BiocompCHATibility Archiv

Our hosts are joined this week by Dr. Ted Heise, convenor of TC 194/WG 14 responsible for the re-write and release 10993-18 Biological evaluation of medical devices —Chemical characterization of medical device materials within a risk management process. This much-anticipated standard is expected to provide greater detail and guidance to the use of characterization within the biological evaluation of medical devices.

“There are no technical changes allowed when FDIS is translated to International standard” – Ted Heise

“The distinction between chemical information and analytical testing is one of the important changes in the new document.” -Ted Heise

“You can use this standard to answer different types of questions and that a well-documented plan can justify an approach to answer one question. “ – Don Pohl

“The document includes a tabulation of solvents with varying degrees of polarity…. It also emphasizes that your solvents should not degrade your test article.” – Ted Heise Discussion points include:

High level overview of the changes to the standard

Discussion of the most significant changes and what it means to manufacturers

The differentiation between material and chemical characterization

Discussion of degradation of materials and the importance of selecting proper solvents for extraction

Discussion of AET (Analytical Evaluation Threshold)

Opinions are their own and do not reflect that of their current or former employers.

Our hosts are joined this week by Dr. Jean Pierre Boutrand, VP of North American Laboratory Services at NAMSA.  During this episode the team discusses the new book, Biocompatibility and Performance of Medical Devices.  Jean Pierre is the Editor of this collection of experiences by esteemed authors in the biocompatibility and medical device profession.  This is the second edition of the book, originally published in 2012 and the focus of the new edition is how to accelerate a product to market and ways to plan for evaluation. 

From the book cover “Biocompatibility and Performance of Medical Devices, Second Edition, brings an understanding of evaluation strategies for ensuring that medical devices and biomaterials are safe and effective and will perform s expected in the biological environments.  This second edition is updated and expanded to include the latest developments in nonclinical research to support rapid market introduction of innovative medical devices and biomaterials.”

Discussion points include:

Pertinent changes since the 2012 edition that effect today’s market

How experts and topics were chosen for this edition of the book

How listeners can win a free copy of the new book

The inspiration and motivation for this type of book in the industry

Enter to win a book at www2.namsa.com/freebook

Opinions are their own and do not reflect that of their current or former employers.

Our hosts are joined this week by NAMSA colleagues, Dr. Sylvie Framery and Dr. Nicolas Martin  – LIVE from the NAMSA training series event in Frankfurt, Germany.  Sheri, Dr. Martin and Dr. Framery have spent the week conducting NAMSA’s biocompatibility training, and discuss the week’s events, the specific questions that seemed to drive the training this week, and any new awareness received from hearing attendee stories and experiences.

 “The MDR mentions that the manufacturer must demonstrate, amongst other things, the safety of its device but does not provide any technical solutions.. that’s why we will use the ISO 10993 series” – Sylvie Framery

“Regarding using post market data - We can always try… it depends on the quality of the data and device as well… we have to have more precise data to cover biocompatibility endpoints” – Nicolas Martin

“If we know the data are out there; to be in compliance with the standard we have to at least look at the data.“ – Don Pohl

“What’s the alternative… I’m not doing biocompatibility after 10 years and waiting 10 years” –  Sheri Krajewski-Bibins

Discussion points include:

EU harmonization of 10993-1: 2018

The Medical Device Regulation (MDR) and biocompatibility

The use of post market surveillance

How to prove biological safety for the “lifetime of the device”

Access NAMSA testing resources here at www2.namsa.com/MDR

Opinions are their own and do not reflect that of their current or former employers.

Our hosts are joined this week by NAMSA colleague, Dr. Phil Smiraldo – LIVE from the NAMSA training series event in Philadelphia.  Sheri, Don and Phil have spent the week conducting NAMSA’s biocompatibility training, and discuss the week’s events, the specific questions that seemed to drive the training this week, and any new awareness received from hearing attendee stories and experiences. 

Discussion points include:

Material information and its usefulness

How to use clinical data for biocomp evaluation

Multi component devices

The hosts each give a main takeaway from the week

And ...Dr Smiraldo joins on his first visit to bicompchatibility for 2 truths and a lie

To connect with Dr Smiraldo

https://www.linkedin.com/in/phillip-smiraldo-phd-dabt-9a976717/

Access NAMSA testing resources here at www2.namsa.com/biocomptraining

Opinions are their own and do not reflect that of their current or former employers.

Lisa Olson, NAMSA’s Global Director of Analytical Services joins Sheri and Don on this special episode.  As Lisa is a recent addition to the NAMSA team, our hosts ask about her background, her thoughts on the future and present state of biocompatibility, and most specifically the use of chemical characterization in the biological evaluation strategy.  The hosts also introduce a new game of 2 truths and a lie, for biocompatibility.

To connect with Lisa, you can find her here at

https://www.linkedin.com/in/lisa-olson-09659511/

Opinions are their own and do not reflect that of their current or former employers.

Access NAMSA testing resources here at www2.namsa.com/csipodcast. There are many mentions of extractions throughout international testing standards and regulations. In this episode, ISO 10993-12 for sample preparations and extraction conditions is discussed. What happens to a sample when it’s received at a lab prior to testing? How does the lab actually extract a piece of plastic and when has the extraction gone too far?

Opinions are their own and do not reflect that of their current or former employers.

Cytotoxicity, sensitization and irritation, sometimes known as CSI, are three of the most common tests performed on medical devices. In this episode, our hosts discuss these tests, common pitfalls and how to address regulatory expectations. 

Opinions are their own and do not reflect that of their current or former employers.