Implementation of the European Guideline 2010/32/EU for the Prevention of Needlestick InjuriesDas Medizinprodukt 03/11, by Andreas Wittmann, Wuppertal
Injuries due to pointed and/or sharp instruments, generally known as needlestick injuries, belong to the one of the biggest infection risks for employees in the healthcare sector. The nation-wide implementation of European guidelines should help protect against the dangers at work. If the existing guidelines 89/391/EC1 (EU Workplace Health and Safety Directive) und 2000/54/EC2 (Protection of Workers from Risks Related to Exposure to Biological Agents at Work) had been implemented consistently in the EU member states, then employee protection against needlestick injuries should have been guaranteed. The experiences made in practically all EU countries have shown us that it is not enough to convert the existing regulations to national law if the risk of needlestick injuries is to be reduced sustainably3.
After the failed attempt to get a European Directive on Protection against Needlestick Injuries decreed in parliament, the only other plausible way has been opened. This envisages an agreement between representatives of the employers and employees on obligatory standards valid throughout Europe. An appropriate directive was signed on 17th July 2009 by EPSU representatives for employers and by HOSPEEM representatives for healthcare employees. On 1st July 2010 this agreement was passed as a European Union guideline4.
The new guideline contains concrete regulations for better protection of employees against injuries with sharp or pointed medical devices. This goes on an integrative approach with the aim of creating working conditions with best possible safety for those working in healthcare, by means of risk appraisal, risk prevention, education, training, increasing awareness and monitoring.
The guideline has to be made national law by all member states within the next 2 years, whereby it must be ensured, that the national regulations prevent exposure of employees to needlestick injuries as far as possible, by introducing the compulsory application of instruments with needle protection, for example. Depending on the legal situation in the member states, changes to existing legislation and decrees will be necessary, or regulations will have to be made new legal norms.
Possible Protective Measures
For the protection of employees, there is a European-wide standardised rule of precedence for protective measures to be taken. Basically, if there a danger at the source to be prevented and this proves unsuccessful, then technical protective measures must be planned. If these also turn out to be insufficient, then a suitable work organization separating people and risk must be envisioned. After these measures, comes protection of the employee by effective personal measures.
In case of blood borne pathogens, a substitution of the risk source is not possible, since patients have to be treated regardless of their infection status. Nowadays, a broad range of instruments are available from the industry for percutaneous interventions, where there is a significantly lower risk of needlestick or cut injuries. Known as “Safety Products”, these employ various mechanisms, ranging from simple hinged shields to elaborate retraction systems, in which the contaminated needle is withdrawn into the safety shield by a spring mechanism, to deactivation mechanisms which make the instrument harmless after use.
Illustration 1: Safety products reduce the risk of needlesticks decisively (Photo: Greiner Bio One)
These are classed as technical protective measures (illustration 1). Organisational protective measures include readily available safety disposal containers, for the quick and safe disposal of contaminated sharp and pointed objects.
Vaccinations for protection, for example against Hepatitis B, can safely prevent an infection in spite of risky contact. Like disposable medical gloves, these count as effective personal protective measures against superficial blood exposure. However, it is so significant, that although not at the top of the precedence list, it is compulsory in the healthcare sector.
Situation in Austria
The Ordinance on Biological Agents5, based on the EU guideline 2000/54/EC has been in practice in Austria since 1998. With the emphasis on “Hygiene, prevention of exposure, vaccination”, the aim is the substitution of sharp, cutting or fragile instruments, wherever possible, by instruments without risk or posing less risk of cuts or needlesticks. Thus, on paper, the legal situation in Austria is one of the most advanced in the European Union, requiring the obligatory application of safe instruments to protect employees from needlestick injuries.
In practice, these kinds of devices – depending on the product group – are by no means applied comprehensively. Furthermore, like in most other EU member states, many of the accompanying EU decree regulations have either not been implemented in Austria, or only partly implemented.
Implementing the EU Directive in Austria
For practically all medical interventions which involve contact with material containing pathogens, it is “unintentional application” of biological agents. However, the risks involved in practice can be easily determined and evaluated.
If it is not possible to prevent handling material containing pathogens, then in future employers will have to do the following:
• Limit unnecessary use of sharp or pointed objects,
• Provide safe instruments, i.e. instruments with needle protection mechanisms,
• Ensure a safe procedure for handling and disposing of sharp or pointed objects and waste
The recapping of needles banned with immediate effect.
In addition, the guidelines specify that safety disposal containers be placed as close as possible to the area where pointed or sharp objects are in use, and that protective vaccinations are on offer for potentially exposed employees.
In future, all needlestick injuries that occur must be recorded in order to be able to check the effectiveness of the protective measures implemented. However, needlestick injuries should be seen as a risk that can never be fully eliminated, and risk prevention should be at the source.
Initial instruction and training of employees, in particular new employees or leasing workers must be obligatory in future and include:
• Correct use of sharp/pointed medical devices with integrated protection mechanisms,
• The risks of exposure to blood and body fluids,
• Preventive measures and safety precautions, work regulations, protective vaccinations,
• The procedure for reporting a needlestick injury,
• The measures to be taken in case of an injury.
The member states are required to impose effective, sensitive punishments against employers, who do not apply the regulations for prevention of cut and needlestick injuries
The costs for occupational safety and safety products are to be covered by the employer. As occupational safety means the responsibility for the life and health of the employee, cost is not an applicable argument. Besides, costs are often overestimated. According to current calculations made by the University of Wuppertal, for example, there is an increase in costs of just €116 per hospital bed per year when converting completely to safety products.6 n direct comparison, the costs of a needlestick injury are much higher. On average, these amount to €480 per registered incident.7
Prof. Dr.-Ing. Andreas Wittmann
Fachgebiet Technischer Infektionsschutz
Bergische Universität Wuppertal
1 Richtlinie 89/391/EWG des Rates über die Durchführung von Maßnahmen zur Verbesserung der Sicherheit und des Gesundheitsschutzes der Arbeitnehmer bei der Arbeit vom 12. Juni 1989 (ABl. EG Nr. L 183, S. 1) zuletzt geändert durch Artikel 1 der Verordnung vom 22. Oktober 2008 (ABl. EG L 311, S. 1) in Kraft getreten am 11. Dezember 2008
2 Richtlinie 2000/54/EG des Europäischen Parlaments und des Rates über den Schutz der Arbeitnehmer gegen Gefährdung durch biologische Arbeitsstoffe bei der Arbeit (Siebte Einzelrichtlinie im Sinne von Artikel 16 Absatz 1 der Richtlinie 89/391/EWG) vom 18. September 2000 (ABl. EU Nr. L 262 S. 21)
3 Report des Berichterstatters Stephen Hughes vor dem Europäischen Parlament, INI/2006/2015
5 Verordnung der Bundesministerin für Arbeit, Gesundheit und Soziales über den Schutz der Arbeitnehmer/innen gegen Gefährdung durch biologische Arbeitsstoffe (Verordnung biologische Arbeitsstoffe - VbA), BGBl. II Nr. 237/1998
6 A. Wittmann, Z. Vrca, B. Neukirch, F. Hofmann (2007). Gesamtwirtschaftliche Kosten durch Nadelstichverletzungen und möglicher Nutzen durch die Einführung sicherer Instrumente. In: Letzel, S., Löffler IK., Seitz C. Dokumentation Deutsche Gesellschaft für Arbeitsmedizin und Umweltmedizin e.V. 47. Jahrestagung. Mainz, Eigenverlag; 2007: 441-444
7 A. Wittmann (2007). The cost-effectiveness of protection systems for sharps. Hospital 3/2007;21-23