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QUOTED. 8 August 2019. Phil Pontikos.

Executive Summary

US FDA investigator and national device expert Phil Pontikos says he's concerned about the large number of medical device recalls because of troubles with sterilization activities. Check out his comments here.

"There are a few problem areas in particular that investigators see when it comes to sterilization. And just to put this in perspective, the amount of recalls that have to do with sterilization is in the 10% to 15% range. That's a pretty hefty number of recalls from year to year, and it hasn’t changed a whole heck of a lot over time." – Phil Pontikos, investigator and national device expert, US FDA

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