PDCA cycle-based optimization of laparoscopic instrument management in digestive surgery supply rooms

Abstract

BACKGROUND

With the widespread application of laparoscopic surgery in digestive surgery, the precise structure and specialized materials of laparoscopic instruments have increased the requirements for processing procedures in supply rooms. Current problems in instrument management, such as unstandardized operations, low efficiency, and unstable sterilization quality, not only affect surgical safety but also increase hospital operating costs. As a scientific quality management tool, the PDCA cycle has demonstrated significant advantages for continuous improvement in the medical field.

AIM

To explore process improvement based on the PDCA cycle in the management of laparoscopic instruments in a digestive surgery room.

METHODS

This study included 138 patients in the conventional group (January 2023 to February 2024) who did not undergo risk control using the PDCA cycle model. Between February 2024 and February 2025, 223 patients in the PDCA group underwent laparoscopic surgery after implementation of the PDCA cycle. The management process for laparoscopic instruments in the supply room was improved based on the PDCA cycle. The incidence of adverse events, detection of multidrug-resistant bacteria, patient infection conditions, instrument cleaning quality, and operating room staff satisfaction with disinfection supply room management were compared between the two groups. Differences between the groups were analyzed using t-tests and χ² tests.

RESULTS

After implementation of PDCA management the quality of instrument handling significantly improved. The incidence of adverse events in the PDCA group was 2.7%, which was significantly lower than 15.2% in the conventional group. Regarding patient infections, the total detection rate of multidrug-resistant bacteria in the conventional group was 8.7%, which was significantly higher than that in the PDCA group (3.6%). Assessment of instrument cleaning quality showed that the nonconformity rates in ATP bioluminescence detection, visual inspection, and inspection with a lighted magnifying glass were significantly lower in the PDCA than in the conventional group. Moreover, the operating room staff satisfaction survey regarding supply room management showed that the satisfaction rate in the PDCA group reached 83.9%, which was significantly higher than that in the conventional group (51.6%).

CONCLUSION

Implementation of PDCA cycle management significantly optimized the processing procedure for laparoscopic instruments in the digestive surgery department. This approach not only reduces the instrument loss rate and hospital operating costs but also improves efficiency and patient safety. The PDCA cycle appears to be an effective method for improving the management quality of laparoscopic instruments in the supply room and is worthy of promotion and application in medical institutions. Future studies should further explore the applicability of this model to the management of different types of instruments to achieve a more comprehensive improvement in medical quality.

Key Words: Laparoscopic instruments; PDCA cycle; Supply room; Digestive surgery

Core Tip: This study explored process improvement based on the PDCA cycle in the management of laparoscopic instruments in a digestive surgery supply room. The results showed that after implementing PDCA cycle management, the incidence of adverse events decreased from 15.2% to 2.7%, the detection rate of multidrug-resistant bacteria decreased from 8.7% to 3.6%, and operating room staff satisfaction with supply room management increased from 51.6% to 83.9%. The PDCA cycle can optimize instrument handling process, reduce hospital operating costs, and improve operating room efficiency.

INTRODUCTION

With the rapid development of minimally invasive surgical techniques, laparoscopic surgery has become a routine procedure in digestive surgery because of its significant advantages, such as minimal trauma and faster postoperative recovery[1,2]. However, the laparoscopic instruments have complex structures and specialized materials and therefore require precise handling. These instruments have slender channels, precise joint tooth patterns, and numerous easily confused components; improper handling can easily damage them. More critically, the quality of cleaning and sterilization of laparoscopic instruments directly affects surgical safety. Oversight in any processing step can increase the risk of hospital infections[3].

In the current medical environment, controlling medical costs is important for hospital management. Global data show that healthcare costs have risen sharply over the past two years and are expected to continue increasing over the next decade[4]. As an important cost center for hospital operations, improving operating room efficiency is of great significance for reducing the overall medical expenditure[5]. However, the widely implemented separate management model for medical supplies and instruments leads to a cumbersome handover process between the operating room and the supply room. This not only increases management costs but may also affect surgical scheduling due to handover errors, increasing hospital costs. Therefore, establishing a scientific and standardized laparoscopic instrument management system in the supply room has multiple benefits. From the perspective of hospital operation, it can reduce instrument loss rates and optimize the allocation of human and material resources. From the perspective of management efficiency, it can reduce unnecessary quality inspection time. From the perspective of clinical benefits, it can ensure the integrity and safety of surgical instruments, thereby shortening the operation time and improving medical quality[6,7]. Based on current clinical needs, systematic improvement of laparoscopic instrument processing is urgently required and is an inevitable trend for the efficient operation of modern supply rooms[8].

The PDCA cycle was proposed by the quality management expert Dr. Edwards Deming in the 1950s as a systematic management approach. This theory divides the quality management into four interrelated stages, with the core goal of achieving iterative improvement in quality through continuous problem identification, evidence-based decision-making, iterative optimization, and standardized improvement[9]. As a scientific management tool, the PDCA cycle offers several advantages: It is oriented towards patient needs, emphasizes clinical feedback, strengthens multidisciplinary collaboration, and enhances service standardization. Therefore, it has been widely applied in medical quality management and in disease diagnosis and treatment[10,11].

In laparoscopic instrument management, the supply room is the core department for instrument handling, and the quality of its work directly affects surgical safety and hospital operational efficiency. Current practices face systemic challenges such as reliance on experience, insufficient process standardization, and delayed quality monitoring, requiring structured sustainable improvement mechanisms. Integrating the PDCA cycle into supply room management can systematically address these vulnerabilities and has methodological research value: First, it provides a replicable and verifiable quality improvement framework, shifting management interventions from “experience-driven” to “data-driven”, facilitating dissemination and comparative studies across institutions; Second, closed-loop feedback of the “Check-Act” phase can dynamically uncovers latent process risks (e.g., patterns of instrument damage, cleaning blind spots), providing empirical evidence for developing targeted preventive maintenance strategies; Third, this method emphasizes full staff participation and cross-departmental collaboration, helping cultivate an organizational quality management culture and establish a long-term management ecosystem.

Therefore, management improvement based on the PDCA cycle not only in achieves operational goals, such as standardizing equipment handling procedure, optimizing human resources allocation, and reducing adverse events, but also promotes a shift from passive response to active prevention and from local optimization to system construction. Finally, this study provides theoretical support and practical approaches to enhance hospitals’ operational resilience and ensure patient safety. This study elaborates an improvement plan for laparoscopic instrument management based on the PDCA cycle and its implementation process, aiming to provide a quality management example that is both theoretically rigorous and operationally feasible.

MATERIALS AND METHODS

General condition of the patients

This study was approved by the Ethics Committee of the Affiliated Hospital of Jiangnan University Hospital. Between January 2023 and January 2024, 138 patients who did not undergo risk control using the PDCA cycle model were assigned to the conventional group. Between February 2024 and February 2025, 223 patients who underwent laparoscopic surgery after implementation of the PDCA cycle model were classified into the PDCA group.

Inclusion and exclusion criteria

Inclusion criteria: (1) Age > 18 years; (2) Hospitalization in the digestive surgery department of our hospital and underwent corresponding surgery; (3) Good communication skills; and (4) Signed an informed consent form.

Exclusion criteria: (1) Age < 18 years; and (2) Severe organ dysfunction, mental disorders, consciousness disorders, or inability to communicate.

Management method

The control group strictly implemented routine procedures for the laparoscopic instrument supply room and carried out their respective duties, including collection, classification, cleaning, disinfection, drying, inspection, and maintenance of contaminated items, packaging, sterilization, and distribution of sterile items.

The PDCA group adopted the PDCA cycle model, established a quality control team, implemented specialized interventions, and jointly formulated processing procedures for the laparoscopic instrument supply room by digestive surgery doctors, the supply room, and the operating room. The specific steps are as follows.

Plan: To fully understand the use of laparoscopic instruments; the brands, types, models, and related consumables were recorded. Staff procedures were reviewed, existing problems were identified and opportunities for improvement in the current supply room workflow were assessed. The assessment indicated that the laparoscopic instrument management system was not standardized; daily instrument care issues existed (e.g., improper cleaning and disinfection methods); managers were unclear whether disinfection was operating normally; and high-risk links had not been strengthened for monitoring, especially supervision of recovery for cleaning and disinfection of the instruments. Based on these findings, improvement plans were formulated, including improving the management system, developing detailed guidelines for supply and recovery of laparoscopic instruments, clearly defining standardized procedures, establishing a supervision mechanism, conducting regular maintenance of laparoscopic instruments, regularly checking consumables, timely purchasing and replenishing, and organizing relevant staff training etc.

Execution: The plans were implemented strictly, operational standards for each step, and responsibilities and authorities were assigned based on the supply room actual conditions. A fixed full-time staff member was designated to count and recover laparoscopic instruments for digestive surgery. When instruments were removed from the warehouse, the quantity, type, and model were carefully checked and recorded. During recovery, personnel checked the relevant information of the removed from warehouse instruments, confirmed accuracy, and performed pretreatment. During rinsing, contaminated instruments were rinsed under running water to ensure full coverage of instruments surfaces, and pressure water guns were used to rinse cavities or puncture needles to initially remove body fluids and blood. Particular attention was paid to cleaning difficult-to-reach areas such as joint, locks, joint positions and handles. When loading cleaned and disinfected instruments, staff operated strictly according to the requirements of the fully automatic spray-cleaning machine. For detachable laparoscopic instruments, components were disassembled, cleaned, and disinfected individually. After cleaning, disinfection, and drying, cleaning quality was assessed using visual inspection and a lighted magnifying mirror; instrument were then classified and packaged, labels were affixed, and the packages were sent for sterilization. Sterilized instruments were preserved and organized after sterilization. Staff training was organized regularly, focusing on procedures for instruments entering and leaving storage, precautions, and behavioral norms of supply room personnel. Laparoscopic instruments were inspected and maintain regularly to promptly identify and eliminate potential faults. Improvement plans were updated and implemented.

Inspection: Information on daily laparoscopic instruments use was collected, including inventory in/out records, disinfect records, consumable storage records, and relevant analyses were conducted. Based on the analysis, problems in management were identified. Random spot checks were conducted at random time points or according to a set schedule, and instruments were comprehensively assessed across key dimensions, such as instrument performance, in/out records, and disinfection and cleaning effects.

Handling: A summary meeting was held based on daily inspection results, laparoscopic instruments in the digestive surgery department, and infection control conditions. Problems and deficiencies were identified, targeted countermeasures, the management process was optimized, and goals and plans for the next stage were determined.

ATP testing method

ATP testing is a rapid method for evaluating the laparoscopic instrument cleaning. By detecting residual ATP on instrument surface, this method indirectly reflects the presence of organic matter residues or microbial contamination and helps determine whether cleaning meets standards. This method is characterized by speed and sensitivity and is often used for immediate monitoring of medical device cleaning quality.

Specific testing method: The ATP test stick was placed at room temperature for 15 minutes in advance. At the same time, the ATP detector was turned on, the time and date were calibrated, and calibration of all parameters were completed. The detector was then operated according to the manufacturer’s instructions and the data was recorded.

Visual inspection and illuminated magnification: Using visual inspection and a illuminated magnifying mirror, staff checked for visible stains and rust marks on joints, tooth grooves, the lumen of laparoscopic instruments, and instruments surfaces. All laparoscopic instruments that failed cleaning quality inspection were returned to the decontamination area for manual cleaning by a designated person.

Satisfaction of operating room staff regarding management of the disinfection supply room

Satisfaction was evaluated using a self-made department questionnaire covering aspects such as work attitude, work efficiency, communication ability, emergency response ability, and standardization of sterile package packaging. Scores were calculated using a 100-point scale. A score of ≥ 80 was considered satisfactory, 60-79 was considered basically satisfactory, and < 60 was considered unsatisfactory. Total satisfaction = (number satisfied + basic satisfied)/total number × 100.

Statistical analysis

Results were entered into a computer for score conversion. Statistical analysis was performed using SPSS version 26 (IBM, Armonk, NY, United States). Measurement data are presented as mean ± SD, while count data are presented as n (%). Between group comparison was performed using the t-test and χ² test.

RESULTS

General information of patients

The χ² test or t-test was conducted on the general information of the two groups. The results showed that there were no significant differences in sex, age, or disease type between the two groups (P > 0.05). In the conventional group, there were 66 males (47.8%) and 72 females (52.2%); in the PDCA group, there were 109 males (48.9%) and 114 females (51.1%). The mean age was 58.6 ± 8.32 years in the conventional group and 56.4 ± 7.96 years in the PDCA group. The baseline characteristics were balanced and comparable between the groups (Table 1).

Table 1 Comparison of general data between the two groups of patients, n (%).

Item	Sex		Age (years)	Disease types
	Male	Female		Gastric cancer	Colon cancer	Benign gallbladder disease	Bile duct cancer	Others
Conventional group	66 (47.8)	72 (52.2)	58.6 ± 8.32	28 (20.3)	22 (15.9)	39 (28.3)	14 (10.1)	35 (25.4)
PDCA group	109 (48.9)	114 (51.1)	56.4 ± 7.96	49 (22.0)	38 (17.0)	56 (25.1)	22 (9.9)	58 (26.0)
χ2	0.038		-1.120	0.517
P value	0.846		0.312	0.972

Incidence of adverse events

There was a statistically significant difference in the total incidence of adverse events between the groups (P < 0.05). The incidence of adverse events was significantly lower in the PDCA group than in the conventional group (2.7% vs 15.2%; P < 0.05). Specifically, instrument assembly errors, missing parts, and improper packaging were significantly lower in the PDCA group than in the conventional group (P < 0.05), whereas there was no statistically significant difference in instrument damage between the groups (P > 0.05) (Table 2 and Figure 1A).

Figure 1 Comparison of adverse event occurrence rates, infection rates, cleaning quality and ATP test results occurrence rates between the two groups. A: Adverse event occurrence rates; B: Infection rates; C: Cleaning quality and ATP test results of the two groups of endoscopic instruments. ^aP < 0.05, ^bP < 0.05, ^cP < 0.05, ^dP < 0.05.

Table 2 Comparison of adverse event occurrence rates between the two groups, n (%).

Item	Assembly error	Part missing	Instrument damage	Packaging not standard	Total occurrence rate
Conventional group	5 (3.6)	6 (4.3)	1 (0.7)	9 (6.5)	21 (15.2)
PDCA group	1 (0.4)	2 (0.9)	0 (0.0)	3 (1.3)	6 (2.7)
χ2	5.257	4.685	1.620	7.108	19.331
P value	0.022	0.030	0.203	0.008	0.000

Detection of multidrug-resistant bacteria and patient infection status

The total detection rate of multidrug-resistant bacteria was 8.7% in the conventional group, which was significantly higher than that in the PDCA group (3.6%) (P < 0.05). There were no significant differences in multidrug-resistant Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli, methicillin-resistant Staphylococcus aureus, and vancomycin-resistant Enterococcus between the two groups (P > 0.05). However, the detection rates of each resistant bacterium was lower in the PDCA group than in the conventional group (Table 3 and Figure 1B).

Table 3 Comparison of multidrug-resistant bacteria detection and infection rates between the two groups of patients, n (%).

Item	Multidrug-resistant Pseudomonas aeruginosa	Klebsiella pneumoniae	Escherichia coli	Methicillin-resistant Staphylococcus aureus	Vancomycin-resistant Enterococcus	Total detection rate
Conventional group	1 (0.7)	3 (2.2)	6 (4.3)	1 (0.7)	1 (0.7)	12 (8.7)
PDCA group	1 (0.4)	2 (0.9)	4 (1.8)	1 (0.4)	0 (0.0)	8 (3.6)
χ2	0.118	1.018	2.065	0.118	1.620	4.251
P value	0.731	0.313	0.151	0.731	0.203	0.039

Comparison of cleaning quality by visual inspection, lighted magnifying mirror and ATP detection

There was a statistically significant difference in cleaning quality between the two groups (P < 0.05). The ATP test failure rate and the visual/Light magnifying mirror inspection failure rate were significantly lower in the PDCA group than in the conventional group (P < 0.05) (Table 4 and Figure 1C).

Table 4 Comparison of cleaning quality and ATP test results of the two groups of laparoscopic instruments, n (%).

Item	Total number of instruments	Number of defective items detected by ATP testing	Number of defective items detected visually and lighted magnifying mirror
Conventional group	289	9 (3.1)	16 (5.5)
PDCA group	513	5 (1.0)	12 (2.3)
χ2		4.934	5.608
P value		0.026	0.018

Satisfaction of operating room staff with the management of the disinfection supply room

There was a statistically significant difference in the operating room staff satisfaction with the disinfection supply room between the two groups (P < 0.05). In the PDCA group, the proportion of satisfied staff was 83.9%, compared with 51.6% in the conventional group. The overall satisfaction rate was significantly higher in the PDCA group than in conventional group (96.8% vs 83.9%; P < 0.05) (Table 5 and Figure 2).

Figure 2 Satisfaction of operating room staff regarding management of the disinfection supply room. A: PDCA group; B: Conventional group.

Table 5 Satisfaction of operating room staff regarding management of the disinfection supply room, n (%).

Item	Satisfied	Basically satisfied	Unsatisfied	Total satisfaction rate (%)
Conventional group	16 (51.6)	10 (32.3)	5 (16.1)	83.9
PDCA group	26 (83.9)	4 (12.9)	1 (3.2)	96.8
χ2	7.619
P value	0.022

DISCUSSION

Several studies have confirmed that laparoscopic surgery, a widely used minimally invasive technique in digestive surgery, has advantages such as less trauma, faster recovery time, and less bleeding[12-14]. However, surgical safety and effectiveness depend heavily on the quality of cleaning and disinfection of laparoscopic instruments. The PDCA cycle is a continuous quality improvement methodology and has been widely applied in various management fields[15,16], particularly in medical equipment management. Therefore, this study compared conventional management and the PDCA cycle models for processing procedures in a laparoscopic instruments supply room in digestive surgery.

During the surgical procedure, because of the complex structure and multiple pores of laparoscopic instruments, body fluids and tissue debris may remain if cleaning is insufficient, becoming a breeding ground for microorganisms[17]. Infection control can reduce hospitalization time, alleviate the medical economic burden, and improve patient prognosis[18]. Therefore, this study focused on the detection of drug-resistant bacteria and patient infectious status. The results showed that the total detection rate of multidrug-resistant bacteria in the PDCA group (3.6%) was significantly lower than that in the conventional group (8.7%). In addition failure rates in ATP bioluminescence detection, visual inspection, and inspection and lighted magnifying mirror inspection decreased significantly. These findings indicate that the PDCA cycle improves the sterilization quality by optimizing cleaning and disinfection processes, such as strengthening the cleaning of difficult-to-clean cavities, disassembling detachable components for individual handling, and preserving instruments appropriately after cleaning. This improvement is a key factor in reducing infection risk. Crowley et al[3] also demonstrated that closed-loop management of disinfection process can reduce microbial residues, supporting the findings of this study.

Moreover, the incidence of adverse events in the PDCA group (2.7%) was significantly lower than that in the conventional group (15.2%), with notable improvements in assembly errors, missing parts, and improper packaging. This directly supports the role of the PDCA cycle in the standardization process. Human error has been effectively reduced through problem identification in the planning stage (e.g., non-standardized systems and improper cleaning methods), specialized operations in the execution stage (such as fixed personnel for recycling and detailed cleaning procedures), and multidimensional monitoring in the inspection stage. Qiu and Du[19] reported that PDCA plays an important role in the hygiene management of hospital operating rooms. The adoption of PDCA-based continuous improvement management measures in operating room hygiene management can effectively increase disinfection and sterilization compliance rates and reduce pathogenic bacteria detection rates, and surgical site infection rates. The satisfaction rate of the medical staff in the operating room increased from 51.6% to 83.9%, indicating improved cross-departmental collaboration efficiency following implementation of the PDCA cycle. Through the joint formulation of processes by the digestive surgery, supply and operating room department the cumbersome handover issues seen in traditional separate management were resolved.

As continuous and scientific management method[20,21], PDCA enables comprehensive review of equipment characteristics (e.g., brand, model, and consumables expiration dates) by clinicians, the supply room, and the operating room, forming the basis for process optimization. This is the “Plan” stage. Subsequently, in the “Do” stage, standardized operations are implemented variability through refined cleaning parameters and assignment clear responsibilities. During the “Check” data such as during adverse events, staff satisfaction, and bacterial infection are collected for dynamic monitoring. Finally, in the “Act” stage, identified problems are addressed based on feedback, further optimizing operations. Ultimately, a closed loop of “problem -improvement-re-evaluation” is formed.

This study has certain limitations. The single-center design may limit generalizability. Differences in resource allocation across hospitals may affect PDCA implementation. Future multicenter studies with larger sample sizes are needed to verify the broader applicability of PDCA. In addition, when combined with an Internet of Things traceability system and other quality management tools, laparoscopic instruments management may be further improved.

CONCLUSION

This study confirmed that the PDCA cycle, through systematic problem identification, standardized execution, dynamic monitoring, and continuous optimization, significantly improves the management quality of laparoscopic instruments in digestive surgery. It has achieved remarkable results in reducing adverse events, controlling infection risks, and enhancing staff satisfaction. This model provides a replicable practical framework for instrument management by medical institutions, particularly in the complex and high-risk laparoscopic instruments and warrants further promotion and in-depth research.