Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients

Key Points

• 1The regulation classifies a specific blood-clotting measurement device (coagulation system) as a Class II medical device, meaning it requires moderate oversight but not the most stringent approval process
• 2The device measures viscoelastic properties of whole blood, which essentially means it tests how blood's thickness and ability to clot change during surgery in real-time
• 3This classification applies specifically to perioperative patients—people undergoing surgical procedures—where quick blood clotting assessments can prevent dangerous bleeding complications
• 4Manufacturers of these devices now have a clearer regulatory pathway and know what standards their products must meet to be approved and sold
• 5Surgeons and anesthesiologists can more reliably use these devices to guide decisions about blood transfusions and blood-clotting medications during operations

Key Dates