Biomedical Instrumentation and Technology最新文献_第5页

2019 Peer Reviewers: BI&T Peer Reviewers: 2019. 2019同行评审:BI&T同行评审:2019。

Biomedical Instrumentation and Technology Pub Date : 2020-01-01 DOI: 10.2345/0899-8205-54.1.78

引用次数: 0

Analysis: Particulate Limits for Intravascular Devices: Considerations for Polymer Coating Embolism. 分析:血管内装置的微粒限制:聚合物涂层栓塞的考虑。

Biomedical Instrumentation and Technology Pub Date : 2019-11-25 DOI: 10.2345/0899-8205-53.6.426

A. Chopra

{"title":"Analysis: Particulate Limits for Intravascular Devices: Considerations for Polymer Coating Embolism.","authors":"A. Chopra","doi":"10.2345/0899-8205-53.6.426","DOIUrl":"https://doi.org/10.2345/0899-8205-53.6.426","url":null,"abstract":"Lubricious polymer coatings are increasingly used on intravascular devices to facilitate easier access and navigation through tortuous blood vessels. Recent reports highlight the separation and downstream embolism of polymer particles affecting the vasculature and various organs. The Food and Drug Administration (FDA) acknowledges polymer coating embolism as an iatrogenic complication of intravascular devices and continues to close gaps in standards related to coating integrity. The Association for the Advancement of Medical Instrumentation established particulate testing as an industry standard for evaluating coating integrity of intravascular devices. The FDA recognizes this standard; however, challenges exist in setting particulate limits that may compromise device function without sufficient clinical data. The microscopic nature of polymer emboli not visible with available imaging modalities has impacted reporting. This has also resulted in a reduced number of manufacturer-driven product development projects related to coating integrity. On the other hand, recent procedural trends have supported the innovation of coated devices with expanded indications, requiring particulate evaluations and release limits. This article proposes a methodology to set particulate limits for intravascular devices given existing clinical, regulatory, and manufacturing challenges. The approach with standardization requirements enables characterization, comparison, and evaluation of lubricious coatings from various manufacturers. It incorporates a step-by-step procedure that adds scrutiny to the application of coatings while ensuring device function is not impacted. Together with particulate assessments, clinicopathologic and animal studies permit an understanding of particulate ranges from commercially available devices and setting of particulate limits for new device evaluations.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"53 6 1","pages":"426-432"},"PeriodicalIF":0.0,"publicationDate":"2019-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2345/0899-8205-53.6.426","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43616679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 2

Feature: As HTM Evolves, Soft Skills Become More Important. 特点:随着HTM的发展，软技能变得更加重要。

Biomedical Instrumentation and Technology Pub Date : 2019-11-25 DOI: 10.2345/0899-8205-53.6.438

S. Michaud

{"title":"Feature: As HTM Evolves, Soft Skills Become More Important.","authors":"S. Michaud","doi":"10.2345/0899-8205-53.6.438","DOIUrl":"https://doi.org/10.2345/0899-8205-53.6.438","url":null,"abstract":"Advances in technology and the growing integration of medical equipment with information technology (IT) are changing the skill sets necessary for healthcare technology management (HTM) professionals to perform their jobs. As the field rapidly evolves on a technical level, HTM professionals also are expected to communicate and address the needs of individuals outside their departments—from patients, to vendors, to hospital administrators. HTM's expanding reach into other departments and disciplines brings with it a growing need for soft skills training. Unlike hard skills, which are specific, measurable qualities and abilities, soft skills refer to behaviors for effective and friendly interactions with other people. Examples of soft skills include: • Communication • Courtesy/customer focus • Flexibility/adaptability • Integrity • Interpersonal skills • Positive attitude/passion • Professionalism • Responsibility • Teamwork • Work ethic Without these skills, many in the field will feel underprepared when they are inevitably tasked with resolving workplace conflicts and developing professional relationships or as they transition into leadership positions. BI&T interviewed several members of the HTM community to learn more about the growing importance of soft skills training during various career stages, as well as how and where these techniques are being taught.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"53 6 1","pages":"438-442"},"PeriodicalIF":0.0,"publicationDate":"2019-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2345/0899-8205-53.6.438","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41842286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 2

Sterilization Straight Talk: Staying Clean in a Dirty World: The Environmental Challenges of Sterile Processing. 灭菌直通车：在肮脏的世界里保持清洁：无菌加工的环境挑战。

Biomedical Instrumentation and Technology Pub Date : 2019-11-25 DOI: 10.2345/0899-8205-53.6.465

W. Balch

引用次数: 0

Troubleshoot It: Laser Safety in Healthcare Facilities Is a Big Deal, for a Variety of Reasons. 疑难解答：医疗机构的激光安全是一件大事，原因多种多样。

Biomedical Instrumentation and Technology Pub Date : 2019-11-25 DOI: 10.2345/0899-8205-53.6.468

B. Crossley

引用次数: 0

Cyberinsights: Cybersecurity: Strategy versus Reality. 网络洞察：网络安全：战略与现实。

Biomedical Instrumentation and Technology Pub Date : 2019-11-25 DOI: 10.2345/0899-8205-53.6.458

Axel Wirth

引用次数: 1

Ten Questions With: Stéfan Robert. 10个问题:

Biomedical Instrumentation and Technology Pub Date : 2019-11-25 DOI: 10.2345/0899-8205-53.6.409

S. Robert

引用次数: 0

Preparing for the Next Cyber Storm: Are You Ready? 为下一次网络风暴做准备:你准备好了吗?

Biomedical Instrumentation and Technology Pub Date : 2019-11-25 DOI: 10.2345/0899-8205-53.6.412

G. Stern

引用次数: 3

Analysis: Classifying Ventilation Modes and Improving Operator Training with ISO 19223:2019. 分析：根据ISO 19223:2019对通风模式进行分类并改进操作员培训。

Biomedical Instrumentation and Technology Pub Date : 2019-11-25 DOI: 10.2345/0899-8205-53.6.420

Debra R. Milamed, N. S. Jones

{"title":"Analysis: Classifying Ventilation Modes and Improving Operator Training with ISO 19223:2019.","authors":"Debra R. Milamed, N. S. Jones","doi":"10.2345/0899-8205-53.6.420","DOIUrl":"https://doi.org/10.2345/0899-8205-53.6.420","url":null,"abstract":"The Centers for Disease Control and Prevention has reported that more than 300,000 patients are ventilated in the United States each year. Human factors and communication issues have been cited as the two most common causes of ventilator-related sentinel events, according to reports of patient mortality or severe harm received by The Joint Commission during 2004–15. Over a decade ago, it was determined that the scope of the International Electrotechnical Commission (IEC) standard IEC 60601-1:2005 had to be extended to consider equipment usability in its third edition. The Joint Working Group (JWG) of the International Organization for Standardization (ISO) and IEC subcommittees responsible for critical care ventilators (ISO/TC 121/SC 3 and IEC TC/SC 62D/JWG 1) concurred that there was a wide recognition that a key factor adversely affecting lung ventilator usability was the lack of a standardized vocabulary relating to the modes of operation for these devices. At that time, ISO 4135:2001 was the only international standard that included terms related to devices of that type; however, its scope was restricted to defining terms that were used in standards related to the performance of such equipment and therefore did not cover usage factors. The terms in general clinical use had origins in the early days of mechanical ventilation, when the emphasis was on saving the lives of patients who were unable to breathe on their own, with little attention given to patients' respiratory activity.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"53 6 1","pages":"420-424"},"PeriodicalIF":0.0,"publicationDate":"2019-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2345/0899-8205-53.6.420","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46628225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Setting Standards: AAMI TIR97: A Vital Resource in the Postmarket Management of Medical Device Security. 制定标准：AAMI TIR97:医疗器械安全上市后管理的重要资源。

Biomedical Instrumentation and Technology Pub Date : 2019-11-25 DOI: 10.2345/0899-8205-53.6.462

M. Jump

引用次数: 1