Topic of Hemocomaptibility Testing for Medical Devices

Abstract

Guidance on hemocompatibility testing for Biological Safety Evaluation of Medical Devices in Japan was revised to make it more practical. Due to the characteristics of hemocompatibility testing for medical devices, there are no testing methods and protocols applicable to almost all medical devices, except material-induced hemolysis testing. There was also little information on the testing in Japan. They would make harder for the users in Japan to understand what testing should be conducted as hemocompatibility testing. Therefore, the revised guidance puts the highlight on providing the information so that the users can understand the risk related to the hemocompatibility of medical devices and design the testing according to it appropriately. This paper provides the explanation on the major modified points in the guidance. These information would be helpful to design the hemocompatibility testing for each medical device as well as to understand the guidance.