There are many mentions of extractions in medical device testing. In this episode, our hosts discuss ISO 10993-12 for sample preparations and extraction conditions. What happens to a sample when it’s received at a laboratory before they begin the testing? How do they actually get an extract out of a piece of plastic and when has the extraction gone too far? All of this and more are answered in this episode of BiocompCHATibility.
“If you are looking at the biocompatibility testing, the concept of extractions is going to come up eventually. Basically, trying to get something that we can dose into a study, whatever study that you are doing. If you are trying to simulate what the human body may pull out of a device once the body is exposed to a device. Then you are trying to assess what the hazards are from that exposure. That’s what we use extraction to do.” –Don Pohl
“Who has ever designed a medical device to be suitable for extraction in various vehicles at temperatures higher that is intended to be use? That is literally what you’re asking yourself when considering part 12. You didn’t design it to test it, you designed it to do what it’s supposed to in a clinical application. This causes some frustration.” –Don Pohl
Key Discussion Points include:
- What is the importance of working with your laboratory on selecting extraction conditions?
- Where were the extraction conditions developed?
- What is the rule of thumb to select the appropriate conditions?
- How do you consider the steps to not degrade the extracted chemicals?
Also be sure to check out our Biocompatibility Strategy Navigator.
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.
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.