About this Abstract |
| Meeting |
MS&T24: Materials Science & Technology
|
| Symposium
|
Society for Biomaterials: Biomaterial Applications in Today’s Industry: Development, Translation & Commercialization
|
| Presentation Title |
Regulatory Tools for Assessing Medical Device Leachables: CHemical RISk Calculators (CHRIS) |
| Author(s) |
David M. Saylor |
| On-Site Speaker (Planned) |
David M. Saylor |
| Abstract Scope |
Toxicological risk assessment (TRA) is commonly used to address toxicological concerns associated with chemicals that can leach from medical device materials. TRA currently relies on in vitro extraction testing to estimate the potential for patient exposure, but the clinical relevance of these test results is often ambiguous. We have developed mass transport models that can be used to supplement or in lieu of in vitro testing to provide more clinically relevant exposure estimates. Moreover, we have created web-based applications, collectively known as CHemical RISk calculators (CHRIS), to facilitate the use of these models by the device community.
This presentation will provide an overview of models for both in vivo exposure estimation and in vitro extractables testing. We will describe efforts to conservatively establish model parameters and validate the predictions. Potential benefits and limitations will be discussed, along with ongoing efforts to expand and improve the CHRIS tools. |