Looking for Holes in Sterile Wrapping: How Accurate Are We?

BACKGROUND: Defects in sterile surgical wrapping are identified by the presence of holes through which light can be seen. However, it is unknown how reliably the human eye can detect these defects. QUESTIONS/PURPOSES: The purpose of this study was to determine (1) how often holes in sterile packaging of various sizes could be detected; and (2) whether differences in lighting, experience level of the observer, or time spent inspecting the packaging were associated with improved likelihood of detection of holes in sterile packaging. METHODS: Thirty participants (10 surgical technicians, 13 operating room nurses, seven orthopaedic surgery residents) inspected sterile sheets for perforations under ambient operating room (OR) lighting and then again with a standard powered OR lamp in addition to ambient lighting. There were no additional criteria for eligibility other than willingness to participate. Each sheet contained one of nine defect sizes with four sheets allocated to each defect size. Ten wraps were controls with no defects. Participants were allowed as much time as necessary for inspection. RESULTS: Holes ≥ 2.5 mm were detected more often than holes ≤ 2 mm (87% [832 of 960] versus 7% [82 of 1200]; odds ratio, 88.6 [95% confidence interval, 66.2-118.6]; p < 0.001). There was no difference in detection accuracy between OR lamp and ambient lightning nor experience level. There was no correlation between inspection time and detection accuracy. CONCLUSIONS: Defects ≤ 2 mm were not reliably detected with respect to lighting, time, or level of experience. Future research is warranted to determine defect sizes that are clinically meaningful. LEVEL OF EVIDENCE: Level II, diagnostic study.