Basic Standards for Medical Disinfection Supply Centers (Trial)

The Medical Disinfection Supply Center is an independently established medical institution, excluding disinfection supply centers, disinfection supply rooms set up within medical institutions, and disinfection supply agencies serving medical device manufacturing and operating enterprises. The Medical Disinfection Supply Center mainly undertakes the cleaning, disinfection, sterilization, and supply of sterile items such as reusable diagnostic and therapeutic instruments, utensils, clean surgical gowns, and surgical drapes in medical institutions. It also carries out quality control of the processing procedures, issues monitoring and testing results, achieves full traceability, and ensures quality.

1. Department Setup

At least a disinfection supply room and functional departments such as hospital infection management, quality and safety management, engineering technology management, and information management should be established.

2. Personnel Configuration

(1) At least one nurse with a deputy senior or higher professional technical position qualification and experience in disinfection supply management.

(2) At least one nurse with more than 5 years of hospital infection management experience.

(3) At least three nurses with more than 3 years of disinfection supply work experience, including one with an intermediate or higher professional technical position qualification.

(4) At least two disinfection workers who have obtained the corresponding qualification certificates as required.

(5) At least two full-time engineering technicians with relevant professional knowledge and more than 5 years of related work experience.

(6) Other technical personnel and staff appropriate to the business operations.

3. Basic Facilities

(1) The area used for business purposes should be no less than 85% of the total area. It should have dual power supply or emergency power generation facilities, emergency water supply reserves, backup steam generators, backup compressed air equipment, and important medical equipment and networks should have uninterruptible power supplies to ensure the normal operation of the Medical Disinfection Supply Center.

(2) A production line for cleaning, disinfecting, drying, inspecting, packaging, sterilizing, storing, and distributing hard instruments (surgical instruments made of metal, rubber, plastic, polymer materials, and other hard materials, as well as rigid endoscopes) should be set up, with a building area of no less than 2,000 square meters.

(3) A production line for cleaning, disinfecting, drying, inspecting, folding, packaging, sterilizing, storing, and distributing soft instruments (surgical gowns, surgical drapes, and other infection control instruments that are water-resistant, bacteria-resistant, breathable, wearable, foldable, with bidirectional protection functions, and conform to the surgical instrument classification catalog, excluding ordinary medical textiles) should be set up, with a building area of no less than 2,000 square meters.

(4) A production line for cleaning, disinfecting (sterilizing), drying, storing, and distributing flexible endoscopes should be set up, with a building area of no less than 800 square meters.

(5) Medical textile cleaning and disinfection should comply with relevant national laws, regulations, and standards.

(6) Water purification facilities should be set up, with a building area of no less than 300 square meters.

(7) A specialized area for distribution logistics should be set up, with a building area of no less than 300 square meters.

(8) Office, changing, rest, and living areas should be set up, accounting for 10-15% of the total area.

(9) A temporary storage area for medical waste should be set up, implementing classified management of medical waste.

(10) For microbiological or pyrogen testing, a laboratory should be set up.

(11) A sewage treatment facility should be set up.

(12) The corresponding workflow of work areas should comply with relevant national regulations.

4. Zoning Layout

(1) Main Functional Areas

Decontamination area, inspection, folding, packaging and sterilization area, sterile item storage area, and distribution logistics area, etc.

(2) Auxiliary Functional Areas

Centralized power supply, water supply, steam and detergent distributors, temporary storage for medical waste, sewage treatment facilities, centralized medical compressed air supply, office, changing, rest, and living areas, etc.

(3) Management Area

Quality and safety control (including laboratory), hospital infection control, instrument equipment, logistics, information, and other management departments.

5. Basic Equipment

According to the scale, tasks, and workload, reasonably configure cleaning, disinfection, sterilization equipment, and supporting facilities. Equipment and facilities should comply with relevant national standards or regulations.

(1) Equipment and facilities for cleaning surgical hard instruments (surgical instruments made of metal, rubber, plastic, polymer materials, and other hard materials, as well as rigid endoscopes) should include:

1. Contaminated item recovery tools, sorting tables, manual cleaning sinks, pressure water guns, pressure air guns, oil-free air compressors (equipped with 0.01μm filters), drying equipment, corresponding cleaning supplies, barcode scanning equipment, etc.

2. Mechanical cleaning and disinfection equipment: isolated (double-door) washer-disinfectors, single or tunnel (long) washer-disinfectors selected according to workload, ultrasonic spray washer-disinfectors, variable frequency ultrasonic washer-disinfectors of different frequencies (30-40kHz and 80-100kHz), automatic detergent dispensers, cleaning and disinfection equipment for vehicles and transport containers, etc.

3. Inspection and packaging equipment: instrument inspection tables with lighted magnifiers, insulation testers, packaging tables, instrument cabinets, dressing cabinets, packaging material cutters, medical heat sealers, and clean item loading equipment, etc.

4. Sterilization equipment and facilities: pressure steam sterilizers, clean steam generators, sterile item loading and unloading equipment, and low-temperature sterilization devices should be equipped.

5. Storage and distribution facilities: sterile item storage facilities and transport tools should be equipped.

6. Dedicated sealed transport vehicles with clear separation of clean and contaminated items.

(2) Equipment and facilities for cleaning soft instruments (water-resistant, bacteria-resistant, breathable surgical gowns, surgical drapes, and other infection control instruments that are wearable, foldable, with bidirectional protection functions, and conform to the surgical instrument classification catalog, excluding ordinary medical textiles) should include:

1. Contaminated item classification recovery tools, needle detectors, barcode scanning equipment, etc.

2. Mechanical cleaning and disinfection equipment: isolated (double-door) washing machines, single or tunnel (long chain) washing machines selected according to business volume, automatic detergent dispensers, vehicle and transport container cleaning and disinfection equipment, etc.

3. Dryers: clean clothes dryers (with air filtration devices), tunnel ironing machines, etc.

4. Inspection and folding packaging equipment: surgical gown three-dimensional optical inspection machines, dressing inspection light tables with light sources, automatic surgical gown folding machines, packing tables, traceability systems, bundling machines, sealing machines, transport tools, etc.

5. Sterilization equipment: pressure steam sterilizers, clean steam generators, and other basic sterilization equipment.

6. Storage and distribution facilities: should be equipped with sterile item storage facilities and clean sealed transport vehicles and tools, etc.

7. Dedicated sealed transport vehicles with clear separation of clean and dirty areas.

(3) Cleaning of flexible endoscopes should be equipped with the following equipment and facilities:

1. Contaminated endoscope recovery tools (carts), manual endoscope cleaning sinks, leak detection devices, pressure water guns, pressure air guns, drying equipment and corresponding cleaning supplies, scanning devices, etc.

2. Mechanical cleaning and disinfection equipment: isolated (double-door) endoscope cleaning and disinfection machines, ultrasonic spray cleaning and disinfection machines, variable frequency ultrasonic cleaning and disinfection machines of different frequencies (30-40kHz and 80-100kHz), automatic detergent dispensers, vehicle and transport container cleaning and disinfection equipment, etc.

3. Inspection, packaging, and sterilization equipment: packaging tables, instrument cabinets, dressing cabinets, packaging material cutters, medical heat sealers, and clean item loading equipment, etc.

4. Sterilization equipment and facilities: pressure steam sterilizers, clean steam generators, sterile item loading and unloading equipment, and low-temperature sterilization devices should be equipped.

5. Storage and distribution facilities: should be equipped with clean endoscope drying storage cabinets (with clean dry air and controllable temperature and humidity functions), sterile endoscopes, biopsy forceps, and other surgical instrument sterile storage facilities and transport tools, etc.

6. Dedicated sealed transport vehicles with clear separation of clean and contaminated items.

(4) Quality inspection equipment: temperature and pressure detectors, pyrogen detection devices, water quality testing, harmful gas concentration detectors, disinfection and sterilization effect detection equipment, and other devices.

(5) Information technology equipment: network computers with information reporting and transmission functions, traceability management systems, report management systems, and other information management systems.

6. Management

Establish a quality and safety management system for the medical disinfection supply center, formulate various rules and regulations, personnel job responsibilities, and implement disinfection supply center specifications, standards, and operating procedures formulated or recognized by the state. The rules and regulations should at least include facility and equipment management systems, quality management systems, record traceability and document management systems, fire safety management systems, information management systems, biosafety management systems, hazardous materials management and hazardous chemical use management systems, occupational safety protection management systems, environmental hygiene quality control systems, disinfection isolation systems, cleaning, disinfection, and sterilization monitoring systems, and formulate standard operating procedures suitable for disinfection supply. Staff must participate in learning and training on all rules and regulations, job responsibilities, and process specifications, with records maintained.