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History of the EU legislation introduction

June 27, 2014

For healthcare workers it's important to stay abreast of the latest improvements and changes to the profession as this can either make minor or significant changes to daily activity, protocol and procedures. Organisations and their employees working within the European Union (EU) have been affected by the recent introduction of new legislation, which aimed to improve the health and safety of those working with medical sharps, and reduce their risk of suffering a percutaneous injury.

The EU Sharps Directive
The EU Sharps Directive was introduced as a response to the fact that needlestick injuries are one of the most serious health and safety threats for healthcare workers. Following on from a catalyst sparked by the US in 2000, it became obvious to the European Commission (EC) that further legislation was needed across the continent, as needlestick injuries are a prominent problem for European healthcare workers.

It is estimated that around one million needlestick injuries occur annually across the continent, which doesn't take into consideration the high number of incidents that remain unreported. This poses a real concern for the EU, as needlestick injuries can quickly cause the spread of infections by blood-borne pathogens including hepatitis B, hepatitis C and HIV. 

This is an issue for organisations as the financial implications of employees suffering percutaneous injuries is well reported, especially as it is thought that many incidents are avoidable.

Research has shown that a combination of good working procedures, correct medical instruments with safety and protective mechanisms, and training, can make needlestick injuries a thing of the past. Safety campaigner, Safe in Common has described this as a need to make percutaneous injuries a "never event".

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.

Issues concerning the dangers of needlestick injuries were first raised in 1988 when trade organisations expressed concerns about the dangers of injuries from contaminated medical instruments. A number of years later, in 1991, the Occupational Safety and Health Administration (OSHA) in the US published the "Bloodborne Pathogens Standard" in a bid to protect workers from the risk.

In light of this, a number of studies were conducted across the world and the first pilot safety devices were introduced to the market in 1993. However, it wasn't until November 2000 that America launched its "Needlestick Prevention and Safety Act" to make safety devices a legal requirement in the US.

The following year, the US Department of Labor created new OSHA standards to give healthcare workers guidance on how the law could be applied practically in their everyday work. In the next few years, manufacturers took the matter of safety devices more seriously and focused on developing instruments that could reduce the risk of clinicians suffering injuries from medical sharps. This, although not exclusively, focused on the inclusion of safety mechanisms in needles and scalpels.

In February 2005, the European Parliament adopted a proposal that was adequate to encourage health and safety in the workplace, after various consultations with Member States. It included a number of guidelines but mainly focused on specific preventative measures necessary to protect healthcare workers from injuries caused by needlesticks. The next year, the European Parliament asked the EC to submit a legislative proposal.

The EC sought the opinion of the EU Social Partners on whether there should be legislation to strengthen the protection of healthcare workers from bloodborne infections due to needlesticks and whether a joint initiative by the Social Partners would be appropriate. This resulted in them working together to agree a framework that would prevent needlestick injuries in the healthcare sector. 

Following the consultation, the Social Partners told the Commission that legislation was necessary to prevent injuries from all medical sharps, not just needlesticks. Official negotiations started in January 2009 and by the start of June 2009 an agreement had been reached. 

On July 17th 2009, after approval from the European Commission, the framework agreement was signed by the Social Partners, which meant that, on October 26th, the Commission published a proposal for a Directive to introduce the proposed framework.

In February 2010, the EU Parliament’s Employment and Social Affairs Committee showed their official support for the proposals and, on May 10th 2010, the Directive was introduced to prevent injuries and bloodborne infections among those working in the healthcare industry. This gave all Member States three years to introduce necessary changes and comply with the Directive.

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