Feasibility of medical radioisotope production based on the proton beams at China Spallation Neutron Source

The utilization of a proton beam from the China Spallation Neutron Source(CSNS)for producing medical radioisotopes is appealing owing to its high current intensity and high energy.The medical isotope production based on the proton beam at the CSNS is significant for the development of future radiopharmaceuticals,particularly for theα-emitting radiopharmaceu-ticals.The production yield and activity of typical medical isotopes were estimated using the FLUKA simulation.The results indicate that the 300-MeV proton beam with a power of 100 kW at CSNS-II is highly suitable for proof-of-principle studies of most medical radioisotopes.In particular,this proton beam offers tremendous advantages for the large-scale production of alpha radioisotopes,such as 225Ac,whose theoretical production yield can reach approximately 57 Ci/week.Based on these results,we provide perspectives on the use of CSNS proton beams to produce radioisotopes for medical applications.

Cytotoxicity Tests for Evaluating Medical Devices: An Alert for the Development of Biotechnology Health Products

The risks and damages related to the use of products, technologies and services of sanitary interest can be due to defects or manufacturing failures. Certain products already contain a certain degree of risk, which requires strict quality control in their production, distribution and use, as well as in the disposal of their waste in the environment. With continuous development in science and technology, medical devices must undergo intradermal irritation and testing for sensitization, cytotoxicity, and acute systemic toxicity. In health care, biotechnology aims to provide technology-based products or processes related to energy, food, and health, which are capable of stimulating new businesses, expanding exports, integrating the value chain and stimulating new demands for innovative products and processes, taking into account health policies. The present article was prepared by a bibliographical survey of the electronic databases PubMed, Lilacs, and Bireme. Cell culture testing can be successfully employed, as it is reproducible, rapid, sensitive, and financially accessible for performing in vitro toxicity testing. Thus, it has been possible to optimize the development phase of new products by decreasing animal use or even replacing them in certain tests. Some in vitro assays validated by the Organization for Economic Cooperation and Development in the area of health products have already replaced animal testing.

Medical Products Supply Chain and Its Information System Design

This paper introduces the supply mode of medical products, and analyzes the development trend of medical products supply enterprise in China. From the aspects of basic management, resource integration and database design, we put forward the design concept of the informationization of the supply chain system of medical products in China. The information system can ensure the precision and rationality of the supply of medical products, and provide high-quality services and service efficiency, and meet the different needs of different customers.

National Medical Products Administration: The Product Claiming Using “Cosmeceuticals” or “EGF” Was Illegal

To avoid confusion between the concepts of cosmetics and cosmeceutical, most countries in the world do not advocate the concept of cosmeceutical at the legal level. In part of areas, some products in the category of drugs or quasi-drug have the use purpose of cosmetics at the same time, but these products should meet the regulatory requirements of drugs or quasi-drug. So there are no cosmeceutical products that are solely managed according to cosmetics regulations. On January 10, 2019, the National Medical Products Administration issued the Answers to Frequently Asked Questions on Cosmetics Supervision and Administration (1)(hereinafter referred to as Answers (1)), clarifying the regulatory attitude towards the concepts of cosmeceutical, cosmeceutical products and medical skin care products, and pointing out that the claim of cosmeceutical is illegal.

A review on rules for examination of licensing criteria for producing foods for special medical purpose in China

In this paper,the background,principles,and main contents of the rules for the examination of production licenses of foods for special medical purposes are introduced.The contents including general rules,production sites,equipment facilities,equipment layout,technological process,personnel management,management system and supplementary rules are interpreted item by item.This study has important value and historical significance for promoting the development of Chinese enterprises and industries of foods for special medical purposes.

Association between medical resources and the proportion of oldest-old in the Chinese population

The potential association between medical resources and the proportion of oldest-old(90 years of age and above)in the Chinese population was examined,and we found that the higher proportion of oldest-old was associated with the higher number of beds in hospitals and health centers.

Recommended Medicinal Plants as Source of Natural Products:A Review

Natural product is one of the sources of drugs in pharmaceutical industry,and one of the notable origin of natural product is the medicinal plants.Medicinal plants tend to cure some certain diseases and could be a source for potential drugs.The Department of Health of the Philippines approved 10 medicinal plants namely Allium sativum(Garlic/Bawang),Blumea balsamifera(Nagal camphor/sambong),Cassia alata(Ringworm bush/akapulko),Clinopodium douglasii(Mint/yerba Buena),Ehretia microphylla(Scorpion bush/Tsaang Gubat),Momordica charantia(Bitter Melon/Ampalaya),Peperomia pellucida(Silver bush/ulasimang Bato),Psidium guajava(Guava/Bayabas),Quisqualis indica(Rangoon creeper/niyug-niyogan),and Vitex negundo(Five-leaved Chaste Tree/lagundi).The review was conducted to show that these medicinal plants are capable in treating infections and some diseases.It was found that Allium sativum for the treatmet of wounds,hypertension and tootache;Blumea balsimifera is effective in diuretic treatment for hypertension;Cassia alata for the treatment of scabies,fungal infection,athlete’s foot,tinea flava,ringworm;Clinopodium douglasii for the treatment of muscle pain,arthritis,rheumatism,cough,headache;Ehretia microphylla for the treatment of diarrhea and stomachache;Momordica charantia for the treatment of diabetes mellitus;Peperomia pellucida for the treatment of gout and rheumatism;Psidium guajava for the treatment of wounds and diarrhea;Quisqualis indica for anti-helmintic medicine;and Vitex negundo for the treatment of cough,asthma,and fever.In conclusion,these 10 medicinal plants have natural products that can be used as source for potential drugs.However,there are still many species of ethnobotanical plants that are not yet investigated thoroughly and might be a source for potential drugs.Therefore,more investigations should be done in other species of plant,most especially for the plants with practical used.

Linking Competitors’ Knowledge and Developing Innovative Products Using Data Mining Techniques

In this article, the relationship between the knowledge of competitors and the development of new products in the field of capital medical equipment has been investigated. In order to identify the criteria for measuring competitors’ knowledge and developing new capital medical equipment products, marketing experts were interviewed and then a researcher-made questionnaire was compiled and distributed among the statistical sample of the research. Also, in order to achieve the goals of the research, a questionnaire among 100 members of the statistical community was selected, distributed and collected. To analyze the gathered data, the structural equation modeling (SEM) method was used in the SMART PLS 2 software to estimate the model and then the K-MEAN approach was used to cluster the capital medical equipment market based on the knowledge of actual and potential competitors. The results have shown that the knowledge of potential and actual competitors has a positive and significant effect on the development of new products in the capital medical equipment market. From the point of view of the knowledge of actual competitors, the market of “MRI”, “Ultrasound” and “SPECT” is grouped in the low knowledge cluster;“Pet MRI”, “CT Scan”, “Mammography”, “Radiography, Fluoroscopy and CRM”, “Pet CT”, “SPECT CT” and “Gamma Camera” markets are clustered in the medium knowledge. Finally, “Angiography” and “CBCT” markets are located in the knowledge cluster. From the perspective of knowledge of potential competitors, the market of “angiography”, “mammography”, “SPECT” and “SPECT CT” in the low knowledge cluster, “CT scan”, “radiography, fluoroscopy and CRM”, “pet CT”, “CBCT” markets in the medium knowledge cluster and “MRI”, “pet MRI”, “ultrasound” and “gamma camera” markets in the high knowledge cluster are located.

Integrated Product Development in Rhinoplasty:A Case Study

The 3D simulation in preoperative design for nasal plastic surgery was studied to help patients see the postoperative effects and reduce medical disputes.The study developed and clinically tested an innovative design for surgical guides for nasal plastic surgery,which showed positive results in patient satisfaction and accuracy in achieving the preoperative simulated effect.The study also investigated the process of designing and producing nasal prostheses and how patient feedback could be obtained using third-party social media voting.Patient satisfaction information was collected and evaluated using the Likert scale,and the data statistical analysis was carried out with the SPSS19.0 software.More than 94.1% of the patients were satisfied with the postoperative results.The study provides a good reference case for the integration of knowledge and skills from the medicine,design,and engineering fields in the development of medical devices.

对103家三级公立医院医疗设备配置现状的调查与分析

目的:调查103家三级公立医院医疗设备配置现状,分析比对我国不同区域医院的医疗设备占比,为科学合理地配置医疗设备提供依据。方法:采用文献研究和专家咨询法设计调查问卷,通过“中国医学装备”公众号和“好医工”平台发布电子问卷进行调查,分析医疗设备配置数量、国产占比与医院所在区域及医院床位数的相关性。结果:共回收有效问卷103份,涉及华东、华北、华中、华南、西南、西北和东北的103家三级公立医院,其中华北占18%,华东占37%,华南占19%。华北、华南和华东3个样本区域三级公立医院医疗设备配置的平均台件数为9785台/家、9245台/家和8153台/家,甲乙类设备配置数量较少,与床位数无相关性;华北与华东在床位数、每百张床设备台件数以及每百张床设备金额上差异有统计学意义(t=-2.582、2.939、4.653,P<0.05);生命支持类设备配置数量均与床位数有显著正相关,国产占有率尤其是生命支持类设备的国产占有率有所提高。结论:分析我国公立医院医疗设备配置情况,可为医院更好地适应新版甲乙类大型医用设备目录的调整提供数据支撑,为三级医院在大型医用设备配置和国产化的示范推广提供参考依据,为相关卫生管理部门提供借鉴。

面向创新创业的智能医学工程实习教学探索

以实践教学体系为基础,依托实践教学基地,采用“两面向三结合”的教学模式,并贯通式地融入课程思政元素。“两面向三结合”是指面向创新创业素质培养,在理论培训中将技术原理与企业运营知识相结合;在实践过程中将车间实习和项目研究相结合;在实习中将理论培训与实践过程相结合。教学实践表明,该实习教学方法有利于增强学生的动手能力,提高学生的创新能力,强化学生的创业意识,培养学生的职业精神,达到了预期效果。

Evaluation of the Antimicrobial Activity of Endophytic Fungus Isolated from <i>Cocos nucifera</i>(L.) Cotyledon against Medically-Important Pathogens

The study aimed to evaluate the endophytic fungi isolated from Cocos nucifera (L.) cotyledon for their possible antimicrobial activity. A total of twelve endophytic fungal species were successfully isolated, from which five were selected and presumptively identified, including Aspergillus niger, Raffaelea sp., Aspergillus flavus, Cladosporium sp. and Pseudallescheria spp. based on their macro and microscopic characters. The agar blocks of actively growing pure culture were assessed for antibacterial activity against five human pathogenic bacterial and fungal strains: Escherichia coli (BIOTECH 1634), Bacillus subtilis (BIOTECH 1697), Staphylococcus aureus (BIOTECH 1592), Serratia marcescens (BIOTECH 1748), and Candida tropicalis (BIOTECH 2085). Among the selected five endophytic used for antimicrobial activity screening, the Raffaelea sp. (CN-EF 2) has shown a high zone of inhibition of 11 mm against Bacillus subtilis, 18 mm against Escherichia coli, 15 mm against Staphylococcus aureus, and 11 mm against Candida tropicalis. Correspondingly, Aspergillus niger (CN-EF 1) has shown a zone of inhibition of 16 mm against C. tropicalis. The endophytic fungus Raffaelea sp. was effective against all test organisms except for Serratia marcescens, while Aspergillus niger was only effective for pathogenic fungi C. albicans. Hence, further in-depth studies of the isolated endophytic fungi are needed to determine the mechanisms behind the endophytes’ inhibitory effects.

生命周期评价方法在医药领域的应用现状与研究进展

生命周期评价(life cycle assessment,LCA)方法可以系统识别和评估不同产品与工艺之间的环境问题,确定污染物排放量并最大限度地减少产品和工艺过程中的环境影响。相比于基础大宗化工产品,医药化学品及中间体通常比较复杂,所带来的环境影响更大,通过生命周期评价可以量化分析医药领域中产品全生命周期过程造成的潜在环境影响,以支持医药领域“双碳”目标发展。本文简述了生命周期评价方法的四个步骤:目的和范围的确定,生命周期清单分析,生命周期影响评价和生命周期解释。并在此基础上,从药物生产、医疗器械、医疗服务三方面综述了生命周期评价在医药领域的应用现状和研究进展,指出了现有的医药生命周期评价研究所存在的一些问题,如研究相对较少、数据收集困难,尤其是药物中间体结构复杂、生命周期上游清单数据缺失,以及数据质量不高、生命周期影响评价方法不统一等。最后,针对未来医药领域生命周期评价发展提出相关建议。

产教融合培养应用型口腔医学人才的对策

本文旨在分析产教融合培养应用型口腔医学人才的重要性与对策。通过构建校企协同育人平台、整合临床资源进行教学改革,完善奖学金等奖励机制,培养全面性口腔医学人才,多方合作建立医学生教学资源系统,产教融合毕业实习,校企共同实施创业教育,组建创业指导团队、校企合作构建质量保证机制等,培养应用型口腔医学人才,可以培养适应社会需求、适应高等教育改革新形势、满足口腔医学行业的现实需要。产教融合培养应用型口腔医学人才,有利于更好地促进口腔医学人才的培养,可以组合提高医学生在毕业实习中的工作效率,使医学生的实践活动与临床实践活动实现无缝衔接,从而提高医学生的实践积极性。

临床科室运用成本因素分析法开展医用低值易耗品节流管理实践

目的探讨临床科室运用成本因素分析法开展医用低值易耗品节流管理的效果。方法2022年8月—12月,科室运用成本因素分析法开展低值易耗品节流管理,2023年1月—6月持续观察和评估应用效果。统计一次性注射器(2mL、5mL、20mL)、PVC手套、一次性静脉输液针、一次性止血带及输液胶贴等低值易耗品管理数据,计算人员成本分摊、成本消耗量,统计合理成本结余量。结果运用成本因素分析法实施低值易耗品管理后,价格相同医用低值易耗品合理结余成本共677.22元人民币,价格不同医用低值易耗品合理结余成本共2015元人民币。结论临床科室运用成本因素分析法开展医用低值易耗品节流管理,可减少消耗量,增加合理成本结余,减少科室成本消耗,合理节约医疗资源,强化医务人员节流管理意识,推动科室精细化管理。

基于光学定位的三维超声引导肌肉注射仪设计研究

目的解决光学定位技术在引入肌肉痉挛治疗的注射手术应用中,光学定位设备与现有医用超声仪器之间的不适配问题,旨在进一步提升理论定位精度稳定性,简化必需操作并降低实际应用难度。方法在现有超声仪及相关设备功能基础上,结合光学定位设备工作条件需求进行需求分析,重新构建产品元件功能流模型并映射为网络节点,并基于复杂网络节点重要度评价方法,确定目标产品设计重心点并分层设计,最后采用仿真验证测试设计合理性。结果实验结果符合预期假设,目标节点所对应功能元件与其它节点的相关性程度与目标元件所需兼容连接的复杂度呈正相关。基于实验得出能够适配光学定位仪与超声设备的设计方案,有效解决二维超声导航引导肌肉注射所面临的不直观、不可视等问题。结论基于复杂网络节点的重要度评价方法更适用于复杂功能产品的设计研究,评价结果重要度差异更为显著。

新质生产力视域下医学院校“Python”课程思政融入策略与实践

在新质生产力背景下,医学院校“Python”课程既要关注技术的传授,更要关注培养学生的思想政治素养、实践精神和创新能力。从Python在医学领域的应用出发,文章结合医学院校的专业特点和科研方向,以培养和提高医学生的实践能力及创新能力为目标,不仅制定了不同的培养计划,还根据核心能力培养方向对课程结构、课程设计、教学案例、评价体系等进行了优化,在传授学生知识技能的同时,融入了思政教育元素,可有效提升学生的综合素质和医学人文精神。教学实践证明,这些优化策略提高了学生解决实际问题的能力和创新能力,可助力发掘与培养具有医工融合能力的学生团队,为培养德才兼备的优秀医学人才提供了有力支持。

面向用户需求的移动医疗检测产品服务设计

突发性公共卫生事件频繁发生,目前针对智慧医疗在卫生检测中的研究集中于实验结果环节,对过程环节的服务设计研究少之又少,探索医疗如何结合新技术去应对突发性公共卫生事件、更好地为用户服务为研究目的。通过对不同用户的深入调研,明确产品机会缺口,经过量化分析得到用户关键需求,确定具体设计目标,建立智慧医疗检测交互系统平台及服务流程,最后完成服务系统平台的软硬件载体设计。为实现不同用户需求的医疗检测产品提供方向,也为应对公共卫生事件提供思路。

区域医疗器械发展态势分析——以粤港澳大湾区与长三角地区产业集群为例

目的 客观分析粤港澳大湾区和长三角地区医疗器械发展态势,评估各城市产业布局和发展水平,为国家、区域产业规划和政策制定提供参考。方法 从宏观区域、中观城市和微观产品布局3个层面定量分析并对比两区域医疗器械营收、企业和产品情况。结果 粤港澳大湾区和长三角地区是我国医疗器械集群发展区域,产业规模和营收位居全国前列,呈现明显的上升趋势。其中,深圳市、上海市、苏州市等城市医疗器械企业分布集中,生产第二类、第三类医疗器械的企业占比较高,且有较高的企业活跃度和新注册产品数量。粤港澳大湾区在体外诊断试剂(In Vitro Diagnostic Products,IVD)、医用软件、医用成像器械等方面的生产优势显著,长三角地区的产品布局在IVD、医用成像器械、治疗器械和高分子医用材料方面较为密集,区域内各城市之间形成一定互补。结论 两区域医疗器械发展优势明显,继续加强政策引导和科技、金融投入,激励产业产品持续提质升级,基于本地优势实现区域差异化互补,以及充分利用区位优势是两区域医疗器械产业可采取的发展策略。

深圳推广实施UDI促“三医联动”新发展的实践思考

自2019年以来,医疗器械唯一标识(UDI)推广应用工作正在全国范围内分阶段、分步骤实施。深圳市先行先试,严格按照国家和省市相关政策要求落实相关工作,在UDI政策、标准、技术和应用等多个层面进行了探索,以标准先行、行业宣贯、企业培训、平台应用全方位建设医疗器械追溯体系,UDI的推广实施已取得实质性成效。深圳市形成“一个平台支撑,两个端口发力,三个部门联动,四个标准指引”的工作模式,搭建全省首个UDI追溯平台并于2021年10月14日正式上线启用,以UDI编码为关键信息,采集医疗器械的生产、流通和临床使用信息,为落地实施UDI工作提供技术支撑、精准监管和智慧监管。该平台现已通过数据接口等方式采集了来自深圳400余家制造商的8万多种产品(UDI-DIs),深圳30余家甲级三级医院的100余万条临床患者使用信息。目前,深圳市正以UDI追溯平台作为推动UDI实施工作的实际“抓手”,有序扩大UDI实施企业范围,增加医疗机构试点,丰富数据对接方式。本研究总结了深圳市UDI推广实施过程中遇到的挑战以及应对策略和方法,梳理了深圳市推广UDI实施的成效做法,旨在以推广UDI工作为契机,形成推动“三医联动”应用示范效应和可复制的经验总结,为全面实现深圳市医疗器械全生命周期精准追溯和深圳市医疗器械产业高质量发展贡献力量。