Health and Safety

Executive

Health and Safety (Sharp Instruments in

Healthcare) Regulations 2013
Guidance for employers and employees

HSE information sheet Health Services Information Sheet 7

This information sheet is for healthcare employers The main healthcare employer and their contractors
and employees. It will help you understand your must co-operate and share information to ensure
legal obligations under the Health and Safety (Sharp that risks of sharps injuries are adequately controlled
Instruments in Healthcare) Regulations 2013 (the and that they have the appropriate arrangements
Sharps Regulations). to comply with the Sharps Regulations, as required
by the Management of Health and Safety at Work
The Regulations implement aspects of the European Regulations 1999.
Council Directive 2010/32/EU (the Sharps Directive)
that are not specifically addressed in existing GB For most healthcare employers and their contractors
legislation. They will apply from 11 May 2013. it will be clear that the Regulations apply to them. The
Annex at the end of this information sheet provides
All employers are required under existing health and examples where further clarification is likely to be
safety law to ensure that risks from sharps injuries helpful.
are adequately assessed and appropriate control
measures are in place. The Sharps Regulations
build on the existing law and provide specific detail How do the Sharps Regulations change
on requirements that must be taken by healthcare my responsibilities for managing the
employers and their contractors. risks from the use of sharps?

This information sheet should be read in conjunction Effective safe management of sharps, across all
with other information on managing the risks of sharps sectors, flows from the existing health and safety
injuries, and the associated risks of infection from legislation. In particular, the needs to assess the
blood-borne viruses. HSE guidance and links to other risks, provide appropriate information and training,
and consult with employees. The Sharps Regulations
relevant guidance can be found on HSE’s website.
build on the existing law and provide specific detail
on requirements that must be taken by healthcare
employers and their contractors. These are:
Which employers must take action on
the Sharps Regulations? - regulations 3 Use and disposal of medical sharps
and 4 The Sharps Regulations follow the principles of the
hierarchy of preventative control measures, set out
The employer’s duties in the Sharps Regulations only in the Control of Substances Hazardous to Health
apply if you are either: Regulations (COSHH). However, they require that
employers consider the additional risk control
■■ an employer whose primary work activity is measures below:
the management, organisation or provision of
healthcare (a healthcare employer); or Avoid the unnecessary use of sharps – regulation
■■ a contractor working for a healthcare employer and 5(1)(a)
your staff may be at risk of a sharps injury while on Needles, scalpels etc will remain essential tools
the premises of or working under the management for effective medical care. However, the employer
and supervision of the healthcare employer (for should ensure that sharps are only used where they
example laundry workers, caretakers, cleaners, are required. For example, organisations that have
waste disposal workers, bank nurses and locum reviewed the use of sharps have identified staff using
doctors). However, a contractor’s duties will only needles to carry out tasks for which they are not
apply to the extent of their control of work involving required (for example collection of urine samples from
medical sharps. catheter bags). Needle-free equipment is available for
certain procedures and should be used, where it is
reasonably practicable to do so.

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Where it is not reasonably practicable to avoid help ensure that they use the new equipment safely,
the use of medical sharps, the Sharps Regulations and any reduction in the number of sharps injuries is
require employers to: maintained for longer.

Use safer sharps (incorporating protection If a suitable safer sharp is not available to reduce the
mechanisms) – regulation 5(1)(b) risk of injury, the employer should ensure that safe
The employer must substitute traditional, unprotected procedures for working with and disposal of the sharp
medical sharps with a ‘safer sharp’ where it are in place.
reasonably practicable to do so. The term ‘safer
sharp’ means medical sharps that incorporate features In some circumstances, patients may provide needles
or mechanisms to prevent or minimise the risk of (for example, for administration of insulin) which they
accidental injury. For example, a range of syringes expect a healthcare worker to use and the employer
and needles are now available with a shield or cover has not had an opportunity to ensure that it is a
that slides or pivots to cover the needle after use. The suitable ‘safer sharp’. The employer’s risk assessment
following factors should be considered: should identify if their employees may be faced with
such a request, and make arrangements to ensure
■■ the device must not compromise patient care; that employees have safe systems of work and the
■■ the reliability of the device; appropriate information, training and equipment to
■■ the care-giver should be able to maintain deal with this situation.
appropriate control over the procedure;
■■ other safety hazards or sources of blood exposure Prevent the recapping of needles – regulation 5(1)(c)
that use of the device may introduce; Injuries can occur after a needle has been used if the
■■ ease of use (taking into account the existing clinical healthcare worker holds the needle in one hand and
practices commonly in use by the relevant health attempts to place a cap on the needle with the other
professionals – but not assuming custom and hand (so-called two-handed recapping).
practice is safest);
■■ is the safety mechanism design suitable for the Needles must not be recapped after use unless
application? The following are relevant: the employer’s risk assessment has identified
–– if activation of the safety mechanism is that recapping is itself required to prevent a risk
straightforward, it is more likely to be used; (eg to reduce the risk of contamination of sterile
–– if the safety mechanism is integral to the device preparations). In these limited cases, appropriate
(ie not a separate accessory) it cannot be lost or devices to control the risk of injury to employees must
misplaced; be provided. For example, needle-blocks can be used
–– for many uses a single-handed or automatic to remove and hold the needle cap and so allow safe
activation will be preferable; one-handed recapping.
–– an audible, tactile or visual signal that the safety
mechanism has correctly activated is helpful to Place secure containers and instructions for safe
the user; and disposal of medical sharps close to the work area –
–– the safety mechanism is not effective if it is easily regulation 5(1)(d)
reversible. Regulation 7(6)(c) of COSHH requires systems to
dispose of contaminated waste safely. The Sharps
‘Safer sharps’ do not necessarily remove all risks Regulations supplement this by requiring that clearly
associated with the use of a sharp. For example, marked and secure containers be placed close to the
a needle shield is activated after a procedure is areas where medical sharps are used. Instructions for
completed, but a sharps injury to the healthcare staff on safe disposal of sharps must also be placed in
worker can occur during the procedure (eg when a those areas.
patient moves unexpectedly) and a ‘safer sharp’ will
not prevent this. In many healthcare facilities sharps bins can be placed
next to the healthcare worker so they can drop the
For some procedures, there may be more than one used sharp straight into it. For example, in wards this
person involved in handling, sterilising or otherwise can be achieved by placing the sharps container on
dealing with the sharps. The employer’s COSHH risk the dispensing trolley.
assessment should consider all these aspects, and
identify the appropriate equipment, safe procedures, However, some healthcare workers do not operate
personal protective equipment (PPE) and immunisation in premises in which they have control, for example
required at each stage. paramedics or healthcare workers working in a
patient’s home. In these cases, the employer’s risk
Involving the end users of the equipment and their assessment should select appropriate sharps, specify
representatives in the selection of safer sharps will safe working procedures and provide suitable portable

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sharps containers and means for collection and specific actions in the event of a sharps injury. This
replacement of those. means they need to have procedures in place to
ensure that they can respond effectively and in a
timely manner when an injury occurs.
Information and training
Injured employee’s duty to notify their employer of
The Sharps Regulations supplement existing a sharps accident – regulation 8
requirements to provide health and safety information An employee who receives a sharps injury at work
and training for staff by requiring that it includes must notify their employer as soon as practicable. The
those matters listed below (from Schedule 1 and 2 of employer will need to ensure they have sufficiently
the Sharps Regulations), to the extent that they are robust arrangements to allow employees to notify
relevant to the employee’s work. them in a timely manner, including where the
employee works out-of-office hours or away from the
The information provided to employee – employer’s premises.
regulation 6
Information may be provided in many forms, including As set out above, an employee’s training must be
safe operating systems, safety guides, posters, clear about the requirements for notifying and on the
information on internal staff websites. The employer employer’s procedures for follow-up. This will include
must work with any appointed safety representatives who and how they should notify and what information
in developing and promoting the information to is likely to be useful.
be given to workers (regulation 6(2) and (3)). This
provision recognises the role of union and other safety Recording and investigating the incident –
representatives in helping to raise awareness of the regulation 7(1)
risks from medical sharps. Employers must make a record of the sharps injury
when they are notified of it, whoever provides that
The information provided to employees must cover: notification. They must investigate the circumstances
and causes of the incident and take any action
■■ the risks from injuries involving medical sharps; required. The injured person is required to provide
■■ relevant legal duties on employers and workers; sufficient information to their employer to allow them
■■ good practice in preventing injury; to carry out this investigation.
■■ the benefits and drawbacks of vaccination; and
■■ the support available to an injured person from The record of the injury should include who was
their employer (see requirements on accident injured, and when and where the incident occurred. If
follow-up below). possible, the summary record should contain sufficient
detail to identify what type of sharp was involved, at
Employee training – regulation 6(4) what stage of a procedure or post-procedure/disposal
Training should be in an appropriate form to of the sharp the injury occurred, and the severity of
ensure that your employees know how to work the injury. If the employer has an existing accident
safely and without risks to health with the specific book or other recording system, it will be appropriate
sharps equipment and procedures that they will to use this for the record of sharps injuries.
use. Guidance on ensuring that employees receive
appropriate health and safety training is available in The extent of the accident investigation should be
Health and safety training: A brief guide INDG345 proportionate to the potential severity of the incident.
([Link]/pubns/[Link]). For example, where an employee has injured
themselves with a clean needle as they take it out of
Under the Sharps Regulations, the training provided to the packet it will usually be sufficient to record the
employees must cover: details and ensure they receive any first aid required.
Injuries involving a used needle will involve more
■■ the correct use of safer sharps; analysis and an appropriate record should be kept of
■■ safe use and disposal of medical sharps; and the findings of the investigation.
■■ what to do in the event of a sharps injury (see
requirements on accident follow-up below); The purpose of the investigation should be to establish
■■ the employer’s arrangements for health surveillance whether the employer’s existing risk control measures
and other procedures. are adequate. It should look at underlying and root
causes as well as the immediate factors that led to the
individual incident. Investigations should be conducted
Arrangements in the event of injury with accident prevention in mind, not placing blame.
An investigation of a significant sharps injury may
The Sharps Regulations require employers to take involve expertise from health and safety, occupational

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health and infection control teams (where available). as any successful health and safety management
Any lessons to be learned should be applied across regime, including reviewing procedures to ensure their
an organisation (if appropriate), not just in the location continuing effectiveness. However, the Regulations
or department where the accident occurred. specifically require employers to review, at suitable
intervals, the procedures that are in place to
In the case of an injury where there may have implement the following risk control measures:
been exposure to a blood-borne virus or other
significant infection, the investigation may also ■■ use of medical sharps at work is avoided so far as
involve establishing the infection status of the source is reasonably practicable;
patient (where it is possible to identify the individual). ■■ when medical sharps are used at work, safer
If this information is known, it should be handled in sharps are used so far as is reasonably practicable;
accordance with appropriate requirements for patient ■■ needles that are medical sharps are not capped
confidentiality. If it is promptly shared with the medical after use at work unless the risk of injury to
professional who is treating the injured person, it employees is effectively controlled by use of a
can greatly assist with ensuring they receive the suitable appliance, tool or other equipment;
right treatment or that they do not take unnecessary ■■ in relation to the safe disposal of medical sharps
prophylaxis or anti-viral treatments. that are not designed for re-use:
–– written instructions are available for employees;
Treatment and follow-up of a sharp injury – and
regulation 7(2) –– clearly marked and secure containers are located
The employer must ensure that, when notified of any close to areas where medical sharps are used at
incident in which an employee has been injured by a work.
sharp that has or may have exposed them to a blood-
borne virus, the employee: A suitable review would involve gathering information
on:
■■ has immediate access to medical advice;
■■ has been offered post-exposure prophylaxis and ■■ the degree of compliance with the relevant
any other medical treatment, as advised by a procedures (if the procedures are not being
doctor; and followed there is usually a reason why, such as lack
■■ the employer has considered whether counselling of training, or a genuine practical problem with the
would be appropriate for the employee. procedure itself);
■■ any areas where procedures are absent or
Advice for doctors on the appropriate treatment and inadequate. New ‘safer sharps’ may have become
follow-up for an exposure to blood-borne viruses, available for certain applications or guidance may
including current post-exposure prophylaxis regimes, have been issued from a relevant authoritative
is provided by the Department of Health. body;
■■ consultation with the relevant staff and their
In some circumstances, an occupational health nurse representatives; and
or other suitably qualified and supervised practitioner ■■ injury and incident data.
may provide the assessment and treatment for an
employee injured by a sharp. This service will be
adequate to comply with the requirement for the
advice to be provided by a doctor if:

■■ it is provided within a practice supervised by a

registered medical practitioner; and
■■ it is carried out in accordance with the appropriate
established operating procedure of that practice.

If staff work out-of-hours and/or on premises where

there is not an occupational health service available to
them, the employer must ensure they have sufficiently
robust arrangements that will allow employees to
access treatment in a timely manner. The training they
provide staff should be clear as to where they should
go for treatment.

Review procedures regularly – regulation 5(2)

The Sharps Regulations follow the same principles

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Annex: Further clarification on when the Clinical placement, student assistantship, elective,
Health and Safety (Sharp Instruments in internship or other workplace training
Healthcare) Regulations 2013 apply The employment status of an individual student or
trainee while they are on placement in a hospital or
The following have been raised as examples where other healthcare premises will depend on their exact
some further clarification of the application of the circumstances. The Regulations will apply to the
Sharps Regulations would be helpful. However, it is healthcare employer who is responsible for providing
important to remember that existing legal requirements their training. If there is no employment the student is
still apply, whether or not the Sharps Regulations deemed to be an employee of the employer providing
apply. For example, the need to follow the COSHH the training by virtue of the Health and Safety (Training
hierarchy. for Employment) Regulations 1990.

Contractors Employers and the medical school/academic

A contractor whose employees work at different institution will need to exchange information to
times at healthcare premises and non-healthcare ensure that the risks to the students are adequately
premises (for example, a cleaning firm) is not required controlled. The academic institution is not required to
to comply with the Sharps Regulations when their comply with the Regulations at the premises of the
staff are working at a non-healthcare premises (eg an school or other academic institution itself.
office). However, the existing requirements to ensure
risks from sharps injuries are controlled apply. This Clinical trials in the pharmaceutical sector
means that if cleaners at non-healthcare premises Clinical trials cover a wide range of studies, some of
may encounter drug litter or other unsafely disposed which involve sharps, for example injections of a trial
of used needles, the employer should assess the risk pharmaceutical or collection of blood samples.
and provide the appropriate controls.
Where employees of a healthcare employer (whether
Healthcare workers providing care to people at in a hospital or other premises) carry out trials involving
their homes sharps on behalf of a clinical research organisation/
The Regulations apply to employers whose primary pharmaceutical company the Regulations will apply.
activity is to organise, manage and provide healthcare,
including where their employees provides care for Where employees of a pharmaceutical company
people in their own homes. They do not place any or research organisation carry out trials, the main
duties on the person receiving care, their family activity of their employer is not the management,
members/cohabitees or their appointed attorney. The organisation or provision of healthcare and therefore
employer’s risk assessments and arrangements to the Regulations will not apply. However, if they enter
comply with the Regulations will need to take account healthcare premises to carry out the trial, especially if
of the circumstances that their employees work in, they make use of the host’s facilities (eg sharps waste
including arrangements for any lone workers. disposal), the requirements of the existing legislation to
co-operate and exchange information will apply.
Residential care homes
Whether the Regulations apply will depend on the Pharmacies
nature of the care provided by the home. They will High-street pharmacies are primarily retail businesses
apply if the primary purpose of the home is to provide so the Regulations do not apply. However, if the
healthcare. They will not apply if the main purpose of primary activity of a community pharmacy is to provide
the home is limited to only providing residential care. healthcare then the Regulations will apply. Pharmacies
The residents of either type of home will not have any that are part of a hospital and/or an NHS-run service
duties under the Regulations. will be employed by a healthcare employer and the
Regulations will apply to them.
Bank nurses and other agency workers contracted
to work in healthcare Medical staff working in prisons, schools or other
The employment status of an individual bank non-healthcare workplaces
nurse or agency worker will depend on their exact If an employer’s primary activity is the management,
circumstances. However, if they are employed by organisation or provision of healthcare it does not
an employer whose main activity is the provision of matter where their staff work, these Regulations will
healthcare or they are employed by an agency that apply. For example, the Regulations will apply:
provides services to that main healthcare employer,
the Regulations will apply to risks of sharps injuries ■■ in Scotland, to medical staff providing care in
that arise from their work. prisons employed by NHS Scotland;

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■■ medical staff employed by an independent medical

service who provide primary and occupational
healthcare to workers on offshore platforms;
■■ a healthcare business supplies an occupational
health nurse to attend a non-healthcare
company’s premises to administer vaccinations
for the company’s employees, the healthcare
business will be subject to the Regulations, but
the company will not;

while the Regulations will not apply to the following:

■■ school nurses employed directly by the school;

■■ medical staff providing care in prisons, employed
by the prison itself.

Non-healthcare contractors to a healthcare

employer
Businesses that are contracted to provide non-
healthcare services to healthcare employers, such as
catering and building or plant maintenance, will only
be required to act if those who work for them on the
healthcare employer’s premises may be exposed to
medical sharps while they are working there.

Such a risk should have been identified in a risk

assessment. The term ‘medical sharps’ does not
include kitchen knives or utility knives, as these are not
used to carry out specific healthcare.

Further information

For further information on managing the risks from

sharps injuries, general health and safety advice, or to
report inconsistencies or inaccuracies in this guidance,
visit [Link]/. You can view HSE guidance
online and order priced publications from the website.
HSE priced publications are also available from
bookshops.

This guidance is issued by the Health and Safety

Executive. Following the guidance is not compulsory,
unless specifically stated, and you are free to take
other action. But if you do follow the guidance you
will normally be doing enough to comply with the
law. Health and safety inspectors seek to secure
compliance with the law and may refer to this
guidance.

This publication is available at:

[Link]/pubns/[Link].

You can find more advice at:

[Link]/healthservices/[Link].

© Crown copyright If you wish to reuse this

information visit [Link]/[Link] for
details. First published 03/13.

Published by the Health and Safety Executive HSIS7 03/13 6 of 6 pages