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

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


Since 2007, needlestick regulations have been in place under TRBA250 (Technische Regeln für Biologische Arbeitsstoffe; Technical Rules for Biological Agents). One of the main components of TRBA250 is the call for protective measures, which includes the replacement of medical sharps with safer devices.

TRBA 250 mandates that needle safety devices include the following properties:

  1. One-handed activation
  2. No change in technique
  3. Safety mechanism prevents re-use

Ordinance on Biological Substances (BioStoffV)

In July 2013, the EU sharps directive was signed into Germany's national law, the Ordinance on Biological Substances (BioStoffV). It aims to reduce the risk associated with needlestick injuries, while expanding the law concerning biological agents in the hospital and healthcare sector.

The new version of BioStoffV outlines basic obligations for the employer which, if ignored, would put them at risk of fines. Among the regulations, organizations must conduct a risk assessment, develop the occupational health and safety requirements regarding activities with biomaterials and integrate them into the organisation, planning and design of work.

German law dictates that the STOP principle must be followed, which means that sharps must be substituted by safety devices as a priority, followed by technical, organisational and personnel measures. In order to avoid infection, medical sharps must be replaced by those with no or less risk of sharps injuries, as far as technically possible.

Helpful Links/Guidance:

Richtlinie 2010/32/EU Des Rates - Deutsch

Verordnung über Sicherheit und Gesundheitsschutz bei Tätigkeiten mit Biologischen Arbeitsstoffen (Biostoffverordnung - BioStoffV) - Deutsch

TRBA 250 - Technische Regeln für Biologische Arbeitsstoffe - Deutsch

TRBA 250 - Biological agents in health care and welfare facilities - English

Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA) – (Federal Institute for Occupational Safety and Health)






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