Don’t Forget Packaging!

Operating room with monitor

Published:

Content Type:

Audio

BiocompCHATibility

A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.


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

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Also be sure to check out our Biocompatibility Strategy Navigator.

Ed Arscott, BS

Ed Arscott, BS

Ed has a long history with NAMSA, starting in 1987 and progressing to the role of Manager of Microbiology and In vitro Toxicology. After a 14-year stint with Depuy/J&J, he returned to NAMSA in 2013 as a Senior Product Development Specialist. In this role, Ed provides consultation on various aspects of medical device development, including terminal sterilization methods, packaging shelf-life studies, and cleaning efficacy validation. He is also a subject matter expert for auditing external contract laboratories and sterilization vendors. Ed's recent projects include coordinating the design and validation of a new cleanroom and conducting an epidemiological risk assessment for a reusable oral medical device.

Sheri Krajewski

Sheri Krajewski

Sheri joined NAMSA in 2003 and currently serves as Senior Global Product Marketing Manager of Biological Safety. Sheri has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s Biological Safety Consulting business. Additionally, she created the much sought-after NAMSA Training Series (NTS) for the iological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Don Pohl

Don Pohl

Don Pohl is currently the Manager of Biological Safety & Validation at NAMSA. He holds a Bachelor’s degree from Ohio State University. Don has over 20 years of experience in the pre-clinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.