectious Diseases 2009;41(4):296–302.
8. El Consejo General de Enfermería de España y la Fundación Española de Riesgos Laborales Salud e Higiene. Estudio Epinetac 1996–2002.
9. Royal College of Nursing and Employment Research. Needlestick Injury in 2008. Results from a survey of RCN members. 2008.
10. Memorandum submitted by the Safer Needle Network to Select Committee on Public Accounts. 2nd May 2003.
11. European Biosafety Network. Implementation Guidance for the EU Framework Agreement, Council Directive and Associated National Legislation. Available at: www.europeanbiosafetynetwork.eu/EU%20Sharps%20Injuries%20Implementation%20Guidance.pdf
12. Recital 10, Council Directive 2010/32/EU.
13. Bevan Brittan, Are your sharps policies and procedures up to scratch? Available at: www.bevanbrittan.com/articles/Pages/Sharpspoliciesandprocedures.aspx
14. Fryers vs Royal Victoria Hospital. Thompsons Solicitors, Health & Safety News. Spring 2010.
15. Unison. Preventing Needlesticks with safer Needles. 2008.