Sharp Objects in Health Care 

The European Commission has adopted a proposal aimed at protecting hospital and healthcare workers from injuries caused by sharp objects. This proposal for a Council Directive would achieve this by giving legal effect to the Framework Agreement signed on 17 July 2009 by HOSPEEM (European Hospital and Healthcare Employers’ Association) and EPSU (European Federation of Public Services Unions). These two bodies were recognised as European social partners in the hospital and healthcare sector by the Commission in 2006.


Injuries caused by needles and other sharp instruments, sometimes called sharp or needle-stick injuries, present a common and serious risk to healthcare workers in Europe. The Commission, in its proposal, cites studies that estimate the number of needle-stick injuries in Europe to be approximately 1,200,000 a year.

On 6 July 2006 the European Parliament adopted a resolution on protecting European healthcare workers from blood-borne infections caused by such injuries. The resolution called on the Commission to submit a legislative proposal to this effect. In reaction to this, the Commission launched a consultation with the social partners, who in turn informed the Commission of their intention to negotiate a Framework Agreement on the prevention from sharp injuries in the hospital and healthcare sector. On 17 July 2009, EPSU and HOSPEEM signed the Agreement and informed the Commission of their request to submit the Agreement to the Council for a Council Directive. 

Aim of the Proposal 

The aim of this proposed Council Directive is to implement the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector signed by the European social partners HOSPEEM and EPSU on 17 July 2009. The proposed Council Directive would make the Agreement between the social partners legally binding across the EU. The Agreement, which aims to achieve the safest possible working environment and better protect workers at risk, is set out in the Annex to the proposal.

Risk Assessment 

The Agreement, which applies to all workers in the hospital and healthcare sector, states that a full risk assessment is required before appropriate action to prevent injuries and infections can be carried out. The risk assessment, which is contained in Clause 5 of the agreement, would be conducted by employers, with the findings presented to competent national authorities. Risk assessments would include an exposure determination, an understanding of the importance of a well resourced working environment and would cover all situations where there is injury, blood or other potentially infectious material. Risk assessments must also take into account technology, working conditions, level of qualifications and work related psycho-social factors. 

Preventative Measures

The following measures will be taken on the basis of the risk assessment results:

• Specifying and implementing safe procedures for using and disposing of sharp medical instruments and contaminated waste. These procedures shall be regularly reassessed
• Eliminating the unnecessary use of sharps by implementing changes in practice
• Providing medical devices that incorporate safety engineered protection mechanisms
• Placing effective disposal procedures and clearly marked containers for the handling of disposable sharps and injection equipment as close as possible to the areas where sharps are being used or to be found
• Preventing the risk of infections by implementing safe systems of work
• Using of personal protective equipment
• If the risk assessment reveals that there is a risk to the safety and health of workers due to their exposure to biological agents for which effective vaccines exist, workers must be offered vaccination

Information and Awareness-Raising

The Agreement also calls for employers to take appropriate measures:

• To highlight the different risks connected with sharp implements 

• To give guidance on existing legislation
• To promote good practices regarding the prevention and recording of incidents/accidents
• To raise awareness by developing activities and promotional materials in partnership with representative trade unions and/or workers’ representatives


The Agreement also stipulates that employers must organise and provide mandatory training. This should cover: 

• The correct use of medical devices incorporating sharps protection mechanisms
• Induction for all new and temporary staff
• The risk associated with blood and body fluid exposures

Member States

Member States would be obliged to comply with this Directive two years after its adoption. They would also be obliged to inform the Commission of the legal measures taken to implement the provisions of the Directive. Member States would also have to lay down rules on penalties applicable to infringements of national laws adopted to carry out the provisions of the Directive. In exceptional circumstances the proposed Directive also gives Member States the possibility of an additional year in which to comply.


The Commission states in its proposal that it has scrutinised all the clauses in the Agreement, and that none contravene EU law. The Commission therefore considers that the Agreement meets the condition of legality. The Council may decide to adopt this proposal by qualified majority. Although Article 139(2) of the EC Treaty does not provide for Parliament’s involvement in the legislative procedure, the Commission states that it will inform Parliament of its proposal so that it can, if it so desires, send an opinion to the Commission and the Council. This Directive shall enter into force on the twentieth day following that of its publication in the EU’s Official Journal.