Second stage of the consultation of the social partners on protecting European healthcare workers from blood-borne infections due to needle stick injuries

{REPLY
European Federation of Public Services Unions (EPSU)

Second stage of the consultation of the social partners on protecting European healthcare workers from blood-borne infections due to needle stick injuries
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{Question 1:

The Commission requests the social partners to submit to the Commission an opinion or, where appropriate, a recommendation on the content of the legislative and non-legislative initiatives envisaged in application of Article 13 (3) of the Treaty establishing the European Community}



1. General Remarks

- The EPSU supports in general, the conclusions as drawn by the European Commission on the need to reduce the risks of infections due to the use and handling of medical sharps. We share the analyses concerning the extent of the problem and the impact on the health and safety of workers affected. We believe that an integrative approach including legislative and non-legislative initiatives is the best response to limit these risks.

- This approach needs to include both sector-specific measures related to e.g. hospitals or waste services, and measures which have a general, cross-sectoral coverage. We would like to emphasise that sharp instruments, devices and objects contaminated with biological agents can be found in health/social/dental care facilities and laboratories, but also, amongst many others, at the home of clients and patients, reception centres, public transport, beauty centres, laundry facilities, butcher shops. We realize that there are different levels of risk prevalence. However, this fact does not diminish the need to protect workers against these risks.

- Moreover, we want to note that there are many different situations in which workers can find these contaminated sharp objects in their work environment. Sharp objects can be devices designed for medical purposes like syringes and intravenous catheters, but also other sharp objects like knives, needles, and scissors. These sharp objects can be part of the work equipment and as such become contaminated during the use of the object. In other cases workers come across these objects as material which needs to be processed; sometimes in a direct way, as in the case of laboratory workers or specialized waste processors and sometimes just to transfer or transport these objects from one place to another, as this can be the case for care assistants or cleaners. Unfortunately, there is also a third category of situations in which workers can encounter these objects. Regularly, contaminated sharps are unintentionally left behind or thrown away by users at workplaces or in the public space without any prior notification. This situation constitutes a health risk which is difficult to identify but nonetheless existent. Workers doing their job in these environments with contaminated sharp objects, are in general not aware of their presence, and might discover these objects too late to prevent injuries.

- As our common knowledge about health risks in relation to transcutaneous injuries changes on a regular basis, protection measures should not only aim to reduce the risk of infection with known diseases, but also with a view towards possible unknown diseases. Injuries involving body fluids and blood in particular always entail a risk of infection, even if the “source” is healthy and not suffering blood-borne diseases. In this respect we would like to underline that injuries involving possibly contaminated sharp objects cause high levels of stress and anxiousness to workers and are to be considered a health risk in itself. Measures related to risk assessment and prevention should therefore not be limited to the prevention of infection, but aim to prevent the incidence of injuries with contaminated sharps and transcutaneous contact with body fluids from animals or other persons.

- We would like to suggest that the Commission takes a more inclusive approach than described in the 2nd Stage Consultation paper in order to eliminate as much as possible the risk of injuries and diseases related to accidents with contaminated (sharp) instruments and objects. Initiatives to minimise these risks should include protective measures concerning the use and handling of needle sticks and medical sharps, but they should also protect the worker from injuries with all other kinds of (sharp) instruments and objects, which are (potentially) contaminated with biological agents. We would like to reiterate that the protection should cover all workplaces where there is a verifiable risk to be injured by the use and handling of contaminated (sharp) instruments.


2. Relation to existing legislation

-* As stated in our response to the first stage consultation, we are of the opinion that a health and safety initiative should be in accordance and consistent with the existing legislation and framework on Health and Safety at the workplace.
We would like to mention here in particular:
-* The Framework Directive 89/391 EEC on safety and health
-* Directive 89/655 EEC concerning the minimum safety and health requirements for the use of work equipment by workers at work (amended by directives 95/63/EEC and 01/45/EC)
-* Directive 89/656/EEC on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace
-* Directive 89/654/EEC on the minimum health and safety requirements for the workplace
-* The existing directive 2000/54/EC on the protection of workers from risks related to the exposure to biological agents at work

- In addition, we would like to refer to the relevant legislation in the field of enterprise and industrial policies, including Directive 93/42/EC concerning Medical Devices. It is important to note that medical sharps and other sharp objects which may become contaminated are often used in a social context, and involve contacts with patients and/or clients. They are also available for private and non-professional use. Safety requirements for these devices therefore need to be comprehensive and include considerations of patient safety and consumer safety in addition to workers' safety.


3. Specific measures

- Without being exhaustive we would like to ask for your attention to some specific points related to risk assessment, prevention, and response management in cases of (near) accidents. Results of research show that specific and targeted measures to protect workers against risks related to the use and handling of contaminated sharps have immediate effects. We would like to present you with some considerations in relation to these measures and request you to take the statements below into account when developing any initiatives in this area.

- An appropriate risk assessment is a precondition in any health & safety policy in order to prevent injuries with contaminated instruments. Facts, figures, and statistics about the prevalence of (near) accidents and the circumstances in which they take place are one of the essential tools to gain knowledge about the level of risks in different workplaces and adjust the work environment, training, practices and/or equipment where appropriate.

- EPSU calls for effective reporting, recording, and monitoring systems of (near-) incidents and accidents with contaminated sharps and specifically medical sharps at workplace, local, national, and European level. Recorded information should include specifications about the environment/workplace where the incident took place, the types and brands of the instruments involved and an explanation of the circumstances. It is important, in particular in relation with infectious diseases to respect as much as possible the privacy of the workers involved. A high level of confidentiality needs to be maintained.

- Protection against infectious diseases should involve the implementation of vaccination programmes at workplaces. This rule also applies to work place situations where there is a risk of being injured by contaminated sharps. In cases where effective vaccination exists against identified infectious diseases e.g. hepatitis A and B, this should be made freely available to workers at risk.

- In order to prevent injuries with contaminated sharps, it is crucial to look at the design, use and technology of the sharp devices in medical, veterinary and other relevant workplace settings. It is widely recognized that the use of hollow-bore blood filled sharp objects is one of the main causes of these injuries, but risks related to the use of other kinds of needles, glass items, scalpels, knives, scissors cannot be underestimated. According to Directive 89/655/EEC, employers need to provide to their workers safe working equipment, i.e. instruments and devices that would not pose a risk to the safety and health of the workers. Consistent application of these principles in relation to sharp instruments which (may) become contaminated with biological agents, implies that employers should take well-considered decisions about the types and numbers of instruments they purchase and the availability of these instruments at the workplace in consultation with workers/workers' representatives. These decisions need to take into account the different alternatives, the availability and effectiveness of safety devices and the provision of protective equipment. Employers need to ensure that the use and handling of all these instruments at the workplace is in accordance with the instructions, the standards, and the technical requirements.

- To establish safe work practices concerning the use and handling of contaminated sharps employers need to offer workers a sufficient amount of training and information on a regular basis. Workers need training and information concerning the use and/or handling of sharp instruments in medical, veterinary and other relevant settings, but also on the use/availability of safety devices, protection equipment, the disposal/processing of possibly contaminated objects and effective response management and reporting procedures. This training needs to be part of the standard curriculum and where appropriate be included in the qualification standards. Appropriate training and information also needs to be offered at the workplace in order to update and refresh the skills and take account of workplace practices. Taking into account the high turnover rates and the big numbers of interns and students in many sectors like healthcare, social services and cleaning, this training should also become a standard element of any induction period for workers and other relevant staff members like self-employed and posted workers

- A successful approach to reduce the risks of injuries by contaminated sharps requires a close examination of the working environment and work practices. They have to meet the highest safety requirements, and exclude unnecessary hazardous acts and routines. Key aspect in the implementation of policies involves the availability and proximity of appropriate containers to dispose of or store the possibly contaminated devices. Practices like the recapping of needles or unnecessary handovers of possibly contaminated sharps need to be banned. It has to be borne in mind that (medical) instruments have life cycles, which extend by far the use for medical, veterinary or other relevant purposes; the processing and disposal of these instruments therefore needs to be an integrative part of any policies related to possibly contaminated sharp objects.

- We are, as EPSU, very concerned about the work organisation situation in the many sectors where we organise workers. Fatigue linked to excessively flexible and/or long working shifts have been proven to considerably increase the risk of accidents with contaminated sharps. The same applies to heavy workloads and extreme time pressures. We are of the opinion that a holistic approach to workers' protection needs to address these questions related to work organisation and working time.

- We noticed that the practice of outsourcing e.g. in the area of cleaning, diagnostics and waste disposal and the contracting of self-employed or posted workers, often results in situations where there is a lack of clarity about the responsibilities for the health and safety of workers, clients and patients. This could also increase the risk of accidents with contaminated sharps. Practices and policies of the different actors need to be synchronized in accordance with article 6.4 of Directive 89/391/EEC and based on the principle of collaboration and shared responsibilities in order to ensure the highest level of protection possible.

- Even though effective preventive measures would minimise the risk of injuries and infections, an injury caused by a contaminated sharp can still happen. For this reason, work places need to have appropriate response and follow-up procedures. It is crucial to minimize negative consequences and affected workers need to receive all the necessary support and assistance as quickly as possible, including where appropriate and/or requested rapid post-exposure prophylaxis, counselling and after-care.

- Finally we would like to emphasize the need for European-wide and national awareness campaigns on the subject of prevention and elimination of injuries with potentially contaminated sharps. In order to be effective, these awareness campaigns need to address the sector-specific problems, inform employers, workers and the public about the different risks, and give guidance about the existing legislation and the different prevention tools and methods.

4. Recommendations in relation to existing legislation

- Measures to reduce risks related to the use and handling of contaminated instruments have to be established on the basis of the different relevant directives in conjunction with each other. Amendments to legislation should be drafted so as to guarantee the best general compliance in all fields related to the use and handling of sharp instruments, which are possibly contaminated by biological agents. We are aware that, for instance, consistency and legalistic considerations require adjustments of legislation other than those mentioned below. We however do not consider it appropriate to go into these details in the framework of a second stage consultation.

- Concerning the existing legislation, we are of the opinion that better synergy needs to be reached between the directives on health and safety, work environment, work equipment, protective equipment and biological agents in order to protect workers successfully against injuries with possibly contaminated objects. It is important that management, workers, and workers' representatives are able to develop a clear policy and take suitable measures concerning the protection of workers on the basis of legislation. We are of the opinion that the present legislation does not address all the risks as effectively and clearly as required. Several points need to be refined in relation to the risk of injuries with possibly contaminated sharps in order to facilitate better implementation of the health & safety legislation at sectoral, national, local and workplace level. We therefore request the Commission to present some specific legislative proposals in relation to these risks.

- Even though the directive on biological agents does apply to all workplaces where there is a risk of infection, it does not make a distinction between the risk of direct exposure of biological agents, and exposure to these agents as a result of an injury by the use or handling of contaminated instruments. However, the kinds of measures, that are necessary to limit these risks, can be different. The fact that appropriate measures for the prevention and response to injuries, with possibly contaminated instruments, are mentioned together with non-applicable measures, might cause confusion when employers set up risk assessments and preventive and protection measures in consultation with workers and/or workers' representatives.

- We therefore suggest to the European Commission to add to the present Directive on Biological Agents at Work (2000/54/EC) several specific articles and phrases in order to address adequately the risks related to the use and handling of contaminated sharp objects. We find it appropriate to put these articles in the general chapters I and II and not under the articles related to activities in health and veterinary care facilities other than diagnostic laboratories. As extensively explained in the paragraphs above, the risk to be injured by a contaminated sharp object exists in many different workplaces and settings. We are of the opinion that all these workplaces need to be covered by appropriate legislation. In order to address these risks in relation to specific sectors, we suggest to the Commission to develop annexes to the Directive on Biological Agents at Work. As EPSU, we are in particular interested to see the establishment of specific measures for hospital and health care settings, social services and waste services.

- Even though we aim to be as concrete as possible concerning the recommendations for amendments to existing legislation, we would like to underline that our proposals in relation to the Directive on Biological Agents at Work need to be seen against the background of the measures suggested above in paragraph 3 and to be taken in conjunction with each other. They are deliberately not meant to be considered as separate and independent suggestions.

- In order to avoid misunderstandings, it might be necessary to clarify the use of certain words and terminology in the directive and include them in the list of definitions of article 2. We would recommend to look at words like contaminated, sharp objects, (transcutaneous) injuries, and other technical/medical terms, which have more or diverse meanings.

- Even though the known incidence-rate of accidents related to medical sharps is high in relation to other known accidents, we have chosen to use the term sharp object instead of medical sharp or needle stick in order to cover different risks. There is sufficient scientific evidence available to conclude that a considerable number of transcutaneous injuries with possibly contaminated objects involve other kinds of sharp objects than medical sharps. Even in medical settings, incidents with glass and wires are regularly mentioned in reports and articles.

- In relation to article 3.1, on the scope we would like to include a specific reference to exposure to biological agents as a result of accidents with contaminated sharp objects. We consider the present text too vague, especially if read in the context of the directive on biological agents in its whole. It is crucial that organisations and persons responsible for health and safety protection at the workplace agree that elimination and minimalization of the risk to exposure to biological agents includes the elimination and minimalization of the risk of being injured by a sharp object contaminated with biological agents.

- We also believe that clarification should be given on the different employers' obligations as mentioned under article 5 to 13 of the directive. Many of the articles are relevant but some of the obligations concerning the reduction of risks and on hygiene and individual protection are not entirely appropriate for a situation, where the main hazards consist of the risk of being injured by a contaminated sharp object and where there is not an identifiable risk to be directly exposed to a biological agent. We also note that some risk reduction measures, which are crucial in order to maintain a high level of health and safety, are not mentioned or inappropriately phrased.

- We would therefore like to suggest to include, in Chapter II, some specific provisions related to the use and handling of possibly contaminated sharp objects and specify their application and the application of the other measures listed through article 4.
More precisely, we want to add the following risk reduction measures to be introduced in article 6 for work situations, which involve the use and handling of possibly contaminated sharp objects:
-* modification of work practices to minimise the risk of transcutaneous injuries with contaminated sharp objects and eliminate unsafe work situations.
-* preventing the use and handling of sharp instruments, which might be or become contaminated, for other purposes than for which they are designed
-* use of available safety devices for the use and handling of sharp objects which might be or become contaminated
-* preventing the use of sharp instruments which might be or become contaminated in situations where safe alternatives are available
-* means for safe collection, storage and disposal of potentially contaminated sharp objects

- We want to note that in relation to hygiene and individual protection most of the measures of article 8 are relevant for workers handling or using potentially contaminated sharp objects. However, we suggest adding one additional measure for these groups of workers. That is:
procedures and instructions are specified for using, handling, and processing possibly contaminated sharp objects.

- In relation to article 9 on the information and training of workers, we suggest to extend the training for workers who have to use or handle potentially contaminated sharps with two points:
-* the use and availability of safety devices
-* the collection, storage and disposal of waste and possibly contaminated objects

- We also would like to add a specific provision in Chapter II, which obliges the employers to carry out an effective and immediate response and follow-up to accidents and incidents of potentially health-threatening exposure to biological agents, including where appropriate the rapid provision of existing post-exposure prophylaxis.

- We have noted that the indicative list of activities in Annex I should be extended, and include at least work in cleaning and laundry services, waste disposal, social care and social service settings. Many other workplaces should also be taken in consideration.

- In addition to our recommendations for amendments in the Directive on Biological Agents at Work, we also would like to ask your attention for the standardization procedures in the European Union, including those on the basis of the Directive for Medical Devices (93/42/EC). As explained in our reply to the first stage consultation, we are as trade unions very concerned about the hazards related to the use of medical sharps like hollow-bore needles, scalpels and suture needles. The use of modern technology could considerably lower the existing risks. We consider it important that sufficient information becomes available about the safety and effectiveness of the different technologies vis-à-vis their application and that this information is regularly updated so that it is in accordance with the most recent technological developments and scientific knowledge. We therefore urge the European Community to support existing and future standardisation procedures in these areas, and to make sure that these instruments are fit for their purpose and safe for workers, patients, and users. In areas where standardization already took place, we would like to request the Commission to support the application of these standards and assist social partners in their efforts to develop a safe and healthy workplace. We are of the opinion that much can be gained by a better cooperation between the different actors in the field of health and safety and those in the field of enterprise policy. Mutually supportive activities around reporting and monitoring of incidents and on the application of technological and scientific knowledge would promote safe use and prevent unsafe practices.


{Question 2

The Commission request the social partners where applicable to indicate their willingness to enter into negotiation on the basis of the proposals described in this document in application of Article 138 (4) and Article 139 of the Treaty establishing the European Community}


- As recognised European sectoral social partner organisation in the hospital sector, we would like to develop, on the basis of existing and future legislation on health and safety, sector-specific instruments, which would translate the minimum standards of occupational health and safety into relevant and concrete measures for the hospital workplace. These instruments could for instance provide specifications concerning the application of existing health & safety requirements, but it could also include tools and materials to facilitate health and safety policies, e.g. checklists, toolkits, handbooks, and draft procedures. We would like to work with the Commission on the Guide to prevention and good practice in the hospital and health sector, which is now in preparation. As social partner organisation, we also would like to support and develop specific awareness campaigns and express herewith our interest to be involved in any future campaigns related to the hospital sector

- In more specific terms, we are of the opinion that we could develop together with HOSPEEM as hospital sector social partners a specific interpretation of the measures as mentioned above, and create a social dialogue instrument on the prevention of infections by blood-borne diseases in the hospital sector. This instrument would support the implementation and assist social partner organisations in the interpretation of the existing measures, standards and legislation, e.g. in the acquisition of instruments and devices. We are aware of the fact that there is an economic dimension to the use of different medical and safety devices. This circumstance, however, should not prevent us making the hospital a safer workplace.



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