M
MIREGMGR
AAMI for many years has been the US party with responsibility for sterilization-related standards.
Anyone have any info on the politics or organizational relations underlying that no longer being the case, such that the latest AAMI version of the above standard is not current with the latest ISO version and US FDA no longer recognizes the AAMI version as authoritative?
This was brought to mind today by FDA's publication of a December-issued Warning Letter to Customed, a Puerto Rico kit packer, for (along other things) having their sterilization process validated to AAMI/ANSI 11135-1:2007 instead of ISO 11135:2014.
Clearly FDA regards the 2014 version as effective now. Interestingly, this is not universally known among contract sterilization houses...a Michigan company that we use was not aware of it, for instance, and thinks that there is a three year transition period.
Anyone have any info on the politics or organizational relations underlying that no longer being the case, such that the latest AAMI version of the above standard is not current with the latest ISO version and US FDA no longer recognizes the AAMI version as authoritative?
This was brought to mind today by FDA's publication of a December-issued Warning Letter to Customed, a Puerto Rico kit packer, for (along other things) having their sterilization process validated to AAMI/ANSI 11135-1:2007 instead of ISO 11135:2014.
Clearly FDA regards the 2014 version as effective now. Interestingly, this is not universally known among contract sterilization houses...a Michigan company that we use was not aware of it, for instance, and thinks that there is a three year transition period.
Last edited by a moderator: