Revised: 19 March 2020

Medical Devices

Medical Device Adverse Event Reporting

The process for reporting Medical Device Incidents has changed
Reporting Issues Associated With Medical Devices
Information for consumers
Reporting Timelines
Why report a suspected adverse event?
Non-reportable Events
Medsafe Process
Definitions

The process for reporting Medical Device Incidents has changed

We have updated the form used by industry to record medical device incident reports, and the way in which we manage these. We have done this to improve the efficiency of the reporting process, to ensure that we investigate medical device incidents in a risk-proportionate way.

Summary of changes

• Only the industry form has changed. The healthcare professional and consumer reporting forms remain unchanged.
• We no longer require initial reports of minor injury events, we only require final reports for these.
• Reporting timelines have changed.
• The definitions relating to adverse events and non-reportable events have changed slightly.
• There have been formatting changes to improve readability of the website page.
• The format of the reporting form has been updated, and is now a Microsoft Word Protected Form

Reporting Issues Associated With Medical Devices

Anyone can report an issue associated with a medical device. An issue may relate to an adverse event, or a quality issue. Patients, caregivers, healthcare professionals and suppliers are all encouraged to lodge an adverse event report if an incident has occurred and there is a concern about the safety of the device or its use.

To report an issue associated with a medical device, select the appropriate form from the table below:

Adverse Event Report Forms
Industry (Medical Device Sponsors)	Adverse Event Report (Industry) (Microsoft Word document 117 KB, 4 pages)
Healthcare Professional	Adverse Event Report (Healthcare Professionals) (Microsoft Word document 82 KB, 2 pages)
Consumer	Adverse Event Report (Consumers) (Microsoft Word document 85 KB, 3 pages)

Send your report to us at devices@health.govt.nz

If at all possible please keep the device and its associated packaging as this may be required to be returned for further investigation.

Information for consumers

If you have any concerns about a medical device, you should talk to your doctor, pharmacist, nurse or other health professional. Medsafe cannot give advice about an individual's medical condition or treatment.

Reporting Timelines

It is important that adverse event reports are submitted to Medsafe promptly after the event and that a full description of the event is provided. Medsafe recommends that initial reports are filed within the timeframes below.

Death and Serious Injury (refer to definitions)

• Please submit an initial report as soon as possible, and within 10 calendar days.
• Submit a final report once the investigation has been completed.
• If it is possible that death or serious injury could have occurred due to the incident, this should be reported following “death or serious injury” timelines.

Minor injury (refer to definitions)

• If there could be a market action as a result of this incident (refer to the New Zealand Medicines and Medical Devices Recall Code), submit an initial report within 10 working days.
• Please submit the final report within 120 calendar days. If the final report is not available at 120 days, submit an initial report.
• Where possible, submit the report once the investigation has been completed in full.

Quality issue (refer to definitions)

• If there could be a market action as a result of this incident (refer to the New Zealand Medicines and Medical Devices Recall Code), submit an initial report within 10 working days.
• For all other quality issues, please submit a final report within 120 calendar days
• Where possible, submit the report once the investigation has been completed in full.

Why report a suspected adverse event?

An adverse event is an unintended consequence associated with the use of a medical device or with an implanted medical device. Such events may be indicative of a quality or safety issue that needs to be addressed in some form. By reporting these to Medsafe, seemingly isolated incidents may be collated and responded to.

Some of these events may be known to be associated with the device and may have been advised to you at the time of use.

You do not have to be certain that the medical device caused the adverse event, just suspicious. It may be difficult to determine if a particular medical device has caused the effect in an individual case. When we receive a number of reports with similar events it helps us to determine if the medical device plays a role in the adverse event.

If an issue is related to the quality of a medical device, but no adverse event occurred (i.e. no one was harmed by the device), you can still report this to us using the forms above.

Non-reportable Events

The following events are not considered to be reportable events and need not be reported to Medsafe. Medsafe will not normally investigate such events.

• Deficiency of a new device found by the user prior to its use. The deficiency being one that would always be detected by the user, where no injury has occurred, and it is not likely that a serious injury could occur due to the deficiency.
• Adverse event caused by patient conditions, where the root cause of the event is due to a patient condition.
• Service life or shelf life of the medical device. When the only cause for the adverse event was that the device exceeded its service life or shelf life as specified by the manufacturer and the failure mode is not unusual.
• Malfunction protection operated correctly (i.e. fail-safe). Adverse events which did not lead to serious injury or death, because a design feature protected against a malfunction becoming a hazard.
• Adverse events described in a recall, recall for product correction or hazard alert.
• Issues arising due improper use or maintenance of the device, or due to damage to the device.
• Expected and foreseeable events, which are fully described in the instructions for use.

Medsafe Process

An acknowledgement of receipt of your report will be sent to you.

All adverse events are reviewed by Medsafe with both safety and quality issues being considered. If a trend is identified, evaluation and analysis to investigate the relationship between the device and the adverse event may be carried out.

As part of these reviews 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 similar reports about the device.

Medsafe can take a number of actions in response to a safety concern, for example:

• Request further information from the medical device supplier about the device.
• Inform healthcare professionals and consumers through communications published on the Medsafe website and articles published in Prescriber Update.
• 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 request the supplier to provide an appropriate corrective action to address the issue.

Details from each report are entered into a secure database of all reported adverse events. The information in this database is available for analysis by Medsafe staff to identify possible trends associated with a particular device or group of devices.

Medsafe may publish some information given on the reporting form, such as the name of the medical device, type of adverse event. However, the published data will NOT include names or other identifiable details of the person who made the report or who the report was about.

Definitions

Adverse event

An adverse event meets all of the following criteria.

1. An event must have occurred. Typical events are:
   • A malfunction or deterioration in the characteristics or performance.
   • An unexpected, incorrect or out of specification result or outcome.
   • An inaccuracy in the labelling, instructions for use and/or in promotional materials. Inaccuracies include omissions and deficiencies.
   • The discovery of a serious public health threat.
   • Use error.
2. An identified medical device is associated with the event.
3. The event led to or could have led to injury to a patient or other person.

Serious injury

An injury which meets any of the criteria:

• Life threatening illness or injury has occurred or is likely to have occurred.
• Permanent impairment of a body function or permanent damage to a body structure.
• An unexpected condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Minor injury

An injury which does not meet the criteria of serious as defined above occurred, or is likely to have occurred.

Quality issue

If an issue is related to the quality of a medical device, but no serious injury occurred (i.e. no one was harmed by the device) and it is unlikely that a serious injury could have occurred, you can still report this to us using the forms above.