NIAIC

Reporting an Adverse Incident :

Use our printed form (detailed below) available as a .pdf file or as a MS Word document, or

Complete the on-line incident reporting form

Contact us at the address given below.

Guidance for reporting adverse incidents is contained in the NIAIC Safety Notice MDEA (NI) 2006/01 (PDF 81 KB), distributed in Northern Ireland only.

The other UK Administrations Departments of Health equivalent to MDEA(NI) 2006/01 (PDF 81 KB) are:     

England : MDA/06/01

Scotland : SAN(SC)06/01

Wales : WHC(97)28

If you are in doubt about how to report incidents, please speak to your liaison officer or contact NIAIC.

Incidents relating to medical devices, non-medical equipment, plant and building items must be reported to NIAIC as soon as possible.

The initial report of an incident should contain as much relevant detail including information about any device or equipment involved such as the manufacturer and supplier names, addresses and telephone numbers, product names and serial numbers etc. Having this information available allows us to begin the investigation immediately. Names and contact details of persons who may be contacted for further information should be included.

Outside normal office hours, the Department's Duty Officer can be contacted at Stormont House telephone 02890 520700 giving an indication that the report is for the NIAIC, Health Estates. Otherwise, if a case is less serious it should be reported on the next working day.

If sending in the device, please ensure that it is decontaminated. It is illegal to send contaminated items through the post. Further guidance can be found in MDEA(NI) 2006/01 (PDF 81 KB).

Serious incidents must be reported to NIAIC by the fastest means available.

Telephone reports should be followed up as soon as possible by a written report.

Northern Ireland Adverse Incident Centre (NIAIC)
RoomA7
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast BT16 1US

Tel: 02890 523714
Fax: 02890 523900

Or E-mail us at: NIAIC@dhsspsni.gov.uk

What is an Adverse incident?

An adverse incident is an event which causes, or has the potential to cause, unexpected or unwanted effects involving the safety of patients, staff, users and other people. Every Health & Personal Social Services employee has a duty to see that all safety related incidents and potentially harmful products are reported, even on suspicion.

They can arise from problems with the device, unclear or incorrect instructions, user practices, servicing and maintenance or conditions of use. The importance of an incident is not always obvious, and types of incidents vary from the extremely serious (death or serious injury) to the apparently minor. If adverse incidents are reported and if the chain of events leading up to and contributing to an adverse incident are analysed, it allows the individuals and the organisation involved to identify what went wrong. It is then possible to learn from the incident and to develop strategies which prevent the same thing happening again.

Adverse Incident Investigation

All other reports received by NIAIC are investigated. The method of investigation depends on the risk associated with the incident.

Incidents where there has been a death or serious deterioration in health (or the potential for such) are subjected to an in-depth investigation by our investigation officers. Such investigations may involve contact with the device user and manufacturer, a visit to the site of the incident and testing of the device involved (either by the manufacturer, or an independent test house). It is these investigations which typically result in NIAIC issuing safety advice.

Incidents where there has been a minor injury or no injury, and the potential for a more serious incident is low, are generally most effectively investigated by the device manufacturer. Details of the incident report is forwarded to the manufacturer and NIAIC monitors the progress of the investigation. The manufacturer's final conclusions are passed to the reporter for information or comment.

At all stages of an investigation, the information available is subject to review in order to enable us to reassess the level of investigation and to determine what, if any, action we need to take. During the reviews we involve all investigation team members, including our Clinical and Nursing Professionals to advise on clinical or nursing aspects of the incident and the way the device had been used.

Adverse Incidents - Statistics

Over 150 adverse incidents were reported to NIAIC during 2004. These incidents involved medical devices and other equipment of all kinds, from simple infusion devices to highly sophisticated CT scanners. Also during this period NIAIC released 66 Medical Device/Equipment Alerts.

Other Reporting Responsibilities

Please report adverse incidents to the appropriate organisation. All those involving medical device, non-medical equipment, plant or building items should be reported to NIAIC.

This reporting system does not affect the statutory or other duties of staff locally to take appropriate actions as required legally and/or by line management, as a result of an adverse incident. These include:

to safeguard patients, staff, clients and others

to prevent further use of a product which may be defective

As part of the above actions, Regional Supplies Service may issue their own notices, which identify problems and are used to bring them to the attention of users. These Notices should not be confused with NIAIC's Hazard, Advice and Safety Notices.

RIDDOR

Incidents involving certain types of injury, occupational disease or dangerous occurrence, whether involving medical devices, non-medical equipment, buildings or plant or not, are legally notifiable to the Health & Safety Executive under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (Northern Ireland) 1997 (RIDDOR), and the Ionizing Radiation Regulations (Northern Ireland) 2000.

Notification to NIAIC does not count as, or substitute for, any other report, which should be sent (e.g., in respect of an employee's industrial injury).

DEFECTIVE MEDICINAL PRODUCTS

Guidance on making reports on defective medicinal products was circulated to HSS Boards and Trusts in June 2001. The guidance focused upon medicinal products which are, or may be defective. The guidance was intended to ensure that only hazardous or major defects were reported directly to the Department with other incidents dealt with using local schemes and in consultation with the Regional Pharmaceutical Laboratory Service.

FOOD

Incidents relating to foods involving contamination or potential contamination should be reported immediately to the local environment health officer (EHO) who will decide on what, if any, further action will be taken. The EHO will also report the incident to the Food Standards Agency as necessary.