Aseptic technique and packaging: A study of potential contamination pathways during the usage of sterile packaging in an operating room context

ASEPTIC TECHNIQUE AND PACKAGING: A STUDY OF POTENTIAL CONTAMINATION PATHWAYS DURING THE USAGE OF STERILE PACKAGING IN AN OPERATING ROOM CONTEXT By Tony Trier Healthcare associated infections (HAI) are a significant burden to society in terms of harm to patients as well as being a financial burden. Most recent estimates place the burden to society in tens of billions of dollars, and it is estimated that 1 in 25 patients has an HAI at any given time. In order to address this issue, airborne contaminants, hand sanitation, and reservoirs of bacteria on operating room equipment have been explored in attempt to address contamination of sterile items in the operating room (OR). Packaging has been studied on a very limited basis. In the medical device packaging industry, ISO guidelines are followed in attempt to decrease the risk of sterile items becoming contaminated, not only in transit but in use. Although testing procedures have been developed by ASTM and ISTA for evaluating the ability of packages to maintain sterility during distribution and handling, the usage of packages is less standardized. Aseptic presentation to the sterile field, though referenced in the standard ISO11607-1, does not have evidence-based procedures to evaluate it or a consistent, evidencedbased medical guideline to direct it. To fill these gaps in understanding about aseptic technique and packaging, three studies were conducted. The first objective was to add to a limited body of evidence which suggests that pouch size is a contributing factor to contact between a sterile device and non-sterile surfaces during aseptic transfer, specifically to investigate the source of contact (i.e, the hand or the package). A total of 159 participants opened four packages of two different sizes, with simulated contaminant coatings applied to gloves and packages in a counterbalanced fashion. Products were dispensed into a simulated sterile field and evaluated for contamination in a binary (yes/no) fashion. Although there was insufficient evidence to detect a difference between sources of contamination (P=0.87), large pouches were still found to have a higher rate of contamination than small pouches (P=0.0017). This is consistent with previous findings. The second objective explored what the term aseptic presentation means to healthcare providers involved in peri-Operative environments. To accomplish this, a semi-structured interview was conducted with 13 surgical technologists and 2 nurses. Participants were presented with three styles of packages that, based on previous work, were received positively or negatively by healthcare professionals. Questions involved their experience using the packaging, their experiences learning aseptic technique, and their perceptions of what constitutes “aseptic presentation” and what does not. Interviews were transcribed and analyzed in light of several theories, in particular affordance theory (packaging use) and situated learning (workplace learning) theory. The work herein presents packaging affordances within aseptic presentation, and specifically ties the individualistic nature of affordances to the necessity of field study, and describes packages’ role as a communicator of risk and utility. The final objective was to understand why users interacted with the packages in unintended manners and, using a simulated contaminant and a customized peeling apparatus, to provide pilot data regarding contamination as a result of strength of the seal and position of the pull. Although significant relationships between positions and seal strengths were found (which lead to higher opening forces), the exact reason for the contamination was not identified. However, the work has provided some evidence in support of claims made in other work, and has provided a methodological basis for work that can target specific contaminants (i.e., dust, blood, or hair).