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 in place a number of regulatory legislations that apply to the risks posed by needlestick and sharps injuries.
- EU Council Directive 89/391/EEC Safety and Health at Work states that if risks cannot be eliminated, they must be combated at the source.
- EU Council Directive 89/655/EEC 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.
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
Most recently, the EU has revisited its Directive 2000/54/EC with the aim of making it more stringent and effective, specifically in reducing sharps injuries. On July 6, 2006, the European Parliament introduced legislation to amend this Directive, adding specific recommendations on how best to protect European healthcare workers from blood-borne infections caused by needlestick injuries.
SSI is dedicated to assisting European pharmaceutical companies and healthcare providers understand, prepare for and comply with current and emerging legislation calling for increased needle safety precautions. This includes providing a convenient online resource for the latest information about changes in legislation, as well as developing innovative products, services and solutions that make it easier and more cost-effective to meet these mandates.
