Published: 8 December 2016

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Adverse Event Reporting for Medical Devices

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Prescriber Update 37(4): 53
December 2016

Medsafe monitors the safety of medical devices through adverse event reports. Recent concerns associated with the use of surgical mesh have highlighted the importance of adverse event reporting. Improving reporting of device adverse events was a key finding in a recent report published by the Government Health Select Committee (www.parliament.nz/resource/en-NZ/51DBSCH_SCR69220_1/2ebf5e03f6fae9f78e731ff8ebfce8ded2df857f).

Adverse Event Reporting

Any adverse events suspected to be due to use of a medical device should be reported to Medsafe. Medsafe accepts reports from patients and their carer or relatives, healthcare professionals, New Zealand suppliers/manufacturers of the medical device, Accident Compensation Corporation (ACC) and overseas regulators.

To simplify the reporting procedure, Medsafe is currently redesigning the adverse event reporting forms (the current reporting form is available from the Medsafe website www.medsafe.govt.nz/regulatory/devicesnew/9AdverseEvent.asp). There will be separate reporting forms for patients/consumers, healthcare professionals and suppliers/manufacturers. A consumer reporting form is currently in development and will be published on the Medsafe website shortly.

Adverse event reports are reviewed by Medsafe to determine the appropriate course of action. This can include working with the supplier/manufacturer to address the adverse event and publish communications.

Communications

Medsafe publishes monitoring communications when potential safety concerns are identified with devices. Often Medsafe is seeking additional information from the users of the device (www.medsafe.govt.nz/safety/AlertsArchive.asp).

More detailed information may also be published for example for surgical mesh (www.medsafe.govt.nz/hot/alerts/Surgical_Mesh_Implants_September_2016.pdf).

Recalls and corrective actions are also published on the Medsafe website (www.medsafe.govt.nz/hot/recalls/recallsearch.asp).

Please report any adverse events in relation to medical devices to Medsafe (www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp).