Sharps instruments in healthcare regulations

EC Directive 2010/32/EU (the Sharps Directive) is focused on eliminating, as far as possible, the risk of injury or infection to healthcare workers from medical sharps and was implemented into country law by all European Union (EU) Member States on 11 May 2013. The UK has incorporated the EU Directive into national law by producing the Health and Safety Executive (HSE) document: Health and Safety (Sharp Instruments in Healthcare) Regulations 2013. The Regulations build on existing law and provide specific details on requirements that must be undertaken by healthcare employers and contractors. An excerpt from the Regulations is given here.

The employer’s duties in the Sharps Regulations only apply if you are either:

• an employer whose primary work activity is the management, organisation or provision of healthcare (a healthcare employer); or
• a contractor working for a healthcare employer and your staff may be at risk of a sharps injury while on the premises of or working under the management and supervision of the healthcare employer (for example, laundry workers, caretakers, cleaners, waste disposal workers, bank nurses and locum doctors). However, a contractor’s duties will only apply to the extent of their control of work involving medical sharps. The main healthcare employer and their contractors must cooperate and share information to ensure that risks of sharps injuries are adequately controlled and that they have the appropriate arrangements to comply with the Sharps Regulations, as required by the Management of Health and Safety at Work Regulations 1999. For most healthcare employers and their contractors, it will be clear that the Regulations apply to them.

Effective safe management of sharps, across all sectors, flows from the existing health and safety legislation. In particular, the needs to assess the risks, provide appropriate information and training, and consult with employees. The Sharps Regulations build on the existing law and provide specific detail on requirements that must be taken by healthcare employers and their contractors.

These are:

The Sharps Regulations follow the principles of the hierarchy of preventative control measures, set out in the Control of Substances Hazardous to Health Regulations (COSHH). However, they require that employers consider the additional risk control measures below:

Needles, scalpels, etc, will remain essential tools for effective medical care. However, the employer should ensure that sharps are only used where they

are required. For example, organisations that have reviewed the use of sharps have identified staff using needles to carry out tasks for which they are not required (for example collection of urine samples from catheter bags). Needle-free equipment is available for certain procedures and should be used, where it is reasonably practicable to do so.

Where it is not reasonably practicable to avoid the use of medical sharps, the Sharps Regulations require employers to:

The employer must substitute traditional, unprotected medical sharps with a ‘safer sharp’ where it reasonably practicable to do so. The term ‘safer sharp’ means medical sharps that incorporate features or mechanisms to prevent or minimise the risk of accidental injury. For example, a range of syringes and needles are now available with a shield or cover that slides or pivots to cover the needle after use. The following factors should be considered:

• the device must not compromise patient care;
• the reliability of the device;
• the care-giver should be able to maintain appropriate control over the procedure;
• other safety hazards or sources of blood exposure that use of the device may introduce;
• ease of use (taking into account the existing clinical practices commonly in use by the relevant health professionals – but not assuming custom and practice is safest);
• is the safety mechanism design suitable for the application? The following are relevant:

- if activation of the safety mechanism is straightforward, it is more likely to be used;

- if the safety mechanism is integral to the device

(that is, not a separate accessory) it cannot be lost or

misplaced;

- for many uses a single-handed or automatic activation will be preferable;

- an audible, tactile or visual signal that the safety mechanism has correctly activated is helpful to the user; and

– the safety mechanism is not effective if it is easily reversible.

Safer sharps’ do not necessarily remove all risks associated with the use of a sharp. For example, a needle shield is activated after a procedure is completed, but a sharps injury to the healthcare worker can occur during the procedure (for example, when a patient moves unexpectedly) and a ‘safer sharp’ will not prevent this.

For some procedures, there may be more than one person involved in handling, sterilising or otherwise dealing with the sharps. The employer’s COSHH risk assessment should consider all these aspects, and identify the appropriate equipment, safe procedures, personal protective equipment and immunisation required at each stage. Involving the end users of the equipment and their representatives in the selection of safer sharps will help ensure that they use the new equipment safely, and any reduction in the number of sharps injuries is maintained for longer. 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. In some circumstances, patients may provide needles (for example, for administration of insulin) which they expect a healthcare worker to use and the employer has not had an opportunity to ensure that it is a suitable ‘safer sharp’. The employer’s risk assessment should identify if their employees may be faced with such a request, and make arrangements to ensure that employees have safe systems of work and the appropriate information, training and equipment to deal with this situation.

Injuries can occur after a needle has been used if the healthcare worker holds the needle in one hand and attempts to place a cap on the needle with the other hand (so-called two-handed recapping). Needles must not be recapped after use unless the employer’s risk assessment has identified that recapping is itself required to prevent a risk (for example, to reduce the risk of contamination of sterile preparations). In these limited cases, appropriate devices to control the risk of injury to employees must be provided. For example, needle-blocks can be used to remove and hold the needle cap and so allow safe one-handed recapping.

Regulation 7(6)(c) of COSHH requires systems to dispose of contaminated waste safely. The Sharps Regulations supplement this by requiring that clearly marked and secure containers be placed close to the areas where medical sharps are used. Instructions for staff on safe disposal of sharps must also be placed in those areas. In many healthcare facilities, sharps bins can be placed next to the healthcare worker so they can drop the used sharp straight into it. For example, in wards, this can be achieved by placing the sharps container on the dispensing trolley. However, some healthcare workers do not operate in premises in which they have control, for example, paramedics or healthcare workers working in a patient’s home. In these cases, the employer’s risk assessment should select appropriate sharps, specify safe working procedures and provide suitable portable sharps containers and means for collection and replacement of those.

The Sharps Regulations supplement existing requirements to provide health and safety information and training for staff by requiring that it includes those matters listed below (from Schedule 1 and 2 of the Sharps Regulations), to the extent that they are relevant to the employee’s work.

Information may be provided in many forms, including safe operating systems, safety guides, posters, information on internal staff websites. The employer must work with any appointed safety representatives in developing and promoting the information to be given to workers (regulation 6(2) and (3)). This provision recognises the role of union and other safety representatives in helping to raise awareness of the risks from medical sharps.

The information provided to employees must cover:

• the risks from injuries involving medical sharps;
• relevant legal duties on employers and workers;
• good practice in preventing injury;
• the benefits and drawbacks of vaccination; and
• the support available to an injured person from their employer.

Training should be in an appropriate form to

ensure that your employees know how to work

safely and without risks to health with the specific

sharps equipment and procedures that they will

use. Guidance on ensuring that employees receive

appropriate health and safety training is available in

Health and safety training: A brief guide

INDG345 (www.hse.gov.uk/pubns/indg345.htm).

Under the Sharps Regulations, the training provided to

employees must cover:

• the correct use of safer sharps;
• safe use and disposal of medical sharps; and
• what to do in the event of a sharps injury;
• the employer’s arrangements for health surveillance
• and other procedures.