Reporting problems

with medical devices:

How the representative can help

MHRA’s Clive Bray explains the Agency’s adverse incident reporting system for medical devices and how sales professionals can help safeguard public heath.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the Department of Health charged with protecting and promoting public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and that they are used safely. One way it aims to achieve this is by investigating reports of adverse incidents involving medical devices and instigating corrective actions to reduce the risk of recurrence.

What is an adverse incident?

An adverse incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users or other persons.

Most manufacturers and suppliers capture feedback on their products. If they don’t, they should pay urgent attention to putting an efficient system in place. This will form part of each company’s post-market surveillance system, which should include identifying and capturing relevant data on adverse incidents at an early stage.

Medical device sales professionals are among those closest to the customer. They need to be aware of and facilitate the reporting of adverse incidents to MHRA or other persons.

What leads to an adverse incident?

Causes of adverse incidents involving devices may include:

• design or manufacture problems
• inadequate servicing and maintenance
• unsuitable storage and use conditions
• selection of an incorrect device for the purpose
• inappropriate management procedures
• poor user instructions or training.

Adverse incidents may also be caused by the conditions of use, such as:

• environmental conditions (e.g electromagnetic interference)
• location (e.g devices designed for hospitals may be unsuitable for a community setting).

Why reporting is vital

Any adverse incident involving a device should be reported to MHRA. Some incidents could lead to:

• death or life-threatening illness/injury
• the necessity for medical or surgical intervention
• hospitalisation or prolongation of existing hospitalisation
• unreliable test results and risk of misdiagnosis or inappropriate treatment.

Ongoing faults that maintenance visits have failed to rectify should also be reported, as should other safety or quality problems. These can help demonstrate trends or highlight manufacturing inadequacies. Reports of adverse incidents that appear to be caused by human error are also helpful, since the error may be due to deficiencies in the design of the device or the instructions for use.

Making a report

Reports can be made by a variety of means: online, e-mail, fax, telephone. Online reports may be submitted via the MHRA website or NHSNet at any time. Reporters are routinely kept informed of the progress of the incident investigation and given a summary of the conclusions.

In some cases, investigation reveals the need to communicate device safety advice to users and patients. Medical Device Alerts (MDAs) are the prime means of informing medical device users in healthcare and social care. MDAs warn of particular problems and risks, and recommend appropriate action to minimise them. MDAs are distributed to all NHS trusts and primary care trusts in England via an electronic system (SABS).

On Target Quick Read

• An adverse incident is an event that causes unwanted effects involving the safety of device users. • In 2005, MHRA received 7862 adverse incident reports on medical devices. 2.8% involved a fatality and 10.7% led to serious injury. • Sales professionals are close to the customer and play a vital role in reporting adverse incidents. • Representatives should familiarise themselves with their company’s systems and provide feedback on how these can be improved. • Sales professionals should encourage purchasers and practitioners to report incidents to MHRA.

What can go wrong?

MHRA is concerned with preventing the occurrence of adverse incidents, not with assigning blame or liability. It investigates incidents carefully and objectively to prevent similar incidents occurring elsewhere.

No medical device should ever be considered 100% safe. Constant effort is therefore required to reduce both the rate at which adverse incidents occur and the severity of the outcome. Reporting adverse incidents to MHRA provides valuable information that can help to prevent similar incidents from happening again. The information provided to the Agency helps to build up a picture of what is happening with medical devices across the UK. This is supplemented by reports from around the world. All of this information is regularly reviewed to identify trends.

Experience suggests that although user error may contribute to the cause of many incidents, there are often underlying factors that have influenced the user’s actions. These may be related to the design of the device, or inadequacies in the instructions for use, the management and maintenance of the device, or user training.

MHRA welcomes receipt of all incident reports – even where user error has already been identified as the likely cause. A one-off incident in one health establishment, when combined with information on several other incidents, may point to a need for local action or action by the manufacturer.

Taking action

MHRA can act in a variety of ways to prevent the occurrence of incidents. It may initiate enforcement measures, or monitor action taken by manufacturers to make devices safe. It may remove them from the market.

Equally, it can issue national warnings and recommendations for action to healthcare professionals, or inform relevant authorities in other EU member states.

In 2005, MHRA received 7862 adverse incident reports on medical devices. 2.8% of these involved a fatality and 10.7% a serious injury. 25.5% of the reports prompted ‘in-depth’ MHRA investigations. The Agency published a wide range of advice to healthcare professionals and other users, including 72 MDAs that recommended appropriate actions to minimise the recurrence of the problem. These measures are a major contribution to improving the safety of devices in use.

How you can help

Sales staff can play an important role in the post-market surveillance of medical devices. You can help in several ways:

• Familiarise yourself with your company’s systems for capturing adverse incidents.
• Identify potential adverse incidents at an early stage, and ensure rapid communication to company individuals who report them to MHRA.
• Provide constructive feedback on your own systems.
• Ensure your customers are aware of product safety information concerning your products, and that recommended actions are taken.
• Encourage purchasers to report adverse events, either to you, to your company or to MHRA.

Further information about adverse reporting incidents, online incident reporting facilities and downloadable report forms are available from the MHRA website http://www.mhra.gov.uk

---

Clive Bray is Director of Device Technology & Safety at the Medicines and Healthcare products Regulatory Agency (MHRA).