Quantitative cell culture biocompatibility testing of medical devices and correlation to animal tests.

The biocompatibility of a wide variety of biomaterials was quantitatively assessed, in a physiologically normal environment" as to cytotoxicity induced in WI-38 cells by cell culture medium extracts. Materials tested included PVC plastic, rubber, silicone rubber, polyethylene, polypropylene, acetal, polyurethane, Teflon, nylon, epoxy, and polystyrene. Cell culture test results were correlated to U.S.P. animal tests. Potential test artifacts, lead, barium, cadmium, and endotoxin were tested for cytotoxicity in WI-38 cells. Cell culture methods yielded more positive tests, particularly rubber, PVC plastic and silicone rubber compounds, than observed in U.S.P. animal tests. Positivity in animal tests did not correlate quantitatively to cytotoxic titers in cell culture. Discrepancies between cell cultures tests and animal tests, specifically rubber compounds, were attributable, in some instances, to differentials in elution efficiency between saline, cottonseed oil, and complete MEM cell culture medium. In other instances, particularly PVC plastics, differences between cell culture and animal test results were due to an inherent difference in the two indicator systems to respond to specific toxic moieties.