The definition of medical-grade materials that have existed for years are confusing and ambiguous (Credit: fotofabrika/Adobe Stock)

A panel of experts presented the process and next steps for developing harmonized medical-grade materials with the goal toward establishing biological safety of medical devices. In the session, “Establishing and Maintaining Biological Safety of Medical Devices per ISO 10993-1:2018: A Long and Tortured Process,” Jacqueline Anim, Sr. Principal Mateirals Engineer for Ethicon Endo-Surgery, and Rob Klein, Principal Materials Engineer at AtriCure, said the project reinforces the assurance of patient safety across the medtech industry.

Anim said that the North American Medical Grade Consortium Group (MGMC) will develop medical application forms to create a universal form for correct material/additives/colorant selection to comply with supplier medical policy. MGMC will also lead the U.S. contingent for global harmonization meetings in October in Düsseldorf, Germany.

MGMC has been working on clearly defining the term medical-grade material along with sorting out associated terms such as implant grade, healthcare grade, and pharmaceutical grade. The need to reference multiple agencies (FDA, CDRH, USP, ISO, ASTM) to classify a material, device, or process as medical grade illustrates the importance of establishing a comprehensive, universal definition.

Ethicon announced their first call-to-action at the 2017 MD&M Conference & Exhibition in New York City. This was followed up with Ethicon’s first medical-grade conference and internal JNJ Governance review in August 2017. The mini conference established that the scope and ultimate pursuit of the medical grade definition initiative would focus on defining the basic requirements for medical grade, locked down grade, pharmaceutical packaging grade, and skin contact grade.

Participants of the August conference included polymer OEMs, compounders, color and master batchers, 3D printing materials, distributors, and a leading silicone manufacturer.