Reporting Adverse Incidents

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Guidance on Reporting Adverse Incidents involving Medical Devices

The MHRA (Medicines and Healthcare products Regulatory Agency) is an agency of the Department of Health with responsibility for protecting public health and safety by ensuring that equipment is safe and and effective, and is used safely. The key mechanism by which standards are monitored is the Adverse Incident Report. By reporting any occasions on which a medical device fails to perform to the required standards, users can help to ensure that appropriate steps are taken to prevent any recurrence of the problem.

Click the links to go straight to more information on:

What sort of products are concerned?
What is an adverse incident?
What causes an adverse incident?
Who can make a report?
How to make an adverse incident report
Why you should make a report

What sort of products are concerned?

• hospital beds
• hoists and slings
• stretchers and trolleys
• standing aids
• manual transfer aids
• specialist seating
• walking aids
• wheelchairs
• pressure relief mattresses and cushions
• bathing equipment
• showering equipment
• commodes and incontinence products
• prosthetics and orthotics
• environmental controls
• hearing aids
• communication aids
• This list is not comprehensive, but is indicative of the main product types which are of particular relevance in the care and independent living sector.

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What is an adverse incident?

According to the MHRA, the definition of an adverse incident is:
” an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons”

Adverse incidents do not include non-availability of a required item, and any subsequent problems caused by the lack. These events should be reported instead to see National Patient Safety Agency (NPSA).

What causes an adverse incident?

There are various possible causes for an adverse incident, including:
• poor design or defective manufacturing of the product
• inadequate maintenance and servicing procedures
• lack of training in correct use of the product
• unsafe modifications
• incorrect storage
• selecting the wrong product for the purpose

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Who can make a report?

Anybody – whether you are a medical or care professional, family carer, user of the device, patient, or member of the public. There are no restrictions on the person who can make a report of an adverse incident.

You should, however, check any incident reporting procedures within your organisation, as well, as you may be required to report via a Medical Device Liaison Officer or patient safety manager.

What sort of incidents should be reported?

You do not need to wait for an injury to be caused. If you are aware of a potential problem with the medical device, you should report it. Apart from the obvious adverse consequences of death, illness or injury, other consequences such as delaying recovery or preventing healing should be considered.

If you are aware of an ongoing fault with a piece of equipment, which is not resolved by servicing and maintenance, this should also be considered as an adverse incident.

Even if it appears that human error alone is responsible for the incident, it should be reported, as it might be a result of defective product design or instructions for use.

Minor issues should be reported, as these can also play a part in helping to develop good practice guidance for other users, as well as helping manufacturer with design improvements.

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How to make an adverse incident report

You should report any incidents as quickly as possible, generally within 24 hours.

The fastest way of doing so is online. The MHRA website has a facility to submit reports securely at any time, and this is the way in which 80% of incidents are reported. This is a link to the appropriate page.

If you use online reporting, you will get immediate confirmation and a unique reference number for your report, as well as a PDF copy emailed to any specified address, if you wish.

Other ways of reporting incidents include telephone: 020 3080 7080 (answering machine outside office hours). Any telephone report must be followed up in writing.

If you decide to make the report by email (aic@mhra.gsi.gov.uk) or post, you can download forms from the MHRA website, and either complete them electronically, or print them out and post them to:
MHRA Adverse Incident Centre
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

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Why report an adverse incident?

No product can be entirely free of risk, but the job of the MHRA is to protect public health by working with manufacturers and users to make sure that medical devices are as safe as possible. Most of the time, they work with manufacturers to resolve any reported issues, but if for any reason they are not successful in this, they can take action as the regulatory body.

Prompt reporting of adverse incidents to the Adverse Incident Centre has led to a number of health risks being identified and dealt with early, thus preventing more negative consequences.

How does the MHRA disseminate information?

Medical Device Alerts (MDAs) are the means by which the MHRA advises professional device users of any safety issues, or gives updated advice on using equipment safely. You can find a list of current MDAs on their website – if an MDA is not listed, this means that it has been withdrawn or superseded.

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