A successful step toward replacement of the Draize test for biocompatibility testing of medical devices extracts. The results of the Round Robin Study (RRS) conducted in 2016 to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for medical device are now published in Toxicology In Vitro.
This international RRS, gathering 17 laboratories, was conducted to the initiative of the Working Group 8 for Irritation and Sensitization of ISO Technical Committee 194 on Biological and Clinical Evaluation of Medical Devices (ISO/TC194 WG8). At the last ISO meeting in Korea the New Work Item Proposal (NWIP) ISO/WD 10993-23 for Determination of Skin Irritation of Medical Device Extracts using RhE have been approved and is being written.
This work illustrate how approaches already used in the chemical and cosmetic industries to replace animal testing for some lower-tier toxiciological endpoints can be adapted to other industries such as medical devices.
Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts. De Jong WH, Hoffmann S, Lee M, Kandárová H, Pellevoisin C, Haishima Y, Rollins B, Zdawczyk A, Willoughby J, Bachelor M, Schatz T, Skoog S, Parker S, Sawyer A, Pescio P, Fant K, Kim KM, Kwon JS, Gehrke H, Hofman-Hüther H, Meloni M, Julius C, Briotet D, Letasiova S, Kato R, Miyajima A, De La Fonteyne LJJ, Videau C, Tornier C, Turley AP, Christiano N, Rollins TS, Coleman KP., Toxicol In Vitro. 2018 Jan 8. pii: S0887-2333(18)30001-8. doi: 10.1016/j.tiv.2018.01.001. [Epub ahead of print]
SkinEthic™ RHE for in vitro evaluation of skin irritation of medical device extracts.Pellevoisin C, Videau C, Briotet D, Grégoire C, Tornier C, Alonso A, Rigaudeau AS, Bouez C, Seyler N., Toxicol In Vitro. 2018 Jan 13. pii: S0887-2333(18)30009-2. doi: 10.1016/j.tiv.2018.01.008. [Epub ahead of print]
Preparation of irritant polymer samples for an in vitro round robin study. Coleman KP, Grailer TP, McNamara LR, Rollins BL, Christiano NJ, Kandárová H, De Jong WH. Toxicol In Vitro. 2018 Feb 1. pii: S0887-2333(18)30020-1. doi: 10.1016/j.tiv.2018.01.018. [Epub ahead of print]
Assessment of test method variables for in vitro skin irritaiton testing of medical device extracts. Olsen D, Lee M, Turley A, Toxicology In Vitro. 2017 Nov 24. pii: S0887-2333(17)30362-4. doi: 10.1016/j.tiv.2017.11.012. [Epub ahead of print]