Article 1 and General Principles are to meet the needs of the construction of hospital clean operation department, to meet the requirements of medical development and scientific and technological progress, to improve investment efficiency, and to formulate the construction standards.
Article 2. This construction standard uses the newly built or reconstructed project of clean operating Department of the hospital and the project of Gujing operating room and its auxiliary room built in the non-clean operating Department (area). General Operating Departments (Rooms) Projects with Ventilation and Air Conditioning may be referred to as Licenses
Article 3. The construction of the Ministry of Clean Surgery must abide by the laws and regulations of the State concerning economic construction and health undertakings, and conform to the relevant hygienic standards and clean technology standards.
Article 4. The construction of the clean operation department should adhere to the principle that its comprehensive performance meets the standard, pay attention to air purification, strengthen the protection of the operation area, and the principle of practicality and economy should be adopted in the construction to avoid one-sided pursuit of performance. Article 5 The construction of a clean operation department shall conform to the relevant national standards, norms and regulations in force, in addition to the implementation of the construction standards.
Article 5. The scale and composition of a clean operating Department Article 6 The clean operating Department of a hospital consists of a clean operating room and an auxiliary room, which can be built as a functional area with all the clean operating rooms as the center and the necessary auxiliary rooms as its own system. It can also be built as a functional area with some clean operating rooms as the center and the necessary auxiliary rooms as its own. Room, an independent functional area coexisting with the general operating Department (room).

Article 6. All kinds of clean rooms in the clean operation department shall be classified according to their bacterial concentration and air cleanliness level under empty or static conditions according to Table 1.

Operating room is the combination of medical technology and engineering technology. With the continuous emergence of new medical technology and new surgical tools, the number of operations has increased rapidly. Most of the old operating rooms in hospitals have been unable to meet the application requirements of new technologies in space layout, facility standards and equipment functions. At the same time, people have put forward higher standards for the operation environment and operation quality. New and expanded high-standard clean operating rooms have become one of the key points in the development and construction of hospitals. How to use new technology and materials to design high-standard operating rooms suitable for future development needs is a problem that modern hospitals should consider.
1. Operating room requirements
Operating room is one of the most stringent requirements for aseptic cleanliness in hospitals. The construction, layout, workflow and management of operating room are all designed around aseptic requirements.
Operating room is also a department with intensive medical equipment. In addition to operating bed and shadowless lamp, anesthesia machine, monitoring, electric knife, autologous blood recovery machine, operating microscope, image system and so on have become common operating equipment. With the development of technology, new surgical tools are emerging, such as various kinds of minimally invasive surgical assistant equipment such as soft and hard endoscopy surgery, navigation equipment, stereo positioning system, surgical robots, etc. So many devices are crowded in the operating room, which puts forward higher requirements for equipment layout, installation, distribution and power security.
In addition, the catheter rooms and cystoscopy rooms built in various hospitals are also quasi-operating rooms set up according to the requirements of the operating room. Especially in the catheter room of interventional therapy, the management and use of these departments are basically strictly in accordance with the norms of the operating room. Generally speaking, these departments are also extended operating rooms. These quasi-operating rooms are constructed in the old hospitals by needle insertion. The layout arrangement between these departments and conventional operating rooms should be considered comprehensively in new hospitals.
2. Control Principles of Infection in Operating Room
Preventing and reducing surgical infection is the basic requirement of operating room construction. The methods of infection control include: (1) reducing patients'self-infection by preoperative skin preparation and aseptic coverage of non-surgical areas during operation; (2) strict disinfection or isolation of surgical instruments and articles to reduce exogenous contact infection; (3) reducing dust and microorganisms in the air. Substance particles, reduce the spread of suspended pollutants infection; (4) use of antibiotics. This is a remedy that relies on drugs to control the infection that has occurred.
At present, the common problem in our country is that we only pay attention to the results of infection prevention, but neglect the control of the whole process of infection. The clinical manifestation is to rely on a large number of antibiotics to reduce the incidence of infection after surgery, but the aseptic process of surgery is not strictly controlled.
In order to reduce the abuse of antibiotics, it is necessary to improve the cleanliness of the operating room, strict aseptic operation and management, strengthen the control of the whole operation process, cut off all possible ways of contamination (including air), and prevent bacterial contact with surgical wounds into the human body. This is the current development direction of hospital infection control construction.
3. Clean operating room standards
The construction of clean operating room belongs to the specialty field of hospital building and heating and ventilation technology. Many national standards and norms have been established in this field in China. For example: JCJ4988 "General Hospital Architectural Design Code", FL0106 YFB001-1995 "Military Hospital Clean Operating Department Building Technical Code", Clean Room Construction and Acceptance Code"and so on.
The latest clean operating room standard is GB50333-2002 "Building Technical Specification for Hospital Clean Operating Department" (hereinafter referred to as "Specification") promulgated and implemented by the Ministry of Construction last year. The new Code strictly stipulates and requires the definition, composition, cleanliness grade, cleanliness method, architectural design, technical indicators, construction and acceptance of clean operating room. It also stipulates medical gas, distribution, water supply and drainage, fire protection, and even basic facilities and equipment (such as shadowless lamps, operations) in clean operating room. Beds, viewing lights, walkie-talkies, etc. are also specified in detail. According to the specifications, the operating rooms are divided into four categories according to the degree of sterility or sterility of the operation (see Table 1):
Table 1 Classification of operating rooms
Grade Operating Room Name Grade Suitable for Operating Type
I. 100 Joint Replacement, Organ Transplantation and Heart Surgery in Special Clean Operating Room
II Standard Clean Operating Room 1000 Chest, Abdomen, Bone, Liver, Gallbladder, Pancreas and Plastic Surgery
III. General Clean Operating Room 10000 General Surgery, Gynecology and Obstetrics
IV Quasi-clean operating room 300,000 intestinal perforation, peritonitis, tuberculous abscess and other operations
The cleanliness level of operating room is basically classified according to NASA classification standard. For example, the standard of 100-level laminar flow operating room should be less than 100 dust particles per cubic foot of air greater than 0.5lxm, or less than 3.5 dust particles per liter of air, and the standard of our country should be less than 3500 dust particles per cubic meter; the standard of 1000-level laminar flow operating room should be less than 3.5 dust particles per liter of air. The number of dust particles greater than 0.5 GM in square foot air should be less than 1,000, or less than 35,000 per cubic meter of air, and so on.
As a biological cleanroom, it is actually classified by bacterial concentration, emphasizing that cleanliness is the necessary guarantee for reducing bacteria. According to the concentration of sedimentation bacteria in the operating area, the operating area of Class I operating room should be no more than 0.2/30rain, _90 dishes (5/cubic meters), corresponding Class II operating room should be 0.75/30rain, _90 dishes (25/cubic meters), m operating room should be 2/30min, _90 dishes (75/cubic meters), IV operating room should be 5/30rain and_90 dishes (175/cubic meters). The relevant definitions and standards can be referred to in the Specification. For the acceptance and inspection methods and procedures of the clean operating room project, the specifications also make clear and detailed requirements.
4. Operation room layout
The principle of plane layout of operating room makes the function flow reasonable and the cleanliness streamline distinct (see Fig. 1), so as to reduce cross infection, organize air purification system effectively and economically satisfy the cleanliness quality. According to the successful examples of foreign operating rooms and the requirements of the "Specification", the operating rooms should be laid out according to the principle of three areas and two channels (i.e. operation area, auxiliary area, other room areas, clean and quasi-clean walkway). Before and after operation, personnel and aseptic articles should pass through the clean walkway, and after operation, dirt should pass through the dirt passageway, so as to clean and separate the dirt. After the operation, the contamination can be treated in time and the possibility of cross contamination can be fundamentally reduced.
Reasonably arrange the flow of people and logistics, so that the streamline is short and convenient for the activities of medical personnel. Only in this way can we improve efficiency and effectively prevent cross-infection. The layout of the building should be concise, and the flow of people and logistics should not be too complicated. Otherwise, the staff will abandon the use, such as free walking, more likely to cause pollution.
5. Aseptic Design of Operating Room
The aseptic design of operating room involves all aspects of building and decoration, such as indoor decoration requirements, sterilization methods, automatic control of facilities, etc. But the key is to clean the air in the operating room. The operating environment of the hospital must adopt the air cleaning technology. No ordinary air conditioner can be directly used in the operating room.
The technical requirements of air-conditioning systems for different levels of operating rooms, air distribution in clean rooms and technical selection of air-conditioning equipment and components are described in detail in the Code.
Clean operating room construction and use is very expensive, each simple and clean operating room should adopt an independent set of purification air conditioning units, purification system has at least three-stage air filtration, ceiling centralized air distribution rate is greater than 0.75, ventilation times 20-36 times per hour, the average air speed of 100-level laminar flow operating room working face should reach (0.2). 5-0.35) m/s, 60 m3/h minimum fresh air, noise, pressure, temperature and humidity requirements and so on, all rely on huge power consumption to support. The higher the cleanliness, the higher the construction cost, operation cost and energy consumption. Therefore, the construction of clean operating room should fully consider the operation economy and clinical effectiveness, and whether it needs to build a high-cleanliness control space, such as one-way laminar flow clean operating room should be thoroughly and carefully demonstrated.
It should be recognized that there are many ways to cause infection, mainly through contact, not air. Air purification measures only have potential advantages in preventing infection, and can not guarantee that patients will never be infected. Often, the more sterile the area and the stricter the management of the operating room, the more likely the patient will be infected by direct contact or improper sterile operation of the doctor. Therefore, strengthening the comprehensive aseptic control and management and formulating the whole process and all-round safeguard measures are also important work in the construction of aseptic operating room.
6. Maintainability Principle
In the application of advanced clean operating room, it is unavoidable to face various construction projects such as facility maintenance and upgrading, medical equipment installation and so on. How to isolate the construction operating room effectively so as not to affect the work of other rooms is also a problem that must be considered in the design of the operation department. As long as one operating room needs to be constructed in the old-fashioned design, the whole aseptic system will be destroyed and the whole operating department will not be able to carry out its work. As we all know, the hospital operating room work schedule is very full, it is difficult to arrange a whole period of time for maintenance construction. We have had the experience of hanging a large screen monitor in a clean operating room, destroying the sealed ceiling and installing the hanger because of the need. A simple project has gone through three weeks before and after, and the actual working time is less than one day. Therefore, how to ensure the maintainability in future use is also an important factor in the success of operating room design. The construction of new clean operating room should adopt new wall and decorative building materials as far as possible, which not only reduces the occupied area of wall, but also facilitates the installation and construction of air duct and various water, electricity, gas pipelines and radiation protection. In the future, maintenance and repair can also reduce construction dust and garbage, improve work efficiency and reduce interference and impact on clinical work.
According to the successful experience of operating room construction at home and abroad, it is very effective and necessary to set up technical interlayer in operating room. Although this will occupy a floor area, it is very advantageous for installing and arranging many supply and return air pipelines and various water, gas, electricity and communication pipelines. It is also convenient for installing independent or shared equipment units in clean rooms at all levels. At the operation level, there is no need to reserve a considerable area of rooms and so on, so as to increase the use of operating room area. Efficiency, shorten streamline length. It reduces the complexity of operation room ceiling construction, most of the equipment maintenance work can be carried out in the interlayer, thus reducing the impact on the operation room work.
7. Medical equipment in operating room
With the development of medical technology, more and more medical equipments are used in operation, especially in large-scale operations such as heart, brain and organ transplantation. Not only is the sterile environment highly demanded, but also there are many equipments used in operation. In addition to basic equipments such as electric operating table and shadowless lamp, electric knife, anesthesia, monitoring system and microsurgery are also used. Mirror, cardiopulmonary bypass system, defibrillator, blood examination and analysis system, infusion device, autologous blood recovery equipment, X-ray imaging equipment, as well as video teaching system, information system and so on, all need to work in the operating room at the same time.
Reasonable arrangement of equipment and distribution of power supply is the basis for safe application of equipment. At present, most of the operating room equipment in our country is placed on various trolleys. When working, these equipment revolves around the operating table, and only the machine power cord will spread all over the place. With the development of new medical technology and new business, all kinds of new instruments will continue to increase. Take surgical cutting tools as an example, from ordinary scalpel to high-frequency scalpel, then to argon scalpel, high-frequency plasma scalpel, laser scalpel, ultrasound scalpel, high-pressure water jet scalpel, as well as frozen scalpel and high-temperature surgery. Knife and so on, all kinds of surgical tools have unique functions and functions, and the application of new tools can not replace and eliminate the original tools. Therefore, the new operating room should consider hanging and installing some commonly used equipment to reduce the confusion of the operating room floor.
In the past, we seldom considered the installation of equipment suspension. The main reason is that it is difficult to install and needs civil construction in the operating room. This is because the construction of the operating room did not take into account the need for suspension installation equipment, and therefore did not design the necessary installation structure and facilities. If these considerations are taken into account, the ceiling of the operating room is equipped with a high-strength section steel every 65 cm or so. A wide LCM groove is exposed below the section steel for the installation of the equipment in the operating room, two flanks for the installation of the ceiling, and the section steel is covered with the ceiling, as shown in Figure 2 (where the groove is not used, check with PVC buckle or tape for sealing). First).
With rigid ceilings, the suspension installation of any equipment becomes easier. We can easily install slides. The equipment is installed on the trolley, pulled over when used, pushed aside when not used, and the electrical wiring goes to the ceiling without dragging up and down on the ground. For example, common electrosurgical scalpel, monitoring equipment, operating microscope, medical gas and power supply can be suspended and installed to reduce the ground pipeline in the operating room, so as to facilitate the access and placement of some mobile devices such as X-ray machines.
The construction of rigid large ceiling may be a little more expensive, but it is not a luxury compared with the overall cost of clean operating room. At present, it may be more difficult to supply profiled steel. In this paper, it is hoped that the metallurgical industry in China can develop profiled steel to meet the needs of suspension installation as soon as possible.
8. Power Supply System of Operating Room Equipment
Isolated power supply is a recognized standard for instruments in operating room. Isolated power supply should have safety monitoring and alarm devices. The problem is that with the increase of indoor equipment, power consumption is also increasing. Especially high-power equipment such as some lasers and X-ray machines put forward higher requirements for power supply. The interference between electrical equipment connected to the same power supply must be carefully considered. Each operating room supplied by an isolated transformer can not meet the future. In application, the power supply of high-power equipment should be separated from that of other equipment, independent isolation transformer should be used, and the power socket in operating room should also be marked clearly to indicate different power supply units.
Due to the use of three-phase power supply for individual high-power equipment, it is possible to reserve some three-phase power supply wiring boxes in the operating room or corridor, with power above 20 kW, for future application. Otherwise, it is difficult to find high-power power supply in the clean operation area, which will affect the development of some business.
A common problem in practical application is that all operating room indoor power supply uses the flat three-socket single-phase socket standard in China, while most imported equipment is equipped with European plugs. When the new machine arrives, it will either change the plug or match the wiring board, which will reduce the security of the power connection. China has become an important market of medical devices in the world. We should also establish our own technical standards. The power wiring of imported medical appliances must conform to China's specifications and requirements. Its products are registered in China and conforming to the national standards should be one of the market access conditions. It is hoped that relevant departments will attach importance to this issue.
9. Operating room information system, PACS, etc.
At present, the development of medical imaging technology is very rapid. Various kinds of three-dimensional imaging technology provide abundant tools for the formulation of surgical plan and the guidance of surgical process. It can be imagined that in the near future, conventional X-ray, CT or MRI still images can no longer meet the needs of doctors, because they want to see dynamic and rotating three-dimensional images, so it will be sooner or later to configure a three-dimensional image workstation in the operating room. Stereotactic devices and surgical navigation systems that are now in clinical use require hospitals to provide patients with three-dimensional CT or MRI images. Therefore, from the development point of view, the operating room must be the most important user of hospital PACS system. Regardless of whether the hospital has established PACS system or not, the construction of computer network must not be neglected in the new operating room. Every operating room should reserve network interface.
In addition, with the increasing use of interventional tools and artificial implants, the need for intraoperative X-ray examination is also increasing. Large surgical departments will be equipped with multiple digital mobile C-arm X-ray machines for intraoperative fluoroscopy. C-arm X-ray system can obtain real-time image immediately and take any angle photography. It is efficient. For patients who only need temporary photography, because C-arm X-ray system occupies a large area when working, it is not convenient to push and push in the operating environment, it still needs to be completed by a relatively compact mobile camera.
Intraoperative photography is still solved by bedside photography in radiology department in most hospitals. Its work flow is slow and its efficiency is low. With the popularization of CR and DR technology, it is possible to equip large-scale surgical departments with mobile camera equipment and CR or portable sub-board DR system. If the local CR/DR system is used in intraoperative photography, the image can be obtained immediately after the photography, which greatly improves the efficiency and shortens the operation time.

10. Digital Control of Operating Room
In addition to medical instruments, the clean operating room itself is a complex electromechanical equipment operated by electricity. The air conditioning system alone needs to monitor and control the temperature, humidity, pressure, ventilation, fresh air volume and other parameters of each operating room, and maintain the pressure difference in different clean areas. Clean operating room should strictly control the flow of personnel, so it is necessary to establish a sound internal communication system, and even consider installing a full-field television surveillance system to monitor every operating room in an all-round way. In view of the need of demonstration teaching and consultation of operation, the operation camera (or the head lamp camera worn by the chief knife doctor) should be equipped on the shadowless lamp. It should be necessary equipment for the new operating room (it can be installed on demand, but the line must be embedded in advance). All these information need to be centralized controlled and displayed. Therefore, it is necessary and inevitable trend for technology development to have a central control room (or nurse station) with a TV wall and a row of control computers in modern operating rooms. The control center can centralize the control and management of air conditioning, lighting, image and operation information. In addition, the comprehensive information management of operating room also faces the operation arrangement, personnel scheduling, equipment disinfection, storage and consumption management, as well as the whole process record management of each operation (time, personnel, anesthesia, drug and equipment consumption, operation information release), and so on. This series of complex processes also need to be managed by computer. Incorporate into Hospital Information System (HIS). All of these put forward new requirements for the quality and composition of personnel in the operating room.
11. Environmental Management of Operating Room
With high standard hardware facilities, perfect management measures must be taken to achieve the desired control objectives. The environmental management of operating room should include the following points: (1) perfect management organization, responsibility to people; (2) strict management of personnel flow and logistics; (3) strengthen the hygiene, cleaning and disinfection of operating room; (4) work procedure management of purification equipment, etc.
Errors in any link will destroy the whole sterile environment of the operating room, which will not only not reduce infection, but also increase indoor pollution. From this point of view, management should be more important than construction, without strict management, how high standards of operating room construction will not achieve the effect of reducing infection.
In addition to restrictive management measures, the humanized design of operating room (color and lighting design, environmental background music, patient care measures, etc.) can activate the operating room atmosphere, reduce the tension of patients, and make the medical staff work in a relaxed environment to improve the efficiency of the operation. Help.
In a word, the construction of operating room involves the development of many disciplines and all aspects of hospital. When we decide to build a high standard operating room, we should first make clear what we want to achieve with our money. Only with clear objectives can we carry out the work of scheme design, investment, monitoring and management, and make the construction of high-standard operating rooms really contribute to the improvement of hospital medical level.
Laminar Flow Purification Operating Room
Laminar Clean Operating Room and Laminar Clean Ward Requirements:
Air cfu/m3:<10
Surface cfu/cm3:<5
Hand cfu/cm3: <5 for medical staff
With the continuous improvement and improvement of modern hospital conditions, environment and medical quality, laminar flow equipment has gradually been equipped and applied in the operating room. The following is a brief introduction to the use and experience of laminar flow operating room in our hospital.