The Medical Devices Introductory Course 2020

Vigilance

Q: Did a design feature protect against the fault becoming a hazard?

G: As a precondition, there must be no danger for the patient to justify not reporting. If an alarm system is used, the concept of this system should be generally acknowledged for that type of product

Ex: A manufacturers diagnostic instrument reports a random unusual result and alerts the clinician by sounding an alarm. Although a fault may have occurred, the safety mechanism has protected the patient from a hazard which does not need to be reported.

The Organisation for Professionals in Regulatory Affairs

Vigilance

Q: Was the defect found prior to use and would it always be found prior to use should it occur again?

G : To answer this question the manufacturer must consider how the device is used under normal circumstances. To answer ‘yes’, we need to be absolutely certain that the defect would always be found prior to use

Ex: A manufacturers syringe is found to contain a large foreign body, biological or otherwise, prior to use. Although the presence of such a contaminant may be considered to be a potential cause of harm, if the defect re-occurred under normal circumstances it would be found prior to use (visual check) and therefore not used. Such an incident may not need to be reported.

The Organisation for Professionals in Regulatory Affairs