WHO global benchmarking tool plus rev.VI+ ver. 1 - Regulatory oversight of associated substances and medical devices including in vitro diagnostics (IVDs)

Overview

Several associated substances and medical devices are used during blood and blood component preparation. These include, among others:

• Anticoagulant solutions
• Additive solutions for red blood cells and platelets
• Blood pressure and pulse monitors, thermometers, haemoglobin analysers, and similar devices which are used for donor health assessment 
• Apheresis equipment, automated blood processors, blood bag collection systems, centrifuges, automated red cell washers, gamma and X‐ray irradiators, sterile connection devices, automated blood extractors, plasma freezers, and similar equipment that are used for blood and blood component collection and processing
• In vitro screening test kits used for donor testing and systems for microbial detection, compatibility testing and quality control testing. Some of these testing systems may be automated
• Pathogen reduction technology systems
• Computerized blood management systems, specifically systems that analyse data regarding the suitability of blood and blood components for transfusion (note: the classification of blood management systems as medical devices depends on the specifications of the product and on the national medical devices legislation)