Risk factors for sterile packaging damage in Central sterile supply departments: a retrospective case-control study

To identify independent risk factors for physical damage to sterile packaging in the Central Sterile Supply Department (CSSD) and develop a risk prediction model. A single-center, retrospective 1:3 case–control study was conducted. The case group included instrument sets with packaging damage ( n = 140), and the control group included undamaged sets ( n = 420). Packager and instrument set characteristics were collected. Binary logistic regression identified independent risk factors, and model discrimination was assessed by AUC. Independent risk factors included loan medical instruments (OR = 5.527), larger instrument set size (OR = 2.609), non-woven packaging material (OR = 22.612), higher number of instruments per set (OR = 1.022), and daily workload exceeding 500 packs (OR = 5.738). Double-layer wrapping was a protective factor (OR = 0.040). The model showed good discrimination (AUC = 0.882, 95%CI: 0.847–0.918). Loaned instruments, large sets, non-woven materials, high instrument count, and high workload are independent risk factors for sterile packaging damage, while double-layer wrapping is protective. The prediction model has good clinical discriminative ability for identifying high-risk instrument sets.