Glossary Term
Blood-Contacting Devices
Definition
Blood-Contacting Devices are medical devices designed to come into direct contact with blood during their use. These devices include implants, surgical instruments, and diagnostic tools, such as catheters, stents, heart valves, and extracorporeal circuits (e.g., dialysis machines). They are subject to stringent safety and biocompatibility standards to ensure they do not cause adverse reactions, such as clotting, infection, or hemolysis.
Relevance to the MedTech Industry
Blood-Contacting Devices play a critical role in life-saving and diagnostic procedures, enabling treatments such as cardiovascular interventions, blood sampling, and dialysis. Their development emphasizes minimizing risks to blood components and maintaining device functionality, making them a cornerstone of modern medicine.
Additional Information & Related Terms
Biocompatibility/Biocompatibility Standards Ensures materials are safe for blood-contacting applications.
ISO 10993-4 Governs testing for interactions between medical devices and blood.
Thrombogenicity A key factor evaluated in blood-contacting device safety.
Sterility Assurance Level (SAL) Ensures the sterility of devices that come into contact with blood.