医疗器械电子注册申报规范的实施对策研究

目的:针对医疗器械注册电子申报信息化(eRPS)系统实施中存在的问题,提出构建我国医疗器械注册管理改革和审评审批创新对策。方法:分析医疗器械实施eRPS的国际背景,对比eRPS目录与我国现行法规要求间的对应关系,从网页版和客户端版的不同登录方式阐述eRPS前端功能特点,从eRPS的使用原则、使用步骤、申报流程和使用安全等方面制定eRPS使用规范,并提出解决问题的对策。结果:eRPS的实施能降低申报后补充资料的概率,提升医疗器械注册申报质量,企业可同时将相应的申报资料向国际医疗器械监管机构论坛(IMDRF)成员国提交申请,无需重新调整,提高申报效率。eRPS实施以来,线上电子申报和线下纸质材料申报比例从2019年6-8月的1.1∶1.0,快速增长到到10月份的6.5∶1,线上提交医疗器械注册申请量占注册申报总量的80%。结论:eRPS系统可以为医疗器械全生命周期监管提供数据支撑,并为企业提供从概念认知到实际操作的高效路径,以保障医疗器械电子注册申报规范项目顺利实施。     

TC—I型磁场扫描式理疗机对高血压病人血压的影响

目的：观察TC－I型磁场扫描式理疗机对高血压病人血压的影响。方法：用此机给病人每日磁疗1次,每次30分钟,14天为一个疗程,测量磁疗前后血压。结果：高血压病人经磁疗2次后血压明显下降,3次后达最低值,疗效持续至疗程终了。结论：此机对高血压病人有温和但明显的降压作用。     

一种低成本的新型网络MicroLAN

简述了新型的智能网络MicrolLAN的基本工作原理,结合应用实例介绍了MicroLAN网络的关键器件耦合器,最后讨论了MicroLAN的一线制器件及其应用。     

基于HART协议的实时设备管理系统

讨论了基于HART协议智能设备的实时管理系统,介绍了HART协议的基本规范,以及如何利用已有集散控制系统（DCS）和工厂信息网络的集成实现实时信息共享,取得了良好的实际效果。     

Amplatzer堵闭器治疗动脉导管未闭11例临床观察

[目的]评价Amplatzer堵闭器对动脉导管未闭(PDA)的治疗效果.[方法]应用Amplatzer堵闭器和主动脉造影及6F长鞘输送器置入Amplatzer堵闭器,治疗11例动脉导管未闭患者.[结果]堵闭成功率100%;随访2月～1年,全部病例无残余分流和任何并发症.[结论]应用Amplatzer堵闭器治疗PDA操作简便,安全,有效.     

A novel approach to delivery of extracorporeal support using a modified continuous flow ventricular assist device in a mid‐volume congenital heart program

Extracorporeal life support (ECLS) is an essential component of a modern congenital cardiac surgery program. The circuit components and bedside management team may, however, vary among institutions. Here, we evaluate our initial experience with a modified ventricular assist device—based ECLS circuit primarily managed by the bedside nurse. We hypothesize that our outcomes are comparable to Extracorporeal Life Support Organization (ELSO) registry data. All patients who received ECLS from January 1, 2016 to December 31, 2019 at a single institution were included. Primary outcomes were survival to ECLS decannulation and discharge or transfer. Secondary outcomes included complications from ECLS. Data were compared to available ELSO registry data. Thirty‐seven patients underwent 44 ECLS runs during the study period. Forty percent of patients had single ventricle physiology. Nearly 46% of patients received ECLS as part of extracorporeal cardiopulmonary resuscitation (eCPR). Survival to ECLS decannulation (68.2%) and survival to discharge or transfer (61.4%) did not differ from overall ELSO outcomes (69.7%, P = .870 and 50.7%, P = .136), as well as survival to discharge or transfer in a comparable cohort of ELSO centers (53.1%, P = .081). Patients with complications had a lower rate of survival to discharge or transfer but this did not reach statistical significance (47.7% vs. 75.0%, P = .455). Neurologic (50.0%), hemorrhagic (45.5%), and renal complications (31.8%) were most common in this cohort. A modified ventricular assist device‐based ECLS circuit with primary management by the bedside nurse can provide comparable support in a neonatal and pediatric cardiac surgery population. Cost analyses and further delineation of the complication profile are necessary for a complete characterization of this system.     

Right ventricular free wall perforation during pericardiocentesis,and an inappropriate device selection for percutaneous treatment

Right ventricular (RV) perforation is a rare but life‐threatening complication of pericardiocentesis and is usually treated surgically. We presented a case of RV free wall perforation, which occurred during pericardiocentesis and tried to be closed percutaneously with the Amplatzer vascular plug‐III (AVP‐III) device. The occluder device sealed the perforation, but it was in an insecure position; therefore, the patient underwent surgical repair. As an AVP‐III device, with a middle disk thicker than the RV myocardium, it may cause the RV myocardium to stretch outwards, so it should not be used for the treatment of RV perforation by the transcatheter way.     

Longer Term Outcomes Following High Tibial Osteotomy for Osteoarthritis: A Prospective,Multi-Centre Observational Study Comparing Tomofix and OPTY-LINE Devices

PurposeAssessing surgical accuracy and patient-recorded outcome measures for patients fitted with either the OPTY-LINE intramedullary realignment system or the Tomofix plate for medial opening wedge high tibial osteotomy (HTO).Patients and methodsTwo matched case series of patients with symptomatic medial compartment osteoarthritis without other significant knee pathology. One group comprised of 19 patients receiving the Tomofix plate, whereas another comprised of 12 patients receiving the OPTY-LINE intramedullary nail. Patella-centred long leg alignment radiographs were assessed to calculate surgical accuracy in all cases. Patients completed knee injury osteoarthritis outcome scores (KOOS) and osteotomy surgery patient satisfaction questionnaires pre-operatively and at 24 months post-surgery.ResultsAbsolute surgical accuracy at 2 years post-surgery was a mean 4.2 [standard deviation 3.7] for OPTY-LINE versus 9.2 [SD 7.8] for Tomofix (p = 0.11, Mann–Whitney U test). On average, patients in either the OPTY-LINE or Tomofix cohort reported at least a minimal perceptible clinical improvement—minimum average improvement of 15—for all five KOOS themes. No significant difference in change of KOOS scores over time or patient satisfaction levels were observed between the two cohorts.ConclusionThe OPTY-LINE device for HTO performs to a similar level as the Tomofix device. Surgical accuracy data are promising for OPTY-LINE, but does not seem to readily translate into difference in patient-reported outcomes compared to Tomofix. Even longer follow-up periods, to measure survival rates, and true randomised trials on larger samples can elucidate if there is a benefit for using one device over the other.     

Early experience with a new integrated microwave surgical device,Acrosurg Revo®, for laparoscopic surgery: A case series of two patients

IntroductionAbdominal surgery uses various energy devices for vessel sealing, tissue dissection, and detachment. Currently, Acrosurg Revo® (Nikkiso Co., Ltd., Tokyo, Japan), a novel energy device using microwaves, has been developed for use in laparoscopic surgery. This report describes the early clinical experience of using this device in two cases of laparoscopic surgery.Presentation of caseCase 1 was of a 64-year-old woman who underwent laparoscopic abdominal incisional hernia repair. Case 2 was of a 56-year-old man with a diagnosis of ascending and sigmoid colon cancer who underwent laparoscopic right hemicolectomy and sigmoid colectomy with D3 dissection. Each surgery was completed using Acrosurg Revo® and an endoscopic electrosurgical unit. The postoperative course was uneventful, and both patients were discharged from the hospital without any complications.DiscussionWith this new and novel device, vessel sealing, hemostasis, coagulation, tissue dissection, and detachment were all possible. Notably, there was no spark or mist that hindered the surgical field of view. Furthermore, because microwave coagulation did not result in tissue carbonization, there was a considerable decrease in device tip contamination.ConclusionThe Acrosurg Revo® may be a useful energy device for laparoscopic surgery.