Background to EU Directive

Health and Safety (Sharps Instruments in Healthcare) Regulations 2013

These Regulations implement the EU Council Directive 2010/32/EU on the prevention of sharps injuries in the hospital and healthcare sector. Many of the requirements contained in the Directive already formed part of health and safety law in Great Britain. The new regulations only contain those requirements that are not specifically addressed in existing legislation.

HSE has produced a Health Services Information sheet Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 to assist employers and employees to understand their legal obligations under the Regulations.

The Directive

The Directive is published in the Official Journal of the European Union . Member states, including the UK, have until 11th May 2013 to ensure that the provisions of the Directive have been implemented into national legislation.

The Directive legislates a framework agreement on the prevention of sharps injuries in hospitals and the healthcare sector (signed in July 2009) by the Social Partners – the European Hospital and Healthcare Employers' Association (HOSPEEM) and the European Federation of Public Service Unions (EPSU). These two bodies were recognised as European Social Partners by the European Commission in 2006.

Background to the Directive

In February 2005, the European Parliament adopted a resolution on promoting health and safety in the workplace. This included a call on the European Commission to ensure Member States implemented specific preventative measures necessary to protect healthcare workers from injuries caused by needlesticks in view of the risk of infection from serious blood-borne infections, such as Hepatitis B and C and HIV.

In July 2006, the European Parliament adopted a resolution requesting that the Commission submit a legislative proposal on protecting healthcare workers from blood-borne infections due to needle stick injuries.

The European Commission sought the opinion of the EU Social Partners on whether there should be legislation to strengthen the protection of healthcare workers from blood-borne infections due to needlesticks and whether a joint initiative by the Social Partners would be appropriate.

Following this, the Social Partners were invited to work together to agree a framework to prevent needlestick injuries in the healthcare sector. After consultation and a technical seminar on the issue, the Social Partners informed the Commission of their intention to negotiate on a wider basis covering all types of sharp injuries and not just needlesticks.

Negotiations started in January 2009 and by 2 June 2009 an agreement had been reached. On 17 July 2009, after approval from the European Commission, the framework agreement was signed by the Social Partners.

As a result, on 26 October the Commission published a proposal for a Directive to implement the framework agreement.

On 11 February 2010, the EU Parliament's Employment and Social Affairs Committee adopted a Motion supporting the adoption by the Council of the proposal Directive.

On 10 May 2010, a Directive was introduced to prevent injuries and blood-borne infections to hospital and healthcare workers from sharp instruments such as needles.

Other information on the Directive

  • The Safer Needles Network and the Health, Safety and Wellbeing Partnership Group (HSWPG) - formerly POSHH, have agreed advice for the NHS on preparing for implementation of the sharps Directive. The advice is intended to help employers in ensuring that they are ready and compliant once UK legislation is passed. It provides guidance on the practical implementation of the Directive and should be read in conjunction with relevant national legislation and guidance.
  • The European Biosafety Network  was established following the adoption of the new European Directive on Sharps Injuries to improve the safety of patients and healthcare and non-healthcare workers. The Network has published guidance  that provides a practical toolkit to aid in the implementation of the Directive on the prevention of sharps injuries in the hospital and healthcare sector.

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Updated 2021-09-14