Blood-Contacting Photopolymer Devices: Haemocompatibility, Surface State, Flow, Thrombosis and Sterilisation

Haemocompatibility is a system property of a finished blood-contacting device, the blood population and the imposed flow history. It cannot be inferred from cytotoxicity, resin designation, a low static platelet count or one haemolysis result. Vat-photopolymerised devices introduce coupled variables: conversion and extractables, pixel- and layer-scale topography, inaccessible wash domains, finishing residues, wettability, sterilisation-induced change, geometric flow disturbance and time-dependent surface conditioning by plasma proteins. This review defines a non-compensatory qualification architecture for blood-contacting photopolymer devices. It begins with contact classification and a frozen finished-device state, then links surface chemistry and morphology to protein adsorption, platelets, coagulation, complement, leucocytes, haemolysis and thrombosis under relevant flow. Static screening is separated from dynamic and in vivo evidence. Blood source, anticoagulant, collection-to-test time, shear field, controls and drug exposure are treated as controlled inputs. Sterilisation is a material- processing step requiring post-sterilisation verification rather than a label added after testing. The result is a device-specific evidence matrix with explicit residual uncertainty, without disclosing proprietary formulations or establishing universal acceptance limits.

ER-257 · Version 0.4.