Titan Medical Inc (TMDIF)

[elMoose]

Sterilization processes are under review by FDA and it is possible that new devices have to adhere to new processes and find new suppliers in short supply.



"In light of recent shutdowns of two contract sterilization facilities over environmental concerns, FDA said it is exploring ways to ensure sterilization processes are safe and effective and evolving with the current science."


"In the world of contract sterilization, selecting the most appropriate service provider can be a daunting task.

"Location, turnaround time, cost, chamber equivalency, process controls, and the supplier's regulatory compliance history are all factors that should come into play when choosing a contract sterilization vendor."

https://www.mddionline.com/fda-scrambles-prevent-shortages-wake-sterilization-shutdowns