The Medical Devices Introductory Course 2020

Vigilance

However, even events which meet these criteria may be exempt…

Vigilance

Q: Was the event caused by abnormal use?

G: It is not sufficient for a manufacturer to make an assumption that abnormal use occurred. There must be some form of evidence, such as a statement from the complainant that the device was not being used in accordance with its intended purpose, and that the event was caused by conduct which was beyond any means of risk control by the manufacturer

Ex:Manufacturer receives a customer complaint regarding an event associated with an insulin syringe which has been used to inject botox, and which resulted in serious harm to the patient.

This event must still be evaluated using the procedure and decision tree, however, since the user has stated that they used the device for a purpose other than that which we intended, this might be considered abnormal use, and therefore a vigilance report may not be required.

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