Reducing levels of medical device contamination through package redesign and opening technique

The goal of this research was to evaluate how material curl, package structure and handling of pouches containing medical devices affect rates of contact between non-sterile surfaces and sterile devices during aseptic transfer.

One hundred and thirty-six individuals with practical experience in aseptic technique were recruited. Participants were asked to present the contents of four different pouch designs (a standard, one designed to curl in, another to curl out and one that incorporated a tab) using two transfer techniques. During the first block of trials "standard technique" was used; participants presented using their typical methods to the sterile field. Trials in the second block employed "modified technique"; participants were instructed to grab the package at the top center and present package contents using a single, fluid motion. The outside of the pouch and the backs of the participants' hands were coated using a simulated contaminant before each trial. The simulant was undetectable in the visible spectrum, but fluoresced under a black light. The dependent variable was recorded in a binary fashion and analyzed using a generalized linear mixed model.

Participants were between 20-57 and the averaged year 5.1 years of experience in aseptic technique. The data analysis was based on generalized linear mixed effects (GLMM) model, which accommodates the repeated measurements within the same participant. The effect of the pouch design was significant (P‹0.001), but the effect of aseptic technique did not suggest significance (P = 0.088). Specifically, pouches designed with the material curled outward resulted in significantly fewer contacts with non-sterile surfaces than the other styles, including the inward, tab, and standard styles; this was true regardless of the used aseptic technique, standard (P = 0.0171, P = 0.0466, P = 0.0061, respectively) or modified (P‹0.0001 for all comparisons)).

Results presented here contribute to a growing body of knowledge that investigates packaging as a potential route of contamination for sterile devices during aseptic presentation. Specifically, we provide insights regarding how both package design and opening technique can be informed in ways that build safety into the healthcare system.