Recent Advance of Stainless Steel Used In Non-active Surgical Implantable Medical Device and Regulatory Perspective / 中国医疗器械杂志

Stainless steel has been widely used in non-active surgical implantable medical device of cardiovascular, orthopedics, dental and ophthalmology. In this paper, we mainly focused on development of stainless steel, as well as the material-related standard evolution. We further summarized the recent advancement of stainless steel use in surgical implantable medical device. Insight and regulatory perspective has been further demonstrated.

Comparison Study between the Second and First Editions of ISO/ TS 10974-Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device / 中国医疗器械杂志

ISO/TS 10974 is a general international technical specification (TS) which concentrates on the safety assessment of magnetic resonance imaging (MRI) for active implantable medical devices. ISO/TS 10974 Ed.2 was published in 2018 with substantial revision to Ed.1. To provide a guideline for adopting this recently revised TS in practice, this paper summarized the major changes and analyzed the technical improvements in Ed.2. Moreover, we also discussed current and emerging challenges to MRI safety evaluation remaining in Ed.2. The study revealed the consistency between these two editions with respect to classification of potential patient hazards and testing strategies, whereas Ed.2 has many methodological improvements over Ed.1 in testing methods for RF-induced heating, gradient-induced malfunction, and combined field testing, etc. However, it is still necessary to expand the scope of applicability and to adopt latest research findings into this TS to keep pace with the rapid developments in industry, making it a better guidance in the future.

Study on Electromagnetic Interference Risk of Active Implantable Medical Devices in Multiple Unit Environment / 中国医疗器械杂志

Concerning on the safety risks caused by electromagnetic interference of patients implanted with high-risk active implantable medical devices in the environment of domestic MUs, this study evaluates and focuses on the requirements of electromagnetic compatibility in domestic and international standards for rail transit vehicles, the main mechanism of risks caused by EMI, the actual measurement of environmental data in MUs and the working performance of various active implantables in the compartment. The test results shows that all kinds of active implantable medical device samples works normally in the CRH2A EMU in China, and there is still a large margin between the measured radiation emission in MU and the limit required by the standards.

Advances in Implantable Medical Device Battery / 中国医疗器械杂志

In recent years, active implantable medical devices become a hot spot of the medical device industry. There are still many problems in terms of reliability, capacity and life expectancy because of the subject to material and technical constraints. This review summarizes the development history and current status of the batteries used in active implantable medical devices, and describes the development and problems of zinc-mercury batteries and lithium batteries. The flexible batteries and bio-energy battery and other new battery technology are also expounded. The future of active implanted medical device battery is bound to miniaturization, flexibility, rechargeable direction.

Preclinical immunotoxicity evaluation of implantable medical devices / 医疗卫生装备

The preclinical immunotoxicity evaluation of implantable medical devices was described.Firstly,the guidelines and regulations about the immunotoxicity evaluation of medical devices were summarized.These documents directed the immunotoxicity evaluation of implantable medical devices.Secondly,various aspects concerning the design of the immunotoxicity evaluation experiments were discussed here,including the hazardous effect of potential degradation products,the risk management of medical devices,the tests for interactions,the tests for in vitro cytotoxicity,the tests for local effects after implantation,the tests for irritation and delayed-type hypersensitivity,the tests for systemic toxicity.Thirdly,different types of immune responses with regard to immunotoxicity evaluation were listed and introduced here.In the end,the evaluation of implantable medical devices was expected to be more rigorous in the future.

Preclinical immunotoxicity evaluation of implantable medical devices / 医疗卫生装备

The preclinical immunotoxicity evaluation of implantable medical devices was described.Firstly,the guidelines and regulations about the immunotoxicity evaluation of medical devices were summarized.These documents directed the immunotoxicity evaluation of implantable medical devices.Secondly,various aspects concerning the design of the immunotoxicity evaluation experiments were discussed here,including the hazardous effect of potential degradation products,the risk management of medical devices,the tests for interactions,the tests for in vitro cytotoxicity,the tests for local effects after implantation,the tests for irritation and delayed-type hypersensitivity,the tests for systemic toxicity.Thirdly,different types of immune responses with regard to immunotoxicity evaluation were listed and introduced here.In the end,the evaluation of implantable medical devices was expected to be more rigorous in the future.