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


In Italy, there was already some needlestick safety legislation under law 81/2008, known as the “Consolidated Law on Safety at Work” (Testo Unico Sicurezza Lavoro). It reads: "The employer is under an obligation to provide employees with all general information on the risks present in the workplace and specific information on the risks associated with performance of the tasks assigned to individuals."

The Italian government has now enacted Legislative Decree of February 19, 2014, n. 19 to implement the European Directive 2010/32/EU across the nation. This means that Italian hospitals will not only be encouraged to buy safety devices, but also risk being penalised if they opt to use conventional devices.

The provision applies to all workers who operate in the health sector, both public and private, who may be affected by sharps injuries, including employees, trainees, apprentices, temporary workers, students, and sub-contractors.

The legislation's objective is to apply measures to prevent injury and transmission of infection in the provision of services in the hospital and healthcare setting, in relation to the risks and methods of use and disposal for medical sharps. It aims for the use of equipment considered to be technically more secure, such as medical devices incorporating sharps mechanism protection and security that can protect your hands.

The key elements of Decreto legislativo 19 febbraio 2014

The employer has an obligation to ensure the health and safety of workers in every aspect related to their professional life, including psychosocial factors and the organization of work, in particular:

  • To ensure that health personnel are adequately trained and provided with resources to operate in safe conditions to avoid needlestick injury and subsequent infection;
  • To adopt appropriate measures to eliminate or contain more than the risk of injury and occupational infections through the elaboration of a comprehensive prevention policy which takes account of the most advanced technologies, organization and working conditions, psychosocial factors related to exercise of the profession and of the influence on workers from the workplace;
  • To create conditions which encourage participation from active workers and their representatives in the drafting of comprehensive prevention policies;
  • To never assume a non-existent risk;
  • To ensure adequate awareness-raising measures through a mutual degree of employee involvement and their representatives;
  • To plan and implement prevention initiatives, awareness, information and training and monitoring to assess the degree of impact of sharps injuries in workplaces involved;
  • To promote the reporting of accidents, in order to highlight the systemic causes.

The employer, during risk assessment, must ensure that it includes determining the level of risk of exposure to diseases that can be contracted in relation to working methods, so as to cover all situations of risk involving injuries and contact with blood or other potential carriers of infection.

During risk assessment, employers must identify necessary technical, organizational and procedural rules regarding working conditions, the level of professional qualifications, work-related psychosocial factors and the influence of factors related to the working environment, to eliminate or reduce occupational risks assessed.

Through the risk assessment, the employer shall take the following measures:

  • Define and implement procedures for safe use and disposable of medical sharps and waste contaminated with blood and biological materials;
  • Install containers that are properly marked and technically safe for disposal of medical sharps, with the containers placed as close as possible to the areas in which they are used;
  • Procedures must be periodically subject to an evaluation process to test effectiveness and are an integral part of the programs of information and training of workers;
  • Eliminate the use of sharps when such use is not strictly necessary:
    • Introduce medical devices incorporating protection and security mechanisms;
    • Immediate ban on the practice of manual recapping of the needles in the absence of protective devices and safety for punctures;
  • Conduct training:
    • Proper use of medical devices incorporating sharps safeguards and security;
    • Procedures to be implemented for notification, response and monitoring post-exposure;
    • Prophylaxis to be implemented in case of wounds or punctures on basis of the assessment of the source of the risk and the ability to infect.
  • Awareness-raising activities and the dissemination of information that promote:
    • Support programs be put in place as a result ofinjuries;
    • Different risks associated with exposure to blood and body fluid resulting from use of medical sharps;
    • Standard precautions should be taken towork in safe conditions;
    • Proper procedures and use ofdisposal of medical devices used;
    • Importance of reporting in the case of injury the relevant information about the details of the sharps injury occurrence.
    • The importance of immunization - advantages and disadvantagesvaccination or non- vaccination, be it preventiveor in the case of exposure to biological agents for which there areeffective vaccine. These vaccines should be dispensed free of chargeto all workers and students who provide health care and activities related to it in the workplace.
    • Evaluations of the procedures that need to be taken in case of injury to the worker:
      • To provide immediate care to the injured, including post-exposure prophylaxis and the necessary medical tests and, where appropriate, psychological assistance;
      • Ensure proper notification and subsequent monitoring for the identification of appropriate prevention measures to be implemented through the recording and analysis of the causes, mode and circumstances that led to the occurrence of accidents resulting from sharps injuries, ensuring confidentiality for the worker.
  • Failure to follow the legislative requirement can lead to sanctions for the employer and is punishable with imprisonment and / or fines.

Helpful Links/Guidance:

Direttiva 2010/32/UE del Consiglio - Italiano






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