AbstractThis study aimed to investigate the effect of hazard analysis critical control points (HACCP) system in the assembly of reusable medical devices. A total of 35,841 packages containing reusable medical devices assembled in our hospital’s CSSD before implementation of the HACCP system (from January 2023 to June 2023) were classified into the control group, and 36,159 packages containing reusable medical devices assembled in our hospital’s CSSD after implementation of the HACCP system (from July 2023 to December 2023) were classified into the experimental group. The incidences of assembly defects in the devices and satisfaction rates among device users before and after implementation of the HACCP system were compared. After improvement in staff training, work processes and traceability system during the application of the HACCP system, the incidence of assembly defects decreased from 2.59 to 0.24% (P < 005). Satisfaction rates among device users increased from 95.52 to 97.61% (P < 0.05). Application of the HACCP system to the assembly of reusable medical devices could effectively reduce the rate of assembly defects and improve satisfaction among device users. This could help improve the supply quality of these devices.
IntroductionThe packaging procedures of reusable medical devices involve assembling, packaging, sealing and labeling1. It is one of the steps in the reprocessing of reusable medical devices by the central sterile supply department (CSSD) of the hospital. Assembly refers to checking the type, specifications and quantity of the devices, according to the technical instructions or drawings of device assembly and then placing them in a device tray2. It is one of the key steps in packaging procedures. The quality of assembly is associated with the use, safety and supply efficiency of medical devices3. The assembly defects in reusable medical devices can lead to postoperative infections in patients, reduction in operating room efficiency, and medical accidents4,5,6. With the continuous development of medical technology, the types, model numbers and quantities of reusable medical devices are constantly increasing; the levels of precision and specialization of the devices are also getting higher and higher. This brings great challenges to the assembly of reusable medical devices7. For example, the results of Wang et al.8 have shown that the packaging defect rate of rigid endoscopes was much higher than common surgical instruments after the implementation of the healthcare failure mode and effect analysis in device reprocessing optimization.The hazard analysis and critical control points (HACCP) is used by manufacturers to identify, analyze and evaluate safety hazards that may occur in the manufacturing process. HACCP is also used to determine critical control points in order to take effective measures and avoid or reduce the incidence of problems9,10,11. The HACCP system is usually used for food safety management9. In recent years, the HACCP system has been applied in healthcare, such as nursing quality management, infection control, and medication safety12,13,14,15. However, it may be difficult to determine the critical control points in the healthcare sector and the HACCP system may be unadaptable to complex healthcare procedures. In this study, modern management tools, such as Pareto chart and fishbone diagram, were used to investigate the risk factors associated with the assembly of reusable medical devices, determined the critical control points, and developed risk prevention measures to reduce defect rates. In addition, the application of information management tools helped trace and visualize data concerning the device assembly procedures, thereby significantly improving efficiency and security in management.MethodsEthics approval and consent to participateThis study was conducted in accordance with the Declaration of Helsinki. All research methods were carried out in accordance with the relevant guidelines and regulations. Ethical approval was obtained from the Medical Research Ethics Committee of West China Second University Hospital, Sichuan University [2024 Medical Scientific Research for Ethical Approval No. (442)]. Informed consent was obtained from all participants.General informationA total of 35,841 packages containing reusable medical devices assembled in our hospital’s CSSD from January 2023 to June 2023 were classified into the control group, and 36,159 packages containing reusable medical devices assembled in our hospital’s CSSD from July 2023 to December 2023 were classified into the experimental group. The conventional assembly procedures for devices were applied in the control group, while device assembly procedures optimized using the HACCP system were applied in the experimental group. The number of assembled reusable medical devices was exported from the CSSD information system; the assembly defects were determined and recorded by the CSSD inspection nurses.Reusable medical devices that were cleaned, disinfected and packaged by our hospital’s CSSD staff were included in this study. The exclusion criteria were as follows: (1) disposable medical devices; (2) medical devices which were sent to our hospital’s CSSD for sterilization after being cleaned, disinfected and packaged by other hospitals’ CSSDs; or (3) medical devices handled by medical device companies.Determination of assembly defectsAccording to the national health guidelines of China and relevant literature references1,16,17, the assembly of reusable medical devices should meet the following requirements: (1) the types, specifications and quantities of items contained in the device package should reflect the same information as in the checklist for the device package; (2) the cleaning quality of the devices needs to pass a quality check; (3) the devices should function normally; and (4) the devices should be properly assembled according to relevant requirements. If any of these conditions were not met, the device assembly was considered as a defect.Assembly flowchart for reusable medical devicesCreating an accurate flowchart is the key to successful implementation of the HACCP system. The flowchart must show all steps in a process18. The assembly flowchart for reused medical devices in our hospital is shown in (Fig. 1).Fig. 1Assembly flowchart for reusable medical devices.Full size imageAssembly procedures for the control groupThe conventional assembly procedures for devices were applied in the control group. The details are as follows:Material preparationAll items required for assembly of reusable medical devices were prepared, including device packaging checklists, reusable medical devices that were cleaned and disinfected, device trays, traceability labels, dressings, and sterilization indicators.InspectionThe type, specifications and quantity of reusable medical devices were inspected according to the checklists for device packages. Meanwhile, cleaning quality and functions of the devices were inspected according to the following requirements: ① the surface, articulation joints and grooves of devices were smooth and had no residual substances, such as blood stains, dirt and water stains, and rust spots; ② the devices functioned normally and were not damaged1,19; ③ the types, specifications and quantity of dressings were correct and the quality of dressings passed a quality check.AssemblyThe devices and dressings were placed in device trays after inspection. The placement should meet the following requirements: ① they should be placed in the prescribed sequence (namely, which one should be placed first, and followed by which one), and the prescribed order for left and right and for up and down positions; ② devices with pivot point design, such as scissors and hemostats, should not be fully locked; ③ for container with lid, the lid should be removed from the container, and stacked containers should be separated by absorbent cloth, gauze or medical absorbent paper; ④ the opening orientation of the devices in the package should be consistent; ⑤ lumen-designed devices should be coiled to keep lumen unobstructed; and ⑥ protective measures should be taken for precise and sharp instruments20.Inspection after assemblyAfter assembly, inspection nurses checked the device packages and recorded the all related defects.Assembly procedures for the experimental groupThe HACCP system was adopted for process optimization in the experimental group. The implementation steps were as follows: ① a HACCP team was established; ② hazard analysis was performed; ③ critical control points were determined; ④ preventive measures were formulated and implemented; ⑤ a traceability system was implemented for continuous quality monitoring. The details of the implementation process were as follows:Establishment of a HACCP teamThe HACCP team consisted of 16 people, including a head nurse who was engaged in cross-departmental nursing amongst the CSSD, operating room, Anesthesiology Department and Emergency Department, CSSD head nurse, deputy head nurse, assistant head nurse, research nurse, inspection nurse, packaging team leader, and assembly personnel. All team members were familiar with the national CSSD guidelines of China and device assembly procedures. The team formulated the HACCP assembly scheme to optimize and improve the assembly procedures and management method of reusable medical devices in the CSSD.Hazard analysisAfter discussion by the HACCP team, the classification of device assembly defects were determined as follows: device model number error, device quantity error, dressing type error, dressing quantity error, device function abnormality, and placement error. A self-designed inspection form was used by inspection nurses to record and classify device assembly defects. The assembly data collected for the period from January 2023 to June 2023 was analyzed using the Pareto chart (Fig. 2). Analyzed according to the 80/20 rule, device model number error and dressing quantity error accounted for 50.1 and 31.3%, respectively. They were the main factors leading to the defects in device assembly, so they should be paid more attention to for improvement.Fig. 2Pareto chart for device assembly defects.Full size imageWith the help of the fishbone diagram, the HACCP team analyzed the causes of the above-mentioned two main factors leading to assembly defects, from five aspects: man, machine, material, method, and environment (Fig. 3).Fig. 3Fishbone diagram for factors associated with device assembly defects.Full size imageMan(1) The assembly personnel were nurses and general workers, of which general workers accounted for 92%. General workers usually have low levels of educational attainments, poor learning and understanding abilities, and may not fully master the assembly methods of reusable medical devices. In addition, our hospital’s CSSD adopted a job rotation system. The job positions in the CSSD rotated once every 2 months, which increased the difficulty of learning and working for general workers. Due to the different levels of educational attainments in these workers, individual differences led to various incidences of defects in devices assembled by each general worker. (2) Assembly inspectors were responsible for assembly inspection in all reusable medical devices. They had a heavy workload, so careless and missed inspections occurred because the inspectors wanted to save time. (3) The head nurse and quality control nurses had a low frequency of supervision and paid insufficient attention to device assembly.Machine(1) Information in the printouts of device packaging checklists was incomplete or the text was not legible. (2) The insufficient workbenches were small, thus causing the same batch of devices to not be placed together. This was not convenient for device assembly.Material(1) The device packaging checklists were not standardized. The types, model number and brands in the checklists were not clear. (2) Consumables, such as gauze and sterilization indicators, were repeatedly configured, resulting in quantity error. (3) Due to clinical needs, new devices were purchased, resulting in an increase in the number of errors. (4) There were various types of device packages, and information in some device packaging checklists was similar. Assembly only relying on the text version of the device packaging checklist could result in the high occurrence of errors21.Method(1) The setting of the job positions was unreasonable. Packaging personnel needed to work on the entire packaging process, including assembling, packaging, sealing and labeling. This involved various steps and brought heavy workload for packaging personnel22. The inspection personnel needed to review all reusable medical devices assembled in the packaging area, so they had a heavy workload. (2) The work rules were imperfect. The inspection rules were unclear. There were no specific packaging procedures for special and complex devices and there were no reward and punishment systems for assembly personnel, resulting in inadequate implementation of the inspection.Environment(1) Our hospital’s CSSD was located in a low floor of the building. There was insufficient light in the packaging area, so staff could not detect assembly defects in time during the inspection. (2) There were multiple equipment with high noise levels, which made it difficult for staff to concentrate on work23. (3) There were multiple cleaning machines and sterilizers which produced a lot of heat, resulting in high temperature and humidity in the packaging area and general discomfort for staff, thus affecting normal manipulation.Determination of critical control pointsAfter the hazard analysis of assembly defects, the HACCP team used assessment method to score the factors in the fishbone diagram. The following root causes were determined: heavy workload in inspection; poor learning abilities in general workers; many types of device packages; unreasonable setting of job positions; imperfect work rules; and insufficient number of workbenches. A true cause verification form was designed based on the aforesaid root causes. The true cause verification lasted 20 days, during June 10, 2023 - June 30, 2023. A total of 70 assembly defects were identified during that period (Table 1). The Pareto analysis was performed on the data concerning assembly defects identified during the verification of true causes (Fig. 4). The following critical control points were determined according to the 80/20 rule: poor learning abilities in general workers; many types of device packages; unreasonable setting of job positions; and imperfect work rules.Table 1 True cause verification.Full size tableFig. 4Pareto chart for true cause verification of device assembly defects.Full size imageFormulation of preventive measuresThe following preventive measures were formulated based on the critical control points:Poor learning abilities of general workers① Fixed general workers were arranged for fixed job positions; ② General workers were assigned to different job positions according to their learning abilities. Workers with high incidence of packaging defects and poor learning abilities were assigned to job positions with simple requirements, such as worker positions in ambulatory surgery center and wards. Workers with low incidence of defects and strong learning abilities were assigned to packaging positions for complicated, precise and valuable devices used for operating room and rigid endoscopes. ③ Specific personnel were arranged to regularly organize training and assessment for general workers. The CSSD management took turns to check all packaging personnel every week.Many types of device packages① Device packaging checklists were standardized for accurate checking. These checklists were created in accordance with the order of devices, utensils and dressings, and contained specifications and model numbers. Brand names of special devices were also indicated in the checklists. ② The illustration diagrams of device packages were uploaded to the traceability system for easy consulting during device assembly. Name, quantity, model number and specification of devices - whether they were imported products or the country of origin is China - quantity of components such as screws and sealing ring, and assembly methods, were accurately indicated in the illustration diagrams. ③ A specific person was arranged to receive new devices and create relevant information, such as creating checklists, taking photos of the devices and uploading the photos to the system. ④ Information concerning specifications and model numbers of devices were added.For devices without model number information on device surface, a laser marking machine was used to mark model number information on device surface for assembly checking. ⑤ More training was provided for the CSSD staff - the frequency of periodic training and assessment was increased. Assessment was conducted at least once a week to ensure that every staff member met relevant requirements. Staff members who failed to meet the requirements were allowed to work after retaking the training and passing the assessment24.Unreasonable setting of job positions① Positions with a heavy workload in packaging was split. For example, the rigid endoscope packaging position was divided into the low-temperature packaging position and high-temperature packaging position. ② Position setting was optimized. The packaging position was divided into assembly and packaging. The assembly personnel were only responsible for device assembly, and the packaging personnel were only responsible for packaging, sealing and labeling. This reduced the steps of a single position and reduced the difficulty of manipulation. ③ The number of inspection personnel was increased with the aim of reducing the workload of each of the inspection personnel, ensuring the quality of inspection.Imperfect work rules① The inspection rules was improved with a two-person checking approach being established. After a device package was assembled, inspection personnel were required to check the devices according to device packaging checklist and check the way of placement25. ② Specific assembly procedures were formulated for packages containing special and complex devices, and for guiding assembly and inspection personnel to assemble and check. ③ The reward and punishment systems for assembly personnel were improved. Incidences of assembly defects were included in the work performance assessment, and were directly associated with salary and job promotion.A hazard analysis form for assembly process of reusable medical devices was formulated (Table 2).Table 2 Hazard analysis form for assembly process of reusable medical devices.Full size tableTraceability system for continuous quality monitoringA laser marking machine was used to mark a quick response code on the surface of every reusable medical device. The CSSD traceability system was used to keep track of and record the start and completion time for device assembly process and the information concerning assembly personnel. If assembly defects were found during inspections, the inspection personnel would record them in the system.Based on the data concerning the device assembly process, the assembly time and the details of assembly defects were dynamically evaluated and the intervention measures were dynamically adjusted.EvaluationThe instances of assembly defects from the two groups of reusable medical devices were observed and analyzed, including 6 items: device model number error, device quantity error, dressing type error, dressing quantity error, device function abnormality, and device placement error. Assembly defect rate of reusable medical devices = the number of packages with assembly defects in the statistical period ÷ the number of device packages assembled ×100%.Satisfaction among users of the two groups of reusable medical devices on quality of device supply was investigated and analyzed. A self-designed questionnaire was used to investigate device users’ satisfaction on the following five components: (1) integrity of devices; (2) device assembly quality; (3) dressing assembly quality; (4) device function; and (5) the way of placement. The maximum score for each component was 100 points. The higher the score, the higher level of satisfaction. The reliability and validity values of the questionnaire were 0.79, indicating good reliability and validity.Statistical methodsIBM SPSS 26.0 was used for data analysis. The enumeration data was presented with rate. The Chi-square test was performed for inter-group comparison and the measurement data was presented with (x ± s). A t-test was performed to compare the differences. A statistically significant difference was identified by P < 0.05.ResultsIncidences of assembly defectsThe incidences of assembly defects in the two groups of reusable medical devices are presented in (Table 3).Table 3 Incidences of assembly defects in reusable medical devices in control and experimental groups.Full size tableTypes of assembly defectsThe types of assembly defects in the reusable medical devices in the control and experimental groups are shown in (Table 4).Table 4 Types of assembly defects in reusable medical devices in control and experimental groups.Full size tableSatisfaction rates among clinical department staffSatisfaction rates among clinical department staff before and after implementation of the HACCP system is shown in (Table 5).Table 5 Satisfaction rates among clinical department staff.Full size tableDiscussionSignificance of the HACCP system in assembly of reusable medical devicesThe quality of reusable medical device assembly is directly associated with surgical safety and patient prognosis. Previous studies have shown that device assembly defects may lead to serious consequences, such as surgical delays, functional failures in devices, and postoperative infections, posing a major threat to healthcare quality and patient safety26,27,28. With the popularity of sophisticated surgical instruments, the CSSDs need to reprocess a wide variety of reusable medical devices with increased complexity16,21. The traditional management modes cannot meet the growing requirements of reusable medical device assembly. Other scholars have tried to use quality management tools (such as the healthcare failure mode and effect analysis and the plan-do-check-act cycle) to optimize work processes5,8,19. These studies focused on cleaning and sterilization. There is a lack of studies on systematic risk control for the assembly process of reused medical devices.This study applied the HACCP system in the assembly of reusable medical devices reprocessed by the CSSD staff. Possible hazards in the assembly procedures were analyzed, which determined the critical control points, and proposed preventive measures, thereby formulating scientific and efficient work procedures and management systems29. The implementation of the HACCP system in device assembly improved the quality of device assembly and significantly reduced the assembly defect rates. This has positive significance for improving healthcare quality. It is worth popularizing in the CSSD work.Novelty of the application of HACCP system in reusable medical device assemblyTheory integration and management toolsThis study is the first to combine the HACCP system with modern management tools (such as the Pareto analysis and the fishbone diagram). This broke the limit of application scope of the HACCP system which was usually applied in food safety. The critical control points, such as ‘poor learning abilities of general workers” and “many types of device packages”, were identified through the hazard analysis. Moreover, the targeted intervention measures, such as split of job responsibilities and creation of device assembly illustration diagrams for the traceability system, were proposed. These innovations made up for the neglect of factors concerning manpower and materials in existing research27.Technological innovation: dynamic monitoring of the whole processIn terms of improving technological adaption, this study introduced the traceability system to perform real-time data collection and dynamic monitoring for device assembly. This can solve the problems (such as “data lag” and “traceability difficulty”) that usually occurred in the implementation of the HACCP system in the healthcare sector30. For example, marking a quick response code on the surface of every reusable medical device and creating illustration diagrams for device assembly significantly reduced assembly defects caused by information mismatch, thereby improving the reliability and accuracy of the traceability system.Innovation in management mechanism: equal emphasis on incentive and constraintIn terms of optimizing management mechanism, this study suggested that fixed general workers should be assigned to fixed positions and a two-person checking approach should be established under the implementation of reward and punishment mechanisms. This can combine the HACCP system’s preventative control with behavior incentives, forming a closed-loop management system. This system can improve the standardization of manipulation and provide a reusable management framework for quality management in other healthcare procedures (such as drug allocation and infection control).Differences with previous studiesPrevious studies focus on the improvement of a single process. However, risk control of the whole process of reusable medical device assembly, from material preparation to post-assembly checking, was investigated in our study based on the HACCP system. In addition, multi-dimensional interventions (man, process, technology, and system) were implemented to improve the assembly process. In our study, assembly defect rate decreased from 2.59 to 0.24%. This was significantly lower than 5.2%, the packaging defect rate for rigid endoscopes after the implementation of the healthcare failure mode and effect analysis8. Therefore, the HACCP system is an ideal management tool for complex healthcare work.Effect of the HACCP system on rate of assembly defectsThis study showed that the assembly defect rate of reusable medical devices in the experimental group which implemented the HACCP system was significantly lower than the control group. This benefited from a series of interventions based on the HACCP principles. The interventions played an important role in monitoring and managing the critical control points. The details of the interventions are as follows:
(1)
The fixed general workers being assigned to device assembly positions reduced human errors at critical control points. In the experimental group, the fixed general workers were assigned to device assembly positions. This reduced the complexity and difficulty of learning for them and was conducive to improving their professional skills. This also allowed general workers to focus on the operation of a critical control point, thereby reducing human errors at critical control points.
(2)
The illustration diagrams for devices reflected an improvement in information management for critical control points. After device illustration diagrams were created for the traceability system, the device assembly personnel had a visual impression on device assembly. The illustration diagrams for devices contained detailed information about device packaging checklists and specifications, model numbers and structure of devices. This helped assembly personnel accurately identify critical control points in assembly, thereby reducing defects caused by maloperations and increasing the accuracy rate of device assembly.
(3)
Improving training increased assembly personnel’s hazard identification and control capabilities. After receiving relevant training, the CSSD staff had a clear understanding of the inspection methods, placement methods and key points of inspection in different reusable medical devices. This greatly improved their quality of work31. For example, assembly personnel were able to quickly identify device placement errors or potential contamination risks. This significantly improved the standardization and accuracy of device assembly. Improving training could improve assembly personnel’s professional skills and their abilities to identify risks, thereby ensuring effective implementation of the control measures in the HACCP system.
(4)
The creation of the reward and punishment systems improved supervision and corrective actions for critical control points. The reward and punishment systems aroused the enthusiasm of the CSSD staff and also proved to be effective in supervisory and correctional roles in the HACCP system. Once a deviation at critical control points was found, the reward and punishment systems could urge employees to take immediate corrective actions. The reward and punishment systems constituted an important part of the verification and improvement in the HACCP system, and could ensure the sustained effectiveness of the control measures through the combination of incentive and supervision.
Assembly efficiency improvement by split of job responsibilitiesPosition setting was optimized. The packaging position was divided into assembly and packaging. This significantly improved work efficiency and quality of work. The details of the improvement in work efficiency are as follows:Quantitative improvement (the steps in work procedures and working time was reduced)The job responsibilities for assembly and packaging positions were not clearly split before the implementation of the HACCP system, and the assembly process consisted of 8 steps: material preparation, inspection, placement, checking after assembly, packaging, sealing, labeling, and checking after packaging. After the split of job responsibilities, the number of steps required for a single position were reduced to 4. This simplified the work process. The work content became more specific. The average work time was reduced by 50%.Qualitative improvement (the staff’s concentration at work and familiarity with manipulation requirements was increased)After the split of job responsibilities, assembly and packaging personnel could concentrate on specific tasks. This could reduce distractions caused by task switching. Assembly personnel were more familiar with specifications, model numbers and assembly requirements of devices after receiving professional training. Packaging personnel’s abilities to check details and accurately label the device packages were improved after work processes were standardized. The split of job responsibilities significantly improved the accuracy of manipulation. In addition, the workload and overall difficulty of tasks for a single position was reduced, leading to an reduction in psychological and physical burden on the staff. This could avoid maloperations caused by excessive fatigue.Effect of the HACCP system on satisfaction rate among device usersThis study showed that satisfaction among device users was increased from 95.52 to 97.61% after the implementation of the HACCP system. An increase by 2.09% was small but significant. The studies by Luo et al.32 on ceiling effects showed that increasing satisfaction became very challenging after an satisfaction rate of 95% was reached. This was because further optimization and improvement was limited in case of high satisfaction rates. Any small improvement required more resources and efforts. In our study, the CSSD developed a detailed and strict device assembly procedures and quality criteria under the HACCP system. The assigned personnel assembled the devices in strict accordance with the requirements, greatly reducing the incidence of device assembly defects. Therefore, satisfaction of device users after implementation of the HACCP system was significantly increased, which was consistent with the results of Lyu et al.30.Limitations and future research directionsThis study has demonstrated the effectiveness of the HACCP system in reducing defect rate in the assembly of reusable medical device and improving the quality of work. However, this study had some limitations. First, the study sample size was limited. The study was conducted in a specific department, so the generalization of the results needs to be verified in different hospitals and wider clinical environments. Second, this study focused on the impact of the HACCP system on assembly defect rates and user satisfaction. No analysis of its potential roles in other key quality indicators (such as cost-effectiveness and patient clinical outcomes) was performed. Third, due to the short period of data collection, the sustainability and potential effects of the long-term implementation of the HACCP system were not evaluated. The sample size for future studies should be increased. The data from different types of healthcare institutions and spanning across a longer period of time is required to further validate the applicability and effectiveness of the HACCP system in different contexts.ConclusionsIn this study, the HACCP system was applied in assembly management of reusable medical devices. The systematic risk management measures for the problems caused by increasing complexity and high defect rate in device assembly, were implemented in this study. The results show that the implementation of the HACCP system significantly reduced the assembly defect rate (from 2.59 to 0.24%) and increased satisfaction among device users in clinical departments (from 95.52 to 97.61%) by means of hazard analysis, critical control point management, identification of high-risk steps in the assembly process, and development of multiple interventions, including improving training, assigning the fixed general workers to device assembly positions, and formulating the illustration diagrams for devices. These measures could effectively improve the supply quality of reusable medical devices, thus improving work efficiency and ensuring healthcare safety.The study results showed that the HACCP system has a significant effect in optimizing assembly management and coping with the challenges of complex device management and it could solve the key problems occurred traditional management. This study may provide a reference for application of the HACCP system in healthcare institutions.
Data availability
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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PubMed Google ScholarNa LiView author publicationsYou can also search for this author in
PubMed Google ScholarBiru LuoView author publicationsYou can also search for this author in
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PubMed Google ScholarContributionsYH contributed to the study design. NL carried out the data collection. TH conducted the data analysis. YH drafted the manuscript. BL, LY and WP revised the manuscript. All the authors read and approved the final manuscript.Corresponding authorsCorrespondence to
Biru Luo or Liangying Yi.Ethics declarations
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The authors declare no competing interests.
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Reprints and permissionsAbout this articleCite this articleHuang, Y., Li, N., Luo, B. et al. Effect of hazard analysis critical control points system in the assembly of reusable medical devices.
Sci Rep 15, 9234 (2025). https://doi.org/10.1038/s41598-025-93615-zDownload citationReceived: 12 November 2024Accepted: 07 March 2025Published: 18 March 2025DOI: https://doi.org/10.1038/s41598-025-93615-zShare this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard
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KeywordsCentral sterile supply departmentHazard analysis critical control pointsReusable medical devicesDevice assembly