Law & Regulation

A European Parliament report in 2010 described needlestick injuries as:

" ... one of the most serious health and safety threats in European workplaces... "

Needlestick injuries are a common occupational hazard for healthcare workers:

  • Nurses are most at risk from needlestick injuries
  • Needlestick injuries occur during a wide range of procedures:
    • From venepuncture, injection administration and aspiration ..
    • .. to injection administration and handling clinical waste

EU Directive on Prevention of Sharps Injuries in the Hospital
and Healthcare Sector

What does the EU directive achieve?

To achieve the safest working environment

Independent studies have shown that training, safer working practices and the use of safety-engineered medical devices can prevent more than 80% of needlestick injuries.1

The EU adopted a new Directive in 2010, designed to achieve the safest possible working environment by preventing injuries to workers caused by all medical sharps.

Healthcare organisations should protect workers

The Directive becomes legally binding on 11 May 2013 and obliges healthcare organisations to adopt safety measures that protect healthcare workers from needlestick injuries.

Delaying implementation of safety measures means healthcare workers remain at risk.

The Directive applies to all hospital and healthcare workers, whether they are full-time staff, part-time staff or subcontractors.

What does the EU Directive provide?

The Directive provides

  • Clear guidance on risk assessment
  • Prevention and protection
  • Information and awareness
  • Training
  • Reporting
  • Response
  • Follow-up
Improved safety measures already in practice

Having recognised the ethical and economic reasons for improving healthcare worker safety, many healthcare organisations across Europe have put into practice improved safety measures in advance of the impending legislation.

Who wrote the new directive?

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 European Federation of Public Services Union (EPSU) and the European Hospital and Healthcare Employers’ Association (HOSPEEM).

No other company is better placed to help you prepare for the EU Directive. Find out why.

What are the EU Directive Key Points?

“In achieving the safest possible workplace, a combination of planning, awareness-raising, information, training, prevention and monitoring is essential.”

If there is a danger of infection, assess for risks

In all situations where there is a danger of infection, assessments should be conducted. Any risk assessment must take into account the organisation of the workplace and its resources.

In a hospital environment it is not possible to segregate patients based on risk, as many will be treated before it is known they are carrying serious blood-borne pathogens. Therefore, universal sharps injury prevention measures are appropriate.

For risk elimination, prevention and protection

  • Eliminate unnecessary use of sharps
  • Train and adopt safer working practices and safer sharps disposal
  • Ban re-capping of needles, with immediate effect
  • Use safety-engineered devices
  • Use protective equipment, for example gloves
  • Risk assessments should be conducted in compliance with articles 3 and 6 of Directive 2000/54/EC and Articles 6 and 9 of Directive 89/391/EEC.

    Minimise risk where prevention or elimination is not possible

    Directive 2000/54/EC asserts that where prevention of exposure is not possible, the risk must be minimised through:

    • Keeping the number of workers likely to be exposed as low as possible
    • The design of work processes and engineering control measures - to avoid or minimise the release of biological agents into the workplace

    Where it cannot be eliminated risk should be minimised. Studies have shown that healthcare worker risk can be significantly reduced through the combination of:

    • Training
    • Safer working practices
    • The use of safety-engineered medical devices

    Summary of the new Directive

    The Directive requires that:

    • Employers and workers’ representatives work together to identify and reduce risks.
    • A formal risk assessment is conducted for exposure determination. Where a risk of injury or infection is found, it must be eliminated by:
      • Specifying safety procedures for using and disposing of medical sharps
      • Providing medical devices which incorporate safety-engineered protection mechanisms
      • Banning the recapping of needles
    • Employers provide workers with information on the different risks, existing legislation, good practice in preventing/recording incidents and support programmes
    • Workers receive training in policies and procedures to reduce their risk, including the correct use of medical devices incorporating sharps protection mechanisms
    • Workers report all incidents involving sharps
    • Policies and procedures are in place when a sharps injury occurs, in accordance with national/regional legislation
    • Employers care for injured workers by providing:
      • Necessary medical tests
      • Post-exposure prophylaxis
      • Counselling
      • Rehabilitation
      • Continuing employment
      • Compensation
      • Confidentiality

    If you would like to receive further information or request help, guidance or advice on how to introduce safety-engineered devices in your facility, please contact us via the Contact page of the website.

    Highlights from the TRBA 250 Results

    In Germany, the use of safety-engineered sharps is mandated by the Technical Rule 250 ITRBA 250) except in cases where it can be guaranteed that the patient being treated does not carry a blood-borne pathogen.

    Spain provides its own picture of safety device regulation and adoption. Legislative and regulatory powers reside in each of the individual autonomous regions of Spain, and legislation mandating the use of safety devices now exists in five of the autonomous regions (Baleares, Madrid, Castilla la Mancha, Galicia, Navarra).

    1Sharps Injuries – Stepping Up to the Challenge in Europe. Available at: (accessed September 2011).