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EU Regulatory Response to Sharps Injuries

According to Eucomed, a leading Medical Technology Industry advocacy organization, more than 1 million medical needlestick and sharps injuries are estimated to occur in Europe each year. In reality, this number may likely be higher since 60-80% of sharps injuries go unreported. Sharps injuries lead to a significantly higher risk of transmitted blood-borne pathogens, including HBV (30% risk), HCV (3% risk) and HIV (0.3%).

The European Union (EU) already has a number of regulatory legislations in place that address the risks posed by needlestick and sharps injuries.

  • EU Council Directive 89/391/EC Safety and Health at Work states that if risks cannot be eliminated, they must be combated at the source.

  • EU Council Directive 89/655/EC Work Equipment mandates that employers must provide a safe work environment.

  • EU Council Directive 2000/54/EC Biological Agents states that employers must assess risk and prevent workers' exposure.

  • EU Council Directive 2010/32/EU sets a framework for member countries to implement legislation combatting all medical sharps-injuries, including needle-sticks.

Along with this legislation, the OSHA-EU's European Agency for Safety and Health at Work has launched efforts to educate the healthcare industry about sharps-injuries prevention with a series of Facts Sheets containing recommendations on:
  • Eliminating the use of needles whenever possible
  • Implementing devices with safety features
  • Modifying work practices and avoiding recapping needles
  • Needle safety training for workers