An investigation of the effect of pouch size on hand repositioning and contamination of a medical device .

摘要

Three different pouch sizes were selected and filled with tongue depressors. Pouches were sized such that they maintained an aspect ratio of 6.4 when the pouch surface area was divided by the product surface area. Ninety-seven healthcare providers were each asked to present the tongue depressors of three pouch sizes into a simulated sterile field twice, for a total of six pouches per participant. Pouches and subjects' gloves were coated with Glitterbug cream, which fluoresces under black light, to serve as an indicator of contamination in post hoc analysis.;The rate of contamination and the number of times subjects changed the position of their hands while presenting items to the sterile field were recorded as dependent variables for analysis. A contamination rate of 11.6%, or 65 out of 582 trials, was observed in this study. Of the 65 trials, 32 were in large pouches (16.5% of those tested), 19 in medium pouches (9.8% of those tested), and 14 in small pouches (7.2% of those tested). Pouch size had a significant effect on contamination rate (P=0.0108). Post hoc pairwise comparisons did not indicate a significant difference in the contamination rates generated when the medium pouch was compared with the small (P=0.6196) or the large (P=0.1123), but the large pouch was significantly more likely to be contaminated than the small (P=0.0130). Pouch size was also found to significantly affect the number of hand repositionings that personnel employed (P0.0001). In this case, all post hoc, pairwise comparisons were significant (alpha=0.01). As expected, larger pouches induced a greater number of repositionings. Ramifications for design are discussed.