Assessing Detergent Residuals for Reusable Device Cleaning Validations [0.03%]
评估清洁验证中可重复使用设备清洗后的洗涤剂残留量
Terra A Kremer,Daniel Olsen,Chad Summers et al.
Terra A Kremer et al.
Cleaning chemistries are detergent-based formulations that are used during the processing of reusable medical devices. Manufacturers are responsible for demonstrating the safety of cleaning formulations when they are used during a device pr...
Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices [0.03%]
下一代集成互操作性医疗设备的可用性工程建议
Paolo Masci,Sandy Weininger
Paolo Masci
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 interop...
Selecting a Passive Network Monitoring Solution for Medical Device Cybersecurity Management [0.03%]
为医疗设备网络安全管理选择被动网络监控解决方案
Priyanka Upendra
Priyanka Upendra
The number of cyberattacks and information system breaches in healthcare have grown exponentially, as well as escalated from accidental incidents to targeted and malicious attacks. With medical devices representing a substantial repository ...
Quality Fade in Medical Device Manufacturing: Thinness of Airway Breathing Circuit Plastic [0.03%]
医疗设备制造中的质量衰退：呼吸回路塑料的变薄问题
Rotem Naftalovich,Marko Oydanich,Tolga Berkman et al.
Rotem Naftalovich et al.
Mechanical respirators typically use a plastic circuit apparatus to pass gases from the ventilator to the patient. Structural integrity of these circuits is crucial for maintaining oxygenation. Anesthesiologists, respiratory therapists, and...
Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality [0.03%]
措辞重要性：关于微生物质量的评论和术语定义指南
Gerald McDonnell,Hal Baseman,Lena Cordie-Bancroft
Gerald McDonnell
In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic proc...
Clinical Data Extraction During Public Health Emergencies: A Blockchain Technology Assessment [0.03%]
公共卫生紧急状态下的临床数据提取：区块链技术评估
Joan Brown,Manas Bhatnagar,Hugh Gordon et al.
Joan Brown et al.
Objective: We sought to explore the technical and legal readiness of healthcare institutions for novel data-sharing methods that allow clinical information to be extracted from electronic health records (EHRs) and submitt...
Protecting COVID-19 Vaccine Transportation and Storage from Analog Cybersecurity Threats [0.03%]
保护COVID-19疫苗运输和存储免受模拟网络安全威胁的影响
Yan Long,Sara Rampazzi,Takeshi Sugawara et al.
Yan Long et al.
Deviation from Clinical Routines Can Reveal Sources of Device Design Vulnerability [0.03%]
偏离临床常规可以揭示设备设计弱点的来源
Rotem Naftalovich,Andrew J Iskander,Faraz Chaudhry et al.
Rotem Naftalovich et al.
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 ...
The Case for Medical Device Cybersecurity Hygiene Practices for Frontline Personnel [0.03%]
论医疗设备网络安全基线防护措施在一线人员中的应用
Stephen L Grimes,Axel Wirth
Stephen L Grimes
Determining EMC Test Levels for Implantable Devices in Bipolar Lead Configuration [0.03%]
双极引线配置下植入设备的电磁兼容性测试等级确定方法研究
Seth J Seidman,Howard I Bassen
Seth J Seidman
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 si...