COMMUNICATION FROM THE COMMISSION

Transcription

1 EN EN EN

2 COMMUNICATION FROM THE COMMISSION First stage of consultation of the social partners on protecting European healthcare workers from blood-borne infections due to needlestick injuries 1. INTRODUCTION On 6 July 2006, the European Parliament adopted a resolution on protecting European healthcare workers from blood-borne infections due to needlestick injuries. 1 The resolution requests the Commission "to submit to Parliament within three months of the date of adoption of this resolution on the basis of Articles 137 and 251 of the Treaty, a legislative proposal for a directive amending Directive 2000/54/EC". 2 In accordance with Article 138 of the Treaty, which lays down that "before submitting proposals in the social policy field, the Commission shall consult management and labour on the possible direction of Community action", this document is intended initially to obtain the opinion of the social partners concerning a possible amendment to Directive 2000/54/EC on biological agents at work in order to strengthen the protection of European healthcare workers from blood-borne infections due to needlestick injuries. These injuries constitute one of the major occupational risks facing healthcare workers, and a strengthening of current preventive measures would contribute significantly to reducing these risks. 2. BACKGROUND Despite the lack of harmonised statistics at European level on the scope and seriousness of the problem, it is claimed that hospital and health service staff (nurses, doctors, etc.) are frequently faced, particularly in certain departments and activities (emergencies, intensive care, surgical operations, etc.), with the risk of infections due to injuries caused by needles or other sharp instruments (scalpels, suture equipment, etc.). The consequences may be very serious, with a risk of infections that may give rise to serious diseases such as viral hepatitis or AIDS. Needlestick injuries are caused by the accidental perforation of the skin by a needle potentially contaminated with a patient's blood. Contaminated needles may transmit over 20 dangerous blood-borne pathogens, including the hepatitis B, hepatitis C and HIV viruses. These injuries mostly affect nurses, but doctors and other health workers also run a significant risk, as do staff responsible for cleaning and laundry. It is mainly as a result of percutaneous injuries caused by hollow sharp objects used to collect blood that health service workers contract potentially fatal blood-borne diseases at work /2015(INI) Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC). OJ L 262, , pp EN 1 EN

3 Some studies estimate the number of needlestick injuries at approximately one million per year in Europe. 3 High-risk procedures include blood collection, intravenous cannulation and percutaneous injections. Minute quantities of blood may transmit potentially fatal infections. The prevalence of such infections is considerably higher in the health sector than in the general population. 4 Approximately 10 % of those active in the EU work in the health and social services sector, a significant number of them in hospitals. Health is therefore one of the most important employment sectors in Europe. Community legislation on the subject The "framework" Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work 5 lays down general preventive measures to protect the health and safety of workers. The Directive contains minimum requirements concerning, among other things, risk assessment and the information, training and consultation of workers. In particular, Article 6 of this "framework" Directive contains general principles for prevention which the employer is obliged to implement, namely "avoiding risks", "combating risks at source" and "replacing what is dangerous with what is not dangerous or with what is less dangerous". In addition to the "framework" Directive, some of its individual directives are also applicable in the field of preventing infection risks among staff in the healthcare sector: a) Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work 2 contains provisions aimed at preventing these risks, and lays down particular minimum requirements in this area. The Directive establishes employers' obligations concerning risk prevention. In particular, for any activity likely to present a risk of exposure to biological agents, the nature, degree and duration of exposure for workers must be determined in order to assess any risk to the health and safety of workers and to determine the measures to take. b) The aim of Directive 89/655/EEC concerning the minimum safety and health requirements for the use of work equipment by workers at work 6 (as amended by directives 95/63/EEC 7 and 01/45/EC 8 ) is to ensure a higher level of safety for workers using work equipment, such as medical equipment used in hospitals. The employer must choose work equipment in accordance with the particular working conditions and the risks to workers in order to eliminate or minimise these risks. If it is not possible to use work equipment which does not endanger the health and safety of workers, the employer must minimise these risks. In a) EPINet Data. Dee May RGN, DMS. Period of the study: July 2000 to June b) Surveillance of Occupational Exposures in Italy: the SIROH program, Gabriella De Carli, Vincent Puro, Vincenzo Puro, Giuseppe Ippolito, and the SIROH group, SIROH, c) EPINet Spain, Hermandez Navarette MJ, Arribas Llorent JL, Campins Marti M, Garcia de Codes Ilario. d) Risk of Hepatitis C Virus Transmission following Percutaneous Exposure in Healthcare Workers, 2003 G De Carli, V Puro, G Ippolito, and the Studio Italiano Rischio Occupazionale da HIV (SIROH) Group. a) University of Wuppertal) Hofmann F, Kralj N, Beie M. Needle stick injuries in healthcare - frequency, causes and preventive strategies. Gesundheitswesen. Mai 2002; 64(5): b) Schroebler S., Infektionsrisiko durch Nadelstichverletzungen für Beschäftigte im Gesundheitsdienst, in Dokumentationsband über die 40. Jahrestagung der Gesellschaft für Arbeitsmedizin und Umweltmedizin e.v., Rindt-Druck, Fulda 2000; fortgeführt und ergänzt, persönliche Mitteilung. OJ L 183, OJ L 393, OJ L 79, OJ L 195, EN 2 EN

4 addition, workers must be given adequate instructions and training in the use of the work equipment. c) Directive 89/656/EEC on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace 9 lays down that the use of personal protective equipment is required where risks cannot be avoided or limited by technical means or work organisation methods or procedures. All personal protective equipment must be adapted to the risks encountered, without increasing the level of risk. It must correspond to prevailing conditions at the workplace and be adapted to the person wearing it. It should also be noted that annex I, part II to Directive 93/42/EC 10 concerning medical devices stipulates that devices and manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties. The design must allow easy handling and, where necessary, minimise contamination of the device by the patient or vice versa during use". Any medical device used must also have received the CE mark, attesting to its conformity with the essential requirements of the above-mentioned Directive before it is placed on the market. Initiatives at Community level On 24 February 2005, the European Parliament adopted a resolution on promoting health and safety at the workplace. 11 Among other points, this resolution "calls on the Commission to ensure that Member States implement the specific preventive measures necessary to protect healthcare workers from injuries caused by needles and other medical sharps in view of the risk of infection from potentially fatal blood-borne pathogens (group 3 biological agents); notes that these should include the appropriate application of training, safe working practices and medical technology incorporating sharps protection mechanisms, and that the applicable guidance provided by the European Agency for Safety and Health at Work (FACTS 29, ISSN ) should be employed to determine the minimum standard of protection; considers, nevertheless, that Directive 2000/54/EC also requires further revision to specifically address the risk arising from work with needles and other medical sharps". In the wake of the above-mentioned resolution, on 6 July 2006 the European Parliament adopted a resolution on protecting European healthcare workers from blood-borne infections due to needlestick injuries. The resolution requests the Commission "to submit to Parliament within three months of the date of adoption of this resolution on the basis of Articles 137 and 251 of the Treaty, a legislative proposal for a directive amending Directive 2000/54/EC on biological agents at work. The annex to the resolution contains "detailed recommendations as to the content of the proposal requested". The legislative amendment proposed by the European Parliament to the "biological agents at work" Directive consists essentially of amendments to Articles 2 ("definitions") and 15 ("health and veterinary care facilities other than diagnostic laboratories". These amendments relate in particular to the suppression of the use of cannulas where other safe and effective solutions exist, the use where appropriate of devices equipped with safety systems, changes to professional practices where there is a risk of needlestick injuries including the suppression of the use of recapped needles, and certain specific provisions relating to the training and information of workers and post-exposure prophylaxis OJ L 393, OJ L 169, /2205(INI). OJ C 304 E, EN 3 EN

5 In addition, and on the initiative of the European Commission, a working party was established in 2004 within the Advisory Committee on Safety and Health at Work to analyse possible Community initiatives to strengthen health protection and safety for workers in the hospital sector against all occupational risks. Following a decision taken by the three interest groups (governments, employers and workers), the Advisory Committee turned in 2005 to the preparation of a practical prevention tool in the form of a guide to prevention and good practice in the hospital sector, aimed at the most significant groups of risks in the sector, including those caused by biological agents, such as injuries caused by needles and other sharps. The working party is currently assisting the Commission in preparing technical specifications for an invitation to tender to be launched in 2007 in order to select a contractor to prepare such a guide to prevention and good practice in the hospital sector. Moreover, in 2005 the Commission began work on assessing the practical implementation of Directive 2000/54/EC on biological agents at work in the Member States and in workplaces. An invitation to tender was launched in 2005 to select an external independent contractor to provide the elements for establishing the practical aspects of implementing the Directive, including determining any difficulties encountered by workers, employers and authorities. The final report to be provided by the contractor would be available towards the end of SCOPE OF POSSIBLE COMMUNITY ACTION The Commission attaches great importance to protecting the health and safety of health workers against one of the most frequent and sensitive risks injuries caused by needles and other sharps, owing to the potential seriousness of the consequences but also to its impact on the smooth operation of health services; strengthening health protection for health workers would also have a positive effect on the health of patients and users of health services. Protecting the health of health workers is thus in the interests of society as a whole. In the context of legislation and of existing initiatives such as that described in item 2, the elements contained in Parliament's resolution could be incorporated in a proposal aimed at strengthening certain provisions of Directive 2000/54/EC on biological agents at work. Although the Directive is general in scope, aiming to cover all risks caused by biological agents at work in all sectors, it also contains a specific chapter on "health and veterinary care facilities other than diagnostic laboratories", in which the provisions proposed by Parliament could find a place. On the technical level, the introduction of more precise provisions in Directive 2000/54/EC on biological agents would define more clearly the employer's obligations to strengthen prevention of the risks in question; there would be stricter and clearer measures in terms of the safety of procedures, training and information for workers to be introduced in the course of their daily occupational tasks. 4. TOPICS FOR CONSULTATION In the light of the above, the social partners are called upon to give their opinion on the following questions: (1) Do you consider it useful to take an initiative to strengthen the protection of European healthcare workers from blood-borne infections due to needlestick injuries? EN 4 EN

6 (2) Do you think that a joint initiative by the European social partners under Article 139 of the Treaty establishing the European Community would be appropriate? EN 5 EN