Adverse incidents - our role

 For example:

• a patient, user, carer or professional is injured as a result of a medical device failure or its misuse;
• a patient's treatment is interrupted or compromised by a medical device failure;
• misdiagnosis due to medical device failure leads to inappropriate treatment;
• a patient's health deteriorates due to medical device failure.

Adverse incidents in medical devices may arise due to:

• shortcomings in the design or manufacture of the device itself;
• inadequate instructions for use;
• inadequate servicing and maintenance;
• locally initiated modifications or adjustments;
• inappropriate user practices (which may in turn result from inadequate training);
• inappropriate management procedures;
• the environment in which a device is used or stored;
• selection of the incorrect device for the purpose.

Conditions of use may also give rise to adverse incidents:

• environmental conditions (e.g. electromagnetic interference);
• location (e.g. devices designed for hospitals may not be suitable for use in the community or ambulances).

Potential harm - The occurrence of an incident may identify the potential for harm, even though actual harm has been averted by the timely intervention of healthcare providers or good fortune. The Agency is concerned that users should report all incidents - regardless of whether actual harm has or has not been caused.

Direct and indirect harm - There is also a distinction between direct and indirect harm. Indirect harm may be caused by a device which does not normally come into contact with patients. For example, a malfunctioning in vitro diagnostic device such as an automated analyser may lead to delayed or inappropriate treatment of a patient, thus causing indirect harm. These incidents should also be reported.

Why report adverse incidents to MHRA?
The MHRA aims to prevent adverse incidents happening and, where they have already happened, to prevent them happening again. No device should ever be considered 100% safe and constant effort is therefore required to reduce both the rate at which adverse incidents occur and the severity of the outcome. Reporting incidents to the Agency provides information that may be directly responsible for preventing similar incidents from happening again.

The information provided to the Agency by users, helps to build up a national picture of what is happening with medical devices across the UK. This is supplemented by reports from around the world. All this information is reviewed to identify trends and, where appropriate, early action is taken on specific problems.

Experience suggests that although user error will be the cause, or may contribute to the cause, of many incidents, there are often underlying reasons. These may relate to device management and maintenance or to the adequacy of training for users.

The Agency welcomes receipt of all incident reports even where user error has been identified as the likely cause. A one-off incident in one healthcare establishment, when combined with information of several others, may identify the need for focussed awareness training or for the amendment of manufacturer's usage instructions.

The MHRA does not look to assign blame. The Department of Health document 'An Organisation with a Memory' highlighted the dangers of a blame culture within healthcare organisations. The Agency's aim is to investigate incidents carefully, objectively and in an open manner, and, through this, to prevent similar incidents occurring elsewhere.

This 'prevention' is achieved through:

• enforcement measures;
• monitoring of action taken by manufacturers to make devices safe or to remove them from the market;
• the issue of national warnings and recommendations for action to health and social care professionals;
• informing the relevant authorities in other EU member states and Global Harmonisation Task Force members so that they can consider their own need for action.

What happens when you report an adverse incident?
Database Record - A total of 7,862 adverse incidents were reported in 2005. Receipt of an adverse incident report will prompt the initiation of a number of immediate procedures within the Agency. The first step is the creation of a database entry and formal acknowledgement of receipt. The acknowledgement letter is accompanied by a short information note summarising and explaining the Agency's procedures. An initial assessment of the report will determine the next appropriate action:

•  Referral to another agency - Some of the reports we receive (2.1% in 2005) do not involve medical devices. These are referred, as appropriate, to other bodies such as NHS Estates. The incident reporter is informed accordingly.
• Recording as 'information only' - In 2005 24.6% of incident reports required no immediate action beyond the creation of the database record and acknowledgement of receipt was considered necessary. These were largely cases where the situation had already been resolved, either locally or by the manufacturer.
• Linking to existing investigations - 11.9% of the reports received in 2005 were linked to ongoing investigations and were categorised as 'known' or 'echoes'.

The database of information gleaned from the 'information only' and 'known' categories helps the Agency to maintain an up-to-date picture of the various device types and failure modes. This database is used increasingly to review incident data and to identify significant patterns and trends.

Investigations
All other reports submitted to the MHRA are investigated. The method of investigation depends upon the risk associated with the incident.

Death and serious deterioration in health (or potential for such) - These incidents are among those subject to an in-depth investigation led by one of the Agency's medical device specialists. Such investigations (26.4% in 2005) may involve:

• contact with the device user and manufacturer;
• a visit to the site of the incident;
• testing of the device involved (either by the MHRA's own test facilities, an independent test house, or the manufacturer).

It is these investigations, formerly referred to as 'section investigations', which typically lead to the issue of safety advice by the Agency.

Minor injury and no injury (with low potential for more serious injury) - These incidents are generally most effectively investigated by the relevant manufacturer. In 2005 the Agency investigated almost 29% of incidents in this way: passing details from the incident report to the manufacturer and monitoring the progress of their investigation. The incident reporter is kept informed of progress through routing copies of the Agency's correspondence. In particular, and subject to the manufacturer's permission, the reporter will be provided with a copy of the manufacturer's final report conclusions for their information and/or comment. These are usually referred to as 'standard investigations'.

Review of investigations - At all stages of all investigations, the information available is subject to review. This process enables the Agency to reassess the level of the investigation and to determine what, if any, action is required. These reviews may require the involvement of the Agency's expert clinical team (on clinical aspects of the incident, including the way the device was used); the Committee on Safety of Devices; or the Agency's Register of Experts.

MHRA safety warnings
The MHRA issues safety warnings (Medical Device Alerts) to health and social care providers and other users of medical devices. These warn of particular problems and risks and recommend appropriate action to minimise them. These notices are distributed to NHS trusts and social services for direct action and for onward transmission to relevant healthcare professionals including, where the device is used in primary care, to general practitioners.

Adverse Incident Reports 2007 - DB 2008(02)
Each year the MHRA produces a document summarising the key features of medical device adverse incident reporting throughout the previous calendar year. This document, published as a Device Bulletin, contains a number of charts as well as textual summary and analysis. The latest publication is DB 2008(02).