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Study on the Impact of FOCUS-PDCA Management Model on the Disinfection
Quality of Flexible Endoscopy
[Abstract] Objective: To analyze the impact of FOCUS-PDCA management model
on the disinfection quality of flexible endoscopes. Method: A study was conducted
on 128 flexible endoscopes in our hospital. According to different management plans,
flexible endoscopes were divided into a control group (conventional management
model) and an experimental group (FOCUS-PDCA management model). The flexible
endoscopes evaluated in both control group and the experimental group were 64
each. The ATP values, management quality, and bacterial colony exceeding standards
were observed in two groups. Results: Before management, there was no significant
difference in ATP values between the two groups, with P>0.05; after management,
compared with the control group (106.25 ± 6.812), the ATP value in the experimental
group was lower, with P<0.05. The scores of disinfection standards (4.39 ± 0.49),
cleaning standards (4.22 ± 0.45), management systems (4.13 ± 0.34), and
management assessment (4.97 ± 0.25) in the experimental group were higher than
those in the control group (3.89 ± 0.31, 3.20 ± 0.41, 3.12 ± 0.13, 3.95 ± 0.21), with
P<0.05. In the experimental group, the bacterial colony exceeding standard rate of
gastroscopy was 3.13%, bacterial colony exceeding standard rate of colonoscopy was
0.00%, bacterial colony exceeding standard rate of bronchoscopy was 1.56%, and the
total bacterial colony exceeding standard rate of total colonies was 6.25%, which were
significantly lower than the control group's 12.50%, 7.81%, 12.50%, and 32.81%,
respectively with P<0.05. Conclusion: The FOCUS-PDCA management model is
more conducive to reducing the ATP values of flexible endoscopes, improving the
disinfection qualification rate, and improving management quality. This model is
worthy of further promotion.
[Keywords] FOCUS-PDCA management model; Flexible endoscopy; Disinfection
quality; Impact
Flexible endoscopy is an essential diagnostic and treatment method in
gastroenterology department[1-2]
, which can diagnose diseases and also perform
minimally invasive surgery to actively treat diseases at the same time, including
gastroscopy, duodenoscopy, enteroscopy, endoscopic ultrasound, and
choledochoscopy [3]
. Due to its advantages of minimally invasive, convenient
operation, and significant diagnostic and therapeutic effects, flexible endoscopy has
been widely used in clinical diagnosis and treatment of gastrointestinal diseases.
However, due to the soft material of the flexible endoscope body, it does not have the
effects of resisting high temperature and corrosion. Moreover, the internal structure of
flexible endoscopes is very complex, including the front end, insertion tube, catching
part, and bending part [4-6]
, which leads to unsatisfactory disinfection quality of
flexible endoscopes and increases the risk of hospital infection for patients. Related
studies have shown that [7]
about 30% of hospital infected patients are related to
inadequate disinfection of medical devices. Therefore, it is crucial to strengthen the
disinfection quality management of flexible endoscope. However, due to routine
management not being able to thoroughly clean, the cleanliness of the flexible
endoscope does not meet the standard. PDCA is considered by management as an
effective work procedure and one of the effective quality management methods.
FOCUS-PDCA is a continuous quality improvement management plan proposed by
American Hospital Organizations in the 1990s that has gone through a long
development process from enterprise management to hospital management, and this
program is an extension and improvement of the PDCA cycle. The purpose is to have
a more detailed understanding of each link in the process, in order to achieve the goal
of continuous quality improvement. Since the 20th century, FOCUS-PDCA has been
applied to central laboratory management, critically ill patient management,
ventilator-associated pneumonia management for hospitalized patients, and home care.
The implementation of the FOCUS-PDCA program is divided into 9 steps, including
5 FOCUS steps and 4 Pdca cycles. The purpose of the FOCUS program is to identify
potential issues, while the most important purpose in all of PDCA is to achieve
continuous quality improvement. In terms of disinfection quality management of
flexible endoscope, routine management usually involves monitoring and controlling
the disinfection quality by setting fixed disinfection procedures and checking
inspection processes. The disadvantage of this management approach is that it cannot
quickly adapt to new market demands and technological changes, often leading to
periodic quality issues and blind spots. The FOCUS-PDCA management model
adopts data analysis and technological innovation methods to identify potential
problems and opportunities, and take corresponding improvement measures by
analyzing and optimizing disinfection quality data. In order to seek a more efficient
management model, this study conducted a study on 128 flexible endoscopes in our
hospital and analyzed the clinical effects of the FOCUS-PDCA management model.
1. Data and methods
1.1 Clinical data
A study was conducted on 128 flexible endoscopes in our hospital from January
2022 to December 2022. And the flexible endoscopes that were not used during this
time period were excluded. According to different management plans, flexible
endoscopes were divided into a control group (64) and an experimental group (64).
There was no statistically significant difference in type between the two groups
(P>0.05).
1.2 Methods
The control group was implemented with conventional management model and
the experimental group was implemented the FOCUS-PDCA management model: (1)
F, find: It was found that the cleanliness of flexible endoscope was not up to standard
in the disinfection quality test of flexible endoscope. O, organize: A FOCUS-PDCA
management team was established, with members including the head nurse, senior
nurses, and hospital nurses. C, clarify: After the group was formed, systematic
training would be provided to the members of the group, mainly covering the
FOCUS-PDCA management process, management objectives, and precautions. U,
understand: Afterwards, the team members were assessed to ensure that they fully
grasped FOCUS-PDCA management. S, select: For those who did not pass the
assessment, education and training should be strengthened until they passed the
assessment. If their compliance was poor or they still could not pass the assessment
after multiple education and training, it was needed to replace their management
personnel in a timely manner. (2) P, plan: An internal meeting was conducted to
analyze the current disinfection quality status of flexible endoscopes and identify
quality issues in management. Based on actual work needs, operational standards, etc.,
management plans and goals were developed based on existing problems. The
existing problems: ①The staff had weak self-protection awareness, inadequate
concepts, and a lack of disinfection and sterilization knowledge, which led to errors
easily occurring in the actual operation process. ②The management system was not
perfect, the management process was not standardized, and the awareness of the staff
was weak, which made them not follow the relevant operations in their work,
resulting in poor cleaning quality. ③ Poor sterilization and disinfection techniques
had resulted in uneven quality of medical devices. ④ Management personnel had
weak management awareness and did not pay enough attention to existing safety
hazards. A management plan and objectives were developed according to the above
issues, which mainly included strengthening the training of staff, improving their
professional levels, and deepening their awareness of protection. Management
systems were improved and management processes were optimized to ensure that the
intervention measures were reasonable, scientific, and standardized. At the same time,
the source of infection should be severely controlled, and multiple areas should be
divided according to the nature of work, such as cleaning areas, disinfection areas,
sterile areas, etc. Personnel were strictly prohibited from moving between each area,
completely eliminating all adverse factors that affected quality, and then effectively
improving management quality. (3) D, do: ①
: The management of hand hygiene was
strengthened, multiple hand sinks were equipped in each area, hand sanitizers were
placed, and 7-step hand-washing method was pasted to ensure that staff's hand
hygiene met the standards. At the same time, regular safety training was conducted to
enhance the self-management awareness of staff, and the promotion of accidents was
strengthened to improve the handling ability of staff. ②
: During the process of
retrieving, cleaning, and disinfecting flexible endoscopes, it was necessary for staff to
strictly follow relevant operating procedures and continuously improve their
operational skills based on standardized operating procedures. For the recycled
flexible endoscopes, professional staff would first organize and classify all recycled
flexible endoscopes. After the sterilization and disinfection treatment of the flexible
endoscopes was completed, professional staff would conduct an inspection to classify
flexible endoscopes again and place in a sterile room for backup, for qualified flexible
endoscopes. The relevant information about the flexible endoscopes were recorded in
detailed for subsequent taking and placement. In addition, the staff should inspect all
cleaning and disinfection equipment before cleaning to ensure normal operation of the
equipment. If a malfunction occurred, it needed to be reported as soon as possible and
repaired or replaced in a timely manner. ③
: Knowledge lectures on disinfection work
were regularly conducted, requiring the team members to actively participate. The
content mainly involved cleaning methods and disinfection methods of flexible
endoscopes, in order to further consolidate the basic knowledge of staff and improve
operational skills. ④
: The concentration of disinfectants in the disinfection room
needed to be measured regularly to prevent excessive concentration from affecting the
quality of life of staff. At the same time, bacterial and microbiological testing was
regularly carried out in the disinfection room to ensure that it was always in a sterile
state. (4) C, check: The head nurse conducted daily spot checks on the work and
incorporated the results into the performance evaluation. Based on the actual
inspection results, the head nurse praised or criticized the staff to improve their work
enthusiasm. Timely guidance and rectification were provided for existing problems to
improve management quality. the scopes at fixed events needed to be reviewed for
regional leaders. Monthly special inspections or comprehensive inspections were
required for the quality control team. (5) A, act: The data obtained during the
monthly inspection process were analyzed and summarized, and scientific and
effective methods and measures were jointly developed through the analysis of the
information and data to avoid existing problems in the remaining cycle of activities, in
order to promote the continuous improvement of management quality.
1.3 Observation indicators
The ATP values [8]
, management quality (disinfection specification, cleaning
specification, management system and management assessment), and the situation of
bacterial colony exceeding standards (bacterial colony exceeding standard rate of
gastroscope, bacterial colony exceeding standard rate of enteroscope, bacterial colony
exceeding standard rate of bronchoscopy, total bacterial colony exceeding standard
rate) [9-10]
and other indicators of the two groups were observed.
1.4 Statistical analysis
The data were processed by using SPSS 21.0 statistical software. The
measurement data were represented in the form of (X ± S) and the counting data
were represented in the form of percentage "%". For the comparison between the two
groups, independent sample t-test was used for measurement data, and chi square test
was used for counting data. P<0.05 indicated a statistically significant difference.
2. Results
2.1 Comparison of ATP values between the two groups before and after management
Before management, the ATP value of the control group was 6012.25 ± 1093.12,
while the ATP value of the experimental group was 6012.78 ± 1025.85, and there was
no significant difference in ATP values between the two groups, with P>0.05. After
implementing the conventional management model, the ATP value of the control
group was 106.25 ± 6.812, while the ATP value of the experimental group was 71.12
± 4.531. The ATP values of both groups were significantly decreased, with P<0.05;
compared with the control group, the ATP value in the experimental group was lower
and the difference was statistically significant, with P<0.05. Please refer to Table 1 for
details.
Table 1 Comparison of ATP values between two groups before and after management
(X ± S)
Group
Nu
mbe
r of
case
Before
management
After
management
T value P value
s
Contr
ol
group
64
6012.25±1093.
12
106.25±6.812 43.139 0.000
experi
mental
group
64
6012.78±1025.
85
71.12±4.531 46.290 0.000
t value 0.002 3.435
P
value
0.498 0.000
2.2 Comparison of management quality between the two groups
In the results of comparison of management quality between the two groups, the
scores of disinfection standards (4.39 ± 0.49), cleaning standards (4.39 ± 0.49),
management systems (4.13 ± 0.34), and management assessment (4.97 ± 0.25) in the
experimental group were higher than those in the reference group, and the difference
was statistically significant, with P<0.05, as shown in Table 2.
Table 2 Comparison of management quality between the two groups (X ± S, points)
Group
Nu
mbe
r of
case
s
Disinfectio
n
standards
Cleaning
standards
manageme
nt systems
Manageme
nt
assessment
Contr
ol
group
64 3.89±0.31 3.20±0.41 3.12±0.13 3.95±0.21
experi
mental
group
64 4.39±0.49 4.22±0.45 4.13±0.34 4.97±0.25
t value 11.450 18.321 32.391 30.563
P
value
0.000 0.000 0.000 0.000
2.3 Comparison of bacterial colony exceeding standards between the two groups
In the comparison of bacterial colony exceeding standards between the two
groups, the bacterial colony exceeding standard rate of gastroscopy was 3.13% in the
experimental group, bacterial colony exceeding standard rate of colonoscopy was
0.00%, bacterial colony exceeding standard rate of bronchoscopy was 1.56%, and the
total bacterial colony exceeding standard rate of total colonies was 6.25%. The
bacterial colony exceeding standard rate of gastroscope in the control group was
12.50%, the bacterial colony exceeding standard rate of enteroscope was 7.81%, the
bacterial colony exceeding standard rate of bronchoscopy was 12.50%, and the total
bacteria exceeding standard rate was 32.81%. All indicators in the experimental group
were significantly lower than those in the control group, with statistically significant
differences, with P<0.05, as shown in Table 3.
Table 3 Comparison of bacterial colony exceeding standard between the two groups
(n/%)
Group
Nu
mbe
r of
case
s
Gastrosco
pe
Colonosc
opy
Bronchos
copy
Total
exceedan
ce rate
Contr
ol
group
64 8
(12.50) 5(7.81) 8
(12.50)
21
(32.81)
experi
mental
group
64 2(3.13) 0(0.00) 1(1.56) 4(6.25)
X2
value
3.905 5.203 5.856 14.365
P
value
0.048 0.023 0.016 0.000
3. Discussion
In recent years, with the improvement of quality of life and the development of
medical technology, the control of medical quality in clinic has become more and
more strict. Although clinical management plans are continuously improved to
maximize medical quality, medical device safety accidents still occur. Medical
devices are an important part of medical services, involving the diagnosis, treatment,
and monitoring of diseases. However, as hospitals are important places for diagnosing
and treating diseases, the types of pathogens they contain are very complex, which
increases the difficulty of cleaning medical equipment. Related studies have shown
that [11]
compared to conventional medical devices, the phenomenon of unqualified
disinfection quality of flexible endoscopes is more serious. And as the longer use of
flexible endoscopes, the probability of contamination is greater[12]
. At the same time,
due to the lack of conducting experiments related to flexible endoscopes in China,
safety accidents have occurred from time to time [13-14]
. Soft endoscopy, as a
commonly used medical device, is widely used in fields such as gastrointestinal
examination and treatment. Disinfection is an indispensable link in the use of flexible
endoscope, and the control of disinfection quality also directly affects the medical
quality and patient safety. Therefore, it is essential to strengthen the management of
flexible endoscopes.
Compared to conventional nursing management, the key to FOCUS-PDCA
management model lies in everyone's participation [15]
. It is beneficial to improve the
quality of work by implementing a responsibility system, assigning responsibilities to
individuals and clarifying their own responsibilities. At the same time, the
FOCUS-PDCA management model has good interactivity [16-17]
, such as the
communication between staff and medical staff, and communication between staff
and staff. In this situation, it is beneficial to improve the work enthusiasm of the staff.
The results of this study showed that there was no significant difference in ATP values
between the two groups before management, with P>0.05. After management, the
ATP values of both groups were significantly decreased, with P<0.05; but the ATP
value in the experimental group was lower, with P<0.05. The disinfection standards,
cleaning standards, management systems, and management assessments of the
experimental group were higher than those of the reference group, with P<0.05. The
bacterial colony exceeding standard rate of gastroscope in the experimental group was
3.13%, the bacterial colony exceeding standard rate of enteroscope was 0.00%, the
bacterial colony exceeding standard rate of bronchoscopy was 1.56%, and the total
bacterial colony exceeding standard rate was 6.25%, which were significantly lower
than 12.50%, 7.81%, 12.50%, 32.81%, respectively, in the control group, with P<0.05.
It is suggested that the clinical application effect of FOCUS-PDCA management
model is significant. The FOCUS-PDCA management model is divided into four
stages: planning, implementation, results, and improvement, belonging to a complete
set of management procedures [18]
. The unique feature of FOCUS-PDCA management
model is that it is closely linked and rises layer by layer [19-20]
. And it is precisely its
unique characteristic that makes it widely used in hospital nursing management.
Disinfection supply division plays an important role in many departments of hospitals,
mainly because the disinfection of medical devices and the recycling of medical
devices are their main responsibilities. Therefore, the quality and effectiveness of its
work will have a significant impact on the quality of clinical nursing.
The FOCUS-PDCA management model analyzes the current situation of
disinfection quality of flexible endoscopes, identifies problems, formulates
management plans for problems, standardizes operations, improves management
levels, and lays a solid foundation for later work. Further strengthening the training of
staff on this basis can not only effectively improve their self-protection awareness, but
also enhance their professional levels and problem-solving ability, and ensure their
operational standards during the work process, which is conducive to improving the
quality of flexible endoscope disinfection. At the same time, the staff carries out their
work according to the established management plan, which improves the quality and
efficiency of the management personnel's work to some extent and further reduces the
occurrence of adverse events. In addition, the FOCUS-PDCA management model
implement quality control in various stages by establishing teams. If quality problems
occur, the reasons for the quality problems can be identified as soon as possible, and
effective measures can be developed to intervene, reduce the impact of the problems,
and ensure the smooth development of disinfection work. FOCUS-PDCA is a
commonly used continuous quality improvement management model. In medical
management, FOCUS-PDCA management model can improve the management
efficiency of medical institutions, improve the quality of medical services, and
promote patient satisfaction. The application of the FOCUS-PDCA management
model for improving the disinfection quality of flexible endoscopes can improve the
disinfection quality and efficiency, reduce the incidence of medical accidents,
improve patient satisfaction, and enhance the reputation of medical institutions, which
is an important method in medical management.
In the study of disinfection quality of flexible endoscopes, preparation in the
early stage is insufficient, including incomplete data collection, which may affect the
accuracy of research results; in addition, the depth of data analysis is insufficient,
especially for the in-depth analysis of data distribution and the ability to conduct
predict trends, so it is necessary to dig deeper into the data to further improve the
reliability of research conclusions. Finally, the research on the disinfection quality of
flexible endoscope needs to strengthen the combination with practice, pay attention to
the feasibility of practical operations, introduce more scientific and reasonable
operational plans, and better implement them in clinical operations to truly improve
the disinfection quality.
In summary, the FOCUS-PDCA management model is more conducive to
reducing the ATP values of flexible endoscopes, improving the disinfection
qualification rate, and improving the quality of management, which is worth
promoting. Therefore, The disinfection quality of flexible endoscopes improved by
introducing the FOCUS-PDCA management model can not only clarify the
responsibilities and processes of each link, but also improve the operational skills and
control awareness of operators, ultimately achieving comprehensive improvement of
disinfection quality, ensuring patient safety and medical quality.
References
[1] Song Ailing, Zhu Lixia, Sun Nan, Zhang Haiyan, Li Hongtu The application of
centralized management mode based on PDCA cycle in the cleaning and disinfection
of flexible endoscopes [J] International Journal of Management, 2023,42 (04):
584-587
[2] He Shujing The Application of Continuous Quality Improvement Management in
Quality Control of Cleaning and Disinfection of Hard Endoscopic Instruments [J]
Clinical Research, 2023,31 (01): 192-194
[3] Cao Dongdong, Cheng Yaping, Chen Li, Xu Jiali, Guan Lei, Deng Rui Research
on the Application of POCUS-PDCA to Improve the Quality of Manual Cleaning and
Disinfection of Digestive Endoscopy under the Normalization of Epidemic Prevention
and Control [A] Chinese Medical Equipment Association. Compilation of Papers at
the China Medical Equipment Conference and 2022 Medical Equipment Exhibition
(Volume 1) [C]. Chinese Medical Equipment Association: China Medical Equipment
Journal, 2022:5
[4] Xu Rong, Xing Nana, Meng Qianqian The application of a chain management
model based on the 8S management concept in the quality control management of
cleaning and disinfection in endoscopic centers [J] Health Medicine Research and
Practice, 2022, 19 (11): 166-169
[5] Xu Ying The impact of hierarchical management mode on the qualification rate
and management quality of digestive endoscopy disinfection [J] Heilongjiang
Medicine, 2022, 46 (21): 2630-2632
[6] Li Xianli, Chen Fengli, Tang Dezhen, Shen Yulan, Chen Jun Observation on the
effect of refined management in the cleaning and disinfection of digestive endoscopes
[J] Chinese Journal of Disinfection, 2022, 39 (10): 796-797
[7] Wu Yuanyuan, Chen Chenchen, Hu Dingyuan, Hu Jing Application and Effect
Analysis of FMEA in Standardized Disinfection Management of Digestive Endoscopy
[J] Hospital Management Forum, 2022, 39 (03): 75-78
[8] Chen Jie Analysis of the role of quality control circle activities in the cleaning and
disinfection management of flexible endoscopes [J] Gansu Science and Technology,
2022, 38 (05): 110-113
[9] Chai Xiying, Shao Chunmei, Han Yaying, Song Ying, Li Chengcheng The
improvement effect of FOCUS-PDCA management on the disinfection quality of
flexible endoscopes [J] Chinese Journal of Modern Management, 2022-28 (03):
392-395
[10] Liang Zhouchan, Wen Li, Li Xing Observation on the Improvement of
Application Effectiveness of Information Technology in Monitoring and Management
of Cleaning and Disinfection of Soft Endoscopes [J] Smart Health, 2021,7 (36): 33-35
[11] Li Juan The application effect of PDCA cycle in the cleaning and disinfection
management of indoor mirror equipment supply [J] Famous Doctor, 2021, No.120
(21): 175-176
[12] Sun Guijuan The application effect of detail management in the cleaning,
disinfection, and sterilization of endoscopic instruments [J] Medical Equipment, 2021,
34 (20): 34-35
[13] Fan Yan, Hao Sufang Analysis of the impact of improved cleaning and
disinfection processes combined with detailed management on the disinfection quality
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[14] Li Ping, Ye Liling, Lu Yuzhu, Xu Shunji, Tao Fengyu The Application of Refined
Management in Quality Control of Mechanical Cleaning and Disinfection of Hard
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[15] Xie Guiqiong, Wang Lisa, Pan Jun The application of mind mapping combined
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[16] Xu Zhenzhen, Chen Xiangyu, Xu Guifang, Cai Wei, Liu Feng, Li Wen
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[17] Liu Jun, Li Wen, Ma Jiuhong, Wang Ping, Zhang Min Expert consensus on
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[18] Liu Lu, He Wei, Ye Shaosong, Zhang Hong, Lin Hui, Li Chunhua Application of
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[19] Lou Xingyi, Construction and Promotion of a Homogeneous Management
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Study on the Impact of FOCUS-PDCA Management Model on the Disinfection Quality of Flexible Endoscopy .docx

  • 1. Study on the Impact of FOCUS-PDCA Management Model on the Disinfection Quality of Flexible Endoscopy [Abstract] Objective: To analyze the impact of FOCUS-PDCA management model on the disinfection quality of flexible endoscopes. Method: A study was conducted on 128 flexible endoscopes in our hospital. According to different management plans, flexible endoscopes were divided into a control group (conventional management model) and an experimental group (FOCUS-PDCA management model). The flexible endoscopes evaluated in both control group and the experimental group were 64 each. The ATP values, management quality, and bacterial colony exceeding standards were observed in two groups. Results: Before management, there was no significant difference in ATP values between the two groups, with P>0.05; after management, compared with the control group (106.25 ± 6.812), the ATP value in the experimental group was lower, with P<0.05. The scores of disinfection standards (4.39 ± 0.49), cleaning standards (4.22 ± 0.45), management systems (4.13 ± 0.34), and management assessment (4.97 ± 0.25) in the experimental group were higher than those in the control group (3.89 ± 0.31, 3.20 ± 0.41, 3.12 ± 0.13, 3.95 ± 0.21), with P<0.05. In the experimental group, the bacterial colony exceeding standard rate of gastroscopy was 3.13%, bacterial colony exceeding standard rate of colonoscopy was 0.00%, bacterial colony exceeding standard rate of bronchoscopy was 1.56%, and the total bacterial colony exceeding standard rate of total colonies was 6.25%, which were significantly lower than the control group's 12.50%, 7.81%, 12.50%, and 32.81%, respectively with P<0.05. Conclusion: The FOCUS-PDCA management model is more conducive to reducing the ATP values of flexible endoscopes, improving the disinfection qualification rate, and improving management quality. This model is worthy of further promotion. [Keywords] FOCUS-PDCA management model; Flexible endoscopy; Disinfection quality; Impact Flexible endoscopy is an essential diagnostic and treatment method in
  • 2. gastroenterology department[1-2] , which can diagnose diseases and also perform minimally invasive surgery to actively treat diseases at the same time, including gastroscopy, duodenoscopy, enteroscopy, endoscopic ultrasound, and choledochoscopy [3] . Due to its advantages of minimally invasive, convenient operation, and significant diagnostic and therapeutic effects, flexible endoscopy has been widely used in clinical diagnosis and treatment of gastrointestinal diseases. However, due to the soft material of the flexible endoscope body, it does not have the effects of resisting high temperature and corrosion. Moreover, the internal structure of flexible endoscopes is very complex, including the front end, insertion tube, catching part, and bending part [4-6] , which leads to unsatisfactory disinfection quality of flexible endoscopes and increases the risk of hospital infection for patients. Related studies have shown that [7] about 30% of hospital infected patients are related to inadequate disinfection of medical devices. Therefore, it is crucial to strengthen the disinfection quality management of flexible endoscope. However, due to routine management not being able to thoroughly clean, the cleanliness of the flexible endoscope does not meet the standard. PDCA is considered by management as an effective work procedure and one of the effective quality management methods. FOCUS-PDCA is a continuous quality improvement management plan proposed by American Hospital Organizations in the 1990s that has gone through a long development process from enterprise management to hospital management, and this program is an extension and improvement of the PDCA cycle. The purpose is to have a more detailed understanding of each link in the process, in order to achieve the goal of continuous quality improvement. Since the 20th century, FOCUS-PDCA has been applied to central laboratory management, critically ill patient management, ventilator-associated pneumonia management for hospitalized patients, and home care. The implementation of the FOCUS-PDCA program is divided into 9 steps, including 5 FOCUS steps and 4 Pdca cycles. The purpose of the FOCUS program is to identify potential issues, while the most important purpose in all of PDCA is to achieve continuous quality improvement. In terms of disinfection quality management of flexible endoscope, routine management usually involves monitoring and controlling
  • 3. the disinfection quality by setting fixed disinfection procedures and checking inspection processes. The disadvantage of this management approach is that it cannot quickly adapt to new market demands and technological changes, often leading to periodic quality issues and blind spots. The FOCUS-PDCA management model adopts data analysis and technological innovation methods to identify potential problems and opportunities, and take corresponding improvement measures by analyzing and optimizing disinfection quality data. In order to seek a more efficient management model, this study conducted a study on 128 flexible endoscopes in our hospital and analyzed the clinical effects of the FOCUS-PDCA management model. 1. Data and methods 1.1 Clinical data A study was conducted on 128 flexible endoscopes in our hospital from January 2022 to December 2022. And the flexible endoscopes that were not used during this time period were excluded. According to different management plans, flexible endoscopes were divided into a control group (64) and an experimental group (64). There was no statistically significant difference in type between the two groups (P>0.05). 1.2 Methods The control group was implemented with conventional management model and the experimental group was implemented the FOCUS-PDCA management model: (1) F, find: It was found that the cleanliness of flexible endoscope was not up to standard in the disinfection quality test of flexible endoscope. O, organize: A FOCUS-PDCA management team was established, with members including the head nurse, senior nurses, and hospital nurses. C, clarify: After the group was formed, systematic training would be provided to the members of the group, mainly covering the FOCUS-PDCA management process, management objectives, and precautions. U, understand: Afterwards, the team members were assessed to ensure that they fully grasped FOCUS-PDCA management. S, select: For those who did not pass the assessment, education and training should be strengthened until they passed the assessment. If their compliance was poor or they still could not pass the assessment
  • 4. after multiple education and training, it was needed to replace their management personnel in a timely manner. (2) P, plan: An internal meeting was conducted to analyze the current disinfection quality status of flexible endoscopes and identify quality issues in management. Based on actual work needs, operational standards, etc., management plans and goals were developed based on existing problems. The existing problems: ①The staff had weak self-protection awareness, inadequate concepts, and a lack of disinfection and sterilization knowledge, which led to errors easily occurring in the actual operation process. ②The management system was not perfect, the management process was not standardized, and the awareness of the staff was weak, which made them not follow the relevant operations in their work, resulting in poor cleaning quality. ③ Poor sterilization and disinfection techniques had resulted in uneven quality of medical devices. ④ Management personnel had weak management awareness and did not pay enough attention to existing safety hazards. A management plan and objectives were developed according to the above issues, which mainly included strengthening the training of staff, improving their professional levels, and deepening their awareness of protection. Management systems were improved and management processes were optimized to ensure that the intervention measures were reasonable, scientific, and standardized. At the same time, the source of infection should be severely controlled, and multiple areas should be divided according to the nature of work, such as cleaning areas, disinfection areas, sterile areas, etc. Personnel were strictly prohibited from moving between each area, completely eliminating all adverse factors that affected quality, and then effectively improving management quality. (3) D, do: ① : The management of hand hygiene was strengthened, multiple hand sinks were equipped in each area, hand sanitizers were placed, and 7-step hand-washing method was pasted to ensure that staff's hand hygiene met the standards. At the same time, regular safety training was conducted to enhance the self-management awareness of staff, and the promotion of accidents was strengthened to improve the handling ability of staff. ② : During the process of retrieving, cleaning, and disinfecting flexible endoscopes, it was necessary for staff to strictly follow relevant operating procedures and continuously improve their
  • 5. operational skills based on standardized operating procedures. For the recycled flexible endoscopes, professional staff would first organize and classify all recycled flexible endoscopes. After the sterilization and disinfection treatment of the flexible endoscopes was completed, professional staff would conduct an inspection to classify flexible endoscopes again and place in a sterile room for backup, for qualified flexible endoscopes. The relevant information about the flexible endoscopes were recorded in detailed for subsequent taking and placement. In addition, the staff should inspect all cleaning and disinfection equipment before cleaning to ensure normal operation of the equipment. If a malfunction occurred, it needed to be reported as soon as possible and repaired or replaced in a timely manner. ③ : Knowledge lectures on disinfection work were regularly conducted, requiring the team members to actively participate. The content mainly involved cleaning methods and disinfection methods of flexible endoscopes, in order to further consolidate the basic knowledge of staff and improve operational skills. ④ : The concentration of disinfectants in the disinfection room needed to be measured regularly to prevent excessive concentration from affecting the quality of life of staff. At the same time, bacterial and microbiological testing was regularly carried out in the disinfection room to ensure that it was always in a sterile state. (4) C, check: The head nurse conducted daily spot checks on the work and incorporated the results into the performance evaluation. Based on the actual inspection results, the head nurse praised or criticized the staff to improve their work enthusiasm. Timely guidance and rectification were provided for existing problems to improve management quality. the scopes at fixed events needed to be reviewed for regional leaders. Monthly special inspections or comprehensive inspections were required for the quality control team. (5) A, act: The data obtained during the monthly inspection process were analyzed and summarized, and scientific and effective methods and measures were jointly developed through the analysis of the information and data to avoid existing problems in the remaining cycle of activities, in order to promote the continuous improvement of management quality. 1.3 Observation indicators
  • 6. The ATP values [8] , management quality (disinfection specification, cleaning specification, management system and management assessment), and the situation of bacterial colony exceeding standards (bacterial colony exceeding standard rate of gastroscope, bacterial colony exceeding standard rate of enteroscope, bacterial colony exceeding standard rate of bronchoscopy, total bacterial colony exceeding standard rate) [9-10] and other indicators of the two groups were observed. 1.4 Statistical analysis The data were processed by using SPSS 21.0 statistical software. The measurement data were represented in the form of (X ± S) and the counting data were represented in the form of percentage "%". For the comparison between the two groups, independent sample t-test was used for measurement data, and chi square test was used for counting data. P<0.05 indicated a statistically significant difference. 2. Results 2.1 Comparison of ATP values between the two groups before and after management Before management, the ATP value of the control group was 6012.25 ± 1093.12, while the ATP value of the experimental group was 6012.78 ± 1025.85, and there was no significant difference in ATP values between the two groups, with P>0.05. After implementing the conventional management model, the ATP value of the control group was 106.25 ± 6.812, while the ATP value of the experimental group was 71.12 ± 4.531. The ATP values of both groups were significantly decreased, with P<0.05; compared with the control group, the ATP value in the experimental group was lower and the difference was statistically significant, with P<0.05. Please refer to Table 1 for details. Table 1 Comparison of ATP values between two groups before and after management (X ± S) Group Nu mbe r of case Before management After management T value P value
  • 7. s Contr ol group 64 6012.25±1093. 12 106.25±6.812 43.139 0.000 experi mental group 64 6012.78±1025. 85 71.12±4.531 46.290 0.000 t value 0.002 3.435 P value 0.498 0.000 2.2 Comparison of management quality between the two groups In the results of comparison of management quality between the two groups, the scores of disinfection standards (4.39 ± 0.49), cleaning standards (4.39 ± 0.49), management systems (4.13 ± 0.34), and management assessment (4.97 ± 0.25) in the experimental group were higher than those in the reference group, and the difference was statistically significant, with P<0.05, as shown in Table 2. Table 2 Comparison of management quality between the two groups (X ± S, points) Group Nu mbe r of case s Disinfectio n standards Cleaning standards manageme nt systems Manageme nt assessment Contr ol group 64 3.89±0.31 3.20±0.41 3.12±0.13 3.95±0.21 experi mental group 64 4.39±0.49 4.22±0.45 4.13±0.34 4.97±0.25 t value 11.450 18.321 32.391 30.563
  • 8. P value 0.000 0.000 0.000 0.000 2.3 Comparison of bacterial colony exceeding standards between the two groups In the comparison of bacterial colony exceeding standards between the two groups, the bacterial colony exceeding standard rate of gastroscopy was 3.13% in the experimental group, bacterial colony exceeding standard rate of colonoscopy was 0.00%, bacterial colony exceeding standard rate of bronchoscopy was 1.56%, and the total bacterial colony exceeding standard rate of total colonies was 6.25%. The bacterial colony exceeding standard rate of gastroscope in the control group was 12.50%, the bacterial colony exceeding standard rate of enteroscope was 7.81%, the bacterial colony exceeding standard rate of bronchoscopy was 12.50%, and the total bacteria exceeding standard rate was 32.81%. All indicators in the experimental group were significantly lower than those in the control group, with statistically significant differences, with P<0.05, as shown in Table 3. Table 3 Comparison of bacterial colony exceeding standard between the two groups (n/%) Group Nu mbe r of case s Gastrosco pe Colonosc opy Bronchos copy Total exceedan ce rate Contr ol group 64 8 (12.50) 5(7.81) 8 (12.50) 21 (32.81) experi mental group 64 2(3.13) 0(0.00) 1(1.56) 4(6.25) X2 value 3.905 5.203 5.856 14.365
  • 9. P value 0.048 0.023 0.016 0.000 3. Discussion In recent years, with the improvement of quality of life and the development of medical technology, the control of medical quality in clinic has become more and more strict. Although clinical management plans are continuously improved to maximize medical quality, medical device safety accidents still occur. Medical devices are an important part of medical services, involving the diagnosis, treatment, and monitoring of diseases. However, as hospitals are important places for diagnosing and treating diseases, the types of pathogens they contain are very complex, which increases the difficulty of cleaning medical equipment. Related studies have shown that [11] compared to conventional medical devices, the phenomenon of unqualified disinfection quality of flexible endoscopes is more serious. And as the longer use of flexible endoscopes, the probability of contamination is greater[12] . At the same time, due to the lack of conducting experiments related to flexible endoscopes in China, safety accidents have occurred from time to time [13-14] . Soft endoscopy, as a commonly used medical device, is widely used in fields such as gastrointestinal examination and treatment. Disinfection is an indispensable link in the use of flexible endoscope, and the control of disinfection quality also directly affects the medical quality and patient safety. Therefore, it is essential to strengthen the management of flexible endoscopes. Compared to conventional nursing management, the key to FOCUS-PDCA management model lies in everyone's participation [15] . It is beneficial to improve the quality of work by implementing a responsibility system, assigning responsibilities to individuals and clarifying their own responsibilities. At the same time, the FOCUS-PDCA management model has good interactivity [16-17] , such as the communication between staff and medical staff, and communication between staff and staff. In this situation, it is beneficial to improve the work enthusiasm of the staff. The results of this study showed that there was no significant difference in ATP values between the two groups before management, with P>0.05. After management, the
  • 10. ATP values of both groups were significantly decreased, with P<0.05; but the ATP value in the experimental group was lower, with P<0.05. The disinfection standards, cleaning standards, management systems, and management assessments of the experimental group were higher than those of the reference group, with P<0.05. The bacterial colony exceeding standard rate of gastroscope in the experimental group was 3.13%, the bacterial colony exceeding standard rate of enteroscope was 0.00%, the bacterial colony exceeding standard rate of bronchoscopy was 1.56%, and the total bacterial colony exceeding standard rate was 6.25%, which were significantly lower than 12.50%, 7.81%, 12.50%, 32.81%, respectively, in the control group, with P<0.05. It is suggested that the clinical application effect of FOCUS-PDCA management model is significant. The FOCUS-PDCA management model is divided into four stages: planning, implementation, results, and improvement, belonging to a complete set of management procedures [18] . The unique feature of FOCUS-PDCA management model is that it is closely linked and rises layer by layer [19-20] . And it is precisely its unique characteristic that makes it widely used in hospital nursing management. Disinfection supply division plays an important role in many departments of hospitals, mainly because the disinfection of medical devices and the recycling of medical devices are their main responsibilities. Therefore, the quality and effectiveness of its work will have a significant impact on the quality of clinical nursing. The FOCUS-PDCA management model analyzes the current situation of disinfection quality of flexible endoscopes, identifies problems, formulates management plans for problems, standardizes operations, improves management levels, and lays a solid foundation for later work. Further strengthening the training of staff on this basis can not only effectively improve their self-protection awareness, but also enhance their professional levels and problem-solving ability, and ensure their operational standards during the work process, which is conducive to improving the quality of flexible endoscope disinfection. At the same time, the staff carries out their work according to the established management plan, which improves the quality and efficiency of the management personnel's work to some extent and further reduces the occurrence of adverse events. In addition, the FOCUS-PDCA management model
  • 11. implement quality control in various stages by establishing teams. If quality problems occur, the reasons for the quality problems can be identified as soon as possible, and effective measures can be developed to intervene, reduce the impact of the problems, and ensure the smooth development of disinfection work. FOCUS-PDCA is a commonly used continuous quality improvement management model. In medical management, FOCUS-PDCA management model can improve the management efficiency of medical institutions, improve the quality of medical services, and promote patient satisfaction. The application of the FOCUS-PDCA management model for improving the disinfection quality of flexible endoscopes can improve the disinfection quality and efficiency, reduce the incidence of medical accidents, improve patient satisfaction, and enhance the reputation of medical institutions, which is an important method in medical management. In the study of disinfection quality of flexible endoscopes, preparation in the early stage is insufficient, including incomplete data collection, which may affect the accuracy of research results; in addition, the depth of data analysis is insufficient, especially for the in-depth analysis of data distribution and the ability to conduct predict trends, so it is necessary to dig deeper into the data to further improve the reliability of research conclusions. Finally, the research on the disinfection quality of flexible endoscope needs to strengthen the combination with practice, pay attention to the feasibility of practical operations, introduce more scientific and reasonable operational plans, and better implement them in clinical operations to truly improve the disinfection quality. In summary, the FOCUS-PDCA management model is more conducive to reducing the ATP values of flexible endoscopes, improving the disinfection qualification rate, and improving the quality of management, which is worth promoting. Therefore, The disinfection quality of flexible endoscopes improved by introducing the FOCUS-PDCA management model can not only clarify the responsibilities and processes of each link, but also improve the operational skills and control awareness of operators, ultimately achieving comprehensive improvement of disinfection quality, ensuring patient safety and medical quality.
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