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.

Evolving market-shaping strategies to boost access to essential medical products in developing countries with HIV self-testing as a case study

The COVID-19 pandemic has exacerbated health inequities among countries in the Global South with limited access to essential medical products,leading to a higher infection and mortality rate,especially among vulnerable populations.Despite tremendous progress in global health financing,the estimated annual financing gap in developing countries is projected to reach US$371 billion per year by 2030.Therefore,developing market-shaping strategies is of great importance in ensuring adequate supply,affordable prices,and equitable access to essential medical products in low-and middle-income countries.We propose a strategic and appropriate market-shaping intervention framework for governments,international organizations,and NGOs to maximize access to essential medical products in developing countries.In the health field,we believe that market shaping strategy could be defined as a set of purposeful activities that market forces may intervene with to advance the development,production,supply,and distribution of global goods for health,making essential medical products more affordable,accessible,innovative,sustainable and quality assured.We argue that when designing a market-shaping strategy,policy or decisionmakers must take full advantage of the key drivers to keep the market dynamic,interactive,and constantly evolving to meet the unmet medical needs.In addition,different forms of market-shaping interventions are determined by objectives and specific issues to be addressed.More comprehensive market shaping strategies,including the strategic use of market expansion,market disruption,market maintenance,and market contraction alone or together,deserve to be explored and key stakeholders are also expected to join forces to make the intervention more efficient and productive.

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.

数字新质生产力赋能城乡公共医疗服务均等化:理论逻辑、现实问题和实践路径

贯彻落实共同富裕的基本目标,需要解决我国城乡公共医疗卫生体系不平衡、不充分的现实问题,建设更加公平、可持续、高质效的公共医疗服务保障体系。在数字时代背景下,如何运用数字新质生产力赋能城乡公共医疗服务实现上述目标,急需理论探索和实践响应。数字新质生产力能够利用技术嵌入建立底层支撑实现要素创新,通过范式搭建促进管理优化实现质效提升,推动生态构建促进创新链、产业链、人才链三链交互实现数字公共医疗服务和农村经济协同发展,从而持续赋能城乡公共医疗服务均等化。基于创新需求驱动力不足的技术突破瓶颈、数字脱钩与数字鸿沟的管理优化堵点、两大领域三链脱嵌的模式升级困境,需要准确把握数字新质生产力赋能城乡公共医疗服务均等化的实践路径,以制度激励与治理并举加快数字医疗和数字农业双领域产学研政协同,以补短固强与兼顾少数促进多维度数字应用水平提升,以共同契约与模式推广打造多层次医疗供给体系,实现城乡公共医疗服务的机会均等、水平均等和结果均等。

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.

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.

加速器生产重要医用放射性同位素及应用概况

随着核科学技术的快速发展,医用放射性同位素在核医学中发挥着越来越重要的作用,被广泛应用于心脑血管、肿瘤等疾病的诊断和治疗。利用加速器生产医用放射性同位素,具有灵活高效、系统安全、活度高等优势,是确保医用放射性同位素安全、稳定供应的重要生产方式之一。2021年,国家八部门联合发布《医用同位素中长期发展规划(2021-2035)》,明确了我国到2035年前需要重点发展的重要医用同位素有14种,其中9种同位素均可以由加速器生产。本文主要介绍了规划中列出的9种重要医用同位素的加速器生产和应用概况。规划中加速器生产的显像核素主要有^(123)I、^(124)I、^(64)Cu、^(68)Ga、^(89)Zr,治疗核素有^(186)Re、^(103)Pd、^(225)Ac、^(223)Ra。其中,^(225)Ac、^(68)Ge、^(223)Ra是中高能加速器进行同位素生产的重点,也是加速器生产放射性同位素主要的发展趋势。本研究分别对上述诊断和治疗核素的核性质、用途、反应截面及产额、生产方式等进行综述,以期为相关核素生产提供参考。

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。

法律视野下基本医疗服务拟制公共产品属性及国际实践

基本医疗服务本质上是私人产品。健康权入法使基本医疗服务转化为拟制公共产品,而非公共产品或准公共产品。基本医疗服务区别于非基本医疗服务是基本医疗服务成为拟制公共产品的前提,健康从个人事务上升为国家法律义务是基本医疗服务成为拟制公共产品的主要依据,分级诊疗是国家履行被拟制为公共产品的基本医疗服务义务的具体表现。美、英、俄、德等典型国家的立法实践为我国对作为拟制公共产品的基本医疗服务实行全民医保基础上的政府供给提供了可借鉴经验。

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。