Healthcare-associated (nosocomial) infections remain a persistent global challenge and represent a major threat to patient safety (Sandu et al., 2025), particularly in postoperative settings where sterile field integrity is essential (Sartelli et al., 2023). Surveillance data indicate that on any given day in the United States approximately 1 in 31 hospitalized patients has at least one healthcare-associated infection (HAI), corresponding to an estimated 687,000 infections and about 72,000 infection-related hospital deaths annually (Cagle et al., 2022; CDC, 2024). International evidence suggests that the global prevalence of HAIs remains around 7–10% among admitted hospital patients and mortality rates from 7% to 64.6% were reported (Al-Tawfiq, 2025), while rates are significantly higher in low- and middle-income countries where infection prevention systems are often under-resourced (Ahmed et al., 2021; Odoom et al., 2025). In China, large multicenter prevalence surveys have reported inpatient HAI prevalence ranging approximately from 1.6% to 3.1%, with substantially higher infection burdens in intensive care and surgical units. Surgical site infections (SSIs) constitute one of the most frequent postoperative HAIs, commonly reported in 2–5% of surgical procedures in developed healthcare systems, while several Chinese studies have documented higher rates, frequently exceeding 4–6% depending on region, procedure type, and infection control performance (Wang et al., 2018; Dong and Liu, 2025; Yao et al., 2025a). These infections prolong hospitalization, increase antimicrobial exposure and healthcare expenditure, and contribute significantly to morbidity and mortality. Within this context, the CSSD plays a decisive role in infection prevention by ensuring the cleaning, disinfection, functional verification, sterilization, and packaging of reusable surgical devices. Surgical instruments function as extensions of the surgeon’s operative capability; therefore, any compromise in sterile barrier integrity directly increases the potential for microbial contamination and postoperative infection (Rutala and Weber, 2016; Shuai et al., 2025). Previous analyses in Chinese hospitals have demonstrated that packaging-related non-conformities including missing instruments, incorrect instrument types, malfunctioning devices, wet packs, improper sealing, and labeling errors are among the most important risk factors affecting surgical device safety (Zhu et al., 2019; Chen et al., 2022). Logistic regression reports indicate that incorrect packaging methods may increase packaging failure risk more than threefold, while incomplete instrument documentation and mismatched instrument specifications also significantly elevate risk. These findings highlight surgical device packaging quality as a measurable, improvable, and clinically meaningful target within hospital infection prevention systems (Chen et al., 2022; Yi et al., 2022). Quality Control Circle (QCC) methodology, originating in industrial quality management and increasingly applied in clinical healthcare, emphasizes frontline participation, structured root-cause analysis, data-driven improvement, and sustainable performance monitoring. Previous healthcare applications of QCC have demonstrated meaningful reductions in process errors and improvements in clinical quality; however, its application in CSSD management and its potential effect on infection risk remain insufficiently reported (Ou et al., 2025). Keepin mind all this factor and figures CSSD of the healthcare system, this pilot study applied the QCC model in the CSSD of a tertiary hospital to reduce non-conforming surgical instrument packaging and evaluate its potential contribution to hospital-acquired infection risk reduction. The study aimed to identify primary causes of packaging non-conformity, implement targeted improvement measures, and assess measurable outcomes following intervention.

This study involved system improvement without patient-identifiable data or direct patient intervention. Institutional approval for QCC-based quality improvement activities was obtained in accordance with hospital policy, and ethical risk was considered minimal.

The findings of this pilot quality improvement study demonstrate that systematic application of the Quality Control Circle (QCC) model in the CSSD was associated with a significant reduction in the rate of non-conforming surgical instrument packaging, achieving the predefined target of a 50% reduction from baseline. Compared with a baseline non-conformance rate of 0.213%, the post-intervention defect rate reached the computed target of 0.106% corresponding to a ~50% relative reduction, as predicted through our improvement model. The effects were not transient but maintained throughout an extended follow-up period (June–October 2024). Notably, the dominant defect categories nonfunctional/incomplete instruments, missing instruments, and incorrect instrument types showed marked decreases, confirming that targeted QCC measures can structurally optimize quality performance in high-risk processing areas. Our baseline non-conformance rate aligns with previously reported rates of packaging defects in hospital CSSD settings, albeit at the higher end of the spectrum. Several studies have quantified sterile packaging quality outcomes, reporting defect rates predominantly in the range of approximately 1.43‰–1.67‰ (0.143%–0.167%) under rigorous quality inspection frameworks, similar to pre-intervention rates in our cohort (Chen et al., 2022; Yao et al., 2025b). Chen et al. reported surgical package defect rates within this range in a large Chinese hospital cohort, underscoring consistency in dominant defect categories such as incomplete packaging, missing items, and specification errors (Chen et al., 2022). Comparable CSSD quality improvement efforts using structured methodologies have also documented substantial defect reductions. A FOCUS-PDCA quality improvement initiative applied in another Chinese CSSD significantly reduced the distribution defect rate from 1.74% to 0.37% (a ~79% relative decrease), reinforcing the potential of standardized improvement frameworks to drive process quality gains (Huang et al., 2023). These findings indicate that structured, data-driven quality interventions whether QCC or PDCA-based are effective in addressing key failure modes in sterile processing. Other global data also supports the notion that instrument processing errors are amenable to systematic quality interventions. A Lean-oriented improvement study at a U.S. hospital reported a substantial decline in instrument processing errors from 3.0% to 1.5%, with particularly large reductions in packaging and assembly errors (Blackmore et al., 2013). This broader quality improvement evidence highlights that error rates and defect profiles may vary by institution and context, but that targeted process control frameworks consistently yield meaningful improvements.

The success of our QCC intervention likely reflects a confluence of mechanisms. First, rigorous standardization of assembly lists and packaging labels reduced variability in set assembly a known risk factor for instrument mismatches and omissions. The central role of instrument list standardization in reducing packaging defects has been emphasized in other CSSD error-focused research (Pan et al., 2024; Yao et al., 2025b). The enhancing verification protocols and double-check mechanisms introduced redundancy into the packaging process, increasing the likelihood of catching errors before final processing. Redundancy and cross-checks have been highlighted in safety literature as key contributors to error reduction in complex workflows like sterile processing (Alfred et al., 2021). The maintenance and inspection enhancements ensured instruments were functional and compliant with procedural standards before packaging, thereby minimizing nonfunctional or defective instrument errors post-processing. Event tracking and equipment maintenance logs, commonly referenced in CSSD quality systems, also support downstream safety and reduced reprocessing needs (Jing et al., 2022). The workflow optimization and competency reinforcement through structured training improved execution fidelity across packaging steps. QCC’s emphasis on frontline engagement and iterative refinement core tenets of continuous improvement methodologies fostered ownership and accountability for quality outcomes, consistent with Total Quality Management (TQM) and Lean principles documented in healthcare quality literature (Yao et al., 2025b).

Although this study did not directly measure clinical outcomes such as surgical site infections (SSI) or other HAIs, improvements in sterile packaging quality are strongly implicated in enhancing perioperative safety. Packaging defects compromise the sterile barrier, increasing contamination risk during storage, transport, and perioperative handling. Decades of surgical safety research emphasize that sterile supply integrity is a critical upstream determinant of operative infection risks, with systematic safety checks (e.g., the WHO Surgical Safety Checklist) demonstrated to reduce perioperative morbidity and mortality in diverse settings (Squires et al., 2025). Defective packaging may also lead to procedural delays, instrument substitutions, or increased handling, all of which correlate with elevated infection risk profiles in observational surgical cohorts. For instance, delayed procedures due to instrument miscounts have been associated with lengthened operative times and subsequent complications a recognized risk factor for SSI. Although quantification of SSI reduction attributable solely to packaging improvements remains an area for future research, the theoretical and empirical linkages to patient safety are compelling and consistent with current quality paradigms.

Beyond safety outcomes, the observed quality enhancement has tangible economic implications. Based on an estimated annual surgical instrument pack workload of ~400,000, achieving a near-50% reduction in defect rates translates to the avoidance of an estimated ~428 defective packs annually. Assuming that a conservative 15% of defective packs result in damaged instruments requiring replacement, and applying an average procurement cost of ¥2,000 per instrument, our QCC intervention could prevent approximately ¥128,400 in replacement expenditures annually. Additional savings from reduced reprocessing costs (~¥21,400 per year) further support the economic value of sustained quality control implementation. Although the direct costs associated with SSIs were not measured in this pilot, a large body of evidence indicates that SSIs impose a substantial economic burden on healthcare systems. Systematic reviews in low- and middle-income settings have shown that the additional healthcare costs attributable to SSIs can range widely, from approximately US $174 to nearly US $29,610 per case, depending on procedure type, setting, and severity of infection, with consistently higher costs compared with non-SSI patients (Monahan et al., 2020). Moreover, narrative and cohort studies across diverse healthcare systems report that each SSI can result in several thousand dollars (or equivalent) of additional direct medical expenditures, extended hospital stays, and increased resource utilization (Piednoir et al., 2021). These cost estimates are supported by observational evidence from China showing that SSIs are associated with prolonged hospitalization and substantial direct economic loss per patient with infected individuals experiencing longer stays and higher associated costs than matched controls (Zuo et al., 2024). Although figures vary by surgical category and institutional context, the range of economic impact underscores that even modest reductions in SSI incidence through upstream quality improvements such as enhanced sterile processing could translate into meaningful cost savings at the institutional and system level.

Taken together, these data suggest that quality interventions targeting sterile processing not only produce measurable operational efficiencies and cost avoidance but also have the potential to contribute to downstream reductions in adverse clinical events that carry significant treatment costs. This study has several strengths. We employed a structured, theory-based quality improvement methodology (QCC with PDCA) that is repeatable and adaptable to diverse CSSD contexts. Our analysis integrated quantitative defect rate monitoring with categorization and process optimization, enabling a comprehensive assessment of both outcome and process changes. Additionally, the sustained improvement over multiple months post-intervention reinforces the durability and clinical relevance of the approach. This was a single-center study without a concurrent control group, which may limit external generalizability. Some comparisons with historical or external benchmarks, while informative, cannot substitute for controlled, multicenter validation. Additionally, we did not capture direct clinical outcomes such as SSI or HAI incidence, precluding causal inference between packaging quality and infection rates. Future studies should pursue larger, multicenter designs that incorporate clinical outcome metrics, economic evaluations, and long-term sustainability assessments. Emerging technologies such as digital tracking, automated instrument recognition, and real-time quality dashboards may further enhance CSSD performance by reducing reliance on manual checks and improving detection sensitivity promising avenues for future research and practice. Integrating electronic performance feedback and artificial intelligence–assisted inspection tools could amplify the gains achieved through human-centric QCC strategies.

This pilot study demonstrates that structured application of the Quality Control Circle model can substantially improve the quality and safety of surgical instrument packaging in a tertiary hospital CSSD. Through data-driven root cause identification, targeted interventions, and sustained monitoring, the rate of non-conforming packaging was reduced by approximately 50%, with clear optimization of dominant defect categories and stabilization of performance over time. Beyond measurable quality gains, the initiative strengthened process standardization, enhanced professional competency, and fostered a proactive safety culture among CSSD personnel. These findings provide practical evidence that systematic quality management in sterile supply processes is both feasible and impactful, and may contribute meaningfully to reducing downstream risks associated with hospital-acquired infections. The experience offers a replicable improvement model for similar healthcare institutions, while laying a foundation for future multicenter studies to further evaluate clinical outcome benefits and long-term sustainability.