The Medical Devices Introductory Course 2020

Vigilance

Q: Is the exceeded expiry date the only cause of the incident and is the failure mode not unusual?

G: If the incident was not caused by the device being used beyond expiry, then the incident may still need to be reported

Ex: Manufacturer receives a complaint about the performance of a reagent, and it transpires that the reagent had been used 2 days beyond its stated shelf life. Upon investigation, it was determined that this fact was unlikely to have been the cause of the unusual results and that further investigation was required to determine root cause. Despite the reagent having been used beyond its stated shelf life, the event may still need to be reported under these circumstances

The Organisation for Professionals in Regulatory Affairs

Vigilance

Q: Is the event a labeled side effect that is considered foreseeable and clinically acceptable in terms of patient benefit ?

G: Such an event should have been identified and documented as part of the manufacturer’s risk assessment prior to it occurring. Such an event may also be well known in the medical or scientific field. A clinician or other suitably qualified expert should be consulted.

Ex: The manufacturer receives a complaint about a haematoma caused by a needle stick. However, it is usually considered acceptable that a slight haematoma can occasionally result from needle sticks. If acceptable levels and frequency of haematoma are documented and this event is within these, then it may not need to be reported.

The Organisation for Professionals in Regulatory Affairs