Reporting a Defect
Medical Device Adverse Event Reporting
As part of Medsafe's role in monitoring the safety of medical devices in New Zealand, it operates a scheme for the voluntary reporting of adverse events relating to medical devices.
Adverse events are defined as being;
An event or circumstance during healthcare which resulted in unintended or
unnecessary harm to a person (patient/caregiver/healthcare professional)
(Source: New Zealand Incident Management System Policy)
Medical devices are defined in the Medicines Act 1981 and can range from condoms to complex electronic equipment. Other examples include implantable devices, diagnostic and monitoring equipment, in-vitro diagnostic assays, reagents and controls, and disposable equipment such as syringes, wound dressings and gloves.
1/ Why Should Adverse Events be Reported?
Any incident involving a medical device that impacts on the safety of New Zealanders is of interest to Medsafe. Even if the event appears to be isolated Medsafe recommends that it is reported. Similar incidents may have occurred elsewhere and by reporting them to Medsafe events can be collated, monitored and responded to.
2/ Who Can Submit an Adverse Event Report?
Anyone can submit an adverse event report. Patients, caregivers, healthcare professionals and suppliers are all encouraged to lodge a report if there is a concern about the safety of the device or its use.
3/ What types of Events Should be Reported?
Medsafe recommends that reports are submitted when there has been a death or serious injury, or if there was the potential for a death or serious injury, to a patient, caregiver or Healthcare Professional. For organisations using the New Zealand Incident Management System risk assessment protocol all SAC1 and SAC2 events should be reported to Medsafe. SAC3 and SAC4 events may also be reported.
Medsafe is also interested in receiving reports on quality issues such as incorrect labelling, faulty packaging, foreign materials in a device, or a device not working as expected.
4/ How Quickly Should Adverse Events be Reported?
It is important that adverse event reports are submitted to Medsafe promptly after the event. Medsafe recommends that initial reports are filed within the timeframes below;
Death (actual or potential) - within 7 calendar days
Serious Injury (actual or potential) - within 7 calendar days
Injury (actual or potential) - within 30 calendar days
No injury - within 30 calendar days
5/ How is an Adverse Event Report Submitted to Medsafe?
A Microsoft Word reporting form, common to both New Zealand and Australia, should be used to report safety and/or quality issues concerning medical devices to Medsafe. Simply download the form to your computer and fill it in.
Suppliers of medical devices may prefer to submit reports to Medsafe using the TGA MDIR 03b form. When a supplier uses this form to report a New Zealand event to Medsafe it is requested that the WAND Device Notification Number is substituted for the ARTG number.
Completed forms should be sent to Medsafe via email (to robert_jelas@moh.govt.nz), by fax to 04-819-6806, or by post to PO Box 5013, Wellington.
Often it is useful for the actual device involved in the event to be available for examination to determine the cause of the event. Devices involved in adverse events should be isolated and stored in preparation for examination. If a device cannot be retained due to contamination or for other reasons please consider photographing the device in detail prior to disposing of it. Additionally it is recommended that the device packaging is retained to provide information including the catalogue/item number, model designation, batch or lot number, and the expiry date.
6/ What happens to Reports?
All adverse events are reviewed by Medsafe with both safety and quality issues being investigated. As part of these investigations further information may be requested from the reporter and/or the device supplier. If necessary, Medsafe may also contact overseas regulatory agencies to ascertain whether they have received reports about the device.
In response to an adverse event, or series of adverse events, Medsafe may issue an advice or alert. If a product issue is found then Medsafe will work with the supplier on an appropriate corrective action to address the issue.
Quarterly, all investigated reports are anonymised, collated and peer reviewed by an independent group of healthcare professionals nominated by the various professional bodies and colleges. This committee, the Medical Device Incident Review Committee (MDIRC), reviews all adverse events reported in New Zealand and Australia to ensure they have been appropriately responded to. MDIRC may also recommend further action to be taken.
All reports received are retained by Medsafe.
Note - this information is based on the guidelines issued by the Ministry of Health, Study Group 2 of the Global Harmonisation Task Force, and the New Zealand Incident Management System.