In order to regulate the clinical application of radioactive particle implantation therapy, to ensure medical quality and medical safety, this specification is developed. This specification is the minimum requirements for medical institutions and their physicians to carry out radioactive particle implantation therapy technology. This specification refers to the radioactive particle implantation therapy for malignant tumors, except for the radioactive particle implantation therapy for oral and maxillofacial malignant tumors.
The scope of application covered by this specification includes: solid tumor imaging (B ultrasound, CT, MRI, etc.) guided radioactive particle implantation, transendoscopic (including laparoscopy, thoracoscopy, natural tube endoscopy, etc.) radioactive particle implantation, surgical direct vision radioactive particle implantation.
First, the basic requirements of medical institutions
Medical institutions to carry out radioactive particle implantation treatment technology should be appropriate to their functions and tasks.
Tertiary hospitals or oncology hospitals, with health administrative departments approved registration of surgery, oncology, interventional or minimally invasive treatment disciplines, with image-guided technology equipment (such as CT, MRI, ultrasound, endoscopy, etc.) and treatment planning system.
Medical institutions must have a license for the use of Class II or higher radiopharmaceuticals issued by the Food and Drug Administration.
Carry out clinical treatment of tumor for more than 3 years, and its technical level reaches the technical standards of the key departments of related specialties in tertiary hospitals and is in the leading position among tertiary hospitals in the province, autonomous region and municipality directly under the Central Government.
Implementation of treatment site requirements
1.Meet the operation site of radiation particle technology and aseptic operation conditions.
2, all image guided technology equipment (CT, flat panel DSA, MRI, ultrasound) with medical imaging image management system.
3, with the necessary emergency equipment and drugs for rescue surgery accidents, all technical operations are carried out under the monitoring of electrocardiography, respiration, blood pressure, pulse rate, oxygen saturation monitoring.
4.With radioactive particle storage and transportation facilities in accordance with national regulations, and by dedicated personnel.
Protective measures are formulated and implemented in accordance with the relevant national radiation protection standards.
There are at least two physicians in the hospital who have the ability to apply radioactive particle implantation technology clinically, and other professional and technical personnel who have been trained in the knowledge and skills related to radioactive particle implantation therapy and are compatible with the technology carried out.
Second, the basic requirements of personnel
Radioactive particle implantation physician
1.Physicians who have obtained the “Physician’s Practice Certificate” and whose scope of practice is related to the technology.
2. Have more than 10 years of clinical experience in interventional oncology, radiation therapy, nuclear medicine, medical oncology and surgical oncology, and have the qualification of deputy chief physician or above.
Treatment plan maker
1.Physicians who have obtained “Physician’s Practice Certificate” and the scope of practice is to carry out the specialty related to this technology.
2.Physicians with more than 10 years of clinical experience in oncology intervention, radiation therapy, nuclear medicine, medical oncology and surgical oncology, or radiation therapy physicist or nuclear medicine physicist, who are proficient in the treatment planning system of this technology.
Other related health professionals and technicians
After radioactive particle implantation related professional system training and assessment qualified.
Third, the basic requirements of technical management
1.Strictly abide by the operation specification of tumor treatment technology and treatment guidelines, according to the patient’s condition, the physician in charge of the patient, the radioactive particle treatment physician and the treatment plan maker should formulate the treatment plan, treat the patient according to the disease, treat reasonably, and strictly master the indications and contraindications of radioactive particle treatment.
2.Pre-operative radioactive particle treatment plan is strictly formulated, and post-operative treatment plan verification and evaluation are carried out according to the operation specification.
3.Before the implementation of tumor radioactive particle implantation treatment, patients and their families should be informed of the purpose of surgery, risks of surgery, postoperative precautions, possible complications and preventive measures, and sign the informed consent form.
4.Establish a sound system of follow-up after tumor radioactive particle implantation treatment, and follow up and record according to regulations.
5.Establish the system related to the procurement, storage, use and recycling of radioactive particles in accordance with the regulations of radioactive substances management of relevant state departments, and establish the registration file of radioactive particles use.
6.Establish emergency plans for radioactive particles left behind, lost, leaked, etc.
7, medical institutions and physicians in accordance with the provisions of the regular radioactive protection training, environmental assessment.
8, medical institutions and physicians in accordance with the provisions of the regular assessment of the clinical application of radioactive particle implantation therapy technology capabilities, including case selection, surgical success rate, serious complications, drug complications, the occurrence of medical errors, post-operative patient management, patient survival quality, follow-up and quality of medical records.
Other management requirements
1. Use radioactive particles approved by the drug supervision and management department.
2. Establish a registration system for radioactive particles inbound, inventory and outbound to ensure the traceability of the source and destination of radioactive particles. Retain the relevant qualified documents of radioactive particles in the inpatient medical records of patients treated with this technology.
3. shall not violate the reuse of disposable medical equipment related to radioactive particles.
4. Strictly implement national price and financial policies and charge according to regulations.