In this episode, NAMSA’s Senior Product Development Specialist, Ed Arscott, joins our hosts to examine the relationship between packaging and biocompatibility, including: how to evaluate primary packaging for biological safety. The discussion also focuses on the direction provided in ASTM F2475-05 Standard Guide for Biocompatibility Evaluation ofMedical Device Packaging Materials.Listeners can expect to learn:Where to look for guidance on packaging evaluation for medical devicesKey points to consider when looking at material contact to medical devicesEvaluating device/package interactionAssessing cases or primary packaging for reusable devices“I’m happy to help join between the two realms of biocompatibility and packaging.” – Ed Arscott“One common thing in the past was that you saw a lot of cytos being performed on primary packaging.” – Don Pohl“The way that packaging interacts especially with implants; things can occur with packaging and implants that relate directly to product safety.” – Ed Arscott“Part of figuring out what to do or not to do is based on device/packaging interaction.” – Don Pohl“Let’s discuss metal trays for instruments; A form of packaging to evaluate as well.” – Sheri Krajewski“Your level of evaluating for the packaging shouldn’t exceed the evaluation of your device.” – Don Pohl

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