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 the biological evaluation of such devices.

There is activity requested both by the USDA and the EU that greatly impacts the timelines and costs of evaluating these devices for biological safety, so the team shares some strategies and practices used by manufacturers today to meet 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:

• Why the great concern with such devices?
• The differentiation between an end of life evaluation and what might be expected currently by the USFDA.
• The great cost and time involved in such evaluations and burdens on manufacturers.

Opinions are their own and do not reflect that of their current or former employers.