Introduction
This advice is intended to help employers in ensuring that they are ready and compliant once UK legislation is passed. It provides important guidance on the practical implementation of the Agreement and the Directive and should be read in conjunction with them and relevant national legislation and guidance.
Following the advice will help to achieve the safest possible working environment by preventing injuries to workers caused by all medical sharps, including needlesticks, and protecting workers at risk. The advice provides for an integrated approach, establishing policies in risk assessment, risk prevention, training, information awareness-raising and monitoring, and for response and follow-up procedures. It applies to all workers, students and subcontractors in the hospital and healthcare sector, including those who are under the managerial authority and supervision of the employers.
The advice covers the following areas:
Sharps injury
Sharps injury occurs when a needle or other sharp instrument accidentally penetrates the skin. This is also sometimes called a needlestick injury. If the needle or sharp instrument is contaminated with blood or other body fluid, there is the potential for transmission of infection with blood-borne pathogens such as HIV, hepatitis B or hepatitis C virus. This is sometimes called an inoculation injury. The term “sharps injury” will be used throughout this guidance for clarity.
Risk assessment procedures shall be conducted in compliance with articles 3 and 6 of Directive 2000/54/EC and Articles 6 and 9 of Directive 89/391/EEC. They must cover all situations where there is potential for injury or exposure to blood or other potentially infectious material. The Directive also states that any risk assessment must take into account how well resourced and organised the workplace is. The Directive also says that the employer has a duty to ensure the health and safety of workers in every aspect related to the work, including psycho-social factors and work organisation.
Directive 2000/54/EC (safety of workers exposed to biological agents) states:
- Where prevention of workers exposure is not possible, the risk of exposure must be limited to as low a level as necessary in order to adequately protect the health and safety of the workers concerned, in particular by the following measures which are to be applied in light of the results of the risk assessment:
- keeping as low as possible the number of workers likely to be exposed
- design of work processes and engineering control measures so as to avoid or minimise the release of biological agents into the workplace.
The highest risk procedures include blood collection, IV cannulation and percutaneously placed syringes. Small amounts of blood can result in potentially life threatening infection. Hollow-bore needles contain more blood and therefore carry more risk than solid needles.
Risk assessment procedures should be conducted in accordance with the Directive in order to identify how exposure could be eliminated and to consider possible alternative systems.
For further information on how to conduct a risk assessment where the use of needlesticks or sharps are involved please see the needlestick injury section of the NHS Employers health and safety essential guide. This states that risks assessments should be made in all situations where a healthcare worker may be exposed to blood or other potentially infectious material.
The Directive states that employers must comply with the hierarchy of controls as set out in European Directives 89/391 and 2000/54 (implemented in GB by the Management of Health and Safety at Work Regulations 1999 and the Control of Substances Hazardous to Health Regulations 2002). Based on Directive 2000/54, the World Health Organisation (WHO) has also set out measures to eliminate sharps injuries.
Where the results of the risk assessment reveal a risk of exposure, this should be controlled, by:
- Elimination - eliminating the unnecessary use of sharps by implementing changes in practice and on the basis of the results of the risk assessment.
- Engineering controls - providing medical devices incorporating safety-engineered protection mechanisms.
- Safe procedures - specifying and implementing safe procedures for using and disposing of sharp medical instruments and contaminated waste. The practice of recapping shall be banned with immediate effect. These procedures shall be regularly reassessed and shall form an integral part of the measures for the information and training of workers.
- Personal Protective Equipment (PPE) - the use of PPE such as gloves, masks, gowns and so on.
Directive 89/655/EEC (Minimum safety and health requirements for the use of work equipment by workers at work) (implemented in GB by the Provision and Use of Workplace Equipment Regulations 1998) in Article 3.2 says that where risk cannot be eliminated the employer shall take appropriate measures to minimise the risks.
Appropriate measures to minimise the risks would include the provision by employers of safer needle devices and sharps containers. As the Directive stipulates managers should consult with workers’ representatives on the choice and uses of such equipment, identifying how best to carry out training and awareness-raising. When considering these devices the following selection criteria should be applied:
- the device must not compromise patient care
- the device must perform reliably
- the safety mechanism must be an integral part of the safety device, not a separate accessory
- the device must be easy to use and require little change of technique on the part of the health professional
- the activation of the safety mechanism must be convenient and allow the care-giver to maintain appropriate control over the procedure
- the device must not create other safety hazards or sources of blood exposure
- a single-handed or automatic activation is preferable
- the activation of the safety mechanism must manifest itself by means of an audible, tactile or visual sign to the health professional
- the safety mechanisms should not be easily reversible once activated
In the Annex to Directive 89/655/EEC, which specifies the minimum requirements, it states:
2.8 Where there is a risk of mechanical contact with moving parts of work equipment which could lead to accidents, those parts must be provided with guards or devices to prevent access to danger zones or to halt movement of dangerous parts before danger zones are reached.
Comprehensive user training is pivotal to the introduction of safety-engineered medical devices. Experience has shown that when this is done well, in combination with safer working procedures, the implementation of the safety measures is much more effective.
Vaccination should be carried out in accordance with national law and/or practice, including the determination of the type of vaccines. Workers should be informed of the benefits and drawbacks of both vaccination and non-vaccination. Vaccination should be offered free of charge to all workers and students delivering healthcare and related activities at the workplace.
The employer should take the following appropriate measures to raise awareness amongst workers and their managers:
- To highlight the risks of handling sharps;
- To give guidance on existing legislation and local policies;
- To promote good practices and safe systems of work regarding the prevention of sharps injuries
- Promote the importance of recording sharps injuries;
- To raise awareness by developing activities and promotional materials in partnership with representative trade unions and/or workers’ representatives;
- To provide information on support programmes available.
Workers should receive training on policies and procedures associated with the prevention and management of sharps injuries. This should be part of induction for all new and temporary staff and then continue at regular intervals. Training should include:
- the correct use of medical devices incorporating sharps protection mechanisms
- the risk associated with blood and body fluid exposures
- preventative measures including standard precautions, safe systems of work (including the ban on recapping/resheathing) and, the correct use of sharps bins and disposal procedures
- the importance of immunisation and how to access immunisation services
- the reporting, response and monitoring procedures and their importance
- measures to be taken in case of injuries.
Under the Directive workers must immediately report any incident involving sharps to the employer and/or person in charge, and/or to the person responsible for safety and health at work.
Existing procedures for accident reporting involving injuries are to be adapted and revised in conjunction with health and safety representatives.
Employers should ensure that systems are in place for informing the Health and Safety Executive and the Health Protection Agency of sharps injuries where the source patient is known to be infected, or the worker develops an infectious disease following a sharps injury.
Where an injury involving a sharp occurs the employer should:
- take immediate steps for the care of the injured worker, including the provision of post-exposure prophylaxis and the necessary medical tests
- provide appropriate health surveillance
- investigate the causes and circumstances of the incident
- ensure systems are in place to record the incident
- provide counselling support for the injured worker.
The employer should ensure that systems are in place to monitor the effectiveness of local policies and procedures, such as by providing regular reports on numbers and analysis of sharps injuries to the appropriate health and safety committees.
Following the results of monitoring, policies, procedures and training should be regularly reviewed in consultation with workers and their representatives.
The principles which should be observed when taking action include:
- the vital role of a well-trained, adequately resourced and secure workforce in preventing risks
- that employers and workers' representatives shall work together at the appropriate level to eliminate and prevent risks, protect workers´ health and safety, and create a safe working environment, including consultation on the choice and use of safe equipment, identifying how best to carry out training, information and awareness-raising processes. Under UK Health and Safety legislation employers must consult with safety representatives in good time about any measure, which may affect the health and safety of the employees that they represent. Safety representatives must also be consulted at all stages of risk assessment planning and implementation. For more information on their role it is recommended to read the NHS Staff Council Occupational Health and Safety Standards the responsibility of each worker to take care of his or her own safety and the duty of the employer to ensure the health and safety of workers in every aspect relating to their work
- to never assume that no risks exist
- the hierarchy of measures concerning the safety and health protection of workers in the Directive, i.e. to avoid risk, to evaluate remaining risks which cannot be avoided, to combat risks at source and to reduce risks to a minimum
- the importance of a combination of several measures for achieving the safest possible workplace environment
- promoting a ‘no blame’ culture. Incident reporting should focus on systemic factors rather than individual mistakes and systematic reporting must be considered as accepted procedure.
The European social partners in the hospital and healthcare sector, HOSPEEM (European Hospital and Healthcare Employers' Association) and EPSU (European Public Services Union) signed a Europe-wide framework agreement (the Agreement) on the prevention of sharps injuries on 17 July 2009, which has been incorporated into the proposal for a Council Directive (the Directive) – COM (2009) 577 final (26 October 2009) which was adopted by the Council of Ministers on 8 March 2010.
The Agreement and the Directive recognise that the everyday work of healthcare staff puts them at risk of serious infections, with more than 30 potentially dangerous pathogens, including hepatitis B, hepatitis C and HIV, as a result of needlestick injuries. Needlestick injuries are a very serious occupational hazard for healthcare workers. More than one million needlestick injuries are estimated to occur in the European Union each year. Needlestick injuries are one of the most common and serious risks to healthcare workers in Europe and represent a high cost for health systems and society in general. Additionally, the emotional impact of sharps injury can be severe and long lasting, even when a serious infection is not transmitted. Healthcare workers and their families can suffer many months of anguish as they wait to discover whether they have contracted a potentially fatal infection.
Each Member State is required to bring into force national legislation to implement the Directive within the next three years. The Agreement and the Directive will contribute to achieving the safest possible working environment in the hospital and healthcare sector and are binding between employers and workers. The Agreement and the Directive provide the framework to put in place and implement adequate and practical preventative measures in anticipation of the publication of the requested national legislation. National implementation negotiations should begin immediately so that serious occupational risks are reduced as soon as possible.
In implementing this Directive in the UK the guidance should be read in conjunction with: