EU Directive 2010/32/EU - Prevention of Sharps Injuries in the Hospital and Healthcare Sector

Background

More than a million needlestick injuries occur in European hospitals and private medical practice every year. Doctors, nurses, healthcare and cleaning personnel as well as laundry and kitchen workers are thus exposed to a higher risk of infection. To improve the protection of employees in hospitals and the healthcare sector, the Council of the European Union in May 2010 published  Directive 2010/32/EU. It specified rules and minimum requirements to be met to increase the prevention of sharps injuries for their employees. The EU Directive has been in effect in all member states since May 11, 2013. Where necessary, it requires individual countries to amend their laws and regulations at national levels.

Required Actions

To prevent sharps injuries,  Directive 2010/32/EU lists the following actions in descending order regarding their effectiveness:

Implementation of Integrated Safety Systems

The EU directive prescribes the use of safe systems if and when they are available and it is possible to achieve equivalent outcomes with them. Safety engineers recommend that safety systems have the following properties:

  • The safety mechanism is a component of the system and compatible with other accessories.
  • Its activation must be possible by using one hand.
  • Its activation must be possible immediately after use.
  • The safety product must not jeopardize the safety of the patient.
  • The safety mechanism excludes its reusability.
  • The safety product requires no change in the application technique.
  • The safety mechanism must be marked by a clear, tactile or audible signal.

Risk Assessment

The definition of appropriate actions to prevent injuries and infections requires a risk assessment. Directive 2010/32/EU recommends that responsible personnel in hospitals and private medical practice initially analyze the situations in which employees are exposed to a risk of injury and where exposure to blood and other infectious material cannot be excluded.

Needle-Trap: The label with an integrated needle trap meets all legal and market requirements for prefilled syringes protection. The system activation is performed by using one hand and is clearly audible. The system does not cover the syringe. Visual checks through a transparent window are not impaired, thereby facilitating an administrator’s visual inspection of the medication prior to administration. This system does not alter the handling of the syringe. The user merely has to bend the needle trap to the side before performing the injection.

USA – FDA: 510k premarket notification

Needle-Trap’s safety and high quality have been confirmed by the U.S. Food and Drug Administration (FDA). After several tests Needle-Trap achieved the 510(k) clearance letter for marketing in the U.S. The Premarket Notification has the reference number K073206.

This means that Needle-Trap meets the requirements of pharmaceutical manufacturers with global activities as well.