Arrangements for liaison between the Health and Safety
Executive (HSE) and the Medicines and Healthcare Products
Regulatory Agency (MHRA), Medical Devices Division
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Foreword
The aim of this agreement is to describe and promote effective working
arrangements between the Health and Safety Executive (HSE) and the
Medical Devices Division of the Medicines and Healthcare products
Regulatory Agency (MHRA). This agreement does not cover the Medicines
Division of the MHRA.
Good working relationships are particularly important with investigation and
enforcement activity - to enable serious incidents to be investigated efficiently
and with pace. We are making progress in this regard, with the MHRA
recently becoming a signatory to the Work Related Deaths Protocol (WRDP)
for England and Wales. Discussions are currently taking place with the MHRA
on signing up to the Scottish WRDP.
The HSE and the MHRA have a clear common interest in patient safety. This
agreement sets out the commitment of the two organisations to work together
effectively on matters concerning medical devices. In particular: co-operating
on non-fatal accident investigations; investigating fatal accidents in
accordance with the two WRDPs; sharing information; and raising awareness.
This agreement is a living document and will be reviewed on a regular basis.
We commend this agreement to you.
Signed
Geoffrey Podger
Chief Executive
HSE
John Wilkinson OBE
Director Devices Division
MHRA
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Index
1. Introduction
2. Role of the MHRA
3. Role of the HSE
4. Areas of mutual interest
5. Collaborative working arrangements
6. Liaison arrangements
7. Review of arrangements.
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1. Introduction
The purpose of this agreement is to describe and promote effective working
arrangements between the Health and Safety Executive (HSE) and the
Medicines and Healthcare products Regulatory Agency (MHRA), Medical
Devices Division. This agreement does not include the MHRA Medicines
Division.
The MHRA are the regulator for medical devices. With regards medical
devices, the HSE is the regulator concerned with shortcomings by staff,
carers and managers where these relate to systemic failings or work practices
that are not a direct result of shortcomings of the device or instructions for
use.
This agreement sets out the general principles for the HSE and the MHRA to
observe when liaising with each other.
The MHRA and the HSE will work in accordance with the existing
Memorandum of Understanding (MoU) between the HSE, the Department of
Health (DoH) and the Association of Chief Police Officers (ACPO), where the
MoU applies. We acknowledge that this MoU would benefit from a timely
review when resources allow.
When investigating fatal accidents the MHRA will work with the HSE and the
police in accordance with the Work Related Death Protocols (WRDPs) for
England and Wales and Scotland (SWRDP).
This agreement should be read in conjunction with detailed guidance on
enforcement and investigation policy and procedures, for both the HSE and
the MHRA.
2. Role of MHRA
The MHRA is an executive agency of the Department of Health with
responsibility for ensuring that medicines and medical devices are effective
and acceptably safe. The MHRA’s principal aim is to safeguard public health.
All medical devices must be appropriately CE-marked before being placed on
the market in any EU country. The CE-mark is categorised according to a
risk-based assessment of the product. Class I medical devices are in the
lowest risk category and may be placed directly on the market by a registered
manufacturer. Classes II and III devices are in higher risk categories and the
manufacturer must involve a Notified Body in the CE-marking process, before
placing their product on the EU market.
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The MHRA has powers under the various Medical Device Regulations, which
implement the European Medical Devices Directives, to have products
removed from the market and to prosecute manufacturers that place noncompliant or unsafe devices on the market. However, these powers are
applied in a proportionate manner and with the aim of bringing manufacturers
into compliance by voluntary agreement wherever possible and appropriate.
There is a legal requirement for medical device manufacturers to notify the
MHRA of any adverse incidents with their products where there has been
actual, or the potential for, death or serious injury. This is known as the
vigilance system. In addition, healthcare professionals, members of the public
and other users of medical devices are encouraged to report to the MHRA on
a voluntary basis.
When a product is suspected or known to be faulty, the MHRA immediately
works with manufacturers and distributors on the most appropriate and timely
action to take.
The action taken is determined by the scale of the threat posed to the public’s
health. The MHRA is committed to responding promptly and appropriately to
concerns about the safety of medical devices. Reports prompt investigations,
which can result in the issue of Medical Device Alerts or other publications.
3. Role of the HSE
The HSE is responsible for the enforcement of the Health and Safety at Work
etc Act 1974 throughout Great Britain. Its work includes ensuring that ‘risks to
people’s health and safety from work activities are properly controlled’.
The HSE does not, in general, investigate matters of clinical judgement or
matters related to the quality of care. The HSE deal with the major non-clinical
risks to patients such as:
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trips and falls,
scalding,
electrical safety etc, and
with some aspects of risks that affect both staff and patients alike, such
as manual handling.
Such incidents are normally reported to HSE under the Reporting of Injuries,
Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR), and
HSE follow its published incident selection criteria when deciding whether to
investigate.
From 1 April 2011, HSE has followed its ‘Guidance for FOD (and associated
situational examples) http://www.hse.gov.uk/enforce/hswact/docs/guidancefor-fod.pdf http://www.hse.gov.uk/enforce/hswact/docs/situationalexamples.pdf in responding to (non-construction) public safety incidents
where section 3 of the HSW Act 1974 applies. (FOD – Field Operations
Directorate)
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This guidance applies in full where section 3 HSWA applies but the incident is
not RIDDOR reportable. Paragraphs of the guidance, on initial enquiries,
reviewing investigations and recording decisions for incidents harming
members of the public, apply where section 3 HSWA applies and the incident
is RIDDOR reportable.
The HSE’s inspectors have the power to investigate reported fatalities,
injuries, dangerous occurrences and complaints. The HSE’s objective in
investigating incidents and complaints is to determine the underlying causes
and ensure lessons are learned to ensure:
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That action has been taken by the duty holder to manage any ongoing
risk and prevent similar incidents in the future
Wider lessons can be shared with other duty holders
The HSE can determine whether there has been a significant failure to
comply with health and safety law and consider whether enforcement
action is appropriate.
4. Areas of mutual interest – the HSE and the MHRA
There are clear areas of common interest between the two organisations.
Accidents involving medical devices, employees and patients or members of
the public, may be due to shortcomings in medical devices or instructions for
use; the MHRA has the lead interest in these cases.
Accidents may involve shortcomings, by staff, carers, managers or work
practices, that are not a direct result of shortcomings in the device or
instructions for use; the HSE has the lead interest in these cases.
Whatever the cause, these failures and shortcomings can have an adverse
impact on the health and safety of employees, patients or members of the
public.
5. Collaborative working arrangements
5.1. Referral of matters of concern
5. 1.1. The HSE will inform the MHRA, as soon as practicable, when it
becomes clear that information, or emerging evidence from an incident or a
complaint, is relevant to the MHRA. This includes significant dangerous
occurrences such as ones that might have resulted in major injury or death.
5.1.2. MHRA staff will inform HSE as soon as practicable if they are notified of
an incident involving the use of a medical device in relation to a work activity
which has led to major injury or death.
HSE and MHRA staff are aware of relevant contact details.
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5.2. Accident Investigation
5.2.1. Work Related Death Protocols (WRDPs)
When investigating fatal accidents the MHRA will work with the HSE and the
police in accordance with the WRDPs for England and Wales and Scotland
(SWRDP).
[NOTE: the MHRA is now a signatory to the WRDP for England and Wales.
In Scotland, the HSE and the MHRA are currently working together to explore
MHRA signing up to the SWRDP.]
The HSE and the MHRA will agree coordination of any joint investigation at an
early stage. We will ensure that we cooperate such that, for example, any
related prosecution cases are taken at the same time.
We agree that it is important that continuity of evidence rules are followed. If
while carrying out joint investigations, it appears likely that testing of
equipment will be required; we will discuss the need for an external
independent test at an early stage.
[NOTE: the MHRA no longer has a test facility at Blackpool. However, if the
MHRA is the lead investigator, it will arrange for testing by the manufacturer
and provide a medical device specialist as an observer. Only in exceptional
circumstances would funding be made available for independent testing to be
carried out.]
5.2.2. Fatal accident investigation
In England and Wales, with cases where the police are leading (in
accordance with the WRDP), then they will manage all evidence associated
with an investigation potentially involving gross negligence or corporate
manslaughter. If they make a decision not to pursue their investigation beyond
its initial stages, or not to put such a case to the Crown Prosecution Service
(CPS), or if the CPS do not support such a case, then the investigation and
evidence should be handed back to the relevant regulators/ agency (see
section 4 for lead regulator/ agency).
In Scotland, the Crown Office and Procurator Fiscal Service (COPFS) have
responsibility to lead the investigation of any sudden or suspicious death. The
police investigate under the Procurator Fiscal’s direction. Although the Fiscal
cannot direct other agencies such as the HSE and the MHRA, they are
expected to comply with any reasonable requests for assistance. Until
common law crimes (e.g. culpable homicide) or statutory offences enforced by
the police (e.g. corporate manslaughter and corporate homicide) are ruled
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out, then the police, under the direction of the Fiscal, will lead any enquiry.
They will gather, record and keep any evidence, taking advice from the
agency. If the Scottish Work Related Death Protocol (SWRDP) applies, the
police have primacy until serious offences other than health and safety
offences are ruled out – this means a joint investigation with the police
leading.
If primacy passes from the police to the regulator/ agency, then the evidence
can be transferred to the relevant regulator/ agency (see section 4 for lead
regulator/ agency). The police will retain an interest, in case new evidence
emerges pointing towards serious criminal offences and also for the purpose
of securing evidence for any Fatal Accident Inquiry.
5.2.3. Non-fatal accident investigation
Where incidents are thought to be due to shortcomings in the medical device
or its instructions for use, the MHRA will lead that part of the investigation,
liaising with the HSE as necessary.
Where incidents are thought to include shortcomings by staff, carers,
managers or work practices that are not a direct result of the point above, this
aspect will be lead by the HSE, liaising with the MHRA as necessary.
Scotland
In Scotland, all incidents involving medical devices are reported to Health
Facilities Scotland's (HFS) Incident Reporting and Investigation Centre. This
is responsible for co-ordinating investigations, so that root causes can be
established and remedial action is taken. HFS works closely with the MHRA,
as the UK Competent Authority responsible for the regulation of medical
devices throughout the UK; and notifies it of adverse incidents reported in
Scotland together with the results of any investigations. HFS has no
regulatory powers and the MHRA will therefore become involved, as the
competent authority, if enforcement action is considered.
The agency carrying out the investigation will be responsible for keeping safe
and analysing the evidence and deciding if they are going to report the
alleged offence via SRAWEB (Scottish Reporting Agencies Web), the
electronic system for all non police organisations reporting to COPFS. Any
report has to include sufficient evidence to prove the case to the criminal
standard.
5.2.4. HSE Product Safety Teams - For fatal and non-fatal investigations
The MHRA may wish to consult the HSE’s Product Safety Teams as regards
the interpretation of the machinery Essential Health and Safety Requirements
(EHSR) and Supporting Standards. Where medical devices are also
machines, the Medical Devices Directive (MDD) calls up any of the relevant
EHSRs of the Machinery Directive for that medical device. The HSE have
limited resources and therefore prioritises the activities where it provides
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support. It gives highest priority to the investigation of incidents which meet its
criteria for accident investigation and ongoing work arising from such
incidents.
In all cases where there is joint HSE and MHRA involvement, the MHRA will
control the medical devices as potential evidence for the courts.
5.2.5. Keeping people informed
The HSE and the MHRA (and the police if involved) will co-ordinate
arrangements for keeping the injured person, bereaved, witnesses, and other
interested parties such as the coroner, informed of developments in the
investigation; and a media strategy to take account of investigations that are
likely to be high profile/ sensitive.
5.3. Exchange of information
The HSE and the MHRA will consult each other when producing guidance/
interpretations etc on medicines or medical devices.
5.4. Communication and liaison arrangements
5.4.1. Safety Alerts
The MHRA will take the lead on issuing safety alerts to industry and will
communicate these to the HSE. If the issue is very significant, the MHRA will
ask the HSE to issue communications in support.
5.4.2. Awareness raising
The MHRA and the HSE will publicise the working arrangements internally in
both organisations. This agreement will be included in HSE/MHRA
investigation guidance to ensure that it is mainstreamed, the normal way of
doing business.
Externally, the MHRA will work with the HSE to raise awareness of the above
and the MoU with the police. For example, the HSE will disseminate this MoU
via the national and regional work related death liaison committees.
5.4.3. Keeping key staff in touch
A small number (up to 15) of HSE staff with different organisational functions
will sign up to the MHRA website for notification of MHRA publications.
A small number of MHRA staff will check the HSE’s website on a regular
basis for new publications and news alerts.
5.4.4. Communications between the HSE and the MHRA and release
under FOI
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Communications between the HSE and the MHRA are to be treated as
confidential. They are not to be voluntarily released to third parties (subject to
FOI constraints), except DoH and ACPO, without prior agreement.
The HSE and the MHRA will liaise regarding significant requests for
disclosure of information, especially if either party thinks we/ they might want
to make use of an exemption. The HSE and the MHRA will inform each other
if a relevant FOI request is received.
6. Liaison arrangements
HSE’s Public Services Sector and the MHRA will maintain regular liaison.
7. Review of Arrangements
The HSE and the MHRA will meet at agreed intervals to review this
agreement, to ensure its currency and usefulness.
Annex A
Control of medical devices as potential evidence for the courts
1. You must ensure that all exhibits are kept safely and that there is a clear,
identifiable audit trail from the moment that exhibits are seized to the moment
they are presented in evidence. This is because the prosecution may have to
prove that the exhibit before the court is the same exhibit that was referred to
by the witness in his or her statement, or that the exhibit has not been
tampered with illicitly while being retained for court proceedings. See OM
2001/128.
2. In establishing this chain of evidence, each person handling an exhibit must
write a brief statement identifying the exhibit and its whereabouts, stating
when they received it and who they received it from, and saying to whom they
passed it and when.
3. So, for example, in respect of a sample which is seized and taken to a
laboratory for testing, a statement is required covering all the stages from the
taking of the sample or the taking into possession of an article, through
submission to the laboratory, testing etc, and to its production in court. A
statement is required from the officer carrying out the analysis to be able to
say how the sealed sample came into the possession of that officer and how it
was identified.
4. Witness statements – different statutory regimes apply depending on
whether you are in England and Wales or Scotland. In England and Wales
statements’ should be on http://intforms/forms/legal/lp70.pdf. In Scotland,
witness statements should be on http://intforms/forms/templates/lps9.doc.
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