Over 1 million needlestick injuries are estimated to occur in the EU each year. These injuries are gaining increasing recognition as a major hazard on the health and safety horizon. They are the most frequent occupational hazard for nurses, doctors and other healthcare workers (1),  and have the potential to have devastating consequences. In addition, needlestick injuries are estimated to cost each NHS Trust around £500,000 per year (2).

In May 2010 the EU Council adopted a new European Directive on sharps injuries (“sharps”) (3),  which implements a Framework Agreement developed by EU social partners in healthcare (4).  The Framework Agreement was devised following a period of consultation launched as part of the continued EU agenda on health and safety at work and patient safety.

The objective of the Framework Agreement is to protect workers in the healthcare sector and patients at risk of injury from sharps. The ultimate goal is to eliminate the risk of sharp injuries. Where this is not possible, the aim is to reduce risk to the minimal level achievable.

By 11 May 2013 the UK must have in place national legislation to implement the Directive. This means that all employers in the healthcare sector, both public and private alike, will be forced to put the provisions of the Framework Agreement into practice at this time. However, the Framework Agreement was designed to provide a structure for organisations to take practical and effective steps to reduce these serious occupational hazards before the national legislation is published.

The Key Provisions of the Framework Agreement at a Glance

1. Risk Assessment:

a. For every activity/situation where there is a potential for injury/exposure to potentially infectious material

b. To take into account technology, organisation of work, level of qualifications, working conditions, how well resourced and organised the workplace is

c. To identify how exposure could be eliminated

d. To consider possible alternative systems.

2. Safe Procedures:

a. Specify and implement safe procedures for using and disposing of sharp implements and waste

b. To eliminate unnecessary use of sharp implements – in the alternative to limit exposure to as low a level as possible (least number of workers exposed and least release of biological agents into the workplace)

c. Provide safer needle devices where the results of a risk assessment indicate a need

d. Practice of recapping to be banned

e. Use of personal protective equipment

f. Regular review and revision.

3. Training and Information Raising:

a. To highlight the different risks

b. To give guidance on existing legislation

c. To promote good practices in relation to prevention and recording of incidents

d. To inform of the measures to be taken if an injury is sustained.

4. Reporting

a. All workers to immediately report any incident involving sharps to employer/person responsible for health and safety at work.

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 Framework Agreement which sets out practical steps and considerations (5).

A comparison to other countries

Since the adoption of the Needle Stick Safety and Prevention Act 2000, the use of safety engineered devices is mandatory in the United States. In Europe, Spain and Germany are leading the way with regulation in this field, although prior to the Directive any European country that has adopted such policy has done so voluntarily. In 2003 a Needle Stick Injury Bill was put to the House of Commons but never proceeded any further due to time pressures on the legislative calendar.

Current legislation – What will be different?

Many of the underlying principles of the Framework Agreement 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 in that risk assessment. 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. Whilst this is a practice that is frowned upon 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 that 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.

Consequences of Failure to Comply

The Directive requires national legislation to provide for “effective, proportionate and dissuasive penalties in the event of any breach of the obligations (6).”  It is likely that the UK will update or add to the existing health and safety legislation in force. This means that by failing to prevent needlestick injuries employers can be found to be in breach of health and safety regulations. Rather than risk prosecution, many organisations settle such cases resulting in substantial legal expenses and compensation payments.

The Care Quality Commission has the remit to consider any legislation that is brought into force as a consequence of the Directive in determining whether the organisation is adhering to CQC's new regulations. It is well within CQC's remit to investigate whether the organisation is complying with its obligations under any legislation that is brought into force. Failure to comply with any relevant legislation may render the organisation subject to the wide range of enforcement powers wielded by CQC. These powers range from fines, public warnings and compliance notices to closure of services if standards are not met.

The Health and Safety Executive inspects NHS organisations to determine how they manage the risks of exposure to employees from sharps injuries. In recognition of the importance of management and prevention of sharps injuries, the HSE has pushed a programme of inspection on this basis to the forefront 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 an ability to prosecute organisations that do not comply with the requisite standards. This is not a toothless organisation, and it has shown in the past a willingness to prosecute. In addition to 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 serve to heighten scrutiny on the organisation and increase the administrative burdens faced by staff.

Finally, the impact of the negative press that is attracted following a needlestick injury should not be underestimated. The press coverage at the end of 2010 of Worcestershire Acute Hospitals NHS Trust is a case in point. The Trust was fined £12,500 for failure to carry out suitable risk assessments where there was a risk of exposure to blood borne viruses, failure to implement adequate controls and training around them.

The dawn of the new Directive will only serve to increase the obligations on healthcare organisations and the scrutiny that they are placed under. It is important that healthcare organisations respond to the new standards imposed by the Directives now in anticipation of national legislation, so that they are ready when the new standards are enforceable against them.

(1) Move Towards Law on Needlestick Injury, The Clinical Services Journal, May 2010.
(2) Needlestick Injury in 2008, Results from a survey of RCN members, Royal College of Nursing and Employment Research, 2008.
(3) Council Directive 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU.
(4) European Hospital and Healthcare Employers’ Association and European Federation of Public Services Unions, Framework Agreement on Prevention from Sharp Injuries in the Hospital and Healthcare Sector, signed on 17 July 2009.
(5)   European Biosafety Network, “Prevention of Sharps Injuries in the Hospital and Healthcare Sector – Implementation Guidance for the EU Framework Agreement, Council Directive and Associated National Legislation.”
(6) Clause 10, Council Directive 2010/32/EU.


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