理解ISO13485医疗器械质量管理的体系

ISO13485：2003医疗器械质量管理体系可作为企业进行医疗器械的设计和开发、生产、安装和服务,以及相关服务的设计、开发和提供的标准,同时本标准也可用于内部和外部（包括认证机构）评定组织满足顾客和法规要求的能力．现在简单介绍一下这个体系的相关内容。     

实施ISO9001 6年回顾

回顾实施ISO9001质量管理体系对医院关键指标的影响,总结保持ISO9001质量管理体系的主要做法.统计关键指标;回顾如何保持ISO9001质量管理体系的完整性、持续性、适宜性、有效性、创新性.实施ISO9001质量管理体系明显改善了医院主要业绩指标;坚持"原则"才能保持体系的完整性,驱动"三审"才能保持体系的持续性,适时改版才能保持体系的适宜性,持续改进才能保持体系的有效性,联系实际才能保持体系的创新性.精心构建、实施和保持ISO9000质量管理体系,以患者为导向,充分尊重和依靠员工,就一定能谱写医疗质量管理的新篇章.     

Results of the performance verification of the CoaguChek XS system

Background

This is the first paper reporting a performance verification study of a point-of-care (POC) monitor for prothrombin time (PT) testing according to the requirements given in chapter 8 of the International Organization for Standardization (ISO) 17593:2007 standard “Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy”. The monitor under investigation was the new CoaguChek XS system which is designed for use in patient self testing. Its detection principle is based on the amperometric measurement of the thrombin activity generated by starting the coagulation cascade using a recombinant human thromboplastin.

Methods

The system performance verification study was performed at four study centers using venous and capillary blood samples on two test strip lots. Laboratory testing was performed from corresponding frozen plasma samples with six commercial thromboplastins. Samples from 73 normal donors and 297 patients on oral anticoagulation therapy were collected. Results were assessed using a refined data set of 260 subjects according to the ISO 17593:2007 standard.

Results

Each of the two test strip lots met the acceptance criteria of ISO 17593:2007 versus all thromboplastins (bias − 0.19 to 0.18 INR; > 97% of data within accuracy limits). The coefficient of variation for imprecision of the PT determinations in INR ranged from 2.0% to 3.2% in venous, and from 2.9% to 4.0% in capillary blood testing. Capillary versus venous INR data showed agreement of results with regression lines equal to the line of identity.

Conclusion

The new system demonstrated a high level of trueness and accuracy, and low imprecision in INR testing. It can be concluded that the CoaguChek XS system complies with the requirements in chapter 8 of the ISO standard 17593:2007.     

滚动轴承清洁度——环保新方法

随着轴承技术的进步,人们对轴承应用和轴承本身的要求越来越严格,比如越来越高的节能和清洁度要求。本文将论述轴承清洁度问题,根据ISO 281:2007,清洁度是影响轴承寿命的一项关键因素,提高清洁度可以延长轴承的使用寿命,尤其是在真空泵、压缩机、医疗设备等高科技应用领域。     

ISO 9000管理方法在发热门诊护理管理中的应用

探讨ISO9000质量标准在发热门诊运行中对规章制度的建立、严重急性呼吸综合征(SARS)的诊治流程和为发热患者提供高质量护理服务中的应用价值。在发热门诊依据ISO9000标准来实现管理职责的文件化、护理服务项目的流程化、消毒隔离防护的标准化、人力配置的合理化和护理标识的可追溯性的管理。通过ISO9000标准在发热门诊的实际应用，有效地控制传染源，使发热患者和SARS患者得到良好的诊疗服务。     

应用ISO9001:2000标准体系,制定突发事件预案的体会

引入ISO9001:2000系列标准,结合全科医学、护理学、中毒、公共卫生事件应急预案等,制定科学化、规范化、操作性强的标准及流程,提高护理人员对突发事件的处理能力,为抢救病人赢得了时间。     

通过质量体系建设强化研究所内涵发展

按照质量管理八项原则,贯彻IS09001标准,有利于全面规范研究所管理,提高科研声誉;有利于取得顾客的信任;有利于优化研发过程,提高科研成果品质;该体系结构严谨、内容丰富、规定具体、操作性和通用性强.通过标准建设,可进一步促进研究所的科技成果转化为生产力.     

Technical Aspects of the Parkes Error Grid

Background

The Parkes error grid, which was developed in 1994, presented performance zones for blood glucose (BG) monitors with borders that were not mathematically specified at the time the grid was published.

Methods

In this article, we (1) review the history of the Parkes error grid, (2) present the never-before-published exact coordinates and specifications of the grid so that others may produce an exact replica of the original grid, and (3) discuss our suggestions how this metric should be applied.

Results

The new ISO15197:2013 guideline for system accuracy assessment of BG meters for patient self-measurement incorporates use of this metric for defining acceptable accuracy of BG monitors. It is expected that, for regulatory purposes, this document will stipulate that the error grid version for type 1 diabetes should be applied with the caveat that only the A zone represents acceptable accuracy.

Conclusions

It remains to be seen by how much the new error grid, which is currently being developed by the Food and Drug Administration/Diabetes Technology Society/American Diabetes Association/The Endocrine Society/ Association for Advancement of Medical Instrumentation, will deviate from the Parkers error grid.