The Network hosted the 1st European Biosafety Summit in Madrid between 1-2 June 2010 which coincided with the publication of the European Directive in the Official European Journal on 1 June.


EU Sharps Directive

The European Biosafety Summit was convened following the final adoption of the new European Directive on preventing sharps injuries, with a key commitment to improve the safety of patients and healthcare and non-healthcare workers who are at risk of injury from used needles and other medical sharps, which can lead to potentially fatal infections such as HIV and hepatitis B and C.

The European Biosafety Summit welcomed and celebrated the publication of the EU Sharps Directive in the Official Journal of the European Union on 1 June 2010. The Directive was drafted by the European Commission and adopted by the European Council of Ministers. It incorporates the EU Framework Agreement on sharps injuries, negotiated by the EU social partners EPSU and HOSPEEM, and also responds to a European Parliament report on needlestick injuries.

The Summit gave recognition to all those involved in this key achievement including; the important work carried out by the EU social partners, EPSU and HOSPEEM, in negotiating the EU Framework Agreement; the European Commission; European Council of Ministers; Members of the European Parliament; trade unions, associations, organisations, agencies and key academics on this issue. The Summit outlined its unreserved appreciation to all those involved for their years of tireless work and commitment to the prevention and elimination of sharps injuries.

The Summit recognised that the EU Sharps Directive was a key step forward in the prevention of sharps injuries, but also noted that the “real work” begins now, in the effective implementation and transposition of the Directive within the Member States.

Effective Implementation – An integrated approach

The Summit was addressed by leading academics and key stakeholder organisations who presented empirical data. It was clearly outlined that to achieve effective implementation of the Directive and its aims, an integrated approach is key:

Training and awareness

Issues discussed:

  • Importance of adopting relevant specific sharps injuries prevention training as a mandatory requirement within the healthcare sector.
  • Recognition of the importance of high quality training that is reaffirmed on a regular basis.
  • Acknowledgement that sufficient health and safety training, which includes the risks associated with sharps, needs to be provided for all staff at risk, including support staff, contract staff and temporary employees.

Safe working environment and procedures

Issues discussed:

  • The importance of the hierarchy of control.
  • The creation of a ‘no blame’ culture.
  • Implementation of thorough Risk Assessment procedures.
  • The importance of reviewing and engaging with frontline staff to improve reporting protocols, and levels of reporting.
  • The continued promotion and implementation of safe disposal practices.

Safer medical devices

  • The importance of banning the manual recapping of used needles.
  • Recognition that universal usage of safety-engineered medical devices, together with effective training and improved working procedures is necessary to prevent the majority of injuries.
  • The need to increase pressure and support for campaigns aiming to ban the use of conventional medical devices incorporating needles and sharps where safety-engineered alternatives exist.
  • Acknowledgement that not all medical devices sold as ‘safety-engineered’ include sufficiently effective safety features, and that to combat this a clear definition of the essential features of a safety-engineered medical device is required when selecting devices. A definition is outlined in the implementation guidance – published by the European Biosafety Network and distributed at the Summit.
  • The importance of assessing the suitability of safety-engineered devices for differing medical procedures to ensure that the best solution is found.
  • The importance of engagement between the medical technology manufacturing industry and key stakeholders to create the safest and most effective products which are affordable and offer value for money.

Broadening out implementation – protecting all vulnerable workers and patients

The Summit noted that solidarity for all vulnerable workers must be shown. It was discussed that at-risk occupational groups not included within the scope of the Directive must also be protected, along with workers and patients outside of the European Union.

Issues discussed:

  • The vital aim to protect other occupational groups, outside of the healthcare sector to protect all people at risk of sharps injuries.
  • The aim to further raise the profile of the risks associated with sharps injuries, through empirical research and analysis, but also by highlighting the traumatic real life experiences of victims and their families.
  • The importance of solidarity for all workers and patients not only within the member states of the European Union, but from the wider global community. It was noted that this must be considered particularly pertinent in areas where people face the highest risk, notably in developing countries.
  • The prevention of sharps injuries and the associated social and economic costs must be raised in profile. It was noted that within the current economic climate, it is of vital importance that this issue is not ignored, and that the significant long term social and economic gains of prevention are effectively communicated.

European Biosafety Summit – Outcomes and Next Steps

It was agreed that the second annual European Biosafety Summit will be held from 1 June 2011 in a European capital city to review progress on the implementation of the Directive across the European Union and the work of the European Biosafety Network in meeting its objectives. The Summit will also coincide with the first annual European Biosafety Day to be held on 1 June 2011 to raise awareness and celebrate the anniversary of the publication of the EU Sharps Directive.

The Summit in Madrid marked the creation of the European Biosafety Network, with the principal objectives of preventing and eliminating sharps injuries and early legislative implementation of the Directive. The Summit committed to:

  • The creation of the European Biosafety Network. The Network will be a virtual and inclusive network, with the role of sharing and disseminating information and best practice within European Member States and, where appropriate, beyond.
  • The Network including all those attending and invited to the Summit, and other organisations sharing its objectives.
  • Gain the commitment from all members of the Network to actively participate; to promote the aims and objectives of the network; and to work to engage and to expand the Network in association with its aims.
  • The promotion of the European Directive, and implementation guidance, to all workers and employers groups with an interest in eliminating sharps injuries throughout Europe in order to ensure rapid and comprehensive compliance in all Member States.
  • Identify and engage key partners and agencies in association with the aims of the Network.
  • Explore funding streams in association with the aims of the Network.
  • Further explore the creation of a European Biosafety Observatory, in association with existing arrangements and key partners in association with this activity.
  • Promote the highest possible standards in Health and Safety for all occupation groups throughout the world, with particular focus on areas of high risk, including developing countries.

European Biosafety Summit – Resources

The following documents were distributed at the Biosafety Summit, and are also available to download here.

  • Prevention of Sharps Injuries in the Hospital and Healthcare Sector: Implementation Guidance for the EU Framework Agreement, Council Directive and Associated National Legislation.
  • Draft Biosafety implementation guidebook.
  • Council Directive 2010/32/EU of 10 May 2010 implementing the Framework Agreement on prevention from sharps injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU – 1 June 2010.
  • A Call for Action document was published by the European Biosafety Network following the Summit, including input from all of the stakeholders involved, and is available here.