Glossary Term
Incident Reporting
Definition
Incident reporting refers to the formal process of documenting and notifying relevant authorities or stakeholders about adverse events, near misses, or device malfunctions related to medical devices. It is a critical component of post-market surveillance and regulatory compliance, aimed at identifying, addressing, and preventing risks to patient safety.
Relevance to the MedTech Industry
Incident reporting ensures the continuous monitoring of medical device performance in real-world use. By identifying and analyzing incidents, manufacturers, healthcare providers, and regulators can implement corrective actions, enhance device safety, and reduce the likelihood of recurrence. This process is essential for maintaining public trust and meeting regulatory requirements in the medical device industry.
Additional Information & Related Terms
Examples of Applications
Adverse Events: Reporting instances where a medical device contributes to patient harm, such as a malfunctioning infusion pump.
Device Malfunctions: Documenting failures like a defibrillator not delivering a required shock.
Software Errors: Reporting software issues in medical devices, such as incorrect alarm notifications.
Recalls and Field Actions: Using incident data to support voluntary or mandatory recalls.
Related Terms
Corrective and Preventive Actions (CAPA): Ensures incidents are addressed systematically to prevent recurrence.
Post-Market Surveillance (PMS): Incident reporting is a key component of PMS, helping to monitor real-world device performance.
Medical Device Reporting (MDR): FDA’s system for mandatory incident reporting by manufacturers, importers, and healthcare facilities.
Risk Management (ISO 14971): Integrates incident data to update risk assessments and safety measures.