Publications

Published: 6 March 2014
Revised: 31 May 2017

Reporting Medical Device Adverse Events

Prescriber Update 35(1): 13
March 2014

Adverse events that cause injury and that are associated with medical devices should be reported to Medsafe. These events may indicate a quality or safety issue that needs to be addressed. By reporting these to Medsafe, seemingly isolated incidents may be collated and action taken if necessary.

Who can report an adverse event?

Anyone can submit a medical device adverse event report. Patients, caregivers, healthcare professionals and suppliers are all encouraged to lodge an adverse event report if an adverse event has occurred and there is a concern about the safety of the device or its use.

On the Medsafe website there are forms for reporting adverse events and quality issues: (www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp).

What adverse events should be reported?

Medical devices that are associated with adverse events that cause injury should be reported to Medsafe. Further information about what adverse events should be reported to Medsafe can be found on the Medsafe website (www.medsafe.govt.nz/regulatory/devicesnew/9AdverseEvent.asp).

What happens to reports

All adverse event reports submitted to Medsafe are reviewed. Medsafe may then issue advice or an alert as required. If a product issue is found, Medsafe will work with the supplier on an appropriate corrective action to address the issue.

Information about adverse events relating to medical devices that have been reported to Medsafe can be searched online in the Joint Adverse Event Notifications System-Medical devices (JAENS-MD) database.