Arrangements for Liaison Between the Health and Safety Executive (HSE) and the Medicines

Arrangements for liaison between the Health and Safety Executive (HSE) and the Medicines and Healthcare Products Regulatory Agency (MHRA), Medical Devices Division

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 John Wilkinson OBE

Chief Executive Director Devices Division

HSE MHRA

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.

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’sprincipal 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.

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 non-compliant 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:

• 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) in responding to (non-construction) public safety incidents where section 3 of the HSW Act 1974 applies.(FOD – Field Operations Directorate)

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:

• 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; theMHRA 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 tothe 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.

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 theSWRDP.]

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 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-ordinatinginvestigations, 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 theUK; andnotifies 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, ifenforcement 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 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 controlthe medical devicesas potential evidence for the courts.

5.2.5. Keeping people informed

The HSE andthe 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

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 disclosureof 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.