Event-related sterility policy
One recommendation to minimize the risk of non-sterility during a product’s shelf life consists of a careful inspection in order to identify visible failures such as cuts or breaks on gaskets, punctures, tears, wetness, water stains, loosened locks, settled dust following storage on open shelving. Release of the product should be dependent on this visual inspection.
But an inherent problem is that a visual inspection alone can not assess sterility. Experiments of Waked et al who used single-use sterilization wraps for packaging showed that the defect detection rates of visual inspection for punctures ranged from 6.7% for small defect sizes of about 1 mm to 64 % for larger defect sizes of about 3.7 mm (Waked WR, Simpson AK, Miller CP, Magit DP, Grauer JN. Sterilization wrap inspections do not adequately evaluate instrument sterility. Clin Orthop Relat Res 2007;462:207-11). The conclusion is that detection sensitivities were low. Visual inspection is an essential test to control the integrity of the packaging. A shortcoming of this test is its dependency on operator training.