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For the purpose of this part, 4.1.2, 4.1.5, 4.1.7, 7.2.1, 7.2.6, 8.6, 10.2 are recommendatory and the rest are mandatory.
This standard is formulated according to the Law of the People's Republic of China on Prevention and Treatment of Infectious Diseases and the Measures for the Administration of Hospital Infection.
WS 310, consisting of the following three parts under the general title of Central sterile supply department is to standardize the management, operation and monitoring of central sterile supply department from the perspective of prevention and control of hospital infection related to medical equipment:
——Part 1: Management standard;
——Part 2: Standard for operating procedure of cleaning, disinfection and sterilization
——Part 3: Surveillance standard for cleaning, disinfection and sterilization
This part is Part 1 of WS 310.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This part replaces WS 310.1-2009. In addition to a number of editorial changes, the following changes have been made.
——In the scope of application, the requirements of "The sterile supply of the operating department (room) of hospitals that have not yet implemented centralized management of sterile supply shall follow this standard." and "Other medical institutions that have adopted centralized sewage treatment can refer to it." have been deleted;
——Requirements on CSSD information construction (see 4.1.5) have been added, and informative Annex A has been provided;
——Management requirements for implants and loaner are added (see 4.1.6);
——Sterile supply management requirements are added for hospitals that use other hospitals or disinfection service institutions to provide disinfection and sterilization services (see 4.1.8);
——Requirements for establishing a post responsibility system for implants and loaners and conducting regular work quality analysis are added (see 4.3.2);
——Requirements for the allowable concentration of chemical substances in the working area and the building requirements for the collection, temporary storage and handover areas of hospitals providing disinfection and sterilization services by other hospitals or disinfection service institutions are added (see 7.2.7 and 7.3);
——Requirements for water treatment equipment and alarms for allowable concentration of harmful gases in the environment are added (see 8.4 and 8.6);
——Requirements are added that the final sterilized packing material shall meet the corresponding requirements of YY/T 0698 (see 9.8);
——Requirements for the quality indexes of sterilization steam water and steam condensate in clause 10 are added, and informative Annex B is provided with reference to the requirements of GB 8599.
The temperature, relative humidity and illumination requirements of the working area in this part refer to ANSI/AAMI ST79: 2010 Comprehensive Guide to Steam Sterilization and Sterilization Assurance in Health Care Facilities.
The previous edition of this part is as follows:
——WS 310.1-2009.
Central sterile supply department (CSSD)—
Part 1: Management standard
1 Scope
This part of WS 310 specifies the management requirements, basic principles, personnel requirements, building requirements, equipment and facilities, requirements for consumables and water and steam quality of the central sterile supply department (CSSD).
This part is applicable to hospitals and institutions that provide disinfection and sterilization services for hospitals.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated reference, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 5749 Standards for drinking water quality
GB/T 19633 Packaging for terminally sterilized medical devices
GBZ 2.1 Occupational exposure limits for hazardous agents in the workplace—Part 1: Chemical hazardous agents
WS 310.2 Central sterile supply department (CSSD)—Part 2: Standard for operating procedure of cleaning, disinfection and sterilization
WS 310.3 Central sterile supply department (CSSD)—Part 3: Surveillance standard for cleaning, disinfection and sterilization
WS/T 367 Regulation of disinfection technique in healthcare settings
YY/T 0698.2 Packaging for terminally sterilized medical devices—Part 2: Sterilization wrap—Requirements and test methods
YY/T 0698.4 Packaging materials for terminal sterilized medical devices—Part 4: Paper bags—Requirements and test methods
YY/T 0698.5 Packaging materials for terminal sterilized medical devices—Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction—Requirements and test methods
YY/T 0698.8 Packaging materials for terminal sterilized medical devices—Part 8: Re-usable sterilization containers for steam sterilizers—Requirements and test methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 310.2 and GB 310.3 and the following apply.
3.1
Central sterile supply department; CSSD
department in the hospital that undertakes the cleaning, disinfection and sterilization of all reusable medical instruments, apparatuses and articles in each department and the supply of sterile articles
3.2
central management
management mode in which the area of CSSD meets the demand, and the reusable medical instruments, apparatuses and articles are recycled by CSSD for centralized cleaning, disinfection or sterilization; if the hospital areas are scattered, CSSD is set up separately, or if the existing CSSD area is limited, and disinfection areas has been set up in operating room, the cleaning, disinfection or sterilization work is centrally managed by CSSD, including those that are disposed according to WS 310.1 to WS 310.3
3.3
decontamination area
area in CSSD where reusable medical instruments, apparatuses and articles are recycled, classified, cleaned and disinfected (including that for cleaning and disinfection of transportation instruments)
3.4
inspection, packing and sterilization area
area in CSSD where the decontaminated medical instruments, apparatuses and articles are inspected, assembled, packaged and sterilized (including that for dressing making)
3.5
sterile storage area
area in CSSD where sterile articles are stored, kept and distributed
3.6
decontamination
process of removing organic matter, inorganic matter and microorganism from the treated articles
3.7
implant
implantable medical device that is placed in a body cavity formed by surgical procedure or physically existing and has a retention time of 30 days or more
Note: For the purpose of his standard, it refers to non-sterile implantable medical devices that need to be cleaned, disinfected and sterilized by hospitals.
3.8
loaner
devices leased to hospitals by device suppliers for reuse, mainly for implant-related operations
4 Management requirements
4.1 Hospitals
4.1.1 Centralized management shall be adopted. CSSD shall be responsible for recycling, cleaning, disinfection, sterilization and supply of all medical instruments, apparatuses and articles that need be reused after disinfection or sterilization.
4.1.2 Cleaning and disinfection of endoscopic and oral instruments may be carried out according to relevant standards of the nation, or subjected to centralized cleaning, disinfection and/or sterilization by CSSD.
4.1.3 CSSD shall work under the direct leadership of the hospital leaders or relevant functional departments.
4.1.4 CSSD shall be incorporated into the construction plan of the institution, so as to adapt it to the scale, mission and development plan of the institution; sterile supply management shall be brought into medical quality management to ensure medical safety.
4.1.5 CSSD should be incorporated into the information construction plan of this institution, and managed via digital information system. See Annex A for basic requirements of CSSD information system.
4.1.6 The implants and loaners in hospitals shall be treated and managed in accordance with the following requirements:
a) The responsibilities of relevant functional departments, clinical departments, operating rooms and CSSD in the management, handover, cleaning, disinfection, sterilization and early release of implants and loaners shall be clearly defined by the system.
b) Before use, CSSD of the hospital (or disinfection service institution contracted with our hospital according to 4.1. 8) shall clean, disinfect, sterilize and monitor them according to WS 310.2 and WS 310.3; after use, they shall be cleaned and disinfected by CSSD before being returned.
c) An agreement shall be entered into with the device supplier requiring it to:
1) provide instructions for implants and loaners (the contents shall include cleaning, disinfection, packaging, sterilization methods and parameters);
2) ensure adequate disposal time. The devices shall be delivered to CSSD before 15:00 of the previous day of the operation at the latest for selective operation, and delivered in time for the emergency operation.
d) Training of CSSD personnel on implant and loaner disposal shall be enhanced.
4.1.7 CSSD of qualified hospitals are encouraged to provide sterile supply services for nearby medical institutions.
4.1.8 For hospitals that provide disinfection and sterilization services via other hospitals or disinfection service institutions, the sterile supply management shall meet the following requirements:
a) The qualifications of hospitals or disinfection service institutions providing services (including whether they have medical institution practice licenses or industrial and commercial business licenses, and meet the management regulations of relevant departments such as environmental protection) shall be examined;
b) The CSSD zoning, layout, equipment and facilities, management system (including emergency plan) and procedures for recovery, transportation, cleaning, disinfection and sterilization of medical instruments shall be subjected to safety assessment, and an agreement shall be signed to clarify the responsibilities of both parties;
c) A system of handover, quality inspection and acceptance of medical instruments, apparatuses and articles shall be established, and managed by specific persons;
d) The quality of cleaning, disinfection and sterilization shall be evaluated regularly;
e) The problems existing in the process of quality acceptance, evaluation and use shall be fed back to the disinfection service institutions in time, who shall be required to take improvement measures.
4.2 Management responsibilities of and requirements for relevant departments
4.2.1 Under the leadership of the competent dean, relevant departments shall perform corresponding management responsibilities for CSSD within the scope of their respective functions and powers.
4.2.2 The competent department shall
a) formulate plans and plans for implementing central management with relevant departments, and investigate and solve problems arising;
b) rationally allocate staff according to the workload of CSSD together with the personnel management department;
c) take charge the quality management of CSSD cleaning, disinfection, packaging, sterilization, etc., formulate quality indicators, and carry out inspection and evaluation;
d) establish and implement on-the-job training system for CSSD personnel, incorporate the professional knowledge of sterile supply, prevention and control of nosocomial infection and related laws and regulations in the continuing education plan of CSSD personnel, and provide conditions for their study and communication.
4.2.3 Nursing management, hospital infection management, equipment and logistics management departments shall also:
a) guide and supervise the cleaning, disinfection, sterilization and quality monitoring of CSSD, and conduct regular inspection and evaluation;
b) organize and coordinate CSSD and relevant departments to investigate and analyze, and put forward improvement measures in case of iatrogenic infection caused by suspicious medical devices;
c) make hygienic review of design schemes for new construction, reconstruction and expansion of CSSD and put forward opinions on the configuration and performance requirements of cleaning, disinfection and sterilization equipment;
d) review equipment purchase (certificate of conformity, technical parameters), establish a quality audit and acceptance system for equipment installation and maintenance of manufacturers and assign specific personnel for the maintenance and regular overhaul of CSSD equipment, and establish equipment files;
e) ensure the supply and quality of water, electricity, compressed air and steam for CSSD, and regularly maintain and overhaul facilities and pipelines;
f) regularly check all digital instruments used in CSSD, such as pressure gauge and thermometer, and record them for future reference.
4.2.4 Other departments, such as material supply, education and scientific research, shall perform relevant duties under the coordination of CSSD dean or functional departments to ensure the work needs of CSSD.
4.3 Sterile supply center
4.3.1 The sterile supply center shall establish management systems, including job responsibilities, operation procedures, disinfection and isolation, quality management, monitoring, equipment management, device management and occupational safety protection, and emergency plans.
4.3.2 A post responsibility system for implants and loaners shall be established, with permanent staff.
4.3.3 A quality management traceability system shall be established to improve the relevant records of the quality control process.
4.3.4 Work quality shall be analyzed regularly and continuous improvement shall be implemented.
4.3.5 A liaison system with relevant departments shall be established, mainly including the following works:
a) learning about the professional characteristics of various departments, common nosocomial infections and their causes, and the structure, material characteristics and treatment points of special instruments and supplies;
b) providing investigation, feedback and measures on sterilized articles and making a record.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Basic principles
6 Personnel requirements
7 Building requirements
8 Equipment and facilities
9 Requirements for consumables
10 Requirements for water and steam quality
Annex A (Informative) Basic requirements for CSSD information system
Annex B (Informative) Quality indexes of steam supply water and steam condensate of pressure steam sterilizer
