Chairs: Helena Kandarova & Jessica Perrin
The regulatory landscape is becoming increasingly supportive of moving away from animal testing with international recognition of human-relevant non-animal test approaches. However, the number of animals used to fulfill regulatory requirements to ensure that medical devices are safe when interacting with the human body has remained constant over several years. This reflects the slow incorporation of non-animal approaches in regulatory guidelines. Medical devices are often regulated at the national level, which slows the ability of international standards to change. These standards often do not reflect the advancements in new approach methodologies observed for other regulated products. Biocompatibility assessment of medical devices, for example, encompasses a suite of tests performed to ensure safety from a toxicological perspective. The required tests, which often comprise tests on animals, vary depending on the type of medical device, the exposure time, and other characteristics related to national regulatory authorities’ device classification schemes. Two examples will be discussed to illustrate unique challenges faced for medical devices in integrating non-animal approaches into standards published by the International Organization for Standardization (ISO). The first example is qualifying a reconstructed human vaginal epithelial model to replace the rabbit vaginal irritation test in the irritation tests ISO standard (ISO 10993-23:2021). The second example is qualifying the human cell-based pyrogen test, most frequently corresponding to the Monocyte Activation Test, as a suitable method to detect relevant pyrogens in the context of medical devices and replace the rabbit pyrogen test in the pyrogenicity ISO standard (ISO/TR 21582:2021).
Speakers
- Gertrude-Emilia – Converging efforts for the advancement of new approach methodologies in the current regulatory context: safety assessment of medical devices
- Janine Townsend – Practical challenges to the use of NAMs for medical devices – when state-of-the-art science alone is not enough
- Kelly Coleman – in vitro irritation testing for medical devices: validation and regulatory acceptance
- Jessica Perrin – vaginal irritation testing: towards regulatory acceptance of a method using reconstructed human vaginal epithelium
- Seyoum Ayehunie – NAM approach for vaginal irritation assay to evaluate irritation potential of feminine care products and medical devices
- Shabnam Solati – Advancing medical device pyrogen testing through the in vitro monocyte activation test
- Lindsey Borton – Chasing phantoms? A case study on replacing the rabbit pyrogen test for the evaluation of material-mediated pyrogens in medical devices