Don’t Forget Packaging!

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 of Medical Device Packaging Materials. Listeners can expect to learn: Where to look for guidance on packaging evaluation for medical devices Key points to consider when looking at material contact to medical devices Evaluating device/package interaction Assessing 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