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