The Medical Devices Introductory Course 2020

Vigilance

Q: Was the event caused by a patient condition ? (ie. The device performed as intended and did not cause the event)

G: The manufacture must seek advice from either a clinician or another suitably qualified expert. The decision should be evidence based and fully documented

Ex: An example might be a complaint regarding a sample collected into a Vacutainer SST tube which did not clot. If information is available to indicate that the patient was receiving anti-coagulant therapy, a clinician may determine that this therapy was the true root cause of the event, and hence a vigilance report may not be required

The Organisation for Professionals in Regulatory Affairs

Vigilance

Q: Was the device being used within its labeled expiry date / service life / shelf life ?

G: This means the expiry date which is determined by the manufacturer and stated on the information provided with the device

Ex: A complaint is received by the manufacturer, relating to insufficient vacuum in a blood collection tube, resulting in inappropriate blood to additive ratio. If, upon investigation it was determined that the tube had passed its stated expiry date, the incident may not need to be reported

The Organisation for Professionals in Regulatory Affairs