Effects of project management in labeling standardization for new reusable medical device packages: A retrospective study

Abstract

Objective

This study aimed to apply project management to standardize labeling procedures for new reusable medical device packages received by the central sterile supply department and investigate its effect on device assembly quality.

Methods

This was a retrospective study. The central sterile supply department of a women’s and children’s hospital in China used project management to establish labeling standards and standard operating procedures for new reusable medical device packages from August 2025 to October 2025. Central sterile supply department nurses’ awareness rate of labeling standards, pass rate for labeling operations, and assembly defect rate for new device packages before and after project management implementation were compared.

Results

Project management improved central sterile supply department nurses’ awareness of labeling standards to 100% and their pass rate for labeling operations to 100%. The cases of assembly defects caused by missing or nonstandardized labeling information decreased from 16 to 2.

Conclusions

Project management helped formulate labeling standards for new medical device packages and standard operating procedures for package labeling. It reduced the assembly defect rate for device packages, improved the assembly quality of sterile items, enhanced the clinical staff’s satisfaction with the services of the central sterile supply department, and ensured patient safety.

Keywords

Assembly defects labeling new devices project management quality improvement sterile supply

Introduction

The central sterile supply department (CSSD) is a hospital unit tasked with cleaning, disinfecting, and sterilizing reusable medical devices, utensils and supplies as well as providing sterile items to clinical departments.¹ The quality of sterile items directly impacts clinical diagnosis and treatment, thereby affecting patient safety.^2,3 Labeling of sterile packages is one of the important factors associated with package quality.

Sterile package labels are affixed on the outside of the packages to identify medical devices in the packages and facilitate technical instructions and use. They can be handwritten or printed.^4,5 Relevant guidelines issued by the National Health and Family Planning Commission of China state that a sterile package label should include the item name, packager’s name or code, sterilizer number, sterilization batch number, sterilization date, sterilization expiration date, and user department and should ensure traceability;⁶ however, they do not require labels to include details of the items in the packages. In CSSD practice, information such as the names, model numbers, and quantity of items in packages is important for assembly. It can help CSSD staff accurately count, assemble, and inspect items and help users quickly identify item details so they can choose the appropriate sterile packages for clinical use.⁷ CSSD staff may make errors during device assembly due to insufficient or nonstandardized label information about items in the sterile packages. For new reusable medical devices or packages received by the CSSD from clinical departments for the first time, creating standardized label information is critical for subsequent reprocessing procedures. Enhancing the completeness of label information improves the efficiency and service quality of the CSSD. Therefore, standardizing labeling for new reusable medical device packages is essential.

Project management is a process that involves planning, organizing, coordinating, managing, and controlling a project by integrating personnel, methods, and systems and applying knowledge, skills, tools, and technologies. It ensures that a project is completed within the planned timeframe, with high quality and efficiency.^8–11 Project management comprises the five stages of initiation, planning, execution, monitoring and control, and closure. Although it has improved clinical nursing quality,^12–14 its application in CSSD operations remains limited.^15,16 Both project management and labeling standardization for new reusable medical device packages received by the CSSD for the first time are temporary in nature; therefore, project management is a suitable approach for labeling standardization for these packages.

Labeling standardization for new reusable medical device packages can ensure the traceability of sterile items, enhance the CSSD’s work efficiency, and maintain the safety of clinical diagnosis and treatment. However, there is a gap in the application of project management as an efficient tool for standardized labeling of new device packages in the CSSD. Previous studies have not systematically explored project management schemes suitable for CSSD labeling management. This study aimed to apply project management to standardize labeling procedures for new reusable medical device packages received by the CSSD and evaluate its effectiveness in improving device assembly quality.

Methods

Ethics approval and consent to participate

This retrospective study was conducted in accordance with the Declaration of Helsinki of 1975, as revised in 2024. Ethical approval for this study was obtained from the Medical Research Ethics Committee of West China Second University Hospital, Sichuan University on 21 July 2025 (2025 Medical Scientific Research for Ethical Approval No. (227)). Informed consent was obtained from all participants before study initiation. The Standards for Quality Improvement Reporting Excellence (SQUIRE) guidelines were followed.¹⁷

Study objects

CSSD nurses

Inclusion criteria for CSSD nurses were as follows: (a) working at our hospital’s CSSD; (b) possession of a nurse qualification certificate; (c) voluntary participation with informed consent; and (d) possession of basic computer skills. Exclusion criteria were as follows: (a) nurse interns; (b) rotating nurses; (c) nurses assigned to the CSSD for professional skill development; and (d) nurses absent from work ≥6 months.

New reusable medical devices

Inclusion criteria for new reusable medical devices were as follows: (a) newly assembled device sets; (b) packages containing ≥1 devices; (c) newly purchased devices; and (d) device packages not listed in the CSSD’s device package library. Exclusion criteria were as follows: (a) loaner instruments and (b) devices reprocessed for other healthcare settings.

Sample size calculation

All CSSD nurses in our hospital who met the inclusion criteria and did not meet the exclusion criteria during the study period were included. All new reusable medical devices that met the inclusion criteria and did not meet the exclusion criteria during the study period were included.

Project initiation stage

Project background

In 2024, CSSD quality control results and clinical department feedback revealed that medical device assembly defects were the most common issues encountered in packaging procedures.¹⁴ Further analysis showed that defects due to incomplete or incorrect label information for reusable medical devices in sterile packages accounted for the majority of assembly quality issues, particularly in new reusable medical device packages processed by the CSSD for the first time. For instance, device names lacked uniformity, and model numbers or brands were omitted from labels. This stemmed from the absence of labeling standards for new reusable medical device packages, leaving packaging staff unclear about the required label content and thereby increasing assembly errors. Relevant criteria, guidelines, expert consensus, and literature for CSSD work in China require only the item name, packager’s name or code, sterilization date, and sterilization expiration date to be displayed on a label; however, they do not require or mention the inclusion of device details on the label. In practice, CSSD assembly personnel need accurate device details, such as device names, model numbers, brands, and quantity of devices in a package, to assemble devices into packages. If labeling staff can accurately create label information after receiving new device packages and are skilled in labeling, CSSD efficiency and work quality will improve significantly. Therefore, since August 2025, our CSSD has adopted project management to standardize labeling for new reusable medical device packages as a key initiative for the year 2025.

Building a project management team

In August 2025, our CSSD established a project management team comprising six members. The Director of Nursing served as the advisory expert. The other five members, each with >5 years of CSSD work experience, included one head nurse, one deputy head nurse, one research nurse, one teaching nurse, and one quality control nurse. The head nurse initiated the project, while the deputy head nurse acted as the project lead, responsible for planning, organizing, coordinating, and monitoring. All team members participated in the project’s implementation, evaluation, and data management.

Formulating objectives

After discussion, the project management team defined the overall goal and expected key results, considering sterile package labeling practices in China and other countries, international data, and our hospital’s context. The goal was to standardize labeling procedures for new reusable medical device packages to enhance device assembly quality. The expected results were as follows: (a) creating labeling standards and standard operating procedures for new reusable medical device packages; (b) achieving a 100% pass rate for CSSD nurses’ labeling operations of new device packages; (c) ensuring 100% awareness of labeling standards among CSSD nurses; (d) addressing obstacles during project management implementation; (e) reducing device assembly defects by the end of the project; and (f) enhancing CSSD nurses’ responsibility, enthusiasm, confidence, communication and coordination skills, and project management skills.

Identifying project timeline

The project management team created a project timeline to assign deadlines for each task, ensuring controllable progress within the time range. Clear timeframes for each stage supported smooth implementation.

Project planning stage

Project task decomposition

The project management team broke down project tasks to ensure they were independent, consistent, and actionable, facilitating smooth evaluation during the later stages of the project. The following tasks were included: (a) creating labeling standards for new reusable medical device packages; (b) designing assessment forms; (c) conducting baseline survey; (d) refining labeling procedures for new medical device packages; (e) defining the formula to assess CSSD nurses’ pass rate for labeling new device packages; (f) defining the formula to assess CSSD nurses’ awareness rate of labeling standards for new medical device packages; and (g) setting goals for project planning stage.

Determination of a principal for each task

Team members were assigned as principals for each task, with a defined timeline for supervision and quality control.

Labeling standards and standard operating procedures

After consulting literature and brainstorming, the project management team formulated labeling standards for new medical device packages and standard operating procedures for package labeling based on these standards. The goal was to standardize labeling for new medical device packages to enhance packaging quality.

Project execution stage

Baseline survey

In September 2025, a 4-week baseline survey was conducted, involving 15 CSSD nurses who met the inclusion criteria and did not meet the exclusion criteria. The “Assessment Form for Awareness of Labeling Standards for New Medical Device Packages” and the “Assessment Form for Labeling Operations of New Medical Device Packages” were used to assess nurses’ awareness of labeling standards and operational pass rate. Data on issues faced during and after labeling were collected, categorized, and analyzed. New medical device packages that met the inclusion criteria and did not meet the exclusion criteria were included in the study. Data on device assembly defects caused by missing or nonstandardized label information were analyzed to identify the causes of defects (Figure 1).

Figure 1.

Baseline data regarding the number of assembly defects caused by inadequate labeling.

Staff training

The project management team provided 15 CSSD nurses with tiered training regarding the theory and practical skills required for standardized labeling of new device packages in various sessions to familiarize them with labeling steps and workflow. The team designed assessment forms for theoretical and practical labeling based on standards and standard operating procedures. They conducted post-training assessments on days one, three, and five to evaluate effects. The head nurse performed random checks and supervision to ensure training quality.

Manipulation standards and operating procedures

After receiving new reusable medical device packages, the 15 CSSD nurses labeled them in accordance with the labeling standards for new reusable medical device packages and standard operating procedures for labeling. The project management team conducted inspections, provided guidance, and answered questions to ensure that every nurse followed the standards. Information concerning obstacles and confusions encountered by the nurses during new device package labeling was collected. The nurses were permitted to share their suggestions and opinions. The project management team conducted a weekly review on every Friday. They discussed the opinions and suggestions shared by the nurses and made real-time improvements to the standards and operating procedures, such as simplifying the operating procedures and upgrading the information traceability system.

Project post-implementation survey

In October 2025, the project management team used “Assessment Form for Awareness of Labeling Standards for New Medical Device Packages” and “Assessment Form for Labeling Operations of New Medical Device Packages” to survey the 15 CSSD nurses, assessing their awareness and pass rates for new device package labeling after project management implementation. The number of assembly defect cases in new device packages was also recorded during the survey.

Assessment indicators

The assessment indicators were as follows:

CSSD nurses’ awareness rate of labeling standards for new medical device packages. CSSD nurses who scored ≥95% on the assessment for awareness regarding labeling standards were deemed to have passed the assessment. Calculation formula: awareness rate = number of nurses who passed the awareness assessment ÷ the total number of nurses included in the study × 100%.

CSSD nurses’ pass rate for new medical device package labeling. CSSD nurses who scored ≥95% on the assessment for labeling operations were deemed to have passed the assessment. Calculation formula: pass rate = the number of nurses who passed the assessment for labeling operations ÷ the total number of nurses included in the study × 100%. The number of assembly defect cases.

Levels of CSSD nurses’ responsibility, enthusiasm, confidence, communication and coordination skills, and project management skills. Nurse self-assessments and mutual evaluations were conducted using a 0–10 rating scale to assess each nurse’s responsibility, enthusiasm, confidence, communication and coordination skills, and project management skills before and after project management implementation. The 15 CSSD nurses’ mean scores for each variable measured before and after project management implementation were compared. A higher mean score indicated a better outcome.

Project monitoring and control stage

Daily inspections data and stage-wise goal achievement were monitored. Strategic adjustments, problems, and countermeasures from the project execution stage were recorded. Weekly feedback on goal achievement was discussed in morning meetings, ensuring that all CSSD staff members were informed of progress, existing problems, countermeasures, and changes to maintain transparency of the project progress.

Project closure stage

All project materials were compiled, project details and data were analyzed, and results were evaluated for acceptance. The effectiveness of improvement measures was assessed. Project management experience was summarized to consolidate measures, reflect on shortcomings, and make improvements.

Statistical methods

The Statistical Package for Social Sciences (SPSS) software (version 25.0) was used for data analyses. Data were described as frequencies and rates. The chi-square test was used to compare the number of assembly defects caused by inadequate labeling of new device packages.

Results

In total, 15 CSSD nurses were included in the study, with a mean age of 32.60 ± 5.730 years. Among them, six were nurse practitioners, eight were supervising nurses, and one was a co-chief nurse. In total, 695 new medical devices were included in the study. Of these, 138 were placed in 138 separate packages, and the remainder belonged to 57 device sets.

Table 1 presents the percentages of CSSD nurses aware of labeling standards and operational pass rates before and after project management implementation. The baseline survey showed that only five nurses were aware of the labeling standards for new medical device packages, and only six were familiar with labeling operations prior to the implementation of project management. After project management implementation, all 15 nurses were aware of the labeling standards and were familiar with labeling operations.

Table 1.

CSSD nurses’ awareness rates for labeling standards and pass rates for labeling operations of new medical device packages.

	CSSD nurses’ awareness rates for labeling standards	CSSD nurses’ pass rates for labeling operations
Baseline survey	33%	40%
After the implementation of project management	100%	100%
χ²	33.597	33.520
p	<0.001	<0.001
95% confidence interval	0.000001–0.00001	0.000001–0.00001

CSSD: central sterile supply department.

There was a significant reduction in the number of assembly defect cases after project management implementation, as detailed in Table 2.

Table 2.

Details of assembly defects caused by inadequate labeling after project management implementation.

	Number of cases of nonuniform device names	Number of cases of missing model numbers	Number of cases of unstated place of origin (domestic or imported)	Number of cases of omitted special identification information	Total
Baseline survey	5	4	4	3	16
After the implementation of project management	0	1	0	1	2
χ²	18.200	18.866	18.519	16.266	20.726
p	0.008	0.007	0.007	0.009	<0.001
95% confidence interval	0.006–0.010	0.005–0.008	0.005–0.009	0.007–0.011	0.00001–0.0001

CSSD nurses’ responsibility, project management skills, enthusiasm, confidence, and communication and coordination skills improved after project management implementation (Figure 2).

Figure 2.

A radar chart for CSSD nurses’ mean scores for responsibility, project management skills, enthusiasm, confidence, and communication and coordination skills. CSSD: central sterile supply department.

Discussion

This study applied project management for the labeling of new reusable medical device packages received by the CSSD, standardized labeling procedures, and successfully reduced the incidence of assembly defects while improving team coordination.

Project management could help formulate effective labeling standards for new medical device packages and standard operating procedures for labeling

One of the core values of project management is to prevent the randomness and fragmentation of work through clear planning and standardized implementation.^8–11 At the project initiation stage, the research team defined labeling standardization for new medical device packages as a core research target to meet the objective-setting requirement in project management. At the project planning stage, the labeling standards and standard operating procedures were formulated in accordance with the CSSD labeling management requirements.^4–7 The operating requirements and assessment criteria were clarified for each step, thereby resolving problems arising from practices based on experience rather than unified standards. At the project execution stage, targeted training was provided to CSSD nurses, and dynamic evaluations were conducted using assessment forms aligned with the theory of project process control and closed-loop management. This ensured successful training implementation and guaranteed that the nurses’ practices adhered to the established standards. During the project monitoring and control stages, CSSD nurses’ awareness rate of labeling standards for new device packages and their pass rate for labeling operations were tracked in real time to promptly identify and correct operational errors. This ensured that awareness and operational pass rates for both indicators rose from 33% and 40%, respectively, to 100% each, forming a systematic, standardized operating system. This directly demonstrates the positive effect of closed-loop project management in planning, execution, and monitoring and control.¹⁸

Labeling standards and standard operating procedures could effectively reduce assembly defect rates for new medical device packages and improve work efficiency

Labeling standardization using project management significantly reduced assembly defects caused by inadequate labeling, thereby reducing the incidence of quality defects in packaging. This is attributable to the application of quality and scope management in project management. Project quality management emphasizes prevention and process management. It clarified labeling standards and operating procedures, reducing assembly defects caused by inadequate labeling (such as omissions and writing mistakes). This meets the CSSD’s core requirements for the control of quality defects in packaging.¹⁹ Project scope management clarified the content for creating standardized label information and decomposed complex labeling management into different modules—formulating labeling standards, training, assessment, and implementation. This helped prevent problems caused by unclear responsibilities and chaotic processes. This is consistent with previous reports, according to which, project management can decompose complex nursing management content into modules to improve management efficiency.^20,21 The integrated management concept of project management combined labeling management with device assembly and quality inspection, reducing the incidence of rework due to inadequate labeling. This can improve CSSD efficiency, increase clinical staff satisfaction, and reduce complaints from the clinical staff.

Project management could enhance team collaboration and optimize management process

Project management is a multidimensional process. Through process control and quality improvement, project management tools and a point-to-surface approach engaged all CSSD staff members in label standardization for new device packages, addressing limitations in the CSSD’s workflows. Each staff member performed their duty, cooperating to implement project management in a planned, goal-oriented, and efficient manner. Management measures ensured full participation and improved efficiency.²² This approach enhanced CSSD nurses’ professional, communication, and teamwork skills. In this study, nurses actively participated in project activities. The team achieved goals by applying expertise to standardize rules, training, and process. Performance appraisals, linked to task completion with clear rewards and penalties, fostered staff development and collaboration.

The application of project management in the healthcare sector has focused on improving clinical nursing quality,^12–14 while its application in CSSD management remains limited.^15,16 The innovation and characteristics of our study lie in two aspects:

Our study is more specific. Previous studies have focused on overall packaging quality and the entire process of medical device reprocessing within CSSDs. However, our study specifically focuses on labeling standardization for new medical device packages. Considering the characteristics of a one-time, temporary project that affects subsequent procedures, we formulated an adaptive, targeted, and operational project management plan.

The practical benefits of our study results are evident. Our study not only improved CSSD nurses’ awareness rate of labeling standards for new device packages and their pass rate for labeling operations, but also established a systematic, standard operating process for labeling. Moreover, the project goals were linked to performance assessment, forming a complete system of “standards–training–assessment–and motivation.” Compared with similar studies, which were limited to process optimization without sustained outcomes, the observed improvement in our study supports the use of project management to achieve long-term improvements in CSSD workflows. The present study clarified the association between labeling standardization and quality traceability, highlighting the core value of project management in ensuring the quality of sterile items and patient safety. This bridges a gap observed in previous studies by addressing the insufficient attention paid to CSSD labeling management.

The application of project management in labeling standardization for new medical device packages yielded promising results. However, challenges remained, such as fixed operational habits among senior staff, large variety of new medical devices received by the CSSD, homogenization in training and assessment, and insufficient cross-departmental collaboration.

The improvements observed in the CSSD workflow in this study are sustainable. Labeling standards and standard operating procedures for labeling were developed in this study, clarifying the responsibilities and requirements for each step and avoiding rollback after project management. A closed-loop mechanism of “training–assessment–motivation” was established, combining labeling quality with performance assessment. This could continuously stimulate work enthusiasm and standardized labeling among CSSD nurses. In this study, CSSD nurses’ project management awareness and professional skills were improved, providing personnel support for the continuous progress of CSSD workflow. The improvement measures met the CSSD labeling management requirements and were well recognized by CSSD nurses and clinical staff.

Limitations

This study has certain limitations. First, the single-center study design may have introduced biases, limiting the extrapolation of the study results and making them difficult to apply to CSSD labeling management across all hospitals (especially primary and specialized hospitals). Second, the short study period led to inadequate long-term assessment of the sustainability of improvement measures. Staff members implementing new procedures under study conditions are likely to work more carefully than during a routine work day. The true effect of the changes can only be fully assessed when the change has become routine. Third, the assessment indicators were inadequate. They focused on process indicators (CSSD nurses’ awareness rate of labeling standards and pass rate for labeling operations) and short-term outcome indicators (assembly defect rate and clinical staff satisfaction) while lacking long-term outcome indicators such as the incidence of clinical adverse events caused by nonstandardized label information, efficiency of sterile item traceability, and cost–control effect. This could make it difficult to investigate the long-term value of project management. Finally, our study did not fully control for confounding factors, such as nurses’ educational attainment, length of service, level of professional skills, degree of cooperation between the CSSD staff and clinical staff, and the types and quantities of new reusable medical devices. These factors may have interfered with the improvement effect, affecting the rigor of the study results.

Implications for future practice

In future clinical practice, the application of project management can be extended beyond labeling standardization for new reusable medical device packages to encompass the entire CSSD device reprocessing workflow, including collection, cleaning, sterilization, and sterile item storage and distribution. Adaptive project management plans can be formulated for defective reprocessing steps, thereby optimizing overall CSSD management and improving sterile item quality management. Advanced project management tools can be used to strengthen risk management, control, and performance evaluation, thereby improving professionalism in project management. Multicenter studies with large sample sizes from CSSDs across different levels and types of hospitals are needed to validate the generalizability of project management plans. The study period should be extended, and long-term follow-up is required to track the continuing effects of improvement measures, thereby improving the evaluation system, adding long-term outcome indicators, and enhancing the rigor and practicality of the study results. Interdisciplinary and cross-departmental collaboration is required to overcome the limitations of single-department management in the CSSD. A collaborative management model of “CSSD–clinical departments–medical device suppliers” is recommended, and the responsibilities of each party in this model for labeling new device packages need to be clarified to improve communication and collaboration, ensuring the accuracy and completeness of labeling information. Meanwhile, nursing management and quality management theories may be used to optimize labeling management.

Conclusions

The application of project management to labeling of new reusable medical device packages in the CSSD effectively addressed the shortcomings of the traditional management mode through process management and control, thereby achieving improvements such as standardized operations, enhanced efficiency, and optimized team collaboration. Due to study limitations, it is necessary to further improve the system and its application through multicenter, long-term studies to address research deficiencies, provide stronger support for the standardization and scientific development of CSSD labeling management, and ultimately ensure the quality of sterile items and patient safety.

Footnotes

Acknowledgments

Not applicable.

Author contributions

Tingting Yong: Investigation, Data curation, Writing-original draft

Liangying Yi: Conceptualization, Methodology, Writing-review and editing

Wei Pan: Conceptualization, Methodology, Writing-review and editing

Caixia Yuan: Formal analysis, Writing-review and editing

Xiaochun Zhao: Investigation, Writing-review and editing

Jinhui Zhang: Investigation, Writing-review and editing

Consent for publication

Not applicable.

Data availability statement

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Declaration of conflicting interests

The authors declare that there is no conflict of interest.

Ethics approval and consent to participate

Ethics approval of this study was obtained from the Medical Research Ethics Committee of West China Second University Hospital, Sichuan University (2025 Medical Scientific Research for Ethical Approval No. (227)). Informed consent was obtained from all participants before the start of the study.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

ORCID iD

Wei Pan

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