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。

Q4 Medicine

Biomedical Instrumentation and Technology

Pub Date : 2021-11-01 DOI: 10.2345/0899-8205-55.4.132

Paolo Masci, Sandy Weininger

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.

本文报告了下一代集成互操作医疗设备的可用性工程建议的发展。采用基于模型的危害分析方法对互操作性功能中可能导致使用错误的设计异常进行推理。确定了可以减轻设计问题的设计建议。基于一个综合医疗系统的术后护理原型，给出了该方法的应用实例。AAMI/UL技术委员会使用所描述的分析结果为互操作性可用性概念(附录J)的创建提供了信息，该概念包含在新的医疗器械互操作性标准ANSI/AAMI/UL 2800-1:2019的第一版中。所介绍的工作对于开发互操作性标准未来修订版的专家很有价值，因为它记录了用于创建部分标准的分析方法的关键方面。该贡献对制造商也很有价值，因为它演示了如何在开发的早期阶段，当系统的具体实现尚未可用时，对医疗系统的使用相关方面进行基于模型的分析。

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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。

Q4 Medicine

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

Validating a thermal disinfection process for the processing of medical devices using moist heat via direct temperature monitoring is a conservative approach and has been established as the A0 method. Traditional use of disinfection challenge microorganisms and testing techniques, although widely used and applicable for chemical disinfection studies, do not provide as robust a challenge for testing the efficacy of a thermal disinfection process. Considerable research has been established in the literature to demonstrate the relationship between the thermal resistance of microorganisms to inactivation and the A0 method formula. The A0 method, therefore, should be used as the preferred method for validating a thermal disinfection process using moist heat.

通过直接温度监测验证使用湿热处理医疗器械的热消毒工艺是一种保守的方法，已确定为A0方法。传统使用的消毒挑战微生物和测试技术，虽然广泛用于化学消毒研究，但不能为测试热消毒过程的功效提供强有力的挑战。文献中已经建立了大量的研究来证明微生物对失活的热阻与A0方法公式之间的关系。因此，A0法应作为验证使用湿热的热消毒过程的首选方法。

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。

Q4 Medicine

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

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.

在急诊、重症监护和麻醉科环境中，给病人充分通气的能力是至关重要的，有时也是一项挑战。通常，初始通气是通过使用口罩和一个由临床医生手动挤压的袋子来实现的，以产生正压，并通过患者的气道产生空气或氧气的流动。呼吸回路中或大或小的错误开口都会导致泄漏，从而损害通气能力。麻醉学的标准程序是在每个病例之前检查电路设备和供氧系统。由于口罩本身不是一个与泄漏源相关的设备，一些常见的麻醉机设计使得电路在没有口罩组件的情况下进行测试。我们提出了一个泄漏的例子，导致完全失败的口罩，由于一个微小的撕裂在其袖口的病人的锋利的牙齿边缘。这随后阻止了口罩和患者面部之间形成密封，并使设备无法产生其设计提供的正压。这个例子描绘了一个更广泛的教训，即偏离临床常规可能会暴露出设备设计中未被重视的漏洞来源。

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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

Q4 Medicine

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。

Q4 Medicine

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

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.

在急诊、重症监护和麻醉学环境中，为患者充分通风的能力至关重要，有时也是一个挑战。通常，初始通气是通过使用面罩和由临床医生手动挤压的袋子来实现的，以产生正压并使空气或氧气流过患者的气道。呼吸回路中的大或小错误开口可能导致泄漏，从而影响通气能力。麻醉学的标准程序是在每个病例发生前检查电路设备和氧气输送系统。由于面罩本身不是一个与泄漏源相关的设备，因此一些常见的麻醉机设计是在没有面罩组件的情况下测试电路的。我们举了一个例子，由于患者锋利的牙齿边缘在口罩的袖口上有一个微小的撕裂，导致口罩完全失效。这随后防止了面罩和患者面部之间形成密封，并使该装置无法产生设计用于输送的正压。这个例子描述了一个更广泛的教训，即偏离临床常规可能会揭示设备设计中未被重视的漏洞来源。

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引用次数: 0

Full Issue. 完整的问题。

Q4 Medicine

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。

Q4 Medicine

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。

Q4 Medicine

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。

Q4 Medicine

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

Validating a thermal disinfection process for the processing of medical devices using moist heat via direct temperature monitoring is a conservative approach and has been established as the A0 method. Traditional use of disinfection challenge microorganisms and testing techniques, although widely used and applicable for chemical disinfection studies, do not provide as robust a challenge for testing the efficacy of a thermal disinfection process. Considerable research has been established in the literature to demonstrate the relationship between the thermal resistance of microorganisms to inactivation and the A0 method formula. The A0 method, therefore, should be used as the preferred method for validating a thermal disinfection process using moist heat.

通过直接温度监测验证使用湿热处理医疗器械的热消毒过程是一种保守的方法，已被确定为A0方法。消毒挑战微生物和测试技术的传统使用，尽管被广泛使用并适用于化学消毒研究，但并不能为测试热消毒过程的功效提供强有力的挑战。文献中已经进行了大量研究，以证明微生物对灭活的耐热性与A0方法配方之间的关系。因此，A0方法应被用作验证使用湿热的热消毒过程的首选方法。

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。

Q4 Medicine

Biomedical Instrumentation and Technology

Pub Date : 2021-07-01 DOI: 10.2345/0890-8205-55.3.91

S. Seidman, H. Bassen

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.

某些低频磁场会对植入式医疗设备造成干扰。电磁兼容性（EMC）标准规定向评估中的设备注入电压，以简化测试，同时近似或模拟低频磁场的真实暴露情况。EMC标准ISO 14117:2012涵盖植入式起搏器和植入式心律转复除颤器（ICD），规定感应导线双极配置的测试水平为单极配置水平的十分之一。制定该标准的委员会对这种测试水平差异及其临床相关性提出了质疑。为了评估EMC测试水平的问题，我们进行了分析计算和计算建模，以确定这种差异的基础。基于法拉第定律的分析计算确定了37.6厘米导线中的磁感应电压。研究了在远端电极和环形电极之间具有不同间距的双极引线配置中的感应电压。将这种双极引线配置中感应的电压与单极引线配置中的感应电压进行比较。使用电磁场模拟软件对各种导线配置进行了计算建模。除远端和近端外，绝缘的两根导线均浸入盐水传导介质中。引线是平行的，并且沿着它们的长度彼此紧密间隔。分析计算和计算建模都支持在双极模式下继续使用十分之一的振幅降低来测试起搏器和ICD。ISO 14117的最新版本包含了这项研究的基本原理。

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引用次数: 0