Central Sterile Supply Department I, Hunan Provincial People’ s Hospital (The First Affiliated Hospital of HunanNormal University), No. 61 Jiefang West Road, Changsha City, Hunan 410005, China, Hunan 410005, China
Juan Zhou, E-mail: 415521822@qq.com
Dongling Liu at 735335122@qq.com
纸质出版:2025-10-15
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Juan Zhou, Dongling Liu, Caixia Yang, 等. A Cross-Sectional Survey on Management and Processing Practices for Loaner Surgical Instruments and Implants Among 861 Hospitals in China[J]. Sterile Supply, 2025,4(3):166-178.
Zhou Juan,Liu Dongling,Yang Caixia,et al.A Cross-Sectional Survey on Management and Processing Practices for Loaner Surgical Instruments and Implants Among 861 Hospitals in China[J].Sterile Supply,2025,04(03):166-178.
Juan Zhou, Dongling Liu, Caixia Yang, 等. A Cross-Sectional Survey on Management and Processing Practices for Loaner Surgical Instruments and Implants Among 861 Hospitals in China[J]. Sterile Supply, 2025,4(3):166-178. DOI: 10.11910/j.issn.2791-2043.2025.3.05.
Zhou Juan,Liu Dongling,Yang Caixia,et al.A Cross-Sectional Survey on Management and Processing Practices for Loaner Surgical Instruments and Implants Among 861 Hospitals in China[J].Sterile Supply,2025,04(03):166-178. DOI: 10.11910/j.issn.2791-2043.2025.3.05.
Objective
2
This study aimed to investigate the current status of the management and processing of loaner surgical instruments and implants in healthcare institutions across China and to provide evidence for standardizing practices in this field.
Methods
2
A cross-sectional study was conducted in October 2024 using a self-administered questionnaire developed based on industry standards
clinical guidelines
and a literature review. The survey was distributed via a questionnaire platform Wenjuanxing to central sterile supply department (CSSD) in secondary and tertiary hospitals in China.
Results
2
Valid responses were collected from 861 hospitals across 18 provinces. Significant disparities were observed between tertiary and secondary hospitals across multiple domains (
P
<
0.05). In management
differences were noted in the clinical departments using loaner instruments
the provision of handover forms by suppliers
the frequency of organized training
the assignment o
f dedicated CSSD personnel/position for loaner instruments
and the establishment of departmental-level management systems. During handover
disparities existed in the availability of an independent receiving area
the use of information traceability systems
the presence of a dedicated loaner instrument module within those systems
the establishment of information-sharing platforms
the ability of the system to track instrument quantities
and the cleanliness of delivered instruments. For cleaning
disinfection
and sterilization
differences were found in compliance with manufacturer instructions
the use of validated washer-disinfector programs for loaner instruments
cleaning verification
the use of dedicated sterilization programs specific to loaner instruments
the basis for sterilization parameter selection
and the frequency of early instrument release. In post-use processing
variations were identified in preprocessing practices
the timeliness of instrument retrieval (within two days)
the maintenance of return records
and the traceability of those records.
Conclusion
2
While the management and processing of loaner surgical instruments and implants in China show a trend toward standardization
significant gaps remain. There is a pressing need to strengthen dedicated staffing
establish independent processing zones
accelerate the implementation of comprehensive traceability systems
promote the use of validated cleaning and sterilization protocols
and improve post-use handling and return procedures.
DIVI S N , KEPLER C K , BOODY B S , et al . Consensus on implants in infections after spine surgery [J ] . Clinical Spine Surgery: A Spine Publication , 2020 , 33 ( 4 ): 163 - 171 .
GOVAERT G A M , KUEHL R , ATKINS B L , et al . Diagnosing fracture-related infection: Current concepts and recommendations [J ] . Journal of Orthopaedic Trauma , 2020 , 34 ( 1 ): 8 - 17 .
DE MELO COSTA D , DE OLIVEIRA LOPES L K , PEREIRA L A , et al . Management of surgical instruments at loaner companies in upper-middle and high-income countries: The other side of the coin [J ] . Infection , Disease & Health, 2022 , 27 ( 4 ): 235 - 238 .
GYAN T , MCAULEY K , STROBEL N A , et al . Determinants of morbidity associated with infant male circumcision: Community-level population-based study in rural Ghana [J ] . Tropical Medicine & International Health , 2017 , 22 ( 3 ): 312 - 322 .
LIU J M , DENG H L , CHEN X Y , et al . Risk factors for surgical site infection after posterior lumbar spinal surgery [J ] . Spine , 2018 , 43 ( 10 ): 732 - 737 .
WU S L , LIU P , LI P G . Analysis of etiological characteristics and risk factors of postoperative infection in surgical patients [J ] . Journal of Pathogen Biology , 2024 , 19 ( 12 ): 1492 - 1495 .
XU Q , QIAN W M , ZHAO T Y , et al . Investigation on the current management situation of foreign surgical instruments in 1 166 public hospitals in China [J ] . Chinese Nursing Management , 2022 , 22 ( 10 ): 1477 - 1481 .
JIANG L H , LI S P , YAO S X . Investigation on the status of centralized management of foreign medical devices in level 2 primary hospital of Dali prefecture [J ] . China Medical Device Information , 2021 , 27 ( 17 ): 26 - 28 .
WU Y Y , XU T T , XIONG L J , et al . Management of loaner medical instruments and implants in hospitals in Hubei Province [J ] . Chinese Journal of Infection Control , 2022 , 21 ( 5 ): 420 - 429 .
CAO Y , LIU K , YUAN X N , et al . Survey on management status of surgical instruments and dressings in 187 hospitals in 14 provinces of China [J ] . Chinese Journal of Infection Control , 2018 , 17 ( 7 ): 591 - 596 .
CHEN D F , WANG Z Z , LIU Y Q , et al . Current status of management of foreign devices and implants in 311 hospitals in China [J ] . Chinese Journal of Nosocomiology , 2021 , 31 ( 22 ): 3479 - 3482 .
TIAN H , LI Y , WANG P , et al . Investigation on cleaning, disinfection and management of loaned medical devices and implants after use in 209 hospitals in China and their influencing factors [J ] . Chinese Journal of Disinfection , 2024 , 41 ( 3 ): 196 - 198 .
GUO L , MO J J , WU Q , et al . Meta-analysis assessing the contemporary state of disposal practices for loaned instruments in central sterile supply department [J ] . Chinese Journal of Disinfection , 2024 , 41 ( 8 ): 610 - 614 .
ZHANG Q , QIAN L M . Technical Operation Guide for Cleaning, Disinfection and Sterilization of Loaner Surgical Instruments [M ] . 1st ed . Beijing : Beijing Science and Technology Press , 2018 .
National Health and Family Planning Commission of the People’s Republic of China . Central Sterile Supply Department (CSSD) Part 1: Management Standard : WS 310.1—2016 [S ] . Beijing : Standards Press of China , 2017 .
Central sterile supply department (CSSD): Part 2: Standard for operating procedure of cleaning, disinfection and sterilization [J ] . Chinese Journal of Infection Control , 2017 , 16 ( 10 ): 986 - 992 .
Central sterile supply department (CSSD): Part 3: Standard for operating procedure of cleaning, disinfection and sterilization [J ] . Chinese Journal of Infection Control , 2017 , 16 ( 10 ): 986 - 992 .
ZHANG Q , GAO H Y , ZHU T Y , et al . Survey of loaner instrument and implants processing status in 764 hospitals in China [J ] . Chinese Nursing Management , 2019 , 19 ( 1 ): 119 - 122 .
WANG Z Z , CHEN D F , HUANG Q , et al . Investigation on the status quo of standardized handling procedures for foreign medi-cal devices and implants in 311 hospitals across the country [J ] . Chinese Journal of Disinfection , 2022 , 39 ( 1 ): 36 - 40 .
LI A Q , ZHOU J , LI Y Q , YANG H Y . Central Sterile Supply Department Management Manual for Hospital Accreditation [M ] . 1st ed . Beijing : Science Press , 2025 : 45 .
WANG Y J , CHU Y Y , GU M X , et al . Practice and thinking of the gradual improvement of loaned instruments and implants under the leading of regulations [J ] . Chinese Nursing Management , 2023 , 23 ( 8 ): 1134 - 1137 .
ZHANG Y , ZHENG D W , SUN L , et al . Surgical site infection and risk factors of type Ⅰ incisions in orthopedics: A 1∶1 matched case-control study [J ] . Journal of Southeast University (Medical Science Edition) , 2024 , 43 ( 5 ): 771 - 776 .
ZHANG Q , QIAN L M , LI B H . Guidelines for Management and Technology of Central Sterile Supply Department (2022 Edition) [M ] . 2nd ed . Beijing : The People’s Health Press Co., Ltd. , 2022 .
ZHOU J , HUANG Q H , YU ZX . Standard Workflow Charts for Hospital Central Sterile Supply Department [M ] . 1st ed . Hunan : Hunan Science & Technology Press , 2021 .
HU J J , GAO X L , XING L Y , et al . Construction and application of whole-process information management system for orthopedic implants [J ] . Journal of Nursing , 2024 , 31 ( 21 ): 74 - 78 .
QIAN L M , JI K W , ZHANG Q . Current status of information tracking system in central sterile supply departments [J ] . Chinese Journal of Nursing , 2020 , 55 ( 1 ): 123 - 127 .
HAO Y L , DAI H H , SUN Y , et al . A multi-center study on application effect of artificial intelligence system on receiving process of loaner instruments [J ] . Chinese Journal of Nosocomiology , 2023 , 33 ( 2 ): 291 - 294 .
WU X N , CHEN H , HE Q , et al . Research and application of artificial intelligence visual recognition system in inspection package quality of external medical instruments in disinfection supply center [J ] . Journal of Nurses Training , 2024 , 39 ( 2 ): 161 - 163 .
CUI Q , LI M C , ZHAN M , et al . Current management status of loaner medical instruments and implants in hospital central sterile supply department from 2008 to 2021: A Meta-analysis [J ] . Chinese Journal of Infection Control , 2022 , 21 ( 5 ): 430 - 438 .
DE MELO COSTA D , DE OLIVEIRA LOPES L K , VICKERY K , et al . Reprocessing safety issues associated with complex-design orthopaedic loaned surgical instruments and implants [J ] . Injury , 2018 , 49 ( 11 ): 2005 - 2012 .
LIU D L , ZHOU J , LI P , et al . Research on the improvement of handover management of loaner medical devices in central sterile supply departments [J ] . Chinese Journal of Nursing , 2025 , 60 ( S2 ): 18 - 23 .
GUAN L J , WEI J R , YANG L F . Study of sterilization parameters monitoring of external equipment during terilization process [J ] . Chongqing Medicine , 2021 , 50 ( 16 ): 2797 - 2799 .
LIU Y Q , CHEN D F , HUANG Q , et al . Effect of loaner medical devices with different materials on sterilization quality [J ] . Chinese Journal of Disinfection , 2020 , 37 ( 3 ): 181 - 183 .
YUAN Y , LIU Z H . Study on the heating delay of steam sterilization of loaner instruments with different pulsations [J ] . Chinese Journal of Disinfection , 2020 , 37 ( 6 ): 428 - 430 .
PENG K , LIU H R , JIE M , et al . Optimization of pressure steam sterilization monitoring for loaned instruments [J ] . Chinese Journal of Nosocomiology , 2024 , 34 ( 16 ): 2546 - 2550 .
LIU D L , WANG D H , YU Z X , et al . Research progress on cleaning and sterilization of choledochofiberscopes [J ] . Chinese Journal of Disinfection , 2020 , 37 ( 11 ): 855 - 858 .
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