Glossary Term
Serious Adverse Event (SAE)
Definition
A Serious Adverse Event (SAE) is an unwanted and harmful medical occurrence associated with the use of a medical device, drug, or treatment that results in significant health consequences. An SAE is typically defined as an event that leads to death, life-threatening conditions, hospitalization, disability or permanent damage, congenital abnormalities, or any other serious condition that requires medical intervention. SAEs are important indicators of a product's safety profile and must be reported to regulatory bodies such as the FDA or EMA for further investigation and action.
Relevance to the MedTech Industry
Identifying and reporting SAEs is essential to ensuring patient safety and informing regulatory bodies and healthcare professionals of potential risks associated with a medical device or pharmaceutical product. By tracking and addressing SAEs, manufacturers and regulatory agencies can take timely actions, such as device recalls, label changes, or additional warnings, to protect patients and prevent further harm.
Additional Information & Related Terms
Examples of Serious Adverse Events (SAEs)
Cardiovascular Device Failure:
A patient experiences sudden cardiac arrest after receiving a newly implanted pacemaker, necessitating emergency intervention and hospitalization. This would be classified as an SAE.
Drug-Induced Liver Toxicity:
A pharmaceutical company may report an SAE if a patient develops severe liver toxicity after taking a new drug, requiring hospitalization and long-term monitoring.
Surgical Complications:
A serious adverse event can also occur following surgery if a device, such as a stent or implant, causes complications such as infection, device migration, or malfunction, resulting in hospitalization or permanent disability.
Severe Allergic Reaction:
A severe allergic reaction to a medical device or treatment can also be classified as an SAE if it leads to anaphylaxis, hospitalization, or permanent damage.
Related Terms
Adverse Event (AE): Any undesirable experience associated with the use of a medical device or treatment, which may or may not be serious.
Causality: The process of determining whether a specific device or treatment caused an adverse event or whether the event was due to other factors.
Device Recall: The process of retrieving a product from the market or users when it is found to pose a risk to patient safety, often prompted by serious adverse events.
Post-Market Surveillance: The process of monitoring the safety and performance of a medical device after it has been released to the market, often involving the identification of SAEs.
Regulatory Reporting: The requirement to report SAEs to regulatory authorities, such as the FDA or EMA, for further investigation and action to ensure patient safety.