ERC-RMB Participates in ASTM / ISO/ AC 87 Process for Developing Standards for Absorbable Metals
Outcome / accomplishment: Dr. Yeoheung Yun, Dr. Aaron Barchowsky and Dr. Sergey Yarmolenko and Frank Witte, are serving as the ERC-RMB representatives to the AC 87 process, led by Dr Byron Hayes at ASTM and W.L.Gore & Associates. The ERC members are lending their expertise to a to the standards development process in the areas of materials and surface characterization, degradation/corrosion and toxicity/biocompatibility testing with the goal of identifying gaps in the current testing protocols testing standards and developing standards for adoption by ASTM and ISO that more appropriately reflect the unique characteristics of absorbable metals.
Impact / benefits: Participation in AC 87 provides an opportunity for ERC PI’s to learn from the global community and broadly disseminate and increase the impact of findings from ERC investigations. Through this process, the ERC is able to identify, validate and focus research efforts on those topics that will most impact the regulatory pathway and translational potential for devices made from absorbable metals. In particular, this engagement will help the ERC serve its industrial partners.
Explanation / background: The interface between devices with their local in vivo environment is sophisticated, impacted by the surrounding environment such as 1) dynamic loads and 2) fluid flow (perfusion) complex environments induced changes to the material surface, such as pitting, hydrogen enbrittleness and stress induced fracture (different types of corrosion). Testing protocols for metals must evolve from those that currently address relatively inert materials to ones that recognize and support materials that interact dynamically with their environment and in turn influence that environment. Areas in need of testing standardization include: 1) Materials, 2) In vitro - in vivo correlation, 3) Biological evaluation, 4) In vitro degradation testing, 5) degradation product fate, and 6) Bulk corrosion test.
In addition to these presentations, ERC leadership and PIs had the opportunity to build and strengthen relationships with key industrial colleagues and members of ISO, ASTM and the FDA with the unifying objective of developing new standards that reduce the barriers for developing safe and clinically effective absorbable metal devices.