Introduction

The sterilization center for medical supplies is responsible for the cleaning, disinfection, and sterilization of all reusable medical devices, instruments, and items from various hospital departments. The quality of the disinfection process directly affects the safety of patients and healthcare workers, particularly in the control of pathogens1,2. In recent years, with the rapid development of surgical medical technologies, the number of surgeries in typical hospitals has surged, and the variety and quantity of instruments used in surgeries have also significantly increased, such as micro-instruments, endoscopic instruments, and robotic instruments. Consequently, the work requirements and quality standards of the hospital’s central sterile supply department have become increasingly stringent. It is necessary to conduct comprehensive monitoring of all stages, including collection, cleaning, disinfection, packaging, sterilization, storage, distribution, and receipt, to prevent cross-contamination and severe hospital-acquired infections3. However, some medical communities still rely on manual registration methods to manage instrument packs, leading to unclear handovers of instruments between the shared center and hospital community areas, and low management efficiency. Moreover, the management of the effectiveness of medical device packaging faces many challenges. Regular packaging inspections are not only time-consuming and labor-intensive but also increase the risk of contamination of sterilized packaging. The circulation status of instrument packs cannot be queried in real-time, which brings inconvenience to departmental management and makes it difficult to match precisely with patient information.In the event of suspected infection incidents,the lack of systematic investigation methods further highlights the defects in the management process.These issues severely restrict the scientific and safe management of medical instruments in medical communities and urgently need to be improved through the application of information technology and technical upgrades.

Professional, standardized, and scientific management is a prerequisite for ensuring the quality of medical services4,5. However, some primary healthcare institutions face risks in the processes of instrument cleaning, disinfection, and packaging, such as not using specialized cleaning agents, cleaning and packaging quality not meeting standards, and shortages of personnel and equipment6. These problems may lead to incomplete cleaning, which in turn can cause infections, increase patient’s medical costs and hospital stays, and even threaten the lives of patients and healthcare workers. The Medical Reform Office of Zhejiang Province promotes the construction of county-level medical service communities, and various places in Zhejiang have successively established regional shared medical community disinfection centers7. The establishment and implementation of a disinfection center, that combines high-quality equipment resources and a professional medical supply disinfection team, is conducive to the implementation of quality control throughout the entire process of cleaning, disinfection, and sterilization, and the control of hospital infection risk for reusable medical instruments and items, providing higher levels of patient safety8. Currently, however, many medical community disinfection centers have not integrated medical instruments into their full process closed-loop quality traceability system(QTS), and thus have not realized their full information management potential9. Establishing a regional disinfection center that serves many medical communities and relies on cutting edge traceability systems can not only save resources and reduce costs but also improve work efficiency, help control infections, and reduce repeated investments by different hospitals. Therefore, our study focuses on the specific regional shared disinfection center under the context of county-level medical community construction, closely integrating policy support with practical exploration. It proposes a community-based QTS application solution that can achieve full-process monitoring of medical devices, filling the gap in the application of QTS under the regional medical resource-sharing model.

Materials and methods

General information

This study adopted a single-group target value design, and the quality of instrument validity management was used as the main outcome index10. By collecting the previous data of the unit, the effective rate of the management of instrument package validity in the shared medical community disinfection center was 96.8% by using the traditional program intervention, and the effective rate of instrument validity management based on the QTS was expected to reach 99.7%. The significance level α was set as 0.05, and the test power (1-β) was 0.90. The sample size was estimated by PASS software11, and the required sample size was calculated as 205 cases. Finally, the medical community equipment packages processed by the Disinfection Center of Futian Street Community Health Service Center in Yiwu City, Zhejiang Province, China from August 2020 to July 2021 were selected as the control group, and the medical community equipment packages processed by the same center from August 2021 to July 2022 were selected as the experimental group. Both groups of devices came from the same medical community hospital, and there was no difference in sterilization methods and other relevant information.

Study groups

Control group: The instruments were processed according to routine procedures. After the instruments were distributed to the medical community units by the center, the medical community units handled the packages through manual checking and registration. Experimental group: The QTS of the disinfection center was applied based on the following specific methods:

  1. (1)

    Construction of the QTS for the disinfection center: The QTS for the center in our study was developed by Hangzhou AwareTec Co., Ltd., a subsidiary of EWELL, which specializes in IoT development and is a national-level enterprise. With a focus on the medical industry, Hangzhou AwareTec Co., Ltd. provides IoT products and services from terminals to applications for hospitals, nursing homes, and other care centers. Referring to the standards of smart hospital construction such as “smart medicine”, “smart service”, “smart management”, etc., for product design and development, the company helps hospitals to build closed-loop management systems for medical processes, improve the work efficiency of medical staff, and improve patient experiences. Currently, the company’s products serve more than 300 hospitals and regional medical centers at all levels.

The QTS of the disinfection center comprises two subsystems: Medical Community Instrument Management and System Management. The system employs a multi-layered development model based on the B/S (Browser/Server) architecture. The frontend is primarily developed using the Vue.js framework in combination with HTML5 and CSS3, while the backend is based on the Java language, utilizing the Spring Boot framework for server-side logic processing and integrating JSP (Java Server Pages) technology to generate dynamic web pages. This architecture not only offers excellent cross-platform compatibility and scalability but also effectively reduces the costs associated with system deployment and maintenance. Additionally, the system supports a mobile app, enabling users to operate and manage the system conveniently anytime and anywhere. In terms of database design, we have chosen the SQL Server database. Through the designed table structures, we can store and manage various types of data related to disinfection supply operations, such as item information, operation records, and monitoring results. The transaction mechanism of SQL Server ensures the integrity of data operations, guaranteeing the accuracy and consistency of data even under multi-user concurrent operations. Moreover, its robust security mechanisms effectively prevent data leakage and unauthorized access, safeguarding the system’s data security.

The system management portion includes database construction and maintenance, as well as the maintenance of the structure between system modules12. The Medical Instrument Management System comprises modules such as instrument inventory recovery, cleaning, disinfection, inspection and assembly, cleaning quality control, sterilization monitoring, instrument distribution, instrument receipt, instrument usage, borrowing and returning packaging, and low inventory alert (Fig. 1). Based on actual operational requirements, we have designed a workflow that involves the recovery of used instruments from clinical departments, followed by rigorous cleaning, sterilization, packaging, and verification processes before redistributing them back to the clinical settings for use. Additionally, we have developed standardized operating procedures following national standards (WS 310-2016)13 and hospital accreditation criteria. By designing the disinfection and supply operations as a closed-loop process, we ensure that each step has clear inputs and outputs, thereby preventing omissions and repetitions in the operational procedures.

Fig. 1
figure 1

The module structure of the quality traceability system in the Fourth Affiliated Hospital, Zhejiang University School of Medicine, disinfection center. The bar chart in the center of the homepage displays the number of packages processed at each stage on the current day. The left-hand menu contains detailed statistical information for each process, allowing users to access the corresponding data interface by clicking. The right-hand side presents early warning information used for quality control activities.

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In accordance with the management procedures of the disinfection center, operators collect information about the medical community instruments, including the name of the hospital, department name, instrument name, instrument list, pictures, instrument cleaning and disinfection information, and sterilization monitoring information. According to the specific number of instrument packages in the hospital area and department, a recovery record is made on a personal digital assistant (PDA)14,15.

  1. (2)

    Application of the QTS in the disinfection center: The dedicated personnel of the medical community unit recycle and pre-treat all used instruments, log in to the QTS of the disinfection center with their work numbers, click on “to be recycled” to enter the input interface, and enter the department instrument package information into the “to be recycled” module, information such as “surgery”, “dressing change package”, quantity “10”, etc. The disinfection center personnel then log in to the QTS with their personal work numbers and click on “recovery”. Next, they check the device package information input during pre-processing and the device package information during actual receipt and counting. The PDA displays the name and quantity of the package to be recycled after selecting the medical community unit and department. If the information is consistent, they click on “confirm recovery”. If the quantity to be recycled is inconsistent with the quantity on hand, they can modify it at the end of the list and then click on “confirm recovery”. The modified information then synchronously issues information reminders to the corresponding medical community units.

    • Cleaning and disinfection traceability records: An operator uses the PDA to bind the instrument package with the actual cleaning personnel and cleaning equipment and records the matching of the cleaning executor, cleaning time, cleaning equipment pot number, pot times, time, cleaning program and cleaning result confirmation, etc.

    • Packaging review traceability record: The QTS of the disinfection center is entered by personnel on the personal computer (PC) side, and the system prints out the barcodes of the instruments that have passed the batch cleaning qualification confirmation. An operator uses a PDA to scan the code to bind the operator and the operation to be performed. The sequence in this process includes packaging, auditing, packaging, and sterilization. Only after the code scanning confirmation of each link can the next link be carried out, and the packer and the reviewer cannot be the same operator. If problems with cleaning quality or abnormalities are found, information registration records are carried out using the “quality inspection” link on the PDA.

    • Sterilization monitoring record: Here a worker logs in to the quality traceability system through a PDA, enters the “sterilization” module, selects the corresponding sterilization pot number, pot times, and sterilization program, scans the instrument barcode, and places the biological process challenge device (PCD) or chemical PCD according to the requirements set by the program. The worker then clicks start sterilization, enters the sterilization state, and the PDA displays that the pot is “being sterilized”. The sterilization equipment Century SV-120 is a high temperature sterilizer produced by STERIS Company in the United States, which is mainly used in hospitals to sterilize high temperature and high humidity items such as medical instruments, surgical instruments, glassware, and their mixtures. The sterilization procedure currently selected is 4 times pulsed pre-vacuum sterilization at 134 degrees Celsius for 4 min and drying for 30 min. This module has a monitoring interception function that reminds the placement type of the monitoring package according to “whether biological monitoring is required”, which is selected when making the package barcode. The first pot time of each day is defaulted to the Bowditch test, the second pot time is defaulted to require biological monitoring, and subsequent judgments on whether there are implants are made according to the package barcode setting. Biological monitoring is then performed for each pot with implants.

    • Distribution traceability record: After sterilization, the operator carries out the physical parameter and chemical indicator qualification sentencing, carries out the qualification confirmation and biological monitoring culture on the PDA, and can only carry out the distribution after the results come out and the qualification registration is performed. To do this the operator clicks on the “distribution module” on the PDA, selects the medical community hospital area and department to be distributed, and the PDA supplies the name and quantity of the packages that have been qualified and are waiting to be distributed. After the code is scanned and distributed, the number of distributed packages is displayed next to the number of packages to be distributed, which is convenient for checking and confirmation. After checking the distribution, the packages are classified according to the hospital area and department and are delivered to the corresponding medical community hospital area by a dedicated vehicle.

    • Receipt and storage record: After the staff of the medical community hospital area receives the instrument package, they open the PDA, click on the “receipt” module, and click on the corresponding department. The PDA then displays the name and quantity of the packages to be received. After the code is scanned and the receipt is checked, the number of received packages is displayed next to the number of packages to be received, which again is convenient for checking and confirmation. After the receipt is completed, the information about the instrument package automatically enters the instrument package library of the hospital area and department. A disinfection center worker then logs in to the QTS of the disinfection center on the PC side, the system displays all the package names, cardinal numbers, inventory quantity, and circulation quantity of the logged-in medical community department, and displays the instrument packages that will expire within 5 days on the right side of the interface, which is convenient for the department to manage the instrument packages en masse.

    • Usage traceability record: When the medical community unit uses the instrument package, it uses the HIS system or logs into the QTS and selects the “disinfection package usage” interface. After entering the patient’s medical record number, the system automatically extracts the patient’s information. The instrument package barcode information is then matched and associated with a patient through the PDA, barcode scanner, or manual entry, and the instrument status changes to “to be recycled”.

Evaluation indicators

  1. (1)

    Medical community instrument quality management: The quality evaluation indicators of the instrument packages in the disinfection center include the accuracy of instrument counting, the pass rate of package validity management, and the accuracy of the traceability system. The quantity of “qualified” instrument packages was counted and its proportion of the total number of packages was calculated to compare the difference between information system traceability management and manual registration management. The larger the proportion, the better the quality management of the medical community’s instruments.

  2. (2)

    Medical community instrument efficiency management: The common daily management of medical community instrument packages includes package usage statistics queries, cost queries, accounting, scrap statistics, package status verification, and information traceability queries. The time required to complete instrument management tasks is defined as the duration consumed to accomplish the aforementioned management tasks. The accuracy of instrument management tasks is quantified by calculating the correct rate.

  3. (3)

    Incidence rate of adverse events in medical community instruments: Adverse events associated with medical devices16 are defined as “various harmful events that occur during the normal use of marketed medical devices, which lead to or may potentially lead to human injury, specifically including device confusion, loss, distribution errors, and information errors, among other situations”. To ensure the accuracy and comparability of the data, we utilized the hospital’s adverse event reporting system to collect the number of reports for all relevant events.

  4. (4)

    User satisfaction: The use of the QTS in the shared disinfection center serves the staff of the medical community, related personnel, and clinical instrument users alike. User satisfaction was assessed using a self-developed questionnaire consisting of 18 items. This questionnaire comprehensively evaluates various aspects, including workflow and efficiency, quality and standards, communication and service, environment and equipment, technology and management, as well as overall satisfaction. Each item offers two options: “satisfied” and “dissatisfied”, with corresponding scores of 1 and 0, respectively. The overall patient satisfaction was evaluated by calculating the total score, which is positively correlated with the level of satisfaction.

Statistical analysis

All research data were recorded in Excel, and R software (version 4.4.2) was used for statistical analysis. Measurement data were first tested for normality; data conforming to a normal distribution were expressed as mean ± standard deviation (mean ± SD), and comparisons between groups were carried out using the independent samples t-test. Data not conforming to a normal distribution were expressed as median and the interquartile range (IQR), and comparisons between these groups were carried out using the rank sum test for independent samples. Count data were represented by the number of cases and percentages, and comparisons between these groups were carried out using the chi-squared test (χ2 test). For each test, P < 0.05 indicated that the difference was statistically significant.

Ethical considerations

This study does not involve human subject research, animal research, and field research. No human genetic information or biological samples were involved in this study. Therefore, ethical approval was not obtained for this study.

Results

Finally, we selected 3028 cases of medical community instrument packages processed by the Community Health Service Center disinfection center, Futian Street, Yiwu City, Zhejiang Province, China from August 2020 to July 2021 as the control group, and 3,302 cases of medical community instrument packages processed by the same center from August 2021 to July 2022 as the experimental group. Both groups’ instruments came from the same medical community hospital, and there was no difference in sterilization methods or other relevant information.

Comparison of management quality and efficiency of two groups of instruments

The instrument counting accuracy rate was 99.70% in the experimental group and 96.85% in the control group, with a statistically significant difference between the groups(RD 95%CI:0.029[0.022,0.035], P < 0.001). In the evaluation of traceability system accuracy, the experimental group also significantly outperformed the control group(RD 95%CI:0.563[0.546,0.580], P < 0.001). In the assessment of packaging effectiveness, the pass rate in the experimental group was significantly higher than that in the control group(RD 95%CI:0.029[0.022,0.035], P < 0.001). The incidence rate of instrument-related adverse events was significantly lower in the experimental group(0.18%)than in the control group(0.52%), with a statistically significant difference between the groups(RD95%CI:0.003[0.001,0.006], P = 0.020). Detailed comparative results are shown in Fig. 2. The average time of statistical query in the experimental group was significantly faster than the control group(MD 95%CI: 79.771[77.031,82.512], P < 0.001). Detailed comparative results are shown in Table 1.

Fig. 2
figure 2

Comparison of the quality of medical community instrument management between the two groups. RD rate difference, 95%CI 95% confidence interval.

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Table 1 Statistical query time consumption and user satisfaction score.
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Comparison of user satisfaction between the two groups

A questionnaire was used to assess staff satisfaction before and after the implementation of the QTS. Results showed that the mean satisfaction score for the traditional management approach was 55.333 ± 9.146, whereas the mean satisfaction score after the introduction of QTS was 65.889 ± 0.900. The difference between the two groups was statistically significant(MD 95%CI: 10.556[5.992,15.119], P < 0.001).

Discussion

The disinfection centers play a crucial role in ensuring the safety and reliability of medical devices. However, traditional manual management methods are no longer sufficient to meet current demands. With the advancement of medical technology, the volume and variety of sterilized items have increased significantly, making it difficult for traditional methods to achieve rapid quality traceability. Therefore, the introduction of modern information technology to establish an informalized QTS is of great significance for ensuring patient safety, reducing adverse events, and facilitating the smooth operation of hospital medical services.

Our study implemented a quality management system in a disinfection center and evaluated its effectiveness in instrument management, and the results demonstrated significant improvements in the pass rate of package expiration management, the accuracy of traceability systems, the precision of instrument counting, and the time consumed for information traceability queries (P < 0.001). These findings suggest that the QTS plays a crucial role in enhancing the management efficiency and quality control level of the disinfection center. The QTS supports collaborative operation between mobile and PC terminals, ensuring real-time data collection and synchronization. This functionality not only encompasses the entire process of device retrieval, cleaning, and disinfection but also guarantees information accuracy and traceability through barcode scanning and data recording. Furthermore, the system incorporates an alert feature for low inventory and expired devices, optimizing inventory management and enhancing the efficiency of healthcare professionals. High-efficiency data acquisition technology is one of the core advantages of the QTS. Through automated data collection, the system can accurately record various data throughout the management process of device packages, thereby reducing errors associated with manual operation. The application of this technology provides a reliable data foundation for the effective management of device package expiration dates and the accuracy of the traceability system. With precise data recording and analysis, the QTS is poised to optimize the supply and management model of medical device packages, enhancing overall management efficiency and safety. Additionally, the QTS offers multi-dimensional data analysis and quality indicator assessment functionalities, providing effective tools for in-depth analysis of device management quality issues. This functionality will facilitate the precise identification of the root causes of quality problems, thereby offering a scientific basis for the improvement of quality management in the disinfection supply center.

Healthcare-associated infections(HAI) are among the most common adverse events in healthcare settings, causing significant harm to patients and healthcare workers and imposing a substantial burden on healthcare systems17. The transmission routes of HAI are diverse, ranging from hand contamination to the spread of pathogens via contaminated objects18. Although a comprehensive understanding of the overall burden of HAI in healthcare settings is still lacking, studies19 estimate that at least 10%-30% of multidrug-resistant organisms are transmitted to patients through the healthcare environment. Therefore, it is crucial to enhance infection control measures in healthcare settings. Optimizing the disinfection processes of medical devices has been proven to effectively reduce the incidence and transmission risk of HAI20. Our study results also confirmed that the implementation of the QTS significantly reduced the incidence of device-related adverse events compared with the control group (P = 0.020), indicating that QTS-related management measures have a significant effect in reducing device-related adverse events. This effectiveness is not only related to the traceback function’s ability to identify the source of infections, thereby clarifying improvement directions but also to the clear attribution of responsibility and the reinforcement of staff’s sense of accountability21. The system meticulously records the operators, operation times, and outcomes of each step, enabling any issues to be traced back to specific individuals. This transparent accountability mechanism not only reduces the phenomenon of buck-passing due to unclear responsibilities but also encourages staff to be more cautious during operations, thereby effectively reducing adverse events caused by human errors. With the acceleration of digital transformation in the medical field, as a core tool for medical device management, QTS will integrate functions such as intelligent data analysis, Internet of Things (IoT) integration, artificial intelligence-driven security protection, and multimodal data integration in the future. The introduction of these features will not only optimize hospital operational processes but also provide safer medical services for patients. In addition, the results of this study demonstrate that although the implementation of the QTS increased the information collection requirements at various stages, the satisfaction of the staff with the user experience was significantly enhanced (P < 0.001). The traditional manual management mode undoubtedly imposes a substantial workload on the staff, whereas the QTS employs unique QR codes for medical devices and the disinfection and sterilization processes, simplifying the information entry process, enhancing efficiency, and further promoting the standardization of management. Throughout the various processes, managers can dynamically and real-time monitor the cleaning, disinfection, and sterilization of medical devices by scanning QR codes, thereby preventing operational errors. Moreover, if non-compliant devices are identified, the system’s traceability management feature enables rapid tracking, accurately identifying high-risk factors for adverse events, and thereby effectively safeguarding patient safety in medical care.

It is important to note that the understanding and mastery of the operation and maintenance of the QTS among relevant personnel are both relatively low, which imposes certain limitations on the evaluation of application effectiveness and data collection. Therefore, we recommend that when the medical community operators conduct system training, they should conduct more on-site demonstrations of operations at each stage and summarize the necessary precautions. Although the system can provide reminders for the recent validity period of the disinfection and sterilization packages in the medical community, first-in-first-out use is still not strictly implemented in practice in medical centers, though this could be improved with appropriate first-in-first-out effectiveness period management. Finally, some functions of the system still need to be optimized, such as adding “voice reminders” to facilitate operators to obtain information more intuitively, customize quality control information, and automatically present data charts, etc. In the future, QTS can be further integrated with other emerging technologies (such as artificial intelligence) to optimize the management process.

Conclusion

In this study, the QTS was implemented in a shared disinfection supply center within a county-level medical community framework. The results demonstrated significant improvements in the management quality and efficiency of medical devices, a reduction in adverse event rates, and enhanced staff satisfaction. The QTS solution offers a cost-effective strategy for optimizing resource utilization and infection control, addressing common management challenges in regional disinfection centers. Our findings provide valuable insights and a reference for similar centers aiming to enhance their operational efficiency and safety.