Process,Material,and Regulatory Considerations for 3D Printed Medical Devices and Tissue Constructs

Three-dimensional(3D)printing is a highly automated platform that facilitates material deposition in a layer-by-layer approach to fabricate pre-defined 3D complex structures on demand.It is a highly promising technique for the fabrication of personalized medical devices or even patient-specific tissue constructs.Each type of 3D printing technique has its unique advantages and limitations,and the selection of a suitable 3D printing technique is highly dependent on its intended application.In this review paper,we present and highlight some of the critical processes(printing parameters,build orientation,build location,and support structures),material(batch-to-batch consistency,recycling,protein adsorption,biocompatibility,and degradation properties),and regulatory considerations(sterility and mechanical properties)for 3D printing of personalized medical devices.The goal of this review paper is to provide the readers with a good understanding of the various key considerations(process,material,and regulatory)in 3D printing,which are critical for the fabrication of improved patient-specific 3D printed medical devices and tissue constructs.

Using laparoscope to remove an ectopic intrauterine device in the anterior wall of urinary bladder:A case report

BACKGROUND An intrauterine device(IUD)is a contraceptive device placed in the uterine cavity and is a common contraceptive method for Chinese women.However,an IUD may cause complications due to placement time,intrauterine pressure and other factors.Ectopic IUDs are among the most serious complications.Ectopic IUDs are common in the myometrium and periuterine organs,and there are few reports of ectopic IUDs in the urinary bladder,especially in the anterior wall.CASE SUMMARY A 52-year-old woman was hospitalized due to a urinary bladder foreign body found via abdominal ultrasound and computed tomography(CT)examination.The patient had a 2-year history of recurrent abdominal distension and lower abdominal pain,accompanied by frequent urination,urgency,dysuria and other discomfort.Ultrasound examination revealed foreign bodies in the bladder cavity,with calculus on the surface of the foreign bodies.CT revealed a circular foreign body on the anterior wall of the urinary bladder,suggesting the possibility of an ectopic IUD.After laparoscopic exploration,an annular IUD was found in the anterior wall of urinary bladder,and an oval calculus with a diameter of approximately 2 cm was attached to the surface of the bladder cavity.The IUD and calculus were successfully and completely removed.The patient recovered well after surgery.CONCLUSION Abdominal ultrasound and CT are effective methods for detecting ectopic IUDs.The IUD is located in the urinary bladder and requires early surgical treatment.The choice of surgical method is determined by comprehensively considering the depth of the IUD in the bladder muscle layer,the situation of complicated calculus,the situation of intravesical inflammation and medical technology and equipment.

Vaginal Testosterone Propionate with Misoprostol Prior to Removal of Intrauterine Devices in Postmenopausal Women

Objective To explore and investigate a new treatment of releasing the risks and pain in removing intrauterine devices （IUD） from postmenopausal women. Methods Totally 240 postmenopausal women who needed to remove IUD were randomly divided into 3 groups. Group A （n =80） were preoperatively treated with 20 g/L vaginal testosterone propionate cod liver oil ointment （1 g/d） over a 2-week span of period, and vaginal misoprostol （200 μg） was one-time used at 2-3 h before operation. Group B （n =80） were treated with oral estradiol valerate （3 mg/d） from 7 d before operation. Other 80 women （group C） were treated with vaginal cod liver oil ointment （1 g/d） over a 2-week span of period before the operation day. The degree of cervical relaxation, operational difficulty, blood loss volume, the length of operation time and visual analogue scales （VAS） were evaluated, also the serum estradiol, testosterone and endometrial thickness were measured before and after medication. Results The degree of cervical relaxation, operational difficulty, blood loss, the length of operation time and VAS in group A were significantly better than those group C （P〈0.01）, whiles its blood loss volume was less than group B （P〈0.05） and there were no significant differences in serum estradiol, testosterone and endometrial thickness before and after medication. Conclusion Preoperative vaginal testosterone propionate combined with misoprostol would reduce the operational difficulties/risks and release the suffering of patients. The study may represent a safe and effective alternative to remove IUD in postmeno- pausal women.

Effects of Copper-Containing Intrauterine Devices on the Endometrium

The use of copper-containing intrauterine devices(Cu-IUDs)is a safe,effective,and long-term contraceptive method.Here,we review the effects of Cu-IUDs on subsequent pregnancy and the morphology,local coagulation function,sensitivity to estrogen and progesterone,cell proliferation,and immune response of the endometrium.Studies on the morphology of endometrium indicate that the use of Cu-IUDs can affect the number and binding capacity of estrogen and progesterone receptors in the endometrium and reduce the response of the endometrium to estrogen and progesterone.The use of Cu-IUDs can also affect the proliferation of endometrial cells,suggesting that the aseptic inflammation caused by Cu-IUDs may differ from chronic infectious or noninfectious inflammation;this highlights that the use of Cu-IUDs provides protection against endometrial proliferative diseases.The use of Cu-IUDs increases local endometrial angiogenesis,bleeding tendency,and fibrinolytic activity,which can result in prolonged menstruation or abnormal uterine bleeding.Additionally,the use of Cu-IUDs can cause the infiltration of numerous lymphocytes,monocytes,macrophages,and other inflammatory cells around the endometrial gland and changes in endometrial immune function,immune cell function,and the number and type of immune molecules.Cu-IUD-induced decidual injury significantly increases the invasiveness of trophoblasts,further affecting the aberrant expression of their growth-,angiogenesis-,and invasion-related factors and improving the formation of the placenta.Moreover,the endometrial damage caused by Cu-IUD placement before embryo transfer can improve both clinical pregnancy and live birth rates;however,specific changes in the immune system after Cu-IUD use as well as its effects on future pregnancies require further investigation.

Cytotoxicity of six copper-bearing intrauterine devices on Chinese hamster ovary cells: the influence of frame, shape and copper surface area

Objective To evaluate the cytotoxicity of six commonly used copper-bearing intrauterine devices （Cu-IUDs） on Chinese hamster ovary （CHO-K1） cells and to investigate the influence of frame, shape and copper surface area of Cu-IUDs on cell toxicity.Methods Cu-IUDs were incubated in 10% FBS-DMEM/F12 culture medium at 37 ℃ for 24 h. The extracts were analyzed by flame atomic absorption spectrometer and were then diluted into different concentrations with culture medium. Finally, cytotoxicity of these original and diluted extracts on CHO-K1 cells was detected by cell counting kit-8 （CCK-8） assay.Results The viabilities of cells treated with the original extracts of six Cu-IUDs （TCu220C bulb, TCu220C, GCu220, GCu300, Yuangong Cu270 and Yuangong Ⅱ- 300） were all below 10% and the cupric ion concentrations in these extracts were 28.22 mg/L, 31.80 mg/L, 92.80 mg/L, 99.74 mg/L, 114.90 mg/L and 119.20 mg/L, respectively. After these original extracts were diluted, significant differences in cytotoxicity were exhibited. IUDs with larger copper surface areas （GCu300 and Yuangong Ⅱ-300） showed more cytotoxicity than those with smaller areas （GCu220 and Yuangong Cu270） respectively; When different shapes of Cu-IUDs were compared, TCu220C bulb showed lower cytotoxicity than TCu220C, and GCu300 exhibited higher toxicity than Yuangong Ⅱ-300; TCu220C displayed significantly lower cytotoxicity than GCu220 due to their differences in frames.Conclusion We presented evidence on the cytotoxic effects of copper ions released from Cu-IUDs on CHO-K1 cells and found that shape, frame together with copper surface area of Cu-IUDs had obvious influence on the cytotoxicity.

Postpartum Intrauterine Device: Use and Follow-Up of Users in the Maternity Ward of the Ratoma Communal Medical Center in Conakry, Guinea

Objective: The aim of this study was to describe the use of the postpartum intrauterine device in the maternity ward of the Ratoma communal medical center in Conakry. Methods: This was a descriptive cross-sectional study carried out between July 1st 2015 and June 30 2016, i.e. a duration of one year. Results: A total of 551 patients received advice on various contraceptive methods. Most of this advice was given in the post-partum period (40.2%) and during antenatal care (39.1%). Of the patients advised, 87 (15.8%) used the intrauterine device. The majority of users (93%) were married and uneducated (63.2%), and 39.1% were poor. The majority (56.3%) of intra-uterine devices were inserted in the immediate post-partum period. The majority of women had no adverse events either during the first six weeks (n = 57;65.5%) or at 3rd months (n = 75;86.2%) or 6th months (n = 76;87.4%) after IUD insertion. Most users remained complication-free throughout the follow-up period (n = 76;87.4% at 6th weeks and 3rd months, and n = 77;88.5% at 6th months). The continuation rate was 89.7% at 6 weeks and 3rd months, and 87.4% at 6th months after insertion. The majority of users (87.0%) were satisfied with the care they received. Conclusion: This study showed very few complications among intrauterine device users, and high continuation and satisfaction rates. The intrauterine device is a long-acting, effective, reversible and safe contraceptive that can be used by most women for birth spacing in Guinea, where women do not regularly visit health facilities.

医疗器械临床试验伦理审查意见的综合分析

目的:研究不同注册分类医疗器械临床试验研究中伦理初始审查意见,为今后医疗器械临床试验伦理审查材料准备提供参考。方法:回顾性收集北京首都医科大学附属北京潞河医院伦理委员会2018年至2023年1月医疗器械临床试验伦理初始审查意见,并对问题进行分类,比较不同类型问题在不同注册分类医疗器械临床试验研究中及新版《医疗器械临床试验质量管理规范》颁布实施前后的发生率的差异。结果:合计收集50份伦理初始审查意见,主要集中于与志愿者知情同意及安全和获益相关的问题。两类问题的发生率分别为80.00%和66.00%。同时,两类问题的发生率均在新版《医疗器械临床试验质量管理规范》实施后呈现明显下降趋势。结论:提示相关从业人员在临床试验伦理材料准备的时候一定要把志愿者的权益和保障放在首位,并且不断更新对法律法规的认识,以规范项目的伦理申报。

Research on Patent Situation of Medical Devices in China

Objective To study the patent situation of medical device industry in China based on patent data.Methods The analysis function of the patent search software incoPat was used to analyze the patent situation from two perspectives:The overall situation and the technical level.Results and Conclusion At present,China’s medical device industry is developing rapidly under the leadership of enterprises as the main body of innovation,but only 16%of patents are authorized.In addition,the technology distribution of medical device industry is mainly related to diagnostic,surgical and identification medical devices and implantable devices,accounting for 59%of the main technology distribution,and their technical effects are mainly related to improving convenience,reducing complexity,and improving safety.The quality of patents related to medical device industry in China is low,the technology distribution is not rich enough,and the level of technical efficacy is low.

医疗器械临床试验立项审查环节质量分析及防范策略

立项审查是提高医疗器械临床试验质量的关键环节。通过对立项阶段发现的典型问题以案例的形式进行综合分析。提出,国家药监部门需进一步完善规章制度,申办者应承担临床试验质量管理责任,临床试验机构应建立完善的立项审查机制,研究者应提高规范意识,以保证试验质量和受试者权益。

25岁以下未育女性负压吸宫术后即时放置两种宫内节育器的随机对照观察

目的:观察25岁以下未育女性负压吸宫术后即时分别放置吉妮致美或含药含铜宫型宫内节育器(IUD)的可行性和效果。方法:将自愿要求人工流产的≤25岁未育早孕女性作为观察对象,随机表法分组,分别放置吉妮致美IUD组(195例)和含药含铜宫型IUD组(简称宫药铜组)(196例)。于负压吸宫术后即时放置IUD,随访6个月,观察IUD的使用效果。结果:两组IUD的顺利放置率≥99%。采用生命表法对IUD的终止情况进行分析。两组均无妊娠发生,宫药铜组无脱落相关终止,吉妮致美组脱落相关终止率为2.09/100妇女年,高于宫药铜组(P<0.05)。吉妮致美组因症取出率为0.53/100妇女年,宫药铜组为1.60/100妇女年,但差异无统计学意义(P>0.05)。吉妮致美组和宫药铜组与IUD使用相关的终止率分别为1.60/100妇女年和2.60/100妇女年,两组间差异无统计学意义(P>0.05)。放置IUD后1、3、6个月随访时,吉妮致美组和宫药铜组IUD副作用的主诉率分别为17.3%、13.4%、6.7%和28.7%、29.5%、21.5%,吉妮致美组低于宫药铜组,差异有统计学意义(P<0.01、P<0.001、P<0.001)。结论:年轻未育女性负压吸宫术后即时放置吉妮致美或宫药铜IUD均安全、可行、避孕效果可靠,与宫药铜IUD相比吉妮致美IUD使用后不适主诉更少,需关注放置技术以减少脱落。

医疗脑机接口技术的法律规制

区别于其他大脑神经技术和传统治疗方法,通过脑机接口技术可以传输、解读和记录神经数据。神经数据经过解码不仅可以反映健康信息,还可以揭露思想隐私。另外,脑机接口技术可以通过刺激直接干预患者的情绪、思想、甚至行为。对于医疗脑机接口技术应该适度规制,需要兼顾生命身体健康权和人性尊严法益,神经数据合理利用和隐私保护。具体规.制路径包括:对医疗脑机接口技术研究进行严格的伦理审查,对脑机接口医疗器械进行特殊的审批监管,对知情同意的履行进行特别的程序保障,对神经数据进行专门的立法保护。

基于美欧医疗器械上市后法规要求对我国建立医疗器械警戒制度的思考

本文旨在深入探讨美国和欧盟的医疗器械上市后监管制度,包括风险监管理念、监管法规体系、上市后临床研究、质量管理体系等,总结出开发风险监测工具、落实风险管理、采用合并报告模式、公开风险信息等经验,为我国医疗器械行业有序发展提供参考。我国可以借鉴美欧医疗器械上市后的监管实践,从提高监管机构能力、建设监测哨点和强化法规框架等方面,建立和试点医疗器械警戒制度。

信息化质量追溯系统在消毒供应中心医疗器械管理中的应用效果

目的:探讨信息化质量追溯系统在消毒供应中心(CSSD)医疗器械管理中的应用效果。方法:选取郑州儿童医院CSSD采取常规管理期间(2020年6月至2021年6月)接收的1018件器械为对照组,选取应用信息化质量追溯系统管理后(2021年7月至2022年7月)接收的1018件器械为观察组。比较两组医疗器械管理质量(清洗、灭菌、包装不合格率)及各科室医护人员对CSSD的满意度。结果:观察组医疗器械清洗、包装、灭菌不合格率均低于对照组,差异有统计学意义(P<0.05);各科室医护人员对观察组服务态度、技术水平、器械供应及时性、器械结构功能、器械无菌性等方面的满意度均高于对照组,差异有统计学意义(P<0.05)。结论:信息化质量追溯系统用于CSSD医疗器械管理可提高管理质量,降低医疗器械清洗、包装、灭菌不合格率,提高各科室医护人员满意度,有效保障医疗安全。

某大型综合医院2021—2023年医疗器械不良事件监测及报告分析

目的通过分析某大型综合医院2021—2023年医疗器械不良事件(Medical Device Adverse Event,MDAE)监测情况,为医疗机构在医疗器械安全使用和不良事件监测工作中提供参考和借鉴。方法采用回顾性分析方法,统计分析该院1082例MDAE报告的报告年份、报告天数、审核结果和涉及的医疗器械名称、产地、管理类别、产品类别、产品分类等情况。结果该院近3年上报的MDAE总数和通过率逐年递增,平均报告天数呈下降趋势(P<0.001)。990例有效报告中,国产、Ⅱ类、无源医疗器械的不良事件例数高于进口、Ⅰ类和Ⅲ类、有源和体外诊断试剂(P<0.001);14-注输、护理和防护器械类的不良事件报告最多(P<0.05),以一次性器械断裂、变形或污染和输液泵、注射泵故障为主要不良表现;03-神经和心血管手术器械造成的严重伤害例数最多(P<0.001),主要为导丝和球囊的断裂、变形导致术中植入失败。结论开展采购、入库到临床使用的全流程追溯,将MDAE监测上报纳入科室目标考核,可加强临床科室和医疗器械管理人员联动,提升医疗机构MDAE监测效能。

SPD助力手术室高值医用耗材精细化管理

对生产厂家、供应商、物流公司、设备物资科及手术室进行规范化管理,利用SPD医用耗材管理系统及智能感知柜管理系统,改变原有手术室高值医用耗材逆向物流的模式,建立院内手术室高值医用耗材的正向物流管理模式及追溯机制,以降低临床医用耗材管理工作强度,实现高值医用耗材可视化管理和精细化管理,为医院进行科学合理的宏观调控提供可靠准确的信息,在保证高值医用耗材使用快捷的同时,最大限度地保证手术室高值医用耗材在使用中的安全性及可追溯性。

定位装置对头面部医学摄影一致性的影响

目的:探讨定位装置对整形美容外科头面部医学摄影一致性的影响。方法:于2021年3月,选取志愿者20例作为研究对象,采用自身对照研究法,每位志愿者先使用传统拍摄法拍摄三组照片,每组照片拍摄角度为左、右45°和左、右90°;30 min后,每位志愿者再使用定位装置拍摄法拍摄三组照片,记录每组拍摄时间。通过Image J软件对每组照片进行距离及角度的测量,对两种拍摄方法测量数据的差值及所用时间进行统计学分析。结果:定位装置拍摄法中左、右45°照的角度差,左、右90°照的角度差,以及左、右45°照的距离差均小于传统拍摄法,拍摄时间也明显短于传统拍摄法(P<0.05)。结论:摄影定位装置的运用,大大提升了整形美容外科头面部医学摄影的一致性,使影像资料更加标准、规范,还缩短了拍照时间,提升了工作效率,提高医、护、患三方满意度。

骨科医疗器械智能验收设备结合医疗器械唯一标识编码在骨科器械管理中的应用效果分析

目的:分析骨科医疗器械智能验收设备结合医疗器械唯一标识(UDI)编码在骨科器械管理中的应用效果。方法:基于UDI编码制定骨科医疗器械UDI应用流程,通过骨科医疗器械智能验收设备识别比对,完成骨科器械的验货和精准计费等全部操作。抽取2023年9-12月份中国中医科学院望京医院骨科手术使用的8317件骨科器械,按照骨科医疗器械智能验收设备使用时间的不同,将2023年9-10月份使用的4072件骨科器械标记为实施前,采用传统模式管理,将2023年11-12月份使用的4245件骨科器械标记为实施后,实施智能验收模式管理。对比骨科医疗器械智能验收设备使用前后的管理效果和不良事件发生率。结果:骨科医疗器械智能验收设备实施后器械验收准确性的管理总有效率为98.78%,明显高于实施前,差异有统计学意义(x^(2)=272.03,P<0.01)。骨科医疗器械智能验收设备实施后不良事件总发生率为8.83%,明显低于实施前,差异有统计学意义(x^(2)=281.38,P<0.01)。结论:骨科医疗器械智能验收设备结合UDI编码能够实现骨科器械的高效配货、精准验收和计费,减少不良事件发生,满足一物一码全流程追溯管理要求,提升骨科医疗器械管理水平。

25岁以下未育女性人工流产后即时落实宫内节育器和短效口服避孕药的临床对照观察

目的:观察25岁以下未育女性人工流产后即时放置宫内节育器(IUD)和使用短效复方口服避孕药(COC)的可行性和使用情况。方法:将≤25岁未育早孕自愿要求人工流产的女性作为观察对象,根据其意愿术后放置IUD或使用COC避孕。IUD组148例,COC组204例,随访6个月观察两组的避孕情况。结果:两组均无妊娠发生。IUD组1例因完全脱落而终止使用,终止率为0.7%。COC组术后3月的累积停用率69.1%,6月达92.1%,停用的主要原因是嫌麻烦/不能坚持服药,占31.4%。术后1,3个月的不适主诉率IUD组高于COC组(P<0.010,P<0.001)。结论:≤25岁未育女性人工流产后即时放置IUD或使用COC避孕均可行高效。IUD组6个月续用率高;COC副作用轻,但需加强咨询,提高续用率。

基于物联网技术的医用耗材全生命周期管理体系构建与应用

医用耗材管理作为公立医院高质量发展和推进精细化管理的重要组成部分,其管理水平和智慧化程度与医院运营发展密切相关。本研究介绍了北京大学深圳医院基于物联网技术的医用耗材全生命周期管理体系的基本架构,并从线上申报与招标采购、耗材分类全流程管理、编码对应与医保收费、合理使用与科学评价等方面详述了实践过程。通过对比分析耗材全生命周期管理体系实施前后的效果,表明基于物联网开展医用耗材全生命周期管理对医院提质增效具有重要意义。

医疗器械检验报告审核和质量管理探讨

目的:医疗器械具有复杂性、特殊性、专业性、涉及门类广等特点,面对医疗器械开放自检及检验市场竞争日益加剧的形势,如何提升检验能力,适应产业的迅速发展,确保检验结果的科学性、公正性、权威性,是各医疗器械检验机构面临的共同挑战。方法:从医疗器械检验面临的挑战、法律法规要求、质量管理体系关注要点等方面进行阐述。结果:通过对报告审核中发现的问题,提出质量改进措施及建议。结论:医疗器械检验机构应持续提升检验能力,发展特色优势领域,积极应对医疗器械快速发展的需要及检验新形势,提质增效,应在医疗器械的质量检验工作中,引入风险管理理念并加强过程控制,从人、机、料、法、环等方面构建起全方位的保障体系,提高检验质量和效率,助力医疗器械高质量发展。