Biomedical Instrumentation and Technology最新文献_第5页

Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices. 下一代集成互操作医疗设备的可用性工程建议。

Biomedical Instrumentation and Technology Pub Date : 2021-11-01 DOI: 10.2345/0899-8205-55.4.132

Paolo Masci, Sandy Weininger

{"title":"Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices.","authors":"Paolo Masci, Sandy Weininger","doi":"10.2345/0899-8205-55.4.132","DOIUrl":"https://doi.org/10.2345/0899-8205-55.4.132","url":null,"abstract":"This article reports on the development of usability engineering recommendations for next-generation integrated interoperable medical devices. A model-based hazard analysis method is used to reason about possible design anomalies in interoperability functions that could lead to use errors. Design recommendations are identified that can mitigate design problems. An example application of the method is presented based on an integrated medical system prototype for postoperative care. The AAMI/UL technical committee used the results of the described analysis to inform the creation of the Interoperability Usability Concepts, Annex J, which is included in the first edition of the new ANSI/AAMI/UL 2800-1:2019 standard on medical device interoperability. The presented work is valuable to experts developing future revisions of the interoperability standard, as it documents key aspects of the analysis method used to create part of the standard. The contribution is also valuable to manufacturers, as it demonstrates how to perform a model-based analysis of use-related aspects of a medical system at the early stages of development, when a concrete implementation of the system is not yet available.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 4","pages":"132-142"},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641419/pdf/i0899-8205-55-4-132.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39851016","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Thermal Disinfection Validation: The Relationship Between A0 and Microbial Reduction. 热消毒验证:A0与微生物减少的关系。

Biomedical Instrumentation and Technology Pub Date : 2021-07-01 DOI: 10.2345/0899-8205-55.3.85

Terra A Kremer, Gerald McDonnell, Emily Mitzel, Nupur Jain, Henri Hubert, Klaus Roth, Philippe Labrie, Alex Villella

引用次数: 0

Deviation from Clinical Routines Can Reveal Sources of Device Design Vulnerability. 偏离临床常规可以揭示设备设计漏洞的来源。

Biomedical Instrumentation and Technology Pub Date : 2021-07-01 DOI: 10.2345/0899-8205-55.3.100

Rotem Naftalovich, Andrew J Iskander, Faraz Chaudhry, Steven Char, Jean Daniel Eloy

{"title":"Deviation from Clinical Routines Can Reveal Sources of Device Design Vulnerability.","authors":"Rotem Naftalovich, Andrew J Iskander, Faraz Chaudhry, Steven Char, Jean Daniel Eloy","doi":"10.2345/0899-8205-55.3.100","DOIUrl":"https://doi.org/10.2345/0899-8205-55.3.100","url":null,"abstract":"The ability to adequately ventilate a patient is critical and sometimes a challenge in the emergency, intensive care, and anesthesiology settings. Commonly, initial ventilation is achieved through the use of a face mask in conjunction with a bag that is manually squeezed by the clinician to generate positive pressure and flow of air or oxygen through the patient's airway. Large or small erroneous openings in the breathing circuit can lead to leaks that compromise ventilation ability. Standard procedure in anesthesiology is to check the circuit apparatus and oxygen delivery system prior to every case. Because the face mask itself is not a piece of equipment that is associated with a source of leak, some common anesthesia machine designs are constructed such that the circuit is tested without the mask component. We present an example of a leak that resulted from complete failure of the face mask due to a tiny tear in its cuff by the patient's sharp teeth edges. This subsequently prevented formation of a seal between the face mask and the patient's face and rendered the device incapable of generating the positive pressure it is designed to deliver. This instance depicts the broader lesson that deviation from clinical routines can reveal unappreciated sources of vulnerability in device design.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 3","pages":"100-102"},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8657845/pdf/i0899-8205-55-3-100.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39346807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Case for Medical Device Cybersecurity Hygiene Practices for Frontline Personnel. 一线人员医疗设备网络安全卫生实践案例

Biomedical Instrumentation and Technology Pub Date : 2021-07-01 DOI: 10.2345/0899-8205-55.3.96

Stephen L Grimes, Axel Wirth

引用次数: 0

Deviation from Clinical Routines Can Reveal Sources of Device Design Vulnerability. 偏离临床常规可以揭示器械设计漏洞的来源。

Biomedical Instrumentation and Technology Pub Date : 2021-07-01 DOI: 10.2345/0890-8205-55.3.100

R. Naftalovich, Andrew Iskander, Faraz Chaudhry, S. Char, J. Eloy

{"title":"Deviation from Clinical Routines Can Reveal Sources of Device Design Vulnerability.","authors":"R. Naftalovich, Andrew Iskander, Faraz Chaudhry, S. Char, J. Eloy","doi":"10.2345/0890-8205-55.3.100","DOIUrl":"https://doi.org/10.2345/0890-8205-55.3.100","url":null,"abstract":"The ability to adequately ventilate a patient is critical and sometimes a challenge in the emergency, intensive care, and anesthesiology settings. Commonly, initial ventilation is achieved through the use of a face mask in conjunction with a bag that is manually squeezed by the clinician to generate positive pressure and flow of air or oxygen through the patient's airway. Large or small erroneous openings in the breathing circuit can lead to leaks that compromise ventilation ability. Standard procedure in anesthesiology is to check the circuit apparatus and oxygen delivery system prior to every case. Because the face mask itself is not a piece of equipment that is associated with a source of leak, some common anesthesia machine designs are constructed such that the circuit is tested without the mask component. We present an example of a leak that resulted from complete failure of the face mask due to a tiny tear in its cuff by the patient's sharp teeth edges. This subsequently prevented formation of a seal between the face mask and the patient's face and rendered the device incapable of generating the positive pressure it is designed to deliver. This instance depicts the broader lesson that deviation from clinical routines can reveal unappreciated sources of vulnerability in device design.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 3 1","pages":"100-102"},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43235255","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

Full Issue. 完整的问题。

Biomedical Instrumentation and Technology Pub Date : 2021-07-01 DOI: 10.2345/0899-8205-51.6.fmi

D. J. King

引用次数: 0

Protecting COVID-19 Vaccine Transportation and Storage from Analog Cybersecurity Threats. 保护COVID-19疫苗运输和储存免受模拟网络安全威胁。

Biomedical Instrumentation and Technology Pub Date : 2021-07-01 DOI: 10.2345/0890-8205-55.3.112

Yan Long, Sara Rampazzi, Takeshi Sugawara, Kevin Fu

引用次数: 2

Protecting COVID-19 Vaccine Transportation and Storage from Analog Cybersecurity Threats. 保护COVID-19疫苗运输和储存免受模拟网络安全威胁。

Biomedical Instrumentation and Technology Pub Date : 2021-07-01 DOI: 10.2345/0899-8205-55.3.112

Yan Long, Sara Rampazzi, Takeshi Sugawara, Kevin Fu

引用次数: 0

Thermal Disinfection Validation: The Relationship Between A0 and Microbial Reduction. 热消毒验证:A0与微生物减少的关系。

Biomedical Instrumentation and Technology Pub Date : 2021-07-01 DOI: 10.2345/0890-8205-55.3.85

T. Kremer, G. Mcdonnell, E. Mitzel, Nupur Jain, Henri Hubert, Klaus Roth, P. Labrie, Alex Villella

引用次数: 1

Determining EMC Test Levels for Implantable Devices in Bipolar Lead Configuration. 确定双极引线配置中可植入器件的EMC测试等级。

Biomedical Instrumentation and Technology Pub Date : 2021-07-01 DOI: 10.2345/0890-8205-55.3.91

S. Seidman, H. Bassen

{"title":"Determining EMC Test Levels for Implantable Devices in Bipolar Lead Configuration.","authors":"S. Seidman, H. Bassen","doi":"10.2345/0890-8205-55.3.91","DOIUrl":"https://doi.org/10.2345/0890-8205-55.3.91","url":null,"abstract":"Certain low-frequency magnetic fields cause interference in implantable medical devices. Electromagnetic compatibility (EMC) standards prescribe injecting voltages into a device under evaluation to simplify testing while approximating or simulating real-world exposure situations to low-frequency magnetic fields. The EMC standard ISO 14117:2012, which covers implantable pacemakers and implantable cardioverter defibrillators (ICDs), specifies test levels for the bipolar configuration of sensing leads as being one-tenth of the levels for the unipolar configuration. The committee authoring this standard questioned this testing level difference and its clinical relevance. To evaluate this issue of EMC test levels, we performed both analytical calculations and computational modeling to determine a basis for this difference. Analytical calculations based upon Faraday's law determined the magnetically induced voltage in a 37.6-cm lead. Induced voltages were studied in a bipolar lead configuration with various spacing between a distal tip electrode and a ring electrode. Voltages induced in this bipolar lead configuration were compared with voltages induced in a unipolar lead configuration. Computational modeling of various lead configurations was performed using electromagnetic field simulation software. The two leads that were insulated, except for the distal and proximal tips, were immersed in a saline-conducting media. The leads were parallel and closely spaced to each other along their length. Both analytical calculations and computational modeling support continued use of a one-tenth amplitude reduction for testing pacemakers and ICDs in bipolar mode. The most recent edition of ISO 14117 includes rationale from this study.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 3 1","pages":"91-95"},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41495190","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