Healthcare Acquired Infections (HAIs) are the cause of substantial pain and emotional stress. On any given day, 1 in every 25 patients in the US has an HAI. This has serious economic ramifications. Although the incidence of HAIs has been reduced through the implementation of varied prevention projects, work remains. Limited work has focused on indirect routes of contamination, and even fewer on packaging and handling as potential contributors. The presented work is among the first objectively investigating how package design and provider technique impact the sterile transfer of medical devices. Specific research goals were:1. To evaluate how package design features (inward curl, outward curl, tab design compared to a traditional, commercial pouch design) affect the likelihood of a device contacting non-sterile surfaces (the outside of the package or the hands of the provider).2. To characterize how aseptic technique (traditional vs. a modified approach) contributes to the likelihood of contact between medical devices and non-sterile surfaces during sterile transfer. 3. To develop a reliable, relatively easy and cost effective methodology that can be used to design and prototype new styles of flexible packages.4. To evaluate how peel geometry (using pouches created with the new prototyping method) impacts rates of contact between transferred devices and non-sterile surfaces.To explore goals 1, 2 and 4, a total of 136 healthcare providers were asked to present devices to a simulated sterile field. Participants’ gloved hands and the outside of test pouches were coated with a contamination simulant and participants were asked to present the contents of different pouch designs using two transfer techniques: “standard technique” where participants presented using their typical approach and a “modified technique” where participants were instructed to grab the package at the top center and transfer contents to the field using a single, fluid motion. Transferred devices were examined to verify the presence of the analyte and data was recorded in a binary fashion (yes/no) and analyzed using a generalized linear mixed model.Results indicated significant main effects of pouch design (p<0.001) and aseptic technique (P=0.0189) on rates of contact with non-sterile surfaces. Pouches designed to curl outward resulted in less contact than all other designs, this was true for both opening techniques: standard technique: (outward vs. commercial, inward and tab pouch) (14±2.5% vs. 26±3.5% (P <0.0047), 25±3.4% (P <0.0140) and 23±3.3% (P <0.0418), respectively) and modified technique (outward vs. commercial, inward and tab pouch) (8±1.8% vs. 22±3.2%, 25±3.5% and 25±3.5% respectively; all comparisons P = <0.0001) (goal 2). In support of goal 4, two geometries were created using a novel prototyping method we developed (goal 3-described within): one geometry represented a chevron pouch while the second was a rounded shape. Each of the two base geometries was modified with the addition of an extra seal intended to result in abrupt force differentials. A significant effect of geometry was indicated (P =0.0108). Specifically, the chevron geometry resulted in a higher rate of contact with non-sterile surfaces (42%±3%) than the round shaped geometry (35%±2%). Data did not support the idea that the addition of the bar intended to induce abrupt transitions in force profile had an effect on device contamination (P=0.1002).
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