The Association for the Advancement of Medical Instrumentation (AAMI) has published a revised standard for sterility which may ease requirements for selecting a sterility assurance level (SAL) for manufacturers. The revised standard could allow manufacturers to use a less-restrictive SAL for medical devices that are sensitive to 10-6 sterilization processes, according to the association.
A SAL 10-6 is the probability that a single microorganism will survive for every million products sterilized, according to the organization. The revised standard allows manufacturers to select a SAL of 10-5 (one in 100,000), 10-4 (one in 10,000) or 10-3 (one in 1,000) for products that are sensitive to the stricter SAL, but doing so requires a risk assessment. “The previous version of [the requirements] was very restrictive in using SALs other than 10-6,” said Trabue Bryans, co-chair of the AAMI Sterility Assurance Level Working Group.
Some products can withstand the higher SALs because of the materials used in the device, according to Gerry O’Dell, president of a consulting agency in Wesley Chapel, Fla., also a member of the AAMI working group. Still, products that are sensitive to moisture or heat may be limited in sterilization processes.
“You may not be able to use certain techniques like steam of ethylene oxide,” she said. “You may get to a point where terminal sterilization can’t get you to 10-6.”
Another option, aseptic manufacturing, is more expensive, O’Dell noted, as it requires sterilizing almost every device component separately, then re-assembling the product in a clean room.
AAMI said the revised standard may save manufacturers money. It is available for purchase here.