Modern trends and achievements in the development of devices and apparatuses for medical research and pratical medicine

Conclusion Analysis of general trends in the development and use of medical devices demonstrates an increasingly growing progress in new generations of various devices and apparatuses. This progress is based on both achievements of fundamental biomedical sciences and high technology, which provide the opportunity of obtaining promising diagnostic and therapeutic results. Domestic medical industry lags behind industrialized countries, particularly in the development of sophisticated devices based on high technology. This is particularly true in case of X-ray systems and devices for laboratory diagnosis. Taking into account specific features of health service in Russia, the main emphasis in supply of domestic medical organizations, hospitals, polyclinics, etc., should be place on production of domestic manufacturers and domestic service infrastructure. In our opinion, the most effective way to overtake the situation is to establish joint ventures with leading foreign manufacturers and to provide substantial support Russian companies producing sophisticated medical and diagnostic devices (e.g., as state order). Reported at the scientific meeting at the Division of Biomedical Sciences, Russian Academy of Medical Sciences. All-Russian Scientific-Research Institute for Medical Instrument Engineering, Moscow. Translated from Meditsinskaya Tekhnika, No. 6, pp. 3–11, November–December, 1997.     

机器人在骨科手术中应用的可靠性与提升空间

背景:骨科手术机器人是一种集医学、电子信息学、机械物理学等多学科、多领域为一体的新型医疗器械,是当代医学信息化、程控化、智能化的一个重要发展方向,在骨科手术中有着安全可靠性与广泛的应用前景。目的:探讨机器人在骨科手术中的应用可靠性及提升空间。方法:以中文检索词"机器人,骨科,手术,精准度"和英文检索词"Robot,Orthopedics,Surgery,Accuracy"分别检索CNKI数据库、维普数据库、万方数据库和PubMed数据库自建库至2019年6月的文献。根据入选标准保留49篇文献,对手术机器人应用于骨科手术的关键问题进行综述。结果与结论:①目前对骨科手术机器人的研究较多,方法较成熟,但是国内手术机器人的研究相对于发达国家还处于初级阶段;②骨科手术机器人技术正朝着人机智能化、图像精细化、形态精微化、手术无创化、远程可控流畅化等方向发展;③推动自主研发骨科手术机器人产品、全方位制定行业规范和临床标准,将是中国智能医疗器械及设备发展的重要导向。     

Clinical pathology accreditation: standards for the medical laboratory

This article describes a new set of revised standards for the medical laboratory, which have been produced by Clinical Pathology Accreditation (UK) Ltd (CPA). The original standards have been in use since 1992 and it was recognised that extensive revision was required. A standards revision group was established by CPA and this group used several international standards as source references, so that the resulting new standards are compatible with the most recent international reference sources. The aim is to make the assessment of medical laboratories as objective as possible in the future. CPA plans to introduce these standards in the UK in 2003 following extensive consultation with professional bodies, piloting in selected laboratories, and training of assessors.     

The role of the user within the medical device design and development process: medical device manufacturers' perspectives

Background  

Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so.     

mHealth data security: the need for HIPAA-compliant standardization

The rise in the use of mobile devices, such as smartphones, tablet personal computers, and wireless medical devices, as well as the wireless networks that enable their use, has raised new concerns for data security and integrity. Standardized Health Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant electronic data security that will allow ubiquitous use of mobile health technologies is needed. The lack of standardized data security to assure privacy, to allow interoperability, and to maximize the full capabilities of mobile devices presents a significant barrier to care. The purpose of this article is to provide an overview of the issue and to encourage discussion of this important topic. Current security needs, standards, limitations, and recommendations for how to address this barrier to care are discussed.     

Editor's Choice

In this first issue of volume 24, you will notice that the formatof Human Reproduction has been altered dramatically, bringingit very much in line with today's standards of publishing. Thisis the first major change in the journal's format since volume1, published in 1986. This ‘cosmetic surgery’ wasmade possible by excellent collaboration between our publisherOxford University Press and the Editorial teams of the threeESHRE Journals. The facelift was also approved by the ExecutiveCommittee of the Society. We like the changes and     

穿戴式颈椎康复设备研究现状与趋势

颈椎康复设备广泛应用于康复科、推拿科等科室,用于各类颈椎病的治疗,有效减轻了医护人员的体力负担,极大地丰富了医生的治疗手段。该文首先简述了颈椎病的分型、治疗方法及其机理;其次,概述了颈椎康复设备的作用机制,并根据驱动方式、作用机理等对市面上现有的颈椎康复设备进行了分类,将其分为六大种类;再次,针对穿戴式颈椎康复设备的国内外研究及发展现状进行了详细介绍与总结;最后,对穿戴式颈椎康复设备未来6个方面（增加牵引维度及模式、提升柔顺性、提升人机耦合性、提升穿戴便携性、加深与传统医学的融合、加快产业化落地）的发展趋势进行了展望。     

Croatian Medical Journal introduces culture, control, and the study of research integrity

Culture, control, and the study of research integrity represents the future goals of the Croatian Medical Journal. This article will highlight research integrity as experienced in the USA by the Office of Research Integrity (ORI) and discuss the framework being developed in Croatia. First, the Croatian Medical Journal seeks to promote a research culture that is aware of research integrity. This will be accomplished through the education and training of Croatian researchers interested in publishing their results in international scientific journals. To facilitate this goal, the Croatian Medical Journal introduces, what it believes to be, the first Research Integrity Editor. Second, the Croatian Medical Journal intends to facilitate the development of an Office of Research Integrity based on ORI model. The Croatian office of research integrity would be authorized to develop regulations to define scientific misconduct, investigate, and develop administrative actions against those found to have committed scientific misconduct. Furthermore, the office would be responsible for developing national education standards for promoting research integrity and the responsible conduct of research. Third, the Croatian Medical Journal is developing a science-based research agenda. This new research agenda will examine topics similar to those presented recently at the first Research Conference on Research Integrity held in Bethesda, Maryland, USA (November, 2000). The initial research topics would include studying those variables and mechanisms that help to promote research integrity and honorable research practices. This Editorial represents the first step towards achieving this goals, by establishing a collaborative relationship between ORI and the Croatian Medical Journal.     

实用新型腹腔内循环热灌注系统的研制及其应用

目的研制一种新型腔内循环热灌注系统并进行初步临床应用，以解决国内热灌注化疗设备入腔内水温高、灌注流量低的问题。方法利用心脏手术体外循环装置，即人工心肺机的单一滚压泵，变温水箱的升温部分，组合成腔内热灌注机。热灌注系统由一次性腔内热灌注装置和灌注机组成，其中热灌注装置包括热灌注插管、灌注环路、腹腔压力监测管路、储液器、变温器。热灌注机由灌注泵、变温水箱、温度、压力和时间监测仪组成。通过20例腔内循环热灌注化疗的临床应用验证此系统是否达到设计要求。结果该腔内循环热灌注系统人腔内水温≤43℃时腹腔内流出体外的水温41．5～42．7℃，灌注流量2000～3000mL／min。结论该实用新型一次性腔内热灌注化疗装置和热灌注机符合国际热灌注化疗标准，实用、安全、方便、有效，适合临床推广应用。     

Les biopuces destinées au diagnostic médical in vitro : avant, pendant et après le marquage CE

Among its missions, Afssaps survey innovating products in the field of in vitro diagnostic, with in particular the biochips. The medical purpose intended by the manufacturer is the key point in determining if a product comes within the scope of the directive 98/79/EC on in vitro diagnostic medical devices (IVDMD). The essential requirements described in Annex I of this directive must be followed to affix CE marking. Thus, the free movement of IVDMD is ensured in the European community either after a self-declaration or after a certification by a notified body for particular devices. Thus, DNA probe devices (known as microchips) used in genetic screening are IVDMD and must be marked CE according to the directive 98/79/EC if the purpose is a medical one. This directive will evolve according to technological and clinical progress. At the European and International level, standards or guidelines could be proposed to the manufacturers for CE marking because these new devices present new technologies and a large extent of medical applications. In Afssaps, measures were taken to survey and to follow innovation, with for example the creation of an IVDMD expert working group. Futhermore, a new structure for innovating projects is set up for an accompaniment of the innovation.     

Bioengineering the Skin–Implant Interface: The Use of Regenerative Therapies in Implanted Devices

This discussion and review article focuses on the possible use of regenerative techniques applied to the interfaces between skin and medical implants. As is widely known, the area of contact between an implant and the skin—the skin–implant interface—is prone to recurrent and persistent problems originated from the lack of integration between the material of the implant and the skin. Producing a long-term successful biointerface between skin and the implanted device is still an unsolved problem. These complications have prevented the development of advanced prosthetics and the evolution of biointegrated devices with new technologies. While previous techniques addressing these issues have relied mostly on the coating of the implants or the modification of the topology of the devices, recent in vitro developed techniques have shown that is possible to introduce biocompatible and possibly regenerative materials at the skin–device interface. These techniques have also shown that the process of delivering the materials has biological effects on the skin surrounding the implant, thus converting bioinert into bioactive, dynamic interfaces. Given that the best clinical outcome is the long-term stabilization and integration of the soft tissue around the implant, this article presents the basis for the selection of regenerative materials and therapies for long-term use at the skin–device interface, with focus on the use of natural biopolymers and skin cell transplantation.     

国内外医学人文教学方法比较

随着医学教育改革的深入,国际范围内医学人文课程的教学方法在不断创新和变革。积极借鉴国外医学人文教学新方法、新观念对于推进国内医学人文教育有着积极作用。本文对英美两国几所主要高等院校的医学人文课程教学方法与国内几所院校进行了对比,试图探讨在医学人文教育方面可以借鉴和思考的地方。     

A Workflow for Ensuring DICOM Compatibility During Radiography Device Software Development

In medical devices, nonconformance with Digital Imaging and Communications in Medicine (DICOM) standard is a serious risk. DICOM nonconformance radiology devices could cause undetected image loss, increasing examination time, and costs in health centers and could even result in the wrong patient treatment. However, there is a rich literature on medical standards that identify the best practices for producing safe and effective medical software. However, these standards do not expressly provide tools to deal with all the relevant DICOM compatibility issues in a specific case. This study aims to introduce a systematic software development workflow that complies with medical standards and ensures DICOM conformance of a new or upgraded radiology software project. In this approach, DICOM conformance gets the highest priority, and the whole software project is organized around it. Software requirement analysis, risk evaluation, and test management tasks are arranged systematically to make the final device DICOM conformant. This conceptual framework was developed during the R&D work towards a novel radiography device, and it could be employed as a roadmap in other medical imaging software projects. The proposed methodology controls the DICOM compatibility risk of the final software, and its systematic evaluation complied with medical standards.

     

Diffusion of Novel Healthcare Technologies to Resource Poor Settings

A new product has completed clinical trials in a distant, resource poor hospital using a few dozen prototypes. The data looks great. The novel medical device solves a widely felt problem. The next goal is to integrate the device into the country’s healthcare system and spread the device to other countries. But how? In order to be widely used, the device must be manufactured and distributed. One option is to license the intellectual property (IP) to an interested third party, if one can be found. However, it is possible to manage the manufacturing and distribution without licensing. There are at least two common means for manufacturing a novel medical device targeted to resource poor settings: (a) formal (contract) manufacturing and (b) informal (local) manufacturing. There are three primary routes to diffusion of novel medical devices in the developing world: (1) local distributors (2) direct international sales and (3) international donations. Perhaps surprisingly, the least effective mechanism is direct importation through donation. The most successful mechanism, the method used by nearly all working medical devices in resource-poor settings, is the use of contract manufacturing and a local distributor. This article is written for the biomedical innovator and entrepreneur who wishes to make a novel healthcare technology or product available and accessible to healthcare providers and patients in the developing world. There are very few documented cases and little formal research in this area. To this end, this article describes and explores the manufacturing and distribution options in order to provide insights into when and how each can be applied to scale up a novel technology to make a difference in a resource poor setting.     

比较中外高等教育以完善我国医学教育评估体系

建立与国际接轨的高等医学教育评估体系,对提高我国高等医学教育的质量具有重要作用.本文对国内外高等教育评估的目的 、评估体系的比较和对各国评估体系的特征进行了分析,对完善我国建立合理、公正的高等教育评估具有重要的参考意义.     

Blood compatibility of polymers:in vitro andin vivo tests

Synthetic materials used for medical prostheses and devices, mainly those which will come into contact with blood, have to provide for specific properties. Three in vitro blood-compatibility tests are presented; one is a screening method (m.t.e.g.) whose results show remarkable correlations to in vivo behaviour, the other two (Nosé-blood-chamber, protein adsorption) yield more basis information on synthetic surfaces. Aspects of toxicity and biodegradation should be included in the definition of ‘blood compatibility’. After preselection by in vitro tests, a material has to pass an in vivo examination in animal experiments (shunt, catheter, tube, test chamber) under haemodynamic conditions. Finally, devices or prostheses in their intended shape, such as the total artificial heart, are implanted in animals.     

医学情报信息跨平台数据整合的应用研究

本文结合国内外医学专题数据库的实际情况,面对目前网络信息量异常庞大,信息检索中遇到的困难,分析了在异构数据库和不同的操作平台环境中,专题数据库整合问题,提出了应用数据融合技术、数据仓库技术等,实现医学情报检索精、准、快、全。重点论述了医学专题数据库整合的建设思路和实现跨库检索的方法。     

Direction or inertia: the future for regulation of surgical implant devices.

The time has arrived when certain standards are to be introduced to control the introduction of and appropriate use of surgical implant devices. Now is the time for the professional groups involved in standards and medical device legislation to become active and develop surgical implant device standards to be applicable for the future. A commission could be established to work with FDA in respect to the requirements for surgical implant devices. It is time for the clinical organizations involved in writing consensus standards to cooperate in the introduction of surgical implant device standards.     

国内外定制式增材制造医疗器械监管法规概述及对行业发展的思考

目的 概述国内外定制式增材制造医疗器械监管法规,分析医疗器械监管科学研究对增材制造医疗器械行业发展的意义,以期能够为生产企业及监管机构未来的工作提供参考。方法 该文通过对国内外关于定制式增材制造医疗器械监管法规及注册体系进行分析,剖析定制式增材制造医疗器械监管法规及注册体系的创新发展对于我国医疗器械行业发展的拉动效应。结果 美国、欧盟、澳大利亚、加拿大、中国均已建立定制式增材制造医疗器械监管法规及注册体系,给出了定制式医疗器械的定义,明确了定制式医疗器械临床使用和上市后监管的要求,但各国间还存在一定的差异,使得各国对于定制式医疗器械的监管模式也稍有差异,建立医疗器械科学监管模式将推动增材制造医疗器械行业发展。结论 构建基于精准风险控制的评价监管体系,加强监管人员、审评人员与科研、医疗人员间的相互协同作用将有助于定制式增材制造医疗器械科学监管模式的构建。     

Policy Interoperability in Stem Cell Research: Demystifying Harmonization

Scientific developments in the field of stem cell research continue to emerge at incredible speed and so too has the contentious debate surrounding their broad implications. Though economic, socio-ethical and legal concerns remain, at both national and international forums; we are witnessing a departure from an “embryo-centric” approach, to one that is focused on the globalization of research and to the ensuing need for policy interoperability. The common response to the challenges associated with the meaning, scope, and ethical significance of variance in national policies, is a call for the creation of uniform legal and ethical standards. However, this call towards policy convergence on the fundamental ethical and governance principles underpinning policies choices has led to confusion and to the mystification of the notion of harmonization. In this article we aim demystify the notion of policy harmonization in the context of stem cell research. We will do so by surveying the diverse elements to be harmonized. We will then present the problems of policy interoperability in the context of the globalization of SC research, in order to propose that the goal of harmonization in this field lies in the identification of prospective strategies to foster seamless cross-jurisdictional collaboration. Finally, policy interoperability will be analyzed through the lens of a range of policy approaches addressing the cross-jurisdictional transfer of hESC lines with the aim of demonstrating that the apparent ethical-political-legal divide in some contexts largely vanishes once we grasp the notion of harmonization and identify points of convergence.