Composition of the Clean Operating Department
3.1.1 Operating Department
The operating department is composed of several operating rooms together with an auxiliary area consisting of auxiliary rooms serving the operating rooms; the rooms in the auxiliary area can be further divided into those directly or indirectly serving the operating rooms. Functional rooms directly serving the operating rooms, such as the sterile dressing storage room, anesthesia room, hand-scrubbing room, (disinfected) instrument storage room, preparation room, and nurses' station, are undoubtedly indispensable; rooms indirectly serving the operating rooms, such as offices, conference rooms, teaching observation rooms, and duty rooms, are also needed. According to the overall requirements of the hospital, functional rooms directly serving the operating rooms may be equipped with clean air-conditioning systems and serve as clean auxiliary rooms, and they should be located within the clean area.
The latest versions of standards in the United Kingdom, Japan, and other countries all address the design of negative-pressure operating rooms for infectious diseases. Since simple and effective means such as adjusting the exhaust air volume or adding exhaust fans can be adopted, a clean operating room can be changed from positive pressure to negative pressure, which expands the uses of clean operating rooms.
3.1.2 Clean Operating Department Specified in China's Architectural Technical Code for Hospital Clean Operating Department
Its composition is as follows:
(1) Clean operating rooms are shown in Table 3.1.
Table 3.1 Clean Operating Rooms
| Class | Operating Room Name | Surgical Incision Category | Suggested Applicable Surgeries |
|---|---|---|---|
| Ⅰ | Special Clean Operating Room | Ⅰ | Aseptic surgeries such as joint replacement, organ transplantation, and aseptic surgeries in neurosurgery, cardiac surgery, and ophthalmology |
| Ⅱ | Standard Clean Operating Room | Ⅰ | Class I incision aseptic surgeries in thoracic surgery, plastic surgery, urology, hepatobiliary-pancreatic surgery, orthopedic surgery, and general surgery |
| Ⅲ | General Clean Operating Room | Ⅱ | Surgeries in general surgery (excluding Class I surgeries), obstetrics and gynecology, etc. |
| Ⅳ | Quasi-Clean Operating Room | Ⅲ | Anorectal surgery and contaminated surgeries, etc. |
(2) Negative-pressure operating rooms are applicable in the following situations:
- Emergency surgeries in which, under emergency conditions, the patient cannot undergo hygienic processing.
- Surgeries involving special infections.
- Emergency surgeries for infectious diseases transmitted via the air route that must be rescued on-site.
When infectious diseases are present or when performing surgery on patients with infectious diseases, the management measures for infectious diseases should be followed, a negative-pressure clean operating room should be established, and an independent air-conditioning system and exhaust system should be adopted, or a clean operating room with convertible positive/negative pressure should be used.
[Reference] According to relevant Japanese standards (see Part Three), the operating room for infectious diseases is explained as follows:
① The operating room for infectious diseases must ensure a clean area of cleanliness Class Ⅱ (according to the Japanese operating room classification, with an airborne bacterial concentration below 200 CFU/m³).
② In surgeries on patients with tuberculosis, measles, or chickenpox, the room must be maintained at negative pressure. In such cases, it is desirable to provide a clean anteroom to prevent contaminated outdoor air from flowing in. In addition, for surgeries on patients with blood-borne sources of infection such as HIV-positive individuals, hepatitis B and C, and syphilis, maintaining positive pressure also poses no problem.
③ The air-conditioning system of the operating room for infectious diseases should preferably be a separate independent system for each room. (3) Clean auxiliary rooms are shown in Table 3.2.
Table 3.2 Main Clean Auxiliary Rooms
| Grade | Room Name |
|---|---|
| Ⅰ | Special laboratory requiring aseptic operation |
| Ⅱ | Extracorporeal circulation perfusion preparation room |
| Ⅲ | Scrub room Preparation room① Pre-anesthesia room Storage room for disposable items, sterile dressings and instruments, and precision instruments Nurses' station Clean corridor Intensive care unit (ICU) |
| Ⅳ | Anesthesia awakening (recovery) room Cleaning corridor |
① Used for disinfection treatment.
(4) Non-clean auxiliary rooms. Non-clean auxiliary rooms shall be provided in the non-clean area of the clean operating department as needed and in accordance with the provisions of relevant standards.
[Reference]
① Operating rooms are roughly divided into five categories according to the degree of sterility: Category 1 operating rooms correspond to Grade Ⅰ clean operating rooms, i.e., sterile purification operating rooms, where deep major operations such as neurosurgery, cardiac surgery, organ transplantation, total joint replacement, ophthalmic surgery, and skin grafting for large-area burns are performed; such operations must not involve any infection-causing factors, otherwise the consequences would be extremely serious. Category 2 operating rooms correspond to Grade Ⅱ clean operating rooms, i.e., general sterile operating rooms, for operations such as splenectomy, nephrectomy, pneumonectomy, and open reduction of closed fractures; in such operations the external conditions are sterile, but during the operation infection may occur due to internal factors. Both of the above two categories are aseptic operations, with Category 1 aseptic operations having even higher requirements. Grade Ⅲ clean operating rooms are applied to operations such as gastric, gallbladder, and appendiceal operations; although the wound itself is already infected, the operation is still performed under aseptic conditions. Category 4 operating rooms are applied to contaminated operations where the wound is already severely suppurated and infected, such as suturing of perforated duodenal ulcer, surgery for appendiceal perforation with peritonitis, and incision and drainage of tuberculous abscesses and abscesses. The third and fourth categories are customarily called septic operations. Category 5 operating rooms are negative-pressure operating rooms, applied to infectious operations, such as operations on patients with Pseudomonas aeruginosa wounds, gas gangrene, and tetanus; such patients carry bacteria themselves and are highly infectious, shedding large quantities of pathogenic bacteria and causing serious pollution to the environment. Such operations have a relatively large impact on the surroundings, so isolation is required, and the air-conditioning system should also be set up separately.
② The composition of the clean operating department (operating room unit) given in Part 4 of the German standard DIN1946 is shown in Table 3.3.
③ Regarding incisions.
(i) Class Ⅰ incisions (aseptic incisions). Class Ⅰ incisions are aseptic incisions, i.e., incisions that, with adequate preparation, can be made to appear sterile as clinically required. Incisions of thyroid operations, simple hernia repair, open reduction of closed fractures, and craniotomy belong to Class Ⅰ incisions.
(ii) Class Ⅱ incisions (potentially contaminated incisions). Class Ⅱ incisions are potentially contaminated incisions, i.e., incisions that, by the nature of the operation, may be contaminated. Subtotal gastrectomy, appendectomy, colon and rectal operations with preoperative bowel preparation, cholecystectomy, pneumonectomy, scrotal and perineal operations, re-opening of recently healed incisions, traumatic wounds within 6 hours, and incisions sutured after primary surgical treatment belong to Class Ⅱ incisions.
(iii) Class Ⅲ incisions (contaminated incisions). Class Ⅲ incisions are incisions in which tissues adjacent to the infected area are directly exposed to infectious matter. Duo- duodenal ulcer perforation suturing, surgery for appendiceal perforation with peritonitis, strangulated hernia surgery, incisions from excision and suture of tuberculous abscesses or sinus tracts, and surgical incisions communicating with the oral cavity, etc. — Class Ⅲ incisions.
The classification of incisions and the grading of incision healing are not the same concept.
Table 3.3 Composition of the Clean Operating Department in the German Standard
| No. | Name |
|---|---|
| 1 | Class A operating rooms requiring a high degree of sterility |
| 2 | Class B operating rooms requiring a general degree of sterility (including emergency operating rooms) |
| 3 | Sterile supplies storage room |
| 4 | Sterile supplies corridor |
| 5 | Scrub room |
| 6 | Pre-operative and post-operative lounge |
| 7 | Instrument room |
| 8 | Operating room corridor |
| 9 | Instrument preparation room |
| 10 | Sterile dressing room |
| 11 | Recovery room |
| 12 | Airlock room for patients |
| 13 | Airlock room for materials |
| 14 | Airlock room for waste |
| 15 | Changing room |
| 16 | Other rooms |
3.1.3 Scope of Applicable Surgery
According to the provisions of the document Hospital Classification and Grading Management, the scope of applicable surgery for each department of hospitals at each grade is as follows:
(1) The surgical content of third-class hospitals is as follows:
Major hepatectomy, complex biliary tract reconstruction, total gastrectomy, surgical treatment of severe intra-abdominal organ trauma.
Surgery for cerebral arteriovenous malformations, emergency treatment of brainstem injury, evacuation of various intracranial hematomas, stereotactic removal of intracranial foreign bodies or ablative procedures, application of microsurgical techniques in craniocerebral surgery.
Autologous kidney transplantation or allogeneic kidney transplantation, adrenal surgery, percutaneous nephroscopic stone removal, transurethral resection of the prostate, total cystectomy.
Open-heart surgery under extracorporeal circulation, coronary artery bypass grafting, management of complex thoracic organ injuries, tracheobronchoplasty, prosthetic vascular grafting.
Artificial joint replacement, limb replantation surgery, arthrodesis, management of complications of severe orthopedic trauma, cervical and lumbar intervertebral disc surgery.
Allogeneic skin fenestration with autologous skin inlay, management of visceral complications of burns, burn treatment, chemical burn treatment.
Vitrectomy, intraocular lens implantation, corneal transplantation, removal of intraocular foreign bodies.
(2) The surgical content of second-class hospitals is as follows:
Subtotal gastrectomy, removal of intrahepatic bile duct stones, partial left hepatic lobectomy, treatment of acute massive gastrointestinal hemorrhage, surgical treatment of severe pancreatitis, percutaneous transhepatic cholangiography (PTC) technique.
Amputation, arthrodesis, surgery for complex open fractures, tendon injuries of the hand, limb replantation, bone and joint tuberculosis sur- surgical treatment, treatment of spinal and spinal cord injuries, artificial joint replacement surgery.
Debridement for open craniocerebral trauma; rescue and treatment of severe traumatic brain injury.
Repair of bladder and urethral injuries, prostatectomy, transurethral cystolithotripsy, ureteral tumor resection.
Emergency treatment of thoracic surgical emergencies, partial pericardiectomy, pulmonary lobectomy, artificial cardiac pacemaker implantation.
Skin harvesting and grafting techniques of various types, skin grafting and transplantation techniques, management of visceral burn complications, diagnosis and treatment of respiratory tract burns, management of deep electrical burns, diagnosis and treatment of burns, diagnosis and treatment of bacteria, fungi, and infections of wounds.
Ophthalmology: management of ocular trauma, management of keratitis and corneal ulcers, cataract extraction and eyeball enucleation, removal of intraocular foreign bodies.
(3) The surgical procedures of Class I hospitals are as follows:
Capable of performing early management and emergency treatment of trauma. Diseases and injuries such as chronic appendicitis, small-area burns (frostbite), and venomous snake bites. Capable of performing general trauma management such as hemostasis, suturing, bandaging, and fracture fixation.
Treatment of major common diseases and some emergency cases; capable of admitting diseases such as acute bacterial conjunctivitis, epidemic conjunctivitis, acute tonsillitis, acute suppurative otitis media, and rhinitis. Prevention of blast-induced (noise-induced) deafness.
Capable of admitting diseases such as influenza, measles, mumps, bacillary dysentery, and malaria.
3.1.4 Number, Class, and Size of Clean Operating Rooms in the Clean Operating Department
The number, class, and size of clean operating rooms should be determined according to the nature, scale, level, and financial resources of the hospital. For general hospitals, when Class I clean operating rooms are required, the number of such operating rooms should not exceed 15% of the total number of clean rooms, with at least 1 room; for specialized hospitals, the number of such operating rooms should be determined according to need.