Last reviewed 3 May 2013
From the 11 May 2013, all healthcare employers will have to implement the new Health and Safety (Sharp Instruments in Healthcare) Regulations 2013.
What do the new regulations cover and how can primary care providers ensure that they are complying with the new law?
Why were the new Regulations introduced?
The new regulations have been on the legislative horizon for some time and have been introduced following widespread concern about the incidence of injuries and illness following accidents involving medical “sharps”, typically needles and blades such as scalpels.
Back in 2011, the European Hospital and Healthcare Employers' Association and European Public Services Unions supported the development of a new directive by the European Parliament on the prevention of sharp injuries in the hospital and healthcare sectors. EU Member States were given three years to implement the requirements of the directive.
The main aims of the agreement are:
to achieve the safest possible working environment
to prevent workers’ injuries caused by medical sharps
to protect workers at risk
to set up an integrated approach establishing policies in risk assessment, risk prevention, training, information, awareness raising and monitoring
to put in place response and follow-up procedures.
The social partners involved, represented in England by the NHS Staff Council, welcomed the agreement and made NHS organisations aware of its content and encouraged them to start working towards compliance.
The new Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 (the Sharps Regulations) were subsequently laid before Parliament and implement aspects of the European Council Directive 2010/32/EU (the Sharps Directive) that were not already specifically addressed in existing UK legislation.
Existing health and safety law, such as the Management of Health and Safety at Work Regulations 1999, require employers to ensure that workplace risks are adequately assessed and appropriate control measures are in place. In addition, the Control of Substances Hazardous to Health Regulations 2002 (COSHH), requires employers to identify any exposure to substances hazardous to health, assess the risks and put measures in place to prevent or reduce and control the exposure.
The Sharps Regulations build on these duties and provide specific detail on requirements that must be taken by healthcare employers and their contractors.
Who do the regulations apply to?
The Sharps Regulations apply to:
employers whose primary work activity is the management, organisation or provision of healthcare
contractors working for a healthcare employer.
In the case of the latter, a contractor’s duties only apply to the extent of their control of work involving medical sharps. The healthcare employer and their contractors must co-operate and share information to ensure that risks are adequately controlled.
What guidance has been produced?
Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 — Guidance for Employers and Employees, has been published as Health Services Information Sheet (HSIS) 7 by the Health and Safety Executive (HSE).
Advice was also produced by the Royal College of Nursing in 2011: Sharps Safety — Guidance to Support Implementation of the EU Directive 2010/32/EU on the Prevention of Sharps Injuries in the Health Care Sector.
What do the new Regulations cover?
The main provisions in the Sharps Regulations for reducing the risks involved in the use of medical sharps should be familiar to those employing current good practice. The provisions state that employers should:
avoid the unnecessary use of sharps where possible
where it is not reasonably practicable to avoid the use of medical sharps, to:
use safer sharps
prevent the recapping of needles
place secure containers and instructions for safe disposal of medical sharps close to the work area.
These measures to prevent sharps injuries are based on the hierarchy of controls used widely in EU health and safety directives. Used in conjunction with suitable risk assessment, the hierarchy provides an effective framework for reducing risks and is based upon the principle that the elimination or substitution of a risk or hazard is always the safest and most effective measure to take. Where a risk cannot be eliminated or substituted entirely — and it is unlikely that the use of needles and blades can ever be eliminated altogether from health care — then the next most effective measure is to introduce “engineering” or physical controls, for example, safer needle devices and sharps containers. Next in the hierarchy are administrative aspects such as policies, training and set work practices, and lastly is the provision of personal protective equipment.
Avoiding the unnecessary use of sharps
The regulations acknowledge that sharps such as needles and scalpels will remain essential tools for effective medical care but regulation 5 requires an employer to ensure they are only used where their use cannot be avoided. Needle-free equipment, the HSE points out, is becoming increasingly available for certain procedures and should be used wherever it is reasonably practicable to do so.
Using “safer” sharps
Where it is not reasonably practicable to avoid the use of medical sharps, the Sharps Regulations require employers to substitute traditional, unprotected medical sharps with modern “safer” sharps wherever possible. Such equipment is designed to prevent or minimise the risk of accidental injury, for example, syringes and needles which are fitted with a shield or cover that covers the needle automatically after use.
The HSE guidance states that, when thinking about the use of such devices, the following factors should be considered.
The device must not compromise patient care.
The device should be reliable.
The care-giver should be able to maintain appropriate control over the procedure.
Whether other safety hazards or sources of blood exposure are introduced.
Ease of use.
Suitability of the safety mechanism design for the application.
The HSE guidance points out that if activation of the safety mechanism is straightforward, it is more likely to be used and if the safety mechanism is integral to the device (ie not a separate accessory) it is less likely to be lost or misplaced. For many uses the guidance acknowledges that:
a single-handed or automatic activation will be preferable
an audible, tactile or visual signal that the safety mechanism has correctly activated is helpful.
The HSE guidance reminds employers that “safer sharps” do not necessarily remove all risks associated with the use of a sharp. They provide an example of a needle shield activated after a procedure is completed, but state that a sharps injury to a healthcare worker can occur at any point in the procedure before this.
Involving the users of the equipment and their representatives in the selection of safer sharps is recommended by HSE to help ensure that any new equipment is used safely.
Preventing the recapping of needles
According to the new regulations, if a suitable safer sharp is not available to reduce the risk of injury, the employer should ensure that safe procedures for working with and disposal of the sharp are in place. The regulations specify that this should include preventing the recapping of needles.
Recapping, or resheathing, needles after use, is a particularly dangerous practice as it can easily lead to a needlestick injury and risk of blood borne infection. Health care employers should ensure they have policies in place which state that needles must not be recapped after use unless a risk assessment has identified that recapping is required as the only way to prevent a risk, such as contamination of sterile preparations.
In these limited cases the HSE guidance states that appropriate devices to control the risk of injury to employees must be provided, such as needle-blocks which can be used to remove and hold the needle cap and so allow safe one-handed recapping.
Containers and instructions for safe disposal of medical sharps
The Sharps Regulations supplement requirements made under COSHH require that clearly marked and secure waste containers — often referred to as sharps boxes or bins — should be placed close to areas where medical sharps are used. Instructions for staff on the safe use of the boxes should be provided.
Staff working in a patient’s home, as is often the case in primary care, should be properly assessed to ensure that they have safe working procedures which may include suitable portable sharps containers.
Arrangements in the event of an injury
Typical accidents involving medical sharps include so-called “needlestick” accidents where the skin is punctured by a potentially infected or contaminated needle. It is important that such incidents in which staff are exposed to blood are managed and followed-up correctly.
The Sharps Regulations require employers to take certain specific actions in response to such an incident.
For example, regulation 8 states that an employer must have sufficiently robust arrangements in place to allow an employee who receives a sharps injury at work to notify their employer as soon as practicable. Arrangements must cover situations where the employee works out-of-office hours or away from the employer’s premises, for example, in patients’ homes.
All employees should be informed about the reporting procedures and told who to contact and when.
Upon notification an employer must make a record of the injury and investigate the circumstances and causes. The record should include who was injured and when and where the incident occurred. HSIS 7 states that, where possible, the summary record should contain sufficient detail to identify what type of sharp was involved, at what stage of a procedure or post-procedure/disposal of the sharp the injury occurred, and the severity of the injury.
The extent of the accident investigation should be proportionate to the potential severity of the incident and should enable the employer to determine if existing control measures are adequate. Any necessary safety actions arising from the investigation should be fully implemented.
In the case of an injury where there may have been exposure to a blood-borne virus or other significant infection, the HSE states that any investigation may also involve establishing the infection status of the source patient, if possible.
Regulation 7 states that the employer must ensure that, when notified of any incident in which an employee has been injured by a sharp that has or may have exposed them to a bloodborne virus, the employee has immediate access to medical advice and is offered appropriate post-exposure prophylaxis. The employer should also consider whether counselling is required for the employee.
Information and training
Regulation 6 of the new legislation states that an employer must provide each employee who is exposed to a risk of injury at work from medical sharps with information and training.
Schedule 1 of the regulations specifies that information provided to employees must cover:
risks from injuries involving medical sharps
relevant legal duties on employers and workers
good practice in preventing injury
the benefits and drawbacks of vaccination
support available to an injured person from their employer.
Information may be provided in many forms, such as policies, safety guides and posters. It can also be included on staff websites.
Regulation 6 requires the employer to work with any appointed safety representatives in developing and promoting the information.
Under Schedule 2 of the Sharps Regulations, the training provided to employees must cover:
the safe use and disposal of medical sharps
the correct use of safer sharps
what to do in the event of a sharps injury
the employer’s arrangements for health surveillance.
Reviewing policies and procedures
The Sharps Regulations specifically require employers to review, at suitable intervals, the procedures that are in place to implement the following risk control measures to ensure that:
the use of medical sharps at work is avoided so far as is reasonably practicable
when medical sharps are used at work, safer sharps are used so far as is reasonably practicable
needles are not recapped after use at work unless the risk of injury to employees is effectively controlled by use of a suitable appliance, tool or other equipment
in relation to the safe disposal of medical sharps that are not designed for re-use:
written instructions are available for employees
clearly marked and secure containers are located close to areas where medical sharps are used at work.
The HSE guidance states that a suitable review would involve gathering information on:
the degree of compliance with the relevant procedures
any areas where procedures are absent or inadequate
consultation with relevant staff and their representatives
injury and incident data.
Complying with the Regulations
GP practices will typically have existing sharps and infection control policies and procedures in place. These should be reviewed with reference to the Sharps Regulations and practice staff made aware of their legal duties in this important area. Senior staff and doctors should demonstrate commitment to the implementation of revised policies, and risk assessments should be reviewed and any necessary improvement measures taken.
Where necessary the practice should assess the need to implement further control measures, including “safer” devices and ensure adequate resources are available to support the purchase and introduction of new safety measures.
Senior staff should work with staff representatives wherever possible and consult as necessary. Any necessary training or information should be provided and staff should be made familiar with revised policies, particularly on the need to prevent the recapping of needles and relating to the safe use of sharps containers.
Health and safety law is criminal law and health care organisations can be subject to enforcement action if they fail to comply with the legal requirements.