Skip to main content
NHS National Services Scotland Home

Report an incident

Published on 08 October 2020

Contents

What to do after submitting a report

Report the incident to other relevant parties

Always report incidents to your local adverse event management system (referred to as Datix).

We will contact the manufacturer or equipment supplier. If you hear anything from them, please send their reply to us so we can assess it along with your report.

IRIC always logs details of incidents in Scotland involving medical devices and passes them to the Medicines and Healthcare Products Regulatory Agency (MHRA). There’s no requirement for you to notify MHRA and it helps avoid duplication if you don’t.

Complete a contamination status certificate (if required)

If any of the items have been in contact with body fluids or tissues you should fill out a contamination status certificate.

Do not try to decontaminate equipment involved in incidents. There may be risks in handling contaminated devices. You could also destroy important evidence. Keep the equipment as close as possible to the state it was in when the incident occurred.

Download a Contamination Status Certificate (DECON1) (Word, 41.3KB).

Always keep devices or equipment involved in an incident. Store items in a secure place so they can't accidentally be put back into use.

Do not delay in taking containment or corrective action. For example, quarantining a batch of affected product, or replacing a defective component.

The manufacturer may request to see the device or ask for it to be returned for further testing. Make sure you consult a senior first.

Contact the manufacturer if you need to return contaminated items

You should not send items through the post if they:

  • have sharp edges
  • are contaminated with body fluids.

The only exception is if a manufacturer provides special instructions and a product return kit. This will allow you to post items safely and in accordance with regulations.

Find out more in the NHS Scotland Guide to the Carriage of Dangerous Goods Regulations (PDF, 291KB). Refer to the section on used medical devices.