Discussion and Concern on Animal Study for Orthopaedic Implantable Devices / 中国医疗器械杂志

In recent years, new orthopaedic implantable devices continue to emerge, which require higher requirements for technical evaluation. Animal study is an important part of the research and development process for the new orthopedic implantable devices, which provides relevant evidence for product design and stereotyping. By introducing the purpose of animal study, and the application of 3R principle (replacement, reduction, refinement) in this field, we summarize the concern on the animal study, in order to provide reference for the development and research of new orthopedic implantable devices and biomaterials. At the same time, the application of evidence-based research methods such as systematic review in the field is introduced, which provides new tools and approaches for the technical review and regulatory science.

Discussion of Application Status and Key Attentions on Registration for Ossicular Replacement Prosthesis / 中国医疗器械杂志

The ossicular replacement prosthesis should have good biocompatibility, stability, easy to install, and excellent sound transmission capacity. In this study, the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures. At the same time, in combination with the current evaluation requirements and evaluation experience, the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products, so as to provide reference for the future work of manufacturers and regulators. The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties, fixation stability, sound transmission characteristics, biological characteristics, and magnetic resonance compatibility.

Analysis of Key Points and Difficulties in Registration Application of Inflatable Bone Expander / 中国医疗器械杂志

With the advantages of inflatable bone expander in the treatment of osteoporotic vertebral compression fractures, the number of applications for registration of such products is increasing. Based on the characteristics of the medical device, this article analyzed and summarized the relevant requirements for the basic information, product performance research, product manufacturing, clinical evaluation, and product instructions that should be focused on the registration application dossiers, as well as comply with the requirements of CMDE. The focus of the registration application for Inflatable Bone Expander should be the standardization of the application dossiers, while the difficulty was the scientific rationality of the research data. Comments and suggestions are provided to relevant practitioners on standardization of registration application dossiers. It may help them to optimize the quality of registration application dossiers while improve the efficiency of registration applications.

Discussion on Clinical Trial Design of Artificial Hip Prosthesis / 中国医疗器械杂志

Recently, the registration of artificial hip prosthesis products increased year by year. In the new version of the provisions for medical device registration, the domestic or import of such products in the registration declaration may need to complete a clinical trial in the country. How to carry out scientific clinical trials of the product design is the common concern of enterprises and clinical trial institutions. To review the guideline and literature concerning registration for artificial hip prosthesis, the focus on clinical trial design of artificial hip prosthesis include clinical inclusion, evaluation standard, sample size. Through the discussion, we hope to provide advice and guidance for clinical trials of this kind of products.

TME or TSD with pelvic autonomic nerve preserving operation for 247 patients with advanced rectal cancer / 肿瘤研究与临床

Objective To investigate effects of rectal cancer to undergo total mesorectal excision (TME)or three space dissection(TSD)with pelvic autonomic nerve preservation(PANP).Methods TME or/ and TSD was applied in 247 Patients with advanced rectal cancer in which 185 cases (74.9 %) underwent PANP(Group P)including TME-PANP(Group Pro)139 cases and TSD-PANP(Group Ps)46 cases.The other 62 cases underwent none-PANP(Group P-)due to tumor invasion.Results There were no death cases for operation inall patients.Group Pm was better than Group Ps in the operation time and the difficulty of proce- dure(P0.05).Conclusion The procedure with TME to preserve pelvic autonomic nerves adapts to the majority of rectal cancer patients.TSD procedure is more complex than TME.Statistically,the survival differ- ence between Patients with TSD and with TME is no defective.The survival time is determined to the tumor's earlier diagnosis and therapy.