IN ONE SIMPLE SENTENCE
Recording and reviewing complaints while identifying and following important or reportable safety events.
What is this service?
Not all complaints are the same. Some are minor dissatisfaction while others may indicate a serious incident. Vigilance identifies, triages and follows important safety events.
GOAL
Ensure important events are not missed, are investigated on time and lead to appropriate action when needed.
What can MICT do here?
Build complaint intake workflows, classify severity, assess device relationship, detect trends/signals, support root-cause analysis and track actions.
TYPICAL INPUTS
What we usually need to start
- Complaint form
- Device and IRC/identifier information
- Event description
- Patient/user information as needed
- Service history and batch/serial information when available
TYPICAL OUTPUTS
What this stage can deliver
- Complaint record
- Triage and classification
- Safety signal
- List of cases requiring investigation
- Complaint-analysis reports
- Inputs to CAPA, PMS and risk management
Important terms in plain language
Complaint
Any report of dissatisfaction or a problem related to device identity, quality, durability, safety or performance.
Vigilance
The process for managing and reporting important medical-device safety events.
Adverse Event
An undesirable event associated with product use that may have a clinical consequence.
Serious Event
An event with serious consequences such as death, major health threat or significant intervention; exact definitions depend on applicable rules.
Root Cause Analysis
Finding the underlying cause of a problem rather than only its visible symptom.
SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR
If a patient reports repeated implausible readings that contributed to an incorrect treatment decision, the complaint requires more serious triage and investigation.