Evaluation of the shelf life of sterile instrument packs

Abstract

No published studies have specifically addressed the shelf life of sterile packaging materials commonly used in dentistry. This study examined the effect of time on the sterile integrity: paper envelopes, peel pouches, and nylon sleeves. Seven thousand two hundred sample packs, each containing three glass rods, were prepared and steam sterilized. After sterilization, half the packs (control packs) were immediately opened and the contents were analyzed for bacterial contamination. The other half (test packs) were randomly sorted and stored in dental treatment operatories. At monthly intervals for 12 months, 100 packs of each type were similarly opened and analyzed. The contamination rates between the control packs were not significantly different from one another. Differences in contamination rates between control packs and test packs for both the paper envelopes (0.4% and 0.7%) and the peel pouches (0.2% and 0.2%) were also insignificant. However, a significant difference ( p < 0.01) between control and test packs (0.3% and 1.5%) was found for the nylon sleeves. This increase was not time related and was attributed to difficulty in removing the glass rods from the nylon packs in a sterile manner. The most important finding was the absence of a trend toward an increased rate of contamination over time for any pack type. This indicates that when these materials are placed in covered storage in dental operatories, a 12-month storage period is not detrimental to their sterile integrity.