The Alchilife R&D team is engaged in tuning-up truly reliable cytotoxicity tests performed according to the ISO 10993-5 standard on medical devices for ophthalmic surgery, including PFCLs, dyes for anterior and posterior segment surgery, and silicone oils.
The unfortunate experience in Spain during the recent years with the use of some commercialized perfluorocarbons has taught us that high purity compounds can still raise serious concerns about patients’ safety, since even small amount of residual impurities can have cytotoxic properties.
In our laboratories, the “direct contact method” according to ISO 10993-5 standard has always been the method of choice to determine the possible toxicological hazard of a product using quantitative and qualitative approach on ARPE-19 and BALB/3T3 cell lines. However, the recent events prompted our researchers to revisit the ISO 10993-5 standard, and now they are about to fine-tune and validate truly reliable cytotoxicity tests to verify the safety of a wide range of medical devices for intraocular use.
If performed on already commercially available products, these tests will serve as a post-market safety evaluation; if performed on raw materials and pipeline products, they will be useful as screening tools before more extensive toxicological testing is performed.
- Pastor et al. Acute retinal damage after using a toxic perfluoro-octane for vitreo-retinal surgery. Retina 2017;37(6):1140-1151.
- Li et al. Study on the in vitro cytotoxicity testing of medical devices(Review).
Biomed Rep 2015;3(5):617-620.
- ISO 10993-5, 2009. Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity. https://www.iso.org/obp/ui/#iso:std:iso:10993:-5:en (accessed 16 July 2019)
- Romano M. Cytotoxicity testing according to ISO 10993-5 of perfluorocarbon manufacturing process residuals. Presentation at Euretina 2018
- Romano MR et al. Evaluation of Cytotoxicity of Perfluorocarbons for Intraocular Use by Cytotoxicity Test In Vitro in Cell Lines and Human Donor Retina Ex Vivo. Transl Vis Sci Technol 2019; 8(5):24.