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An excerpt from Council Directive 2010/32/EU


All hospitals have policies for avoiding, managing and reporting needlestick injuries but audits repeatedly show that there is under-reporting. Such injuries continue to occur both to front-line healthcare workers and to others, including hospital porters and cleaning staff. The major concern here is the risk of blood-borne infection and the possible far-reaching consequences, but minor injuries should not be overlooked.
EC Directive 2010/32 is focused on eliminating, as far as possible, the risk of injury or infection to healthcare workers from medical sharps. It is scheduled for implementation by 11 May 2013, and as it is a Directive, it has to be incorporated in local law. It specifies the minimum requirements that Member States need to implement to protect workers.
This Directive provides for “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”. It also expressly prohibits the recapping of needles and it emphasises the importance of regular, comprehensive and ongoing training for staff in the correct use of protective devices and safe systems of working. An excerpt from the Directive is given here.
Christine Clark PhD FRPharmS FCPP(Hon) – Editor HPE
Clause 1: Purpose
The purpose of this framework agreement is:
  • to achieve the safest possible working environment,
  • to prevent workers’ injuries caused by all medical sharps (including needle-sticks),
  • to protect workers at risk,
  • to set up an integrated approach establishing policies in risk assessment, risk prevention, training, information, awareness raising and monitoring,
  • to put in place response and follow-up procedures.
Clause 2: Scope
This agreement applies to all workers in the hospital and healthcare sector, and all who are under the managerial authority and supervision of the employers. Employers should deploy efforts to ensure that subcontractors follow the provisions laid down in this agreement.
Clause 3: Definitions
Within the meaning of this agreement:
  1. Workers: any persons employed by an employer including trainees and apprentices in the hospital and healthcare sector-directly related services and activities. Workers who are employed by temporary employment business within the meaning of Council Directive 91/383/EEC supplementing the measures to encourage improvements in the safety and health at work of workers with fixed-duration employment relationship or a temporary employment relationship1 fall within the scope of the agreement;
  2. Workplaces covered: healthcare organisations/services in public and private sectors, and every other place where health services/activities are undertaken and delivered, under the managerial authority and supervision of the employer
  3. Employers: natural/legal persons/organisations having an employment relationship with workers.They are responsible for managing, organising and providing healthcare and directly related services/activities delivered by workers;
  4. Sharps: objects or instruments necessary for the exercise of specific healthcare activities, which are able to cut, prick, cause injury and/or infection. Sharps are considered as work equipment within the meaning of Directive 89/655/EEC on work equipment;
  5. Hierarchy of measures: is defined in order of effectiveness to avoid, eliminate and reduce risks as defined in Article 6 of Directive 89/391/EEC and Articles 3, 5 and 6 of Directive 2000/54/EC;
  6. Specific preventative measures: measures taken to prevent injury and/or transmission of infection in the provision of hospital and healthcare directly related services and activities, including the use of the safest equipment needed, based on the risk assessment and safe methods of handling the disposal of medical sharps;
  7. Workers’ representatives: any person elected, chosen or designated in accordance with national law and/or practice to represent workers;
  8. Worker’s health and safety representatives are defined in accordance with Article 3(c) of Directive 89/391/EEC as any person elected, chosen or designated in accordance with national law and/or practices to represent workers where problems arise relating to the safety and health protection of workers at work;
  9. Subcontractor: any person who takes action in hospital and healthcare directly related services and activities within the framework of working contractual relations established with the employer.
Clause 4: Principles
  1. A well trained, adequately resourced and secure health service workforce is essential to prevent the risk of injuries and infections from medical sharps. Exposure prevention is the key strategy for eliminating and minimising the risk of occupationally acquired injuries or infections;
  2. The role of health and safety representatives is key in risk prevention and protection;
  3. The employer has a duty to ensure the safety and health of workers in every aspect related to the work, including psycho-social factors and work organisation;
  4. It shall be the responsibility of each worker to take care — as far as possible — of their own safety and health and that of other persons affected by their actions at work, in accordance with their training and the instructions given by their employer;
  5. The employer shall develop an environment where workers and their representatives are participating in the devel­opment of health and safety policies and practices;
  6. The principle of the following specific preventative measures indicated in clauses 5 to 10 of the present agreement means never assuming that there is no risk. The hierarchy of general principles of prevention according to Article 6 of Directive 89/391/EEC and Articles 3, 5 and 6 of Directive 2000/54/EC is applicable;
  7. Employers and workers’ representatives shall work together at the appropriate level to eliminate and prevent risks, protect workers’ health and safety, and create a safe working environment, including consultation on the choice and use of safe equipment, identifying how best to carry out training, information and awareness-raising processes;
  8. Action needs to be taken through a process of information and consultation, in accordance with national laws and/or collective agreements;
  9. The effectiveness of awareness-raising measures entails shared obligations of the employers, the workers and their representatives;
  10. In achieving the safest possible workplace a combination of planning, awareness-raising, information, training, prevention and monitoring measures is essential;
  11. Promote a ‘no blame’ culture. Incident reporting procedure should focus on systemic factors rather than individual mistakes. Systematic reporting must be considered as accepted procedure.
Clause 5: Risk assessment
  1. Risk-assessment procedures shall be conducted in compliance with Articles 3 and 6 of Directive 2000/54/EC, and Articles 6 and 9 of Directive 89/391/EEC;
  2. Risk assessment shall include an exposure determination, understanding the importance of a well resourced and organised working environment and shall cover all situations where there is injury, blood or other potentially infectious material;
  3. 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.
Clause 6: Elimination, prevention and protection
1. Where the results of the risk assessment reveal a risk of injuries with a sharp and/or infection, workers’ exposure must be eliminated by taking the following measures, without prejudice to their order:
  • specifying and implementing safe procedures for using and disposing of sharp medical instruments and contaminated waste. These procedures shall be regularly reassessed and shall form an integral part of the measures for the information and training of workers referred in clause 8,
  • 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,
  • the practice of recapping shall be banned with immediate effect;
2. Having regard to the activity and the risk assessment, the risk of exposure must be reduced to as low a level as necessary in order to protect adequately the safety and health of the workers concerned. The following measures are to be applied in the light of the results of the risk assessment:
  • place effective disposal procedures and clearly marked and technically safe containers for the handling of disposable sharps and injection equipment as close as possible to the assessed areas where sharps are being used or to be found,
  • prevent the risk of infections by implementing safe systems of work, by:
(a) 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;
(b) training;
(c) conducting health surveillance procedures, in compliance with Article 14 of Directive 2000/54/EC; — use of personal protective equipment;
3. If the assessment referred to in clause 5 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 shall be offered vaccination;
4. Vaccination and, if necessary, revaccination shall be carried out in accordance with national law and/or practice, including the determination of the type of vaccines:
  • workers shall be informed of the benefits and drawbacks of both vaccination and non-vaccination,
  • vaccination must be offered free of charge to all workers and students delivering healthcare and related activities at the workplace.
Clause 7: Information and awareness-raising
As sharps are considered as work equipment within the meaning of Directive 89/655/EEC2 , in addition to information and written instructions to be provided to workers specified in Article 6 of Directive 89/655/EEC, the employer shall take the following appropriate measures:
  • to highlight the different risks,
  • 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,
  • to provide information on support programmes available.
Clause 8: Training
In addition to measures established by Article 9 of Directive 2000/54/EC, appropriate training shall be made available on policies and procedures associated with sharps injuries, including:
  • 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,
  • 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,
  • measures to be taken in case of injuries.
Employers must organise and provide training which is mandatory for workers. Employers must release workers who are required to attend training. This training shall be made available on a regular basis taking into account results of monitoring, modernisation and improvements.
Clause 9: Reporting


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