Biomedical Instrumentation and Technology最新文献_第9页

Setting Standards: Revised ISO 5840 Series Clarifies Testing, Evaluation Procedures for Cardiac Valves. 设定标准:修订的ISO 5840系列澄清了心脏瓣膜的测试、评价程序。

Biomedical Instrumentation and Technology Pub Date : 2020-11-01 DOI: 10.2345/0899-8205-54.6.441

Russ Joseph, Changfu Wu, Ajit Yoganathan

引用次数: 2

Effective Interventions: Turning Healthcare's Wealth of Data into Actionable Information. 有效干预:将医疗保健的大量数据转化为可操作的信息。

Biomedical Instrumentation and Technology Pub Date : 2020-11-01 DOI: 10.2345/0899-8205-54.6.381

Chris Hayhurst

引用次数: 0

Research: Evaluation of Orthopedic Hip Device Recalls by the FDA from 2007 to 2017. 研究:2007年至2017年FDA对骨科髋关节器械召回的评估。

Biomedical Instrumentation and Technology Pub Date : 2020-11-01 DOI: 10.2345/0899-8205-54.6.418

Wesley Peters, Carl Pellerin, Cory Janney

{"title":"Research: Evaluation of Orthopedic Hip Device Recalls by the FDA from 2007 to 2017.","authors":"Wesley Peters, Carl Pellerin, Cory Janney","doi":"10.2345/0899-8205-54.6.418","DOIUrl":"https://doi.org/10.2345/0899-8205-54.6.418","url":null,"abstract":"Background: Medical device recalls have increased in the previous two decades. Orthopedic devices are estimated to constitute 12% of all medical devices recalled. Medical devices enter the market via the Food and Drug Administration's (FDA's) premarket approval (PMA) or 510(k) pathways. This article evaluates orthopedic hip device recalls between Jan. 1, 2007, and Dec. 31, 2017. We hypothesized that the 510(k) approval process would have substantially higher recall rates for defective devices.Methods: The FDA's device recall database was queried for all orthopedic hip devices from Jan. 1, 2007, to Dec. 31, 2017. Each recall included product description, recall number, device class, date of recall posting, date of recall termination, manufacturer, FDA-determined cause for recall, number of recalled units, distribution, product classification, and method of approval [510(k), PMA, or unspecified].Results: In total, 774 orthopedic hip devices were recalled between Jan. 1, 2007, and Dec. 31, 2017. The 510(k) approval process constituted 85% of hip device recalls. The most common FDA-determined cause of hip device recalls was device design, which constituted 37% of 510(k)-approved device recalls but only 6% of PMA-approved device recalls. The most recalled hip devices were hip prostheses. Orthopedic hip device recalls have shown a decrease of about 10 recalls per year during the 11-year period of analysis.Conclusion: Devices approved through the 510(k) process, compared with the PMA process, were more likely to be recalled for design defects. Although device design is the most common reason for device recall, many recalls are due to suboptimally standardized processes (e.g., packaging, process controls, device labeling). Overall, orthopedic hip device recalls decreased during the period of analysis (2007-17).","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"54 6","pages":"418-426"},"PeriodicalIF":0.0,"publicationDate":"2020-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38389830","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

Research: Fluorescence Microscopy-Based Protocol for Detecting Residual Bacteria on Medical Devices. 研究:基于荧光显微镜的医疗器械残留细菌检测方案。

Biomedical Instrumentation and Technology Pub Date : 2020-11-01 DOI: 10.2345/0899-8205-54.6.397

Michael Wong, Yi Wang, Hao Wang, April K Marrone, Shanil P Haugen, Kaumudi Kulkarni, Ralph Basile, K Scott Phillips

{"title":"Research: Fluorescence Microscopy-Based Protocol for Detecting Residual Bacteria on Medical Devices.","authors":"Michael Wong, Yi Wang, Hao Wang, April K Marrone, Shanil P Haugen, Kaumudi Kulkarni, Ralph Basile, K Scott Phillips","doi":"10.2345/0899-8205-54.6.397","DOIUrl":"https://doi.org/10.2345/0899-8205-54.6.397","url":null,"abstract":"Standard methods are needed to reliably and efficiently assess bacterial contamination of processed medical devices. This article demonstrates a standard operating procedure (SOP) for fluorescence microscopy-based detection of residual bacteria on medical devices (BAC-VIS). BAC-VIS uses a 4',6-diamidino-2-phenylindole (DAPI) stain with fluorescent microscopy to quickly and cost-effectively detect bacterial contamination of processed medical device parts. The BAC-VIS protocol was optimized and achieved greater than 80% staining efficiency and a signal-to-noise ratio of more than 20 using four representative organisms. The SOP was first validated for use on a buildup biofilm model, accessory channels of contaminated clinically used devices, and inoculated endoscope end caps and O-rings. The buildup biofilm model was used to evaluate BAC-VIS after repeated treatment of adherent bacteria with three common high-level disinfectants: glutaraldehyde, ortho-phthalaldehyde, and peracetic acid. Next, BAC-VIS was used to assess clinically used endoscope parts that cultured positive for Gram-negative bacteria. DAPI-stained cells were found on all culture-positive devices, especially in grooves and imperfections on the surface. Finally, BAC-VIS was used to detect bacteria on inoculated endoscope device components. The results showed potential for BAC-VIS to be a valuable tool for industry and academic/medical researchers for investigations of contaminated medical devices. Results obtained using BAC-VIS can increase understanding of the role of design in cleanability, wear, and prevention of contamination and may lead to improvements in materials and design that could make processed endoscope use safer for patients. Of note, this protocol is not for detecting bacteria on scopes or scope parts that will be put back into clinical use.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"54 6","pages":"397-409"},"PeriodicalIF":0.0,"publicationDate":"2020-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38730645","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: 3

Troubleshoot It: ECG Cart Not Giving 12-Lead Readout? Follow These Steps to Find a Solution. 排除它:心电图车没有给出12导联读数?遵循以下步骤找到解决方案。

Biomedical Instrumentation and Technology Pub Date : 2020-11-01 DOI: 10.2345/0899-8205-54.6.448

Becky Crossley

引用次数: 0

Frontlines: A Year of Change. 《前线:变革的一年》

Biomedical Instrumentation and Technology Pub Date : 2020-11-01 DOI: 10.2345/0899-8205-54.6.378

Gavin Stern

引用次数: 0

Cover Story: Matters of Perspective: Appreciating Diversity and Promoting Inclusion in Health Technology Professions. 封面故事:观点问题:欣赏卫生技术专业的多样性和促进包容性。

Biomedical Instrumentation and Technology Pub Date : 2020-09-01 DOI: 10.2345/0899-8205-54.5.318

Chris Hayhurst

引用次数: 0

Cyberinsights: Talking about the Software Supply Chain. Cyberinsights:谈论软件供应链。

Biomedical Instrumentation and Technology Pub Date : 2020-09-01 DOI: 10.2345/0899-8205-54.5.364

Axel Wirth

引用次数: 1

Ten Questions With ... Ed Margerrison. 关于……的十个问题艾德Margerrison。

Biomedical Instrumentation and Technology Pub Date : 2020-09-01 DOI: 10.2345/0899-8205-54.5.316

Ed Margerrison

引用次数: 0

Analysis: Electroencephalography Acquisition System: Analog Design. 分析:脑电图采集系统:模拟设计。

Biomedical Instrumentation and Technology Pub Date : 2020-09-01 DOI: 10.2345/0899-8205-54.5.346

Daniel Rostami Alkhorshid, Seyyedeh Fatemeh Molaeezadeh, Mikaeil Rostami Alkhorshid

引用次数: 2