Knowledge Articles

Are you complying with the EU Sharps Directive?

By : Mölnlycke Health Care, April 15 2014Posted in: Knowledge Articles

The EU Sharps Directive took effect on 11 May, 2013. Are you complying?

Mölnlycke can help you fulfil the requirements of the EU Sharps Directive and offer the support you need to ensure that your workplace is the safest it can be from needlestick and other sharps injuries. From the Biogel® range of surgical gloves and its innovative puncture-indication system to the availability of safety components as a part of Mölnlycke® Procedure trays to the overall commitment to safety and efficiency, Mölnlycke can be a partner in helping you achieve full compliance with the EU Sharps Directive.

The EU Sharps Directive

What is the EU Sharps Directive and when does it take effect?

The EU Sharps Directive sets forth a framework for implementing a European-level initiative for adopting best practices to ensure the safest possible working environment for health care workers.

On 10 May 2010, the directive was introduced as a way to prevent injuries and blood-borne infections to health care workers from sharp instruments. European Union member states must implement directive provisions within their national legislation by 11 May 2013.

Why is the EU Sharps Directive being introduced?

The EU Sharps Directive came about in response to the fact that needlestick injuries are one of the most serious health and safety threats for health care workers. In fact, an estimated one million needlestick injuries occur in Europe each year1, not taking into account the number of unreported events. These injuries are of concern as they bear the danger of infections by blood-borne pathogens including hepatitis B, hepatitis C and HIV. It probably goes without saying that needlestick injuries, in addition to being expensive, cause severe distress for affected health care workers and their families2. In the UK it is estimated that needlestick injuries cause costs of approximately 500,000 GBP per year for each NHS Trust.3

What information is contained in the EU Sharps Directive?

The EU Sharps Directive sets a framework in place that includes measures for how to address risk assessment, risk prevention, training and information, awareness raising and monitoring and response and follow-up procedures in relation to sharps injuries.

More information

To read more information about the directive, please consult the additional information below:

In light of the EU Sharps Directive, Mölnlycke is able to offer a selection of safety devices that have engineered features built into the product design to assist in preventing needlestick injuries. These components can be incorporated into current Mölnlycke procedure tray specification(s) and into any new tray configurations.

In addition, Biogel® indication systems support the Directive by offering better protection than just standard double gloving. Available in both latex and non-latex, they have a 97 percent accuracy rate in identifying punctures4 compared to just 8 percent without.


  1. Prevention from sharp injuries at the workplace; European Agency for Safety and Health at Work.
  2. Prevention of Sharps Injuries in the Hospital and Healthcare Sector, Implementation Guidance for the EU Framework Agreement, Council Directive and Associated National Legislation, European Biosafety Network
  3. Needlestick injury in 2008, Results from a survey of RCN members, Royal College of Nursing, 2008
  4. Wigmore SJ & Rainey JB, ‘Use of Coloured Undergloves to Detect Glove Puncture.’ BSJ 1994: 81: 1480
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