MvPI – Severity of Medical device Adverse events (MDAE) and Timeframe for reporting an event

As per Guidance document on MvPI, Severity of an adverse event was broadly classified into three categories.

1. Death of a patient, user of the device or other person
2. Serious injury to a patient, user or other person – Serious Injury (also known as serious deterioration in state of health) is either a life-threatening illness or injury, permanent impairment of a body function, cause congenital abnormality or permanent damage to a body structure – a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure. The interpretation of the term “serious” is not easy and should be made in consultation with a medical practitioner whenever appropriate. The term ―”permanent or prolonged impairment” means irreversible impairment or damage to a body structure or function, excluding minor impairment or damage. Medical intervention is not in itself a serious injury. It is the reason necessitating medical intervention that should be used to assess the reporting of an event.
3. No Death or Serious Injury occurred but the event might lead to death or serious injury of a patient, user or other person, if the event recurs or not addressed or prevented within adequate time by healthcare professional. They are also termed as “Near Miss event”.
   • All events do not lead to death or a serious injury. The non-occurrence of such a result might have been due to circumstances or to the timely intervention of healthcare personnel.

Timeframe for reporting an event or Incident: