Another area where the
FDA has spent some of their focus is on particulates generated by medical
devices. A particulate is defined by USP 788 as “Particulate matter consists of mobile, randomly-sourced,
extraneous substances, other than gas bubbles, that cannot be quantitated by
chemical analysis due to the small amount of material that it represents and to
its heterogeneous composition.”
was released with a section on the clinical significance of particulate matter which basically concludes that particulates less than 100 um are not a major concern. There is less evidence showing any particles larger than 100 um are safe (although they may be). This just further highlights the inadequacy of using USP 788 as a particulate specification for medical devices.