首都医科大学附属北京友谊医院
BEIJING FRIENDSHIP HOSPITAL, CAPITAL MEDICAL UNIVERSITY
病 例 摘 要 病 例 摘 要
The implementation and quality check of Chinese endoscopic cleaning and disinfection
Wei Jian
Nursing Collaborative Group,CSDE
National Clinical Research Center for Digestive Diseases Beijing Friendship Hospital，Capital Medical University
2018-4
content
Introduction of endoscopy center,Beijing Friendship Hospital
Cleaning and disinfection status of endoscopy in China
Quality Control and evaluation criterion of
endoscopy in China
content
Introduction of endoscopy center,Beijing Friendship Hospital
Cleaning and disinfection status of endoscopy in China
Quality Control and evaluation criterion of
endoscopy in China
Beijing Friendship Hospital
founded in 1952
94000m
2，194000 associated area,3200 staffs 1500 beds ，10000 outpatients/day, 70000
inpatients/year
Endoscopy Center
Diagnosis and treatment of digestive endoscopy is one of the most characteristic departments
Digestive endoscopy training center is one of two endoscopy training centers assigned by CMA
Renowned as National Clinical Research
Center for Digestive Diseases in 2014
Endoscopy Center
Area ：1700 m
2Operation Room:10 （GI Room =8 +ERCP Room=2）
Recovery Room:1
Cleaning and Disinfection Room:1 Endoscopy Storage Room:1
Material Storage Room:1 Central Control Room:1
Computer Stimulator Room:1
Conference Room:1
Endoscopy Center
GI Room
Endoscopy Center
ERCP Room
Recovery Room
Endoscopy Center
Cleaning and Disinfection Room
Endoscopy Storage Room
Endoscopy Cencer
Computer Stimulator Room
Conference Room
content
Introduction of endoscopy center,Beijing Friendship Hospital
Cleaning and disinfection status of endoscopy in China
Quality Control and evaluation criterion of
endoscopy in China
History of digestive endoscopy in China
Semi-flexible Endoscope
fibergastroend oscope
First ERCP performed by Dr
Chen
magazine about endoscopy
International digestive endoscopy Convening CSDE foundation
1997
Gastro2013
2010
1950 1970 1973 1985 1991 1992 2013
EUS 2010
1984
Chinese digestive endoscopy training center
It has progressed rapidly in a relatively short period of Digestive Endoscopy in China
Survey of Digestive endoscopy in China
（2012）
31 provinces
endoscopy center : 6,128
endoscopists ：26,203
cases：28,770,000
Diagnosis and Treatment Situation
Items Amounts
Proportion
Gastroscopy 22,504,000 78.1%
Therapeutic gastroscopy 1,630,000 -
Upper GI ESD 34,000 -
Colonoscopy 5,832,000 20.2%
Therapeutic colonoscopy 1,036,000 -
Colon ESD 17,000 -
EUS 196,000 0.7%
Therapeutic EUS 11,000 -
ERCP 196,000 0.7%
Enteroscopy 26,000 0.1%
Capsule endoscopy 48,000 0.2%
Endoscopy Nurses
Endoscopy Nurses：
14,532
Doctors:Nurses
ratio=1:0.55
Severe Shortage!
Cleaning and Disinfection
Manual cleaning and disinfection counts for the majority
Glutaraldehyde is mostly used disinfectant
——data from The survey report of digestive endoscopic diagnosis and treatment technology in China(2012)
SGNA put it that infection control is the most important matter in endoscopic nursing
practice
Regulation for Cleaning and disinfection technique of flexible endoscope in China
“Regulation for Cleaning and disinfection technique of flexible endoscope”-2004 version
“Consensus opinion among endoscopic cleaning and disinfection experts in China”-2014 version
“Regulation for Cleaning and disinfection technique of flexible endoscope”-2016 version
Remodified all the time
Regulation for Cleaning and disinfection
technique of flexible endoscope in China
Process
drying final rinsing
disinfection rinsing cleaning leak checking
pretreatment
Process
Procedure room
Reprocessing room
pre-cleaning
leak testing
cleaning
rinse
disinfection
rinse
dry
Manual flow
leak testing cleaning
rinse disinfection
dry rinse
Auto flow
Storage room / Cabinet
content
Introduction of endoscopy center,Beijing Friendship Hospital
Cleaning and disinfection status of endoscopy in China
Quality Control and evaluation criterion of
endoscopy in China
Quality Control and evaluation criterion of endoscopy in China
quality detection of cleaning quality detection of disinfection
disinfectants/sterilizing agent concentration detection disinfectants/sterilizing agent detection on bacteria contamination
detection of last cleaning water environment detection
hands hygiene detection
quality check process record and traceability
Quality Check-disinfection of endoscope
（1）Visual Observation
（2）Enlarge Visual Observation
（3）biofilm process
（4）Protein and blood residue detection
（5） ATP bioluminescence aasay
Quality Check-disinfection of endoscope
What's ATP bioluminescence aasay ？
ATP is located in all living cells as the energy source of creatures.It not only can reflect the microbial load of detected items but can reflect residue of other
substances.ATP bioluminescence aasay is such an technique that can evaluate the cleanness of items.
ATP interacts with fluorescein under the effect of
luciferase.The fluorescence intensity is proportional to ATP contents.By detecting RLU,we could get the ATP contents of detected substances.
Quality Check-disinfection of endoscope
Disinfected endoscopes should be detected biologically per quarter.We use rotation sampling method in 25%
ratio. If the sum is less than 5,they all should be
detected.Once larger than 5,detection number should be no less than 5.
Once endoscopic cleaning and disinfection machine is installed or repaired,we should perform biological
detection of disinfected endoscopes.It can only be put into use once qualified.
引自WS 507-2016软式内镜清洗消毒规范
Quality Check-disinfection of endoscope
other detection of endoscopic cleaning and disinfection machines should follow the government regulation.
Once suspected endoscopy-associated infection occurs, we should organize and coordinate inter-departments to carry on investigations and put corrective actions.
Once it's suspected that nosocomial infection is associated with endoscopic operation,we should use method to detect pathogenic bacteria in terms of GB 15982 regulation.
软式内镜清洗消毒规范（2016）
引自WS 507-2016软式内镜清洗消毒规范
Quality Check-disinfection of endoscope
内镜消毒质量监测（微生物培养）
引自 WS 507-2016软式内镜清洗消毒规范
carry on concentration detection in terms of product instruction
If it's not mentioned the frequency of concentration detection in product instruction,we should perform concentration detection of disposable disinfectants/sterilants per batch.The concentration of reused disinfectants/sterilants should be detected once applied and then detected each time per usage.Once the number of
disinfected endoscopes reach 50% of required ones,detection should be made before each endoscope is disinfected.
The PH and available chlorine concentration of electrolyzed
oxidizing water should be detected on water outlet before usage.
引自 WS 507-2016软式内镜清洗消毒规范
disinfectant concentration detection
detection of disinfectants bacteria contamination condition
It should be detected per quarter in terms of regulation about WS/T 367.
Method:using sterile pipette to suck 1.0ml diluted
solution(1.0ml detected disinfectants+9.0ml neutralizer) to plate,filling 15-20ml 40-45℃ melting nutrient agar per
plate,cultivating 72h in 36℃ ± 1℃ thermostat,and counting the bacterial colonies.It should be made bacteria detection if suspected to be associated with Outbreak of nosocomial infection.
引自 WS/T 367-2012 医疗机构消毒技术规范
calculation and result judgement
disinfectants bacteria contamination calculation formula:
=mean bacteria colonies per plate × 10× dilution times
result judgement
（1）
sterizing agents in used ：no bacteria
（2）
bacteria contamination of disinfectants in uesd：
≤10CFU/mL；
（3）
others
≤100CFU/mL。引自WS/T 367-2012 医疗机构消毒技术规范
quality detection of disinfection condition on last cleaning water 、environment and hands
regular detection of last cleaning water: sum of bacteria colonies ≤10CFU/100mL, sterile water without bacteria
detection of disinfection condition on hands of staff:
um of bacteria colonies ≤ 10CFU /cm
2per quarter
.quality detection of disinfection condition on last cleaning water 、environment and hands
Detection per quarter of disinfection condition on treatment rooms,cleaning and disinfection rooms should follow WS/T 367, sterilizing endoscopic treatment rooms should reach the requirement of unclean operation(Grade II environment).sum of bacteria colonies ≤ 4CFU (15min · 9cm diameter
plates.sum of bacteria colonies in other
area(Grade III environment) ≤ 4CFU(5min · 9cm
diameter plates).
Quallity process document and traceability
document all surveillance results and preserve;
Endoscopic traceability management ：treatment date、the patients and endoscopes numbers 、the process duration and the staff name has uniqueness.
Document requirement:
（1） Traceability
（2） concentration detection documents should be preserved longer than 6 months
（3） other detection documents should preserved longer than
3 years.
management of traceability
The document of cleaning、rinsing、disinfection、final rinsing should be included and traced.
Each cleaning staff and endoscope has own ID card scan Upload instantly to ensure reality and objectivity.
the information of endosocpists、patients、nurses、operation
duration could be traced by using endoscopic workstation.
Quality Check-disinfection of endoscope ： training is vitally important
Most provinces in China has held varieties of trainings
Each endoscopy nurse has learned the lastest knowledge of cleaning and disinfection of endoscopy
1
2
Training Form
Training Form
academic conference
training curriculum
hands-on course
online course
academic platform
Meeting and Course
more and more academic meetings and course will be held in the future
In order to build a academic exchange platform, Nursing Collaboration
Group, Association of Digestive Endoscopy, Chinese Society of Medicine was founded in 2014
Academic Exchange Platform
Hands-on Course
teaching trainees cleaning and
sterilizing knowledge directly
Future
Automated endoscope
reprocessor is the main tide automobilization and
informationization
high quality of quality control
