An introduction to IRIC and reporting adverse incidents

What is IRIC?

IRIC is Scotland’s national Incident Reporting and Investigation Centre.

IRIC provides specialist safety and risk management support to Scotland’s health boards and local authorities. IRIC manages the trending, investigation and resolution of incident reports it receives involving medical devices, IVDs, estates, facilities, social care equipment and PPE. IRIC also publishes safety alerts when risks need mitigating actions at local level. This helps to keep patients, users, staff, contractors and visitors safe.

IRIC manages and operates the following at national level:

• adverse incident reporting and investigation system
• safety alert system
• incidents and alerts safety officer network (ISON)

IRIC aims to improve the safety of equipment and facilities in Scotland’s health and social care sectors.

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 health and safety of patients, users and other persons such as staff, contractors and visitors

The main features of an adverse incident are:

• actual events, but also includes near misses and safety concerns
• usually things that are unexpected or could not have been anticipated
• risk control measures were missing, inadequate or unused

What is a near miss?

Reporting incidents where no-one has been injured is very important. By reporting near misses a failure trend could be picked up and dealt with before other organisations are affected or anyone is injured. Reviewing near misses regularly helps promote learning.

What is a safety concern?

If you think you’ve identified a safety issue with equipment before an adverse incident or near miss has occurred then please report it to IRIC. You don’t have to wait for an incident to happen.

What are the possible causes of an adverse incident?

Equipment related adverse incidents can be caused by a wide range of contributory factors including:

• design flaws
• manufacturing defects
• material degradation
• poor instructions for use or failure to follow them
• incorrect use
• damage during transportation
• inadequate maintenance
• failure to plan for replacement

What should you to report to IRIC?

You should report adverse incidents involving the following types of equipment:

• medical devices
• in-vitro diagnostic medical devices (IVDs)
• estates and facilities equipment
• social care equipment
• personal protective equipment (PPE)

Examples of equipment and failures to report to IRIC

Why is it important to report to IRIC?

CEL(2009) 43 sets out the responsibilities of Chief Executives in health boards and local authorities for ensuring that procedures exist for the reporting of adverse incidents. There must also be systems in place for the dissemination of safety advice and for ensuring risk control measures relating to health, social care, estates and facilities equipment are in place.

IRIC has a specific remit from Scottish Government under CEL(2009) 43 to operate a national adverse incident reporting and investigation system. IRIC coordinates any investigations to establish the root causes and to prevent or reduce any identified risks

Everyone has a responsibility to report adverse incidents involving equipment, firstly to their employer’s local risk management system and secondly to IRIC’s national system.

This ensures that health boards and local authorities deliver care services safely across Scotland. Learning from adverse incidents reduces the likelihood of recurrence and ensures the safe delivery of care.

How do I report to IRIC?

Contact IRIC at nss.iric@nhs.scot to request an account which will enable you to report your adverse incidents to us.

IRIC will send you log-in details (username and password) with a link to our incident reporting webform.

If your organisation has a firewall that won’t allow access to our reporting webform then we can provide an alternative form for you to use.

What does IRIC do with your incident report?

Your incident report is referred to our in-house team of product specialists working within Health Facilities Scotland and NHS Scotland Assure. We review, risk assess, triage and trend every incident report sent to us.

We may wait to see if your incident report is part of a wider trend, or alternatively escalate your report for immediate investigation with the manufacturer. If the problem cannot be resolved by the manufacturer, a safety alert may be issued highlighting the safety concerns you have raised and the actions to be taken to prevent further harm.

Reporting incidents allows us to identify all the contributory factors, equipment, user related or systemic factors (eg. inspection, maintenance, training etc) and helps to reduce the risk of recurrence.

If your incident involves a medical device, IRIC will automatically inform the MHRA (Medicines & Healthcare products Regulatory Agency). You do not need to contact MHRA to do this as IRIC ensures your incident report is added to MHRA’s UK-wide surveillance system.

What is incident trending?

Every incident report submitted to IRIC becomes a live data point on our incident trending system and is actively monitored for a minimum of two years.

Analysis of the incident data in IRIC’s trending system is used to detect emerging adverse trends involving equipment and facilities within Scotland’s healthcare and social care sectors. If an adverse trend is apparent, we will look more closely and may open an investigation.

Trending analysis is performed on the following data fields:

• equipment category
• suspected problem
• health impact
• manufacturer
• model