Reusable Devices and the Challenges with Biocompatibility
Our hosts are joined this week by Stephanie Taylor, Staff Scientist – Toxicology and Biocompatibility at DePuy Synthes Companies. During this episode, the team discusses the reprocessing of reusable devices and the challenges of the ever-changing landscape of biological evaluation. As activity is requested both by the U.S. FDA and the EU that greatly impacts the timelines and costs of evaluating reusable devices for biological safety, the team shares a few strategies and practices used by manufacturers today to meet these high regulatory expectations.
“The end goal is a defensible position.” – Stephanie Taylor
“The magic number 6? I don’t know if that’s justifiable.” – Don Pohl
“What’s your biocomp at the end of life? You have to be able to figure that out.” – Stephanie Taylor
“Biocomp is interesting, challenging and a little bit magical at times.” – Stephanie Taylor
Discussion points include:
- The large concern with reusable devices and why
- Differentiation between an end-of-life evaluation and what might be expected currently by the U.S. FDA
- The great cost and time involved in such evaluations and burdens on manufacturers
Also be sure to check out our Biocompatibility Strategy Navigator.