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


For Belgian health sector employees, preventing the risk of biological agents became subject to more specific rules in April 2013. The already established rule, Article 3 of the Royal Decree of 4 August 1996, was given further clarification surrounding the use of medical sharps.

The updated legislation gives more responsibilities to the employer and explains that they are now obliged to manage, organize and deliver health care and the services directly related to their employees, contractors and subcontractors who may be at risk of sharps injuries. The information to the contractors must provide clarity on the risks of working with sharp instruments as well as preventative measures taken. The employer must also ensure that employees of contractors and subcontractors receive the right training and instructions in connection with medical sharps.

Risk analysis and prevention

Concerning risk analysis, the employer must examine all situations where employees can become injured by a sharp medical instrument during the work day.

During the risk assessment, the employer shall take into account:

The technology and the material used;
The organization of the work;
Working conditions;
The level of qualification;
Work-related psychosocial factors;
The influence of environmental factors at work.

On the basis of this risk assessment, the employer will take preventive measures, including information provision and providing user manuals for medical sharps.

The employee continues to be committed to the following measures if the risk assessment shows that there is a danger of injury and/or infection by medical sharps:

Ending the unnecessary use of medical sharps by changing the way in which work is conducted. Based on the findings of the risk assessment, the employer is also required to incorporate safety-engineered protection mechanisms in the tools;
Ban the recapping of needles;
Establishing and implementing safe procedures for using and disposing of medical sharps and contaminated medical waste. These procedures should be regularly reviewed;
Employing clearly marked and technically safe containers for disposing of sharp medical instruments and contaminated medical waste, as close to the areas where these tools are used;
Highlight the various risks associated with the use of a medical sharp devices;
Creating awareness by developing activities and promotional materials.

The employer is also responsible for explaining the risks and the preventive measures during the induction period. Compliance with the measures on the prevention of injury and/or infection by a sharp medical instrument is the responsibility of the employer.





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


Smiths Medical maintains this website to enhance public access to changes in international law. Our goal is to keep this information timely and accurate. If errors are brought to our attention, we will try to correct them. However, Smiths Medical accepts no responsibility or liability whatsoever with regard to the information on this site.

This information is:

  1. of a general nature only and is not intended to address the specific circumstances of any particular individual or entity;
  2. not necessarily comprehensive, complete, accurate or up to date;
  3. sometimes linked to external sites over which Smiths Medical has no control and for which Smiths Medical assumes no responsibility;
  4. not professional or legal advice (if you need specific advice, you should always consult a suitably qualified professional).
  5. Smiths Medical may collect personal (or personally identifiable) and non-personal information in connection with this website. Once you choose to provide us with this information, it may be used to support your relationship with Smiths Medical.

It is our goal to minimize disruption caused by technical errors. However some data or information on our site may have been created or structured in files or formats that are not error-free and we cannot guarantee that our service will not be interrupted or otherwise affected by such problems. Smiths Medical accepts no responsibility with regard to such problems incurred as a result of using this site or any linked external sites.


Europe, North America, South America, Asia, Australia


United Kingdom, Germany, France, Spain, Belgium, Portugal, Australia, United States, Austria, The Netherlands, New Zealand, Italy, Canada