Safety On Point - Safety Legislation

Among clinicians, healthcare workers and staff, accidents involving "medical sharps" occur frequently, at an estimated rate of 3.5 million incidents per year worldwide. Many of these cases can be attributed to mishaps wih IV catheters, hypodermic needles, blood collection devices and vascular access needles.

A needlestick injury or case of blood exposure can devastate the healthcare institution, the practice and the victim, who needs to be tested for possible transmission of blood-borne infection. For a victim who contracts an infection or a disease, there is medical care and even the prospect of long-term health consequences.

Taking measures to avoid needlestick and blood exposure is the best defense, and it makes good sense.

Safety On Point

EU Directive 2010/32/EU Legislation Overview

The EU Directive 2010/32/EU is implementing a Framework Agreement on the prevention from sharp injuries in the hospital and healthcare sector.

The scope of the Directive applies to all workers in the hospital and healthcare sector who are exposed to a risk of injury from medical sharps while at work on the healthcare premises. Employers and employees have a responsibility to ensure safe working practices which includes following guidelines and directives set out by the EU.

The purpose of the Directive is to achieve the best possible working practices by the introduction of safer sharps systems as well as dedicated reporting procedures and staff training.

The Directive requirements build on existing requirements such as the Health and Safety at Work Act 1974 and the Provision and Use of Work Equipment Regulations 1998.

The deadline for member states of the European Union to implement appropriate changes in needlestick and medical sharp protection was May 11th 2013. Now this has passed and the UK, along with other EU states, has had to ensure its policy comes in line with the EU Directive 2010/32/EU in order to comply and reap the benefits for its healthcare workers.

Helpful Links/Guidance:

href="">Official Journal of the European Union L/134/66 (2010) Council Directive 2010/32/EU

Health & Safety Website

Health & Safety Information Sheet

Health & Safety at Work Act 1974

Safer Needles Network

Royal College of Nursing guidance

European Biosafety Network




United Kingdom, Germany, France, Spain, Belgium, Portugal, Australia, Austria, Italy


Before the EU Directive 2010/32/EU came into effect, France had some needlestick legislation under the Decree No. 2001-1016 of 5 November 2001, which concerns the creation of a risk assessment document on the evaluation of hazards for the safety and health of workers. The legislation mandated that this log be updated at least once a year, as well as whenever there were significant changes in the workplace affecting workers' health and safety conditions.

Code du travail; Decree 2001-1016 had three requirements for risk prevention:

  1. General safety requirement for the employer>: The employer must transcribe into a single document the results of the risk assessment for safety and health of workers in the entire property.
  2. Obligation to carry out risk assessment
  3. Implementation of the general principles of prevention

The key elements of Decree No. 2013-607

France enacted Decree No. 2013-607 on 9 July 2013, which protects workers who are at risk of biological infections due to their contact with medical sharps. This decree introduced a new Article R4424-11 in the Labour Code, requiring the employer to follow a risk assessment for sharps safety and, where appropriate, to take the necessary steps to remove them.

The objectives of the Directive are to strengthen the obligations of employers in the prevention and protection of workers within inpatient and outpatient sectors.

  • Ensure maximum safety in the workplace;
  • Prevent injuries to medical workers by sharp object;
  • Defines a strategy to develop an evaluation policy, risk prevention, training and awareness.

The three key steps include:

  • Evaluation in order to prevent and eliminate risk to protect health and safety of workers;
  • Identify workers at risk;
  • Eliminating the risk by implementing a series of measures, when the results reveal a risk of injury from sharps and / or infection.

Helpful Links/Guidance:

Directive 2010/32/UE du Conseil – Français

Arrêté du 9 juillet 2013 relatif à la prévention des risques – Français






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