Reliability and Safety Testing of a Ventilator Remote Control System Against Communication Failures and Network Disruptions.

Introduction: The need for remote ventilator control has been highlighted by the COVID-19 Public Health Emergency. Remote ventilator control from outside a patient's room can improve response time to patient needs, protect health care workers, and reduce personal protective equipment (PPE) consumption. Extending remote control to distant locations can expand the capabilities of frontline health care workers by delivering specialized clinical expertise to the point of care, which is much needed in diverse health care settings, such as tele-critical care and military medicine.

Applying Medical Device Informatics to Enable Safe and Secure Interoperable Systems: Medical Device Interface Data Sheets.

This article describes the concept of Medical Device Interface Data Sheets (MDIDSs) to document and characterize medical device interface data requirements, the processes for creating MDIDSs, and its role in supporting patient safety and cybersecurity of current systems while enabling innovation in the area of next-generation medical Internet of Things (IoT) platforms for integrating sensors, actuators, and applications (apps).

Respiratory Gas Analysis-Technical Aspects.

A technology-focused review of respiratory gas analysis, with an emphasis on carbon dioxide analysis, is presented. The measurement technologies deployed commercially are highlighted, and the basic principles and technical concerns of infrared spectroscopy and mainstream versus sidestream gas sampling are discussed. The specifications of particular interest to the clinician, accuracy and response time, and the related standard, with typical values for a capnometer, are presented.

The Importance of State and Context in Safe Interoperable Medical Systems.

This paper describes why "device state" and "patient context" information are necessary components of device models for safe interoperability. This paper includes a discussion of the importance of describing the roles of devices with respect to interactions (including human user workflows involving devices, and device to device communication) within a system, particularly those intended for use at the point-of-care, and how this role information is communicated. In addition, it describes the importance of clinical scenarios in creating device models for interoperable devices.

The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems.

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device standards and the need for these standards to address medical device informatics.

Capturing Essential Information to Achieve Safe Interoperability.

In this article, we describe the role of "clinical scenario" information to assure the safety of interoperable systems, as well as the system's ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore, improving the communication from clinicians to medical device and information technology system developers.

Using the features of the time and volumetric capnogram for classification and prediction.

Quantitative features derived from the time-based and volumetric capnogram such as respiratory rate, end-tidal PCO, dead space, carbon dioxide production, and qualitative features such as the shape of capnogram are clinical metrics recognized as important for assessing respiratory function. Researchers are increasingly exploring these and other known physiologically relevant quantitative features, as well as new features derived from the time and volumetric capnogram or transformations of these waveforms, for: (a) real-time waveform classification/anomaly detection, (b) classification of a candidate capnogram into one of several disease classes, (c) estimation of the value of an inaccessible or invasively determined physiologic parameter, (d) prediction of the presence or absence of disease condition, (e) guiding the administration of therapy, and (f) prediction of the likely future morbidity or mortality of a patient with a presenting condition. The work to date with respect to these applications will be reviewed, the underlying algorithms and performance highlighted, and opportunities for the future noted.

Continuous monitoring of respiratory flow and CO(2):challenges of on-airway measurements.

In this article, the challenges of simultaneous respiratory gas concentration and flow measurements in a breathing circuit are reviewed. The tradeoffs that were considered in the development of a clinically useful on-airway combination CO(2)/flow sensor are discussed as well as the applications enabled by this on-airway combination CO(2)/flow sensor.

Infrared measurement of carbon dioxide in the human breath: "breathe-through" devices from Tyndall to the present day.

The ability to measure carbon dioxide (CO(2)) in the breath of a patient or capnometry, is one of the fundamental technological advances of modern medicine. I will chronicle the evolution and commercialization of mainstream capnometry based upon infrared measurement of CO(2) in the breath using information from the historical record and personal interviews with many of the developers.

Capnographic waveforms in the mechanically ventilated patient.

A focus on patient safety has heightened the awareness of patient monitoring. The importance of clinical applications of capnography continues to grow, as reflected by the increasing number of medical societies recommending its use. Recognition of changes in the capnogram assists in clinical decision making and treatment and can increase patient safety by alerting the clinician to important situations and changes.