评价介入超声科无菌物品管理规范的制定与应用效果，为同类介入操作场所的感染控制（感控）质量提升提供循证依据。

采用单中心回顾性前后对照研究，以2022年1月1日为规范实施时间节点，比较实施前（2021年1-12月，9 938例次）与实施后（2022年1-12月，11 079例次）介入超声诊疗的质控指标差异。基于“循证-共识-试运行-修订”四步法制定规范，涵盖入库验收、分类存放、有效期与批号管理、无菌薄膜与探头套使用、清点与交接、不良事件上报、培训与考核7个核心维度。主要评价指标包括物品缺陷发现率、疑似污染事件发生率（并按操作风险等级分层）、手卫生依从率、培训考核首次合格率、不良事件及时处置率与感控专项检查评分。

实施前后操作类型构成差异无统计学意义，具有可比性。实施前后高危因素差异无统计学意义，基线均衡。规范实施后，物品缺陷发现率由1.26%降至0.35%（χ²=55.51，P<0.001）；疑似污染事件发生率由0.18%降至0.06%（χ²=6.13，P=0.013），其中高风险操作下降尤为显著（0.36%→0.09%，χ²=6.86，P=0.009）；手卫生依从率由81.20%提升至96.56%（χ²=36.24，P<0.001）；不良事件及时处置率由62.50%提升至95.65%（Fisher’s P=0.043）；感控专项检查评分由（94.94±0.53）分提升至（98.63±0.36）分（Z=-3.73，P<0.001）。培训考核首次合格率由80.00%提升至94.12%（Fisher’s P=0.133），呈现临床改善趋势但差异无统计学意义，样本量不足是主要原因。

采用基于循证制定的四步法介入超声科无菌物品管理规范，可显著降低物品缺陷与污染事件（尤以高风险操作最为突出），提高手卫生依从性与感控专项检查评分，是可推广的科室级质量改进路径。

To evaluate the development and implementation effects of a standardized sterile supply management protocol in the interventional ultrasound department, and to provide evidence-based references for improving infection control quality in analogous interventional settings.

A single-center retrospective pre-post-controlled study was conducted, with January 1, 2022, designated as the protocol implementation date. Quality control indicators were compared between the pre-implementation period (from January to December 2021, 9 938 procedures) and the post-implementation period (from January to December 2022, 11 079 procedures). The protocol was developed using a four-step methodology comprising evidence synthesis, expert consensus, pilot implementation, and iterative revision. It encompassed seven core domains: receipt and acceptance inspection, classification and storage, expiration date and lot number management, use of sterile drapes and probe covers, inventory counting and handover procedures, adverse event reporting, and staff training and competency assessment. Primary outcome measures included the sterile item defect detection rate, suspected contamination event rate (further stratified by procedural infection risk), hand hygiene compliance rate, first-attempt training assessment pass rate, timely adverse event response rate, and infection control audit score.

No statistically significant difference was observed in procedure-type distribution between the two periods, confirming comparability. All baseline infection risk factors were comparable between the two periods. Following protocol implementation, the sterile item defect detection rate decreased from 1.26% to 0.35% (χ²=55.51, P<0.001), and the suspected contamination event rate declined from 0.18% to 0.06% (χ²=6.13, P=0.013), with the reduction most pronounced in high-risk procedures (0.36% to 0.09%, χ²=6.86, P=0.009). Hand hygiene compliance improved from 81.20% to 96.56% (χ²=36.24, P<0.001), and the timely adverse event management rate increased from 62.50% to 95.65% (Fisher’s exact test, P=0.043). The infection control inspection score rose from (94.94±0.53) to (98.63±0.36) (Z=-3.73, P<0.001). The first-attempt training assessment pass rate improved from 80.00% to 94.12% (Fisher’s exact test, P=0.133), demonstrating a clinically meaningful upward trend that did not reach statistical significance. The insufficient sample size was the primary reason.

The evidence-based four-step sterile item management protocol developed for the interventional ultrasound department significantly reduces sterile item defects and contamination events (particularly in high-risk procedures), and improves hand hygiene compliance and infection control inspection scores. This approach represents a generalizable, department-level quality improvement pathway applicable to similar interventional ultrasound practice settings.