Medical and Surgical Materials Committee Approves Latest Complement Activation Standard
Understanding how blood within a human body will interact with any substance with which it comes in contact is a crucial part of any medical process. A new practice recently approved by ASTM International Committee F04 on Medical and Surgical Materials and Devices is one of a series of standards that evaluates the complement activating properties of solid materials intended for use in contact with blood. The standard, F 2567, Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials, is under the jurisdiction of Subcommittee F04.16 on Biocompatibility Test Methods.
According to Dan Lyle, research biologist, U.S. Food and Drug Administration, Center for Devices and Radiological Health, Practice F 2567 was developed as a result of industry requests to the FDA for guidance on how to acceptably perform complement activation analysis on materials intended for use in blood or tissue-contacting medical devices. The test methods that were then developed at the CDRH Office of Science and Engineering Laboratories were subsequently submitted for ballot to become ASTM International standards through Subcommittee F04.16.
Anything that contacts blood has the potential to activate complement. This list would include medical device materials and biomaterials, transplanted organs, tissue-engineered products, drugs and encapsulated cells. The primary function of normal complement activation is to provide part of the initial immune defense against invading microorganisms in the body. However, if complement activation occurs inappropriately, it can result in lung/heart dysfunction, life-threatening shock, hyperacute rejection of transplanted animal organs, localized tissue destruction and altered biomaterial function.
While F 2567 deals with the classical pathway (triggered by the presence of antibodies caught up in the device material), two separate ASTM standards are devoted to the other main pathways of complement activation in the body. These standards are F 1984, Practice for Testing for Whole Complement Activation in Serum by Solid Materials (screening for any complement activation by any pathways) and F 2065, Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (triggered by chemical structures in or on the device material).
All of the standards in the complement activation series will be useful to companies, manufacturers and developers of new materials intended for use in blood or tissue-contacting medical devices that are anticipating or conducting biocompatibility tests for submission of their product applications to the FDA.
Technical Information: Dan Lyle, U.S. Food and Drug Administration, Rockville, Md.
ASTM Staff: Daniel Schultz
May Committee Week