Reporting an Adverse Incident
Guidance for reporting adverse incidents to NIAIC is contained in DB(NI) 2010-001 (PDF 36 KB) distributed in Northern Ireland only.
To report an incident click on the link below for the report form available as a Word or pdf file and return this directly by e-mail or post to the NIAIC, at the address on the form.
Ref For Reporting
If you are in doubt about how to report incidents, please contact the NIAIC or if you work for a HSC body contact your Medical Device liaison officer. Incidents relating to medical devices, non-medical equipment, plant and building items must reported to NIAIC as soon as possible.
Please provide as much information as possible in completion of any Incident report form. Information about the medical device or item of equipment involved should include details of the manufacturer and supplier including address and telephone number, the individual product name and the serial number if available . Names and contact details of persons who may be contacted for further information are also required to assist in any investigation.
An adverse incident is an event which causes, or has the potential to cause, unexpected or unwanted effects that will involve the safety of patients, staff, users and other people..
Adverse incidents can occur from malfunction of the device, unclear or incorrect user instructions, user practices, equipment servicing and maintenance or the conditions of use. The importance of an incident is not always obvious, and types of incidents can vary from the extremely serious (death or serious injury) to the apparently minor.
Adverse incidents should be reported including near misses and minor safety issues as trending of these incidents can indicate serious underlying issues.
On NIAIC receipt of and adverse incident report it will be subject to a risk assessment and triage. This process enables NIAIC to focus its specialist resources directly upon those issues which present the greatest risk to patient safety, and where its active intervention will make a positive difference to the resolution of the problem. As part of this process not only are all incident reports recorded, risk assessed and reviewed in as much detail as possible, but the investigative activity is supported throughout by an expanded and developed system for identifying, analysing and acting upon emerging incident signals, patterns and trends. The overall process may also involve one of the NIAIC investigative staff contacting the reporter directly for further information.
Depending on the Risk Assessment and triage of the adverse incident report the following actions will be undertaken.
- For serious reported incidents where direct intervention by the NIAIC or the MHRA can have the most positive effect, a medical device specialist will take personal responsibility for leading the investigation, liaising with the NIAIC clinical team as required. These specialist led investigations may involve contact the reporter as well as with the manufacturer. They may also require a site visit and/or examination and analysis of the device concerned. The specialist will keep the reporter updated throughout the investigation and, when complete, will advise all relevant parties of the outcome and any action taken.
- NIAIC will pursue other incident reports directly with the manufacturer (monitored investigations), requiring them to investigate the incident under NIAIC supervision, and to report as soon as possible. When NIAIC are satisfied with the manufacturer’s response and any action taken, we will provide the reporter with details from the investigation report and outcome. If we are not fully satisfied with the manufacturer's response or consider that further advice is necessary, NIAIC or the MHRA will initiate appropriate action.
- Some incident reports are not subject to further investigation individually but are recorded in detail on NIAIC’s adverse incident database as part of a continuing trending and surveillance process. . This may occur in circumstances where a number of reports of similar incidents are received. The database covers all incident reports (including those subject to specialist led or monitored investigations) and is central to the strategy for handling adverse incidents. The continuous analysis of the collated adverse incident data not only provides important background data for triage and investigation processes, but enables the initiation of new investigations where those data have identified emerging failure patterns and unexpected reporting trends.
Please note that all of these investigations may take some time to complete. This will depend on the precise nature and circumstances of the incident and the extent of the investigation and analysis required.
The above process ensures that every incident report not only contributes to the NIAIC and the MHRA’s knowledge about medical devices and their usage, but also helps to protect the safety of patients, carers, healthcare workers and other medical device users. The reports enable appropriate action to be taken in order to prevent recurrence of incidents .
Where necessary we will issue safety guidance to health and social care workers. This is usually starts with the manufacturer releasing a FSN but may result in a medical device alert, but may also be a targeted letter, poster or leaflet.