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.