European Council Directive 2010/32/EU. Over a million needlestick injuries yearly in Europe VACUETTE. Safety Products provide reliable protection.

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1 European Council Directive 2010/32/EU Over a million needlestick injuries yearly in Europe VACUETTE Safety Products provide reliable protection.

2 Over a million needlestick injuries yearly in Europe - employees in the healthcare field have a risky job. The European directive for preventing injuries from sharp / pointed objects in the hospitals and healthcare sector More than 30 pathogens can be found in patients blood Injuries from sharp or pointed medical instruments are still among the greatest dangers for employees in the hospital and the healthcare sector. Over 30 pathogens, including Hepatitis B and C as well as HIV can be transmitted with a needle puncture. Even the smallest amounts of transmitted blood can lead to life-threatening infections. The final date: May 11 th, 2013 According to the decisions makers, this has to be changed. The European social partners have reached a framework agreement on the prevention of needlestick injuries, which became a European Union guideline in By May 11 th, 2013, the directive must be passed as national law in each member state. The goal: The greatest possible safety The goal is to create a working environment with the greatest possible safety for all employees in the healthcare field. This should be achieved via information and training to highten awareness of the dangers on the one hand, whilst on the other through risk evaluation and focused risk elimination by means of appropriate safety measures, e.g. using safety instruments with needle protection covers. To ensure that legislation is implemented as soon as possible in each member state, the European Biosafety Network was established. The organization is meant to support and advise the national procedures with orientation guides, information and reporting. A number of countries are leading by example In the face of the massive dangers, it is advisable to begin immediately with the onsite application. In some member states, for example in Germany or Spain, some measures were taken already before the European directive to prevent these dangers. The experience gained through these steps show that with a combination of training, safe working procedures, the use of medical instruments with safety and protective mechanisms and appropriate control mechanisms, needlestick injuries can be all but completely avoided. No reason to wait any longer Needlestick injuries also represent a great cost factor in the healthcare services sector and for society in general. It is time to avoid these costs now, rather than waiting for legislation to run its course. The emotional effects of injuries from sharp / pointed instruments can be significant and long-lasting, even if no serious infection has been transmitted in the event. Employees in the healthcare services sector and those close to them can suffer for months, until they know with certainty that they have not been infected with a potentially deadly disease. Do not wait for the next needlestick injuries to be reported in your institution. Act now. 2 3

3 Which duties arise from the European Directive? Collaboration Risk assessments must be conducted in all situations in which there is a potential for injury or when contamination with blood or potentially infectious materials is possible. Employer and employee representatives work together at an appropriate level in order to avoid dangers, to protect the health and safety of the employees, and to create a safe working environment. They develop: A general prevention strategy Training programs Safety monitoring procedures Elimination, prevention, and protection Should a risk of infection be identified in the risk assessment, appropriate measures are to be taken, such as: Avoiding unnecessary use of sharp / pointed instruments by implementing revised procedures Identifying and applying safer procedures for the handling and disposal of sharp / pointed medical instruments and contaminated waste An immediate ban on the recapping of (used) needles Provision of medical devices with integrated safety and protection mechanisms Introducing effective disposal procedures Using personal protective equipment Offering vaccinations to employees Information, awareness and training Employees receive information about: The correct use of sharp / pointed medical instruments with integrated safety mechanisms The risks of contact with blood or bodily fluids Protective measures taking common workplace procedures into account The correct use of waste containers for sharp / pointed instruments and disposal procedures The significance of vaccinations and guaranteed access to vaccination services Procedures for reporting, reacting, observation and their significance The necessary measures to be taken in case of injury The employer is obliged to organize and offer trainings at regular intervals, and to ensure that employees are allowed the time to participate. Reporting procedure Accidents and incidents with sharp / pointed instruments are to be reported to the employer immediately. 4 5

4 Reaction and consequent actions Selection criteria for the use of medical instruments with integrated safety functions In the case of an injury, the following measures must be taken without delay: Care of the injured employee, including medical examination, post-exposure prophylaxis, and subsequent medical monitoring. Inspection of the causes and circumstances of the incident, creating a record and taking measures to eliminate the cause of the accident. In the case of an infection of the employee, the rehabilitation measures, further employment and compensation must be considered. The person in question is to be assured of absolute confidentiality. In its guideline for the application of the European directive, the European Biosafety Network gives the following selection criteria for safety instruments: The instrument must not interfere with patient care The instrument must function reliably The safety mechanism must be an integral part of the safety device, and may therefore not be a separate accessory The instrument must be easy to use and may only necessitate a minimal change in the trained medical professional s technique The activation of the safety mechanism must be simple to perform and easy for the healthcare professional to control The instrument must prevent further risk to safety or sources of exposure to blood One-handed or automatic activation is preferable Successful activation of the safety mechanism must be indicated to the trained medical professional by means of an audible, tangible or visible signal The safety mechanism should not be reversible after activation The long path leading to this point came from 20 years of intense efforts Trade unions warn of the dangers involved in injuries from contaminated instruments. The first simple safety products appear on the market. OSHA* publishes the Bloodborne Pathogens Standard in order to protect workers from the risks. More and more studies and publications from all over the world describe the enormous extent and sometimes tragic results of needlestick injuries. November 2000: The US government passes the Needlestick Prevention and Safety Act. The US Department of Labor produces new OSHA Standards for the practical application of the law. Safety products are put into wider use. The product ranges on offer become more widely varied and cost effective. The use of safety products becomes economical. In some countries, more and more hospitals decide to introduce products with safety mechanisms. The European Parliament requests that the European Commission prepare a legislative proposal for the protection of employees in the healthcare field. In Germany, the TRBA 250 comes into effect. (February 2008) In accordance with this, instruments are to be replaced with appropriate safe equivalents, which either minimize or eliminate the risk of punctures or cuts. The closing of a framework agreement between the European social partners HOSPEEM and EPSU. (July 2009) The European Council passes the guideline 2010/32/EU according to which the framework agreement shall serve as the basis for national law. (May 2010) More and more hospitals recognize the advantages and introduce safety products conscious of their responsibility and in anticipation of the upcoming law The EU member states must put the necessary legal and administrational regulations into effect. (May 11th, 2013) Comprehensive user instruction and training are of crucial importance while introducing medical instruments with integrated safety and protective mechanisms. Experience shows that proper technique combined with safe working procedures render the implementation of safety measures much more effective. * OSHA Occupational Safety & Health Administration in the US Department of Labor Among the procedures with the highest risk are blood collection, intravenous cannulation, and percutaneous administration of injections. Small amounts of blood can lead to potentially life-threatening infections. Hollow needles contain more blood and thereby entail greater risks than solid needles. Sources Guideline 2010/32/EU of the council from May 10th 2010 on the implementation of the framework agreement made between HOSPEEM and EPSU for the prevention of injuries from sharp / pointed instruments in the hospital and healthcare sector, Brussels Framework agreement for the prevention of injuries from sharp / pointed instruments in the hospital and healthcare sector HOSPEEM (European Hospital and Healthcare Employers Association) and EPSU (European Federation of Public Service Unions) Brussels, European Biosafety Network: Guideiline for the implementation of the EU framework agreement, the guideline of the council and the related national legislative process 6 7

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