Orthopedic and surgical implant device manufacturers could be spending more time and money on testing than necessary by not considering family grouping when validating the cleaning and sterilization processes that occur at healthcare facilities.
Device manufacturers can use worst case or family grouping for the validations of cleaning and sterilization processes that occur at a healthcare facility unless the device is very unique and specialized.
There are three main approaches to evaluating whether family grouping for cleaning is appropriate for the medical devices a manufacturer is validating--device use, material type, and size and challenge features.
Device Use: If the devices have similar use during surgical procedures, they may qualify for family grouping.
Material Type: If a group of devices are made out of the same metals and soft materials, they could qualify for family grouping.
To further ensure that family groupings were consistent, the relationships among aligned nucleotide sequences encoding VR1 or VR2 were visualized by split decomposition analysis using SPLITSTREE version 3.
Retaining family names, when they can be shown to be reasonable, results in some minor changes to some family groupings.