Our hosts are joined this week by David Parente, Director of Global Sterilization and Biological Safety at Ecolab. During this episode, the team discusses Dave’s chapters in the new book, Biocompatibility and Performance of Medical Devices. Mr. Parente has a long history with the Biological Evaluation process, including the foundation of NAMSA’s first Biological Safety Consulting Team, NAMSA Advisory Services. For many years, he has taught and wrote about the importance of Biological Evaluation Plans, which are informed by his experience as a manufacturer facing regulatory challenges surrounding Biological Evaluation expectations.
“It all speaks to the importance of a plan—plan, evaluate, plan, evaluate. Things change and you have to do this continually.” – Don Pohl
“Every device does not fit on this table.” Sheri Krajewski-Bibins
“If you truly understand the risks your device introduces with its intended use, that’s an active means in evaluating biocompatibility.” – Dave Parente
“As a segue to the 2018 version of 10993-1 and its greater emphasis on one of the aspects of biocompatibility, manufacturing affects the safety of a device.” – Don Pohl
“Originally, everyone just said this is a checklist […] and credit to TC 194, they have slowly over the past 10 years or so transformed biocomp to what it should be—its risk assessment. There are several degrees of risk […] If I have to mitigate this risk, then what’s my plan for mitigation?” – Dave Parente
Connect with Dave here https://www.linkedin.com/in/davidmparente/
Also be sure to check out our Biocompatibility Strategy Navigator.
|Dave Parente, Director of Global Sterilization and Biological Safety, Ecolab
Dave Parente started his career with Terumo Medical Corporation (Elkton, MD) in 1985 in the Chemical Engineering Group working on material qualification studies and biocompatibility. He moved on to Project Engineering and then landed in Regulatory Compliance. In this role, he ended up in the middle of a regulatory sterilization issue which started his career in Sterilization and Sterility Assurance. In 1993, he became the Microbiology Manager for NAMSA’s Georgia Laboratory, eventually becoming Operations Manager and then Laboratory Manager. In 2003, he started NAMSA Advisory Services, NAMSA’s initial foray into Medical Device Consulting. In 2012, he joined ECOLAB as Director of Global Sterilization and Biological Safety for their Healthcare Division. He is a member of ISO Technical Committees TC 198 (Sterilization) and a former member of TC 194 (Biological Safety).
|Sheri Krajewski-Bibins; Product Marketing Manager – Biological Safety, NAMSA
Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She 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, Sheri created the much sought-after NAMSA Training Series for the biological 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; Principal Product Development Strategist, NAMSA
Don holds a Bachelor’s degree from Ohio State University. He has over 25 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.