Health Office Medical Administration [2013] 32

The health bureaus of provinces, autonomous regions and municipalities directly under the Central Government (Health and Family Planning Commission) and the health bureaus of Xinjiang Production and Construction Corps:

In order to strengthen the management of dental implantation technology, standardize the clinical application of dental implantation technology, strengthen the medical quality management and control of dental implantation technology, and ensure the medical quality and safety, our committee has organized and formulated the 'Standards for the Management of Oral Implantation Technology' (which can be downloaded from the medical administration section of our committee's website). It is now issued to you. Please comply with it.

Office of the National Health and Family Planning Commission

23 April 2013

The management standard of dental implantation technology is to standardize the clinical application of dental implantation technology, to ensure the medical quality and safety. This specification is a low requirement for medical institutions and their physicians to develop dental implant technology. The term 'dental implant technology' in this code refers to the technique of implanting artificial implants in the oral cavity or maxillofacial region by surgical method, and then restoring dentition defect, missing or maxillofacial organ defect or missing. Oral implant technology can be divided into simple implant technology and complex implant technology. Simple implant technology refers to the implant technology that can be implanted without complex implant technology treatment in the surgical area and then restored. Complex implant technology refers to the implant technology that can be implanted and restored only after one or more of the following treatments in the surgical area, including bone splitting, maxillary sinus floor lifting, immediate repair, alveolar process distraction osteogenesis, functional jaw reconstruction and facial prosthesis implantation. Repair technology, etc. Dental World Report's Oral Policy

Basic Requirements of Medical Institutions

(1) Medical institutions shall carry out dental implant diagnosis and treatment techniques in accordance with their functions and tasks.

(2) Dental diagnosis and treatment subject approved and registered by the health administrative department.

(3) The division of building area and function, equipment, facilities and staffing of houses shall meet the basic requirements of the Basic Standards for Medical Institutions (Trial Implementation) issued by the former Ministry of Health.

(4) The clinic for dental implant surgery shall be an independent clinic. The clinic for dental implant diagnosis and treatment should be equipped with dental implant power system, implant surgical instruments, implant repair instruments and related special instruments besides basic diagnostic and treatment equipment and ancillary facilities.

(5) Have CT imaging diagnostic equipment and diagnostic ability of curved body or jaw.

(6) The disinfection management of the clinic for dental implant diagnosis and treatment shall conform to the requirements of the Technical Operation Specification for Disinfection of Dental Diagnostic and Treatment Instruments in Medical Institutions.

(7) Medical technicians engaged in the use of radiation devices shall hold the Radiation Worker's Certificate issued by the local health administrative department and carry out diagnostic and therapeutic activities in accordance with relevant provisions. Dental World Report's Oral Policy

2. Basic requirements of physicians

(1) Obtain the Medical Practice Certificate, which covers the stomatology specialty.

(2) Oral practitioners with bachelor's degree or above in stomatology are qualified for more than 120 class hours of formal oral implantology course (including implantology practice); or have accumulated more than 40 credits of Class I in the continuing education of oral implantology; or have received education approved by the Ministry of Education at home and abroad (education approved by the Ministry of Education of China). Institutions) can engage in dental implant diagnosis and treatment activities only after they have received dental implant training and study for 3 months and have obtained a certificate of completion.

(3) Doctors who have worked in a professional dental implant department established in a medical institution for more than three years and who are engaged in the clinical diagnosis and treatment of dental implants can be exempted from training.

Basic Requirements for Technical Management

(1) Strictly abide by the relevant technical specifications and guidelines for diagnosis and treatment, and comprehensively judge the treatment measures according to the patient's condition and the optional treatment plan, so as to treat the disease rationally and strictly grasp the indications and contraindications of oral technology. For patients with contraindications of implantation therapy such as systemic diseases or local diseases, implantation therapy should be implemented as appropriate after the improvement of systemic or local diseases. Patients who have indications for implantation therapy and agree to accept implantation treatment should undergo routine X-ray examination and diagnosis of jaws, necessary blood tests and screening for infectious diseases before **** operation.

(2) For patients who have indications for dental implantation treatment and agree to accept implantation treatment, the physician shall fulfill the obligation of informing and sign the informed consent for implantation treatment.

(3) Medical institutions carrying out dental implant therapy activities shall establish and improve the medical records of implant clinics, which shall be written and managed in accordance with the Basic Standards for Medical Records Written by the former Ministry of Health. The medical records of implant clinics shall also include X-ray examination records, surgical records, treatment records, and registration records of materials used (including implants). Re-visit records, etc.

(4) Medical institutions and physicians regularly receive evaluation of clinical application ability and clinical application effect of dental implantation technology in accordance with regulations, including case selection, success rate of operation, serious complications, drug complications, occurrence of medical accidents, patient management after operation, quality of life of patients, follow-up and medical record quality. Quantity, etc. Dental World Report's Oral Policy

IV. Other Management Requirements

(1) Use of materials, instruments and equipment required for oral implantation technology approved by the State Drug Administration.

(2) Establish a registration system for medical equipment of dental implantation technology to ensure traceability of equipment sources. Retain barcode or other combination of interventional medical equipment in surgical records of patients in hospital