Medical Disinfection Supply Center Management Standards (Trial)

To strengthen the management of the Medical Disinfection Supply Center, improve its management level, ensure the safety of reusable diagnostic and therapeutic instruments, tools, and items, standardize the quality management of the Medical Disinfection Supply Center, and guarantee medical quality and safety, this specification is formulated in accordance with the "Law on the Prevention and Control of Infectious Diseases," "Special Equipment Safety Law," "Nurse Regulations," "Regulations on the Administration of Medical Institutions," "Medical Waste Management Regulations," "Regulations on the Supervision and Administration of Medical Devices," "Hospital Infection Management Measures," "Disinfection Management Measures," "Medical Device Production Quality Management Standards," "Surgical Sheets, Surgical Gowns, and Clean Clothing for Patients, Medical Staff, and Instruments" (YY/T0506 1-7), "Hospital Disinfection Supply Center Part One: Management Specifications" (WS 301.1), "Hospital Disinfection Supply Center Part Two: Cleaning, Disinfection, and Sterilization Technical Operation Specifications" (WS 301.2), "Hospital Disinfection Supply Center Part Three: Cleaning, Disinfection, and Sterilization Effect Monitoring Standards" (WS 301.3), "Disinfection Technical Specifications for Medical Institutions" (WS/T 367), "Flexible Endoscope Cleaning and Disinfection Technical Specifications" (WS 507), "Medical Textile Washing and Disinfection Technical Specifications" (WS/T 508), and other relevant laws, regulations, and related provisions.

This specification applies to independently established Medical Disinfection Supply Centers and does not include disinfection supply centers, disinfection supply rooms set up within medical institutions, or disinfection supply organizations serving medical device manufacturing and operating enterprises.

I. Institutional Management

(1) The Medical Disinfection Supply Center shall be approved by the health administrative department and legally provide disinfection supply services for reusable instruments, tools, and items to medical institutions.

(2) The Medical Disinfection Supply Center shall establish a quality and safety management system, formulate and implement various rules and management systems, comply with national technical specifications, standards, and operating procedures formulated or recognized, clarify staff job responsibilities, implement hospital infection prevention and control measures, and ensure the safe and effective cleaning, disinfection, and sterilization of reusable medical instruments, tools, and items.

(3) The Medical Disinfection Supply Center shall set up an independent quality and safety management department staffed with full-time quality and safety management personnel who hold intermediate or higher professional technical qualifications and possess relevant professional knowledge and work experience. This department is responsible for quality and safety management and control, performing the following duties:

1. Inspect the implementation of rules, technical specifications, and operating procedures.

2. Inspect the work quality of the Medical Disinfection Supply Center, hospital infection management, and instrument and equipment management.

3. Monitor, analyze, and provide feedback on key processes and high-risk factors affecting the cleaning, disinfection, sterilization quality, and medical safety of reusable medical instruments, tools, and items, and propose prevention and control measures.

4. Provide guidance on occupational safety protection and health management for staff.

5. Prevent and control contamination leakage and hospital infections in the Medical Disinfection Supply Center.

6. Supervise and guide the writing, preservation, and information recording of monitoring and testing reports of the Medical Disinfection Supply Center, ensuring the authenticity and timeliness of recorded data.

7. Inspect cleaning agents, instrument consumables, and auxiliary equipment; conduct quality acceptance and audits of cleaning, disinfection, and sterilization supply departments; and propose quality control improvement suggestions and measures.

(4) The finance department shall standardize institutional financial management, strengthen financial supervision, and conduct financial analysis.

(5) The logistics management department shall ensure the quality and daily maintenance of water, electricity, compressed air, and steam supply; regularly inspect and maintain facilities and pipelines; calibrate various digital instruments such as pressure gauges and thermometers on equipment and keep records for reference. It shall also be responsible for fire prevention, theft prevention, and other safety work.

(6) Professional personnel with qualifications such as the "Special Equipment Operator Certificate" shall perform daily maintenance and regular inspections of pressure steam sterilizers and power supply equipment, and keep records. According to safety technical specifications, a request for periodic inspection shall be submitted to the special equipment inspection agency one month before the expiration of the inspection validity period, and the periodic inspection compliance mark shall be placed in a prominent position on the special equipment.

II. Quality Management

The Medical Disinfection Supply Center shall carry out medical quality management work according to the following requirements:

(1) The allocation of health professional and technical personnel shall comply with the provisions of the "Basic Standards for Medical Disinfection Supply Centers (Trial)."

(2) A staff training and assessment plan shall be formulated and implemented to ensure that staff possess professional knowledge and skills related to their duties. Establish management systems and training records for updating professional knowledge, maintaining professional skills, and continuous training of technical personnel. Emphasize safety education and occupational safety protection knowledge training for special equipment operators. Immunization of relevant personnel shall be conducted when necessary to ensure occupational safety for all personnel.

(3) In accordance with ISO 9001, YY/T0287-2017 "Medical Devices Quality Management System - Requirements for Regulatory Purposes," etc., establish and implement a quality management system for the Medical Disinfection Supply Center. Comply with "Hospital Disinfection Supply Center Part One: Management Specifications" (WS 301.1), "Hospital Disinfection Supply Center Part Two: Cleaning, Disinfection, and Sterilization Technical Operation Specifications" (WS 301.2), "Hospital Disinfection Supply Center Part Three: Cleaning, Disinfection, and Sterilization Effect Monitoring Standards" (WS 301.3), "Surgical Sheets, Surgical Gowns, and Clean Clothing for Patients, Medical Staff, and Instruments" (YY/T0506 1-7), and other related technical specifications and standards. Implement quality management systems for all stages of reusable diagnostic and therapeutic instrument recovery, cleaning, disinfection, inspection and maintenance, folding, packaging, sterilization, storage, and transportation, as well as cleaning, disinfection, and sterilization operating procedures, standard operation and maintenance procedures for instruments and equipment, continuously improving the quality of medical disinfection supply.

(4) When the Medical Disinfection Supply Center accepts treatment requests for reusable diagnostic and therapeutic instruments, tools, and items from other medical institutions, it shall sign an agreement with the requesting medical institution, clarifying the responsibilities of both parties and the processes of item transportation and handover. Strengthen on-site handover, quality inspection, and acceptance work, improve signature procedures, standardize management, and ensure safety. Applications for disinfection and reuse of disposable disinfected items shall not be accepted. When providing sterile reusable diagnostic and therapeutic instruments, tools, and items to the requesting medical institution, relevant monitoring and testing result reports shall be provided. When necessary, the Medical Disinfection Supply Center shall provide technical explanations related to monitoring and testing results. Establish quality assurance measures, formulate and implement standard operating procedures for pretreatment, recovery, cleaning, disinfection, drying, folding, inspection and packaging, sterilization, storage, and transportation.

(5) Strengthen quality management of the instrument processing process, standardize the activities of the Medical Disinfection Supply Center, conduct regular quality supervision and inspection, and ensure traceability of results and records. Summarize and analyze problems found during inspections regularly and take measures for continuous improvement. Carry out disinfection and sterilization supply work based on principles of safety, accuracy, timeliness, effectiveness, economy, and ease of use to ensure quality.

(6) Establish emergency response plans to provide timely and safe sterile item services in the event of critical emergencies.

(7) Establish traceability systems, retention period systems, sterile item defect recall systems, etc., to ensure quality, meet medical needs, and continuously improve.

(8) Participate in quality evaluation activities organized by health administrative departments at all levels and accept supervision and management by local health administrative departments.

(9) Staff of the medical disinfection supply center shall have relevant professional education and obtain corresponding professional technical position qualifications and practice qualifications. They shall receive post training recognized by the health administrative department to improve professional technical level and quality management awareness.

(10) Sterilization equipment and cleaning and disinfection equipment shall comply with standards such as WS 310.3 and ISO 17665, and important parameters of sterilization and cleaning disinfection procedures shall be tested annually.

(11) Establish a medical disinfection supply center information system that meets service quality requirements (basic functional requirements of the information system, see WS310.1 Appendix A), establish system data security management systems and emergency measures. It should have the capability to network with the information systems of the institutions served. Information systems shall be used for quality control and traceability of cleaning, disinfection, sterilization, and supply.

(12) Establish a report issuance system for the medical disinfection supply center to ensure reports are accurate, timely, and information is complete. False monitoring and testing result reports shall not be issued.

(13) Medical disinfection supply center reports shall be in Chinese or internationally recognized standardized abbreviations and shall be kept according to national regulations.

(14) The content of qualified cleaning, disinfection, and sterilization quality monitoring reports of the medical disinfection supply center shall comply with relevant national regulations.

(15) When establishing long-term cooperation with other types of medical institutions, the medical disinfection supply center shall conduct safety risk assessments on the processes of recovery, transportation, cleaning, disinfection, and sterilization of diagnostic and treatment instruments. Contracts shall be signed to clarify the responsibilities, rights, and obligations of both parties. A regular contact system shall be established, with feedback and improvement measures for opinions and suggestions.

3. Safety Management

(1) The medical disinfection supply center shall strengthen safety management, enhance hospital infection prevention and control, scientifically set and strictly abide by safety management regulations and safety operation procedures to reduce the risk of hospital infections.

(2) A dedicated person shall be assigned according to relevant regulations to be responsible for the management of item handover between the medical disinfection supply center and other hospital disinfection supply centers to effectively prevent and control cross-contamination.

(3) The architectural layout of the medical disinfection supply center shall follow principles of environmental hygiene and hospital infection management, meet requirements, and ensure reasonable layout, clear zoning, clear signage, separation of clean and dirty flows, no cross-contamination, and no backflow.

(4) The medical disinfection supply center shall be divided into work areas, auxiliary work areas, and management areas.

(5) The ventilation frequency of each work area shall comply with relevant national regulations.

(6) In strict accordance with the "Technical Specifications for Disinfection of Medical Institutions," strengthen management related to the recovery, transportation, storage, and handling of special infection reusable instruments.

(7) In accordance with the "Law on the Prevention and Control of Infectious Diseases," "Medical Waste Management Regulations," "Disinfection Management Measures," and "Medical Institution Water Pollutant Discharge Standard GB18466," strictly harmlessly treat the generated sewage.

(8) Necessary safety equipment and personal protective equipment shall be equipped according to standard precautions, such as dome work caps, masks, face shields, waterproof isolation gowns, special shoes, puncture-resistant gloves, eye washers, noise-reducing earplugs, emergency gas masks and alarm systems to prevent leakage of toxic gases such as ethylene oxide, hydrogen peroxide, formaldehyde, etc. Training shall be strengthened to ensure staff can use them correctly.

(9) When occupational exposure incidents occur during work, corresponding handling measures shall be taken, and relevant departments within the institution shall be promptly notified, records shall be kept and archived to ensure traceability.

(10) Management personnel shall regularly assess risk factors and safety risks of the medical disinfection supply center to ensure safety. Regular safety and fire drills shall be conducted and records kept.

4. Supervision and Management

(1) Health administrative departments at all levels shall strengthen supervision and management of medical disinfection supply centers within their jurisdiction. Health supervision agencies shall conduct on-site supervision and inspection at least once a year. If quality problems or safety hazards are found, immediate rectification shall be ordered.

(2) When performing supervision and inspection duties, health administrative departments have the authority to take the following measures:

1. Conduct on-site inspections of medical disinfection supply centers to understand the situation and collect evidence.

2. Review or copy relevant materials on quality and safety management of medical disinfection supply centers, collect and seal samples.

3. Order medical disinfection supply centers that violate this specification and related regulations to stop illegal and non-compliant behaviors.

(3) For violations of relevant laws, regulations, and this specification, health administrative departments shall impose penalties according to the severity of the situation; if a crime is constituted, criminal responsibility shall be pursued according to law.