Numerous techniques and maneuvers have been described to anesthetize the upper airway in preparat... more Numerous techniques and maneuvers have been described to anesthetize the upper airway in preparation for awake tracheal intubation, notably the nerve block techniques to the superior laryngeal or the glossopharyngeal nerves as well as the topical application of a local anesthetic, in the form of a gel, spray, or inhaler. 1 The current report describes the efficacy of a lollipop containing 150 mg lidocaine HCl for providing upper airway analgesia for patients under-Support was provided solely from institutional and/or departmental sources.
I, Xintao Ma, declare that I have authored this thesis independently, that I have not used other ... more I, Xintao Ma, declare that I have authored this thesis independently, that I have not used other than the declared sources / resources, and that I have explicitly marked all material which has been quoted either literally or by content from the used sources. Neither this thesis nor any other similar work has been previously submitted to any examination board.
During cardiac surgery there is an unmet need for safe transfer of responsibility for patient oxy... more During cardiac surgery there is an unmet need for safe transfer of responsibility for patient oxygenation back and forth from the anesthesia to the perfusion teams. Prior to cardiopulmonary bypass (CPB), lung ventilation is performed by the anesthesia machine ventilator and is the responsibility of the anesthesia team. During CPB, lung ventilation is halted and oxygenation is performed by the CPB oxygenator and perfusion team This recurrent transfer throughout the procedure introduces the rare but serious possibility of a "never event", resulting in the patient's lungs not being ventilated upon stopping the CPB and potentially leading to catastrophic hypoxemia. Monitors and alarms on the anesthesia and bypass machines would not be useful when the other device is operating so they are routinely put into a standby mode until needed. Consequently, in the event that the handoff is missed, there are no alarms to catch the situation. To solve this unmet need, we propose a novel interoperable, context-aware system capable of detecting and acting if this rare situation occurs. Our system is built on the open-source OpenICE framework, allowing it to seamlessly work with a variety of ventilator and bypass machines.
To the Editor We read with interest Dr Weininger et al’s 1 recent article on safe interoperabilit... more To the Editor We read with interest Dr Weininger et al’s 1 recent article on safe interoperability. The need to look at the entire system, identify clinical scenarios, and apply systems engineering to design safe interoperable systems is appealing. The authors make an excellent point on the need for standards to promote and allow for successful communication and interoperation of medical devices. We would, however, like to highlight the need for standards in one area in particular—the electronic medical record (EMR). In the United States, the 2009 Affordable Care Act provided incentives to install EMRs that resulted in a dramatic increase in their adoption.2 Nearly all Americans now have their data stored in some type of EMR. While details of the storage may vary from system to system, in almost all cases the EMR serves as the central repository for patient data. This includes not just vital signs and orders, but also laboratory results and pertinent medical history. It is precisely because of this vast amalgamation of clinical knowledge that we suggest that its integration into safety systems would bring tremendous benefits. In describing their example of a patient-controlled analgesia pump, the authors state, “The system queries the hospital information system for the patient’s weight, age, and medication list ...” Unfortunately at this time there are no existing standards for structuring these data, let alone for querying them. The 2 largest EMR systems—EPIC (Verona, WI) and Cerner (Kansas City, MO)—use significantly different data structures, and, in the case of EPIC, fundamental elements (such as the units for weight) differ from 1 institution to the next. A potential solution to this problem is the adoption of Fast Healthcare Interoperability Resources (FHIR), an opensource health level-7 standard to promote the transmission of data out of the EMR.3 Unfortunately, EPIC and Cerner only support FHIR to a limited extent, and even in the upcoming EPIC release, FHIR support will still be limited to the core patient-centric elements, such as vital signs, laboratory results, medications, providers, allergies, etc, and overlook data necessary for perioperative integration, such as procedure scheduling and admission/discharge/transfer data. Additionally, the fact that many of the FHIR resources do not provide real-time data significantly diminishes the impact of safe interoperability. Moreover, the specific calls and structure for FHIR differ not only between the EMRs, but also from 1 institution to the next. This forces each institution to create its own custom interface to support the FHIR and integrate with other devices. Collectively, these factors create a costly barrier to entry and greatly inhibit integration, especially in community hospitals that lack technical resources. While FHIR may not be the perfect solution today, we encourage the broader anesthesia community to work with the EMR vendors and others to leverage this framework to create true interoperability between EMRs and devices.
If a perfusionist weans a patient off the heart lung machine (HLM) and the anesthesiologist has n... more If a perfusionist weans a patient off the heart lung machine (HLM) and the anesthesiologist has not re-started the ventilator, the patient will become hypoxic. The objective of this project was to create a redundant safety system of verbal and electronic communication to prevent failure to ventilate errors after cardiopulmonary bypass. This objective could be realized by building an electronic communication bridge directly between the HLM and ventilator. A software application was created to retrieve and interpret data from the pump and ventilator and trigger a programmed smart alarm. The software is able to interpret data from the pump and ventilator. When both are off simultaneously (defined as a pump flow of 0 L/min with a respiratory rate of 0 breaths/min), the application will raies an alarm. Communication between a pump and ventilator is possible, enabling the deployment of a safety system that could exist in the operating room (OR) as a standalone alarm. A device dataset can ...
The complexity of the healthcare ecosystem and the trans-disciplinary convergence which is essent... more The complexity of the healthcare ecosystem and the trans-disciplinary convergence which is essential for its function, makes it difficult to address healthcare as one domain. Data curation and analysis of the information may boost our health related knowledge. Increasing connectivity and improving infrastructure may help, among other things, to uncover facts and observations which may influence the future of global health.
This poster describes our initial work in applying assurance cases to the requirements engineerin... more This poster describes our initial work in applying assurance cases to the requirements engineering processes necessary in building interoperable medical device systems. 1998 ACM Subject Classification D.2.9 Management, K.6.3 Software Management, K.6.4 System Management Overview Habli and others have described the application of assurance case methods to support goal-oriented requirements engineering [3]. Atwood describes the application of goal-structuring notation (GSN) to make visible the domain knowledge and assumptions that support the validity of a specific requirement, noting the value of making this available for subsequent analysis on a requirement change or reuse across a system family [2]. Among the objectives of the CIMIT MD PnP Program is to develop one or more instances of systems that, using the same family of systems components and interfaces, satisfies the functional and non-functional needs of four distinct clinical scenarios [4] according to the criteria set forth ...
Objective: In this study, we built a mobile continuous Blood Oxygen Saturation (SpO2) monitor, an... more Objective: In this study, we built a mobile continuous Blood Oxygen Saturation (SpO2) monitor, and for the first time, explored key design principles towards daily applications. Methods: We firstly built a customized wearable computer that can sense two-channel photoplethysmogram (PPG) signals, and transmit the signals wirelessly to smartphone. Afterwards, we explored many SpO2 model building principles, focusing on linear/nonlinear models, different PPG parameter calculation methods, and different finger types. Moreover, we further compared PPG sensor placement principles by comparing different hand configurations and different finger configurations. Finally, a dataset collected from eleven human subjects was used to evaluate the mobile health monitor and explore all of the above design principles. Results: The experimental results show that the root mean square error of the SpO2 estimation is only 1.8, indicating the effectiveness of the system. Conclusion: These results indicate ...
Many surgeons believe that long turnover times between cases are a major impediment to their prod... more Many surgeons believe that long turnover times between cases are a major impediment to their productivity. We hypothesized that redesigning the operating room (OR) and perioperative-staffing system to take advantage of parallel processing would improve throughput and lower the cost of care. A state of the art high tech OR suite equipped with augmented data collection systems served as a living laboratory to evaluate both new devices and perioperative systems of care. The OR suite and all the experimental studies carried out in this setting were designated as the OR of the Future Project (ORF). Before constructing the ORF, modeling studies were conducted to inform the architectural and staffing design and estimate their benefit. In phase I a small prospective trial tested the main hypothesized benefits of the ORF: reduced patient intra-operative flow-time, wait-time and operative procedure time. In phase II a larger retrospective study was conducted to explore factors influencing the...
2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability (HCMDSS-MDPnP 2007), 2007
... Bob Wilson Glenn Himes, PhD The MITRE Corporation [email protected] The MITRE Corporation ghi... more ... Bob Wilson Glenn Himes, PhD The MITRE Corporation [email protected] The MITRE Corporation [email protected] ... listing [1]. The medical device listing database is updated monthly and contains information submitted by device manufacturers about the generic categories of ...
Background New operating room (OR) design focuses more on the surgical environment than on the pr... more Background New operating room (OR) design focuses more on the surgical environment than on the process of care. The authors sought to improve OR throughput and reduce time per case by goal-directed design of a demonstration OR and the perioperative processes occurring within and around it. Methods The authors constructed a three-room suite including an OR, an induction room, and an early recovery area. Traditionally sequential activities were run in parallel, and nonsurgical activities were moved from the OR to the supporting spaces. The new workflow was supported by additional anesthesia and nursing personnel. The authors used a retrospective, case- and surgeon-matched design to compare the throughput, cost, and revenue performance of the new OR to traditional ORs. Results For surgeons performing the same case mix in both environments, the new OR processed more cases per day than traditional ORs and used less time per case. Throughput improvement came from superior nonoperative per...
Our goal is to improve patient outcomes and safety through medical device interoperability. To ac... more Our goal is to improve patient outcomes and safety through medical device interoperability. To achieve this, it is not enough to build a technically perfect system. We present here our work toward the validation of middleware for use in interoperable medical cyber-physical systems. This includes clinical requirements, together with our methodology for collecting them, and a set of eighteen `design pillars' that document the non-functional requirements and design goals that we believe are necessary to build a successful interoperable medical device system. We discuss how the clinical requirements and design pillars are involved in the selection of a middleware for our OpenICE implementation.
Technology in Anesthesiology: Opportunities for Innovation o Updated equipment procurement langua... more Technology in Anesthesiology: Opportunities for Innovation o Updated equipment procurement language that may reduce device vulnerabilities The CSTF proposes to liaise with experts in the FDA, the ASA Committee on Equipment and Facilities, the APSF Committee on Technology, the Society for Technology in Anesthesia, and standards bodies such as ISO Technical Committee 121, IEC 62, AAMI A/R, and UL, to reach technical and clinical subject matter experts. In addition, the CSTF could collaborate with labs that test and evaluate cybersecurity solutions to facilitate sharing the results with hospitals for implementation.
Numerous techniques and maneuvers have been described to anesthetize the upper airway in preparat... more Numerous techniques and maneuvers have been described to anesthetize the upper airway in preparation for awake tracheal intubation, notably the nerve block techniques to the superior laryngeal or the glossopharyngeal nerves as well as the topical application of a local anesthetic, in the form of a gel, spray, or inhaler. 1 The current report describes the efficacy of a lollipop containing 150 mg lidocaine HCl for providing upper airway analgesia for patients under-Support was provided solely from institutional and/or departmental sources.
I, Xintao Ma, declare that I have authored this thesis independently, that I have not used other ... more I, Xintao Ma, declare that I have authored this thesis independently, that I have not used other than the declared sources / resources, and that I have explicitly marked all material which has been quoted either literally or by content from the used sources. Neither this thesis nor any other similar work has been previously submitted to any examination board.
During cardiac surgery there is an unmet need for safe transfer of responsibility for patient oxy... more During cardiac surgery there is an unmet need for safe transfer of responsibility for patient oxygenation back and forth from the anesthesia to the perfusion teams. Prior to cardiopulmonary bypass (CPB), lung ventilation is performed by the anesthesia machine ventilator and is the responsibility of the anesthesia team. During CPB, lung ventilation is halted and oxygenation is performed by the CPB oxygenator and perfusion team This recurrent transfer throughout the procedure introduces the rare but serious possibility of a "never event", resulting in the patient's lungs not being ventilated upon stopping the CPB and potentially leading to catastrophic hypoxemia. Monitors and alarms on the anesthesia and bypass machines would not be useful when the other device is operating so they are routinely put into a standby mode until needed. Consequently, in the event that the handoff is missed, there are no alarms to catch the situation. To solve this unmet need, we propose a novel interoperable, context-aware system capable of detecting and acting if this rare situation occurs. Our system is built on the open-source OpenICE framework, allowing it to seamlessly work with a variety of ventilator and bypass machines.
To the Editor We read with interest Dr Weininger et al’s 1 recent article on safe interoperabilit... more To the Editor We read with interest Dr Weininger et al’s 1 recent article on safe interoperability. The need to look at the entire system, identify clinical scenarios, and apply systems engineering to design safe interoperable systems is appealing. The authors make an excellent point on the need for standards to promote and allow for successful communication and interoperation of medical devices. We would, however, like to highlight the need for standards in one area in particular—the electronic medical record (EMR). In the United States, the 2009 Affordable Care Act provided incentives to install EMRs that resulted in a dramatic increase in their adoption.2 Nearly all Americans now have their data stored in some type of EMR. While details of the storage may vary from system to system, in almost all cases the EMR serves as the central repository for patient data. This includes not just vital signs and orders, but also laboratory results and pertinent medical history. It is precisely because of this vast amalgamation of clinical knowledge that we suggest that its integration into safety systems would bring tremendous benefits. In describing their example of a patient-controlled analgesia pump, the authors state, “The system queries the hospital information system for the patient’s weight, age, and medication list ...” Unfortunately at this time there are no existing standards for structuring these data, let alone for querying them. The 2 largest EMR systems—EPIC (Verona, WI) and Cerner (Kansas City, MO)—use significantly different data structures, and, in the case of EPIC, fundamental elements (such as the units for weight) differ from 1 institution to the next. A potential solution to this problem is the adoption of Fast Healthcare Interoperability Resources (FHIR), an opensource health level-7 standard to promote the transmission of data out of the EMR.3 Unfortunately, EPIC and Cerner only support FHIR to a limited extent, and even in the upcoming EPIC release, FHIR support will still be limited to the core patient-centric elements, such as vital signs, laboratory results, medications, providers, allergies, etc, and overlook data necessary for perioperative integration, such as procedure scheduling and admission/discharge/transfer data. Additionally, the fact that many of the FHIR resources do not provide real-time data significantly diminishes the impact of safe interoperability. Moreover, the specific calls and structure for FHIR differ not only between the EMRs, but also from 1 institution to the next. This forces each institution to create its own custom interface to support the FHIR and integrate with other devices. Collectively, these factors create a costly barrier to entry and greatly inhibit integration, especially in community hospitals that lack technical resources. While FHIR may not be the perfect solution today, we encourage the broader anesthesia community to work with the EMR vendors and others to leverage this framework to create true interoperability between EMRs and devices.
If a perfusionist weans a patient off the heart lung machine (HLM) and the anesthesiologist has n... more If a perfusionist weans a patient off the heart lung machine (HLM) and the anesthesiologist has not re-started the ventilator, the patient will become hypoxic. The objective of this project was to create a redundant safety system of verbal and electronic communication to prevent failure to ventilate errors after cardiopulmonary bypass. This objective could be realized by building an electronic communication bridge directly between the HLM and ventilator. A software application was created to retrieve and interpret data from the pump and ventilator and trigger a programmed smart alarm. The software is able to interpret data from the pump and ventilator. When both are off simultaneously (defined as a pump flow of 0 L/min with a respiratory rate of 0 breaths/min), the application will raies an alarm. Communication between a pump and ventilator is possible, enabling the deployment of a safety system that could exist in the operating room (OR) as a standalone alarm. A device dataset can ...
The complexity of the healthcare ecosystem and the trans-disciplinary convergence which is essent... more The complexity of the healthcare ecosystem and the trans-disciplinary convergence which is essential for its function, makes it difficult to address healthcare as one domain. Data curation and analysis of the information may boost our health related knowledge. Increasing connectivity and improving infrastructure may help, among other things, to uncover facts and observations which may influence the future of global health.
This poster describes our initial work in applying assurance cases to the requirements engineerin... more This poster describes our initial work in applying assurance cases to the requirements engineering processes necessary in building interoperable medical device systems. 1998 ACM Subject Classification D.2.9 Management, K.6.3 Software Management, K.6.4 System Management Overview Habli and others have described the application of assurance case methods to support goal-oriented requirements engineering [3]. Atwood describes the application of goal-structuring notation (GSN) to make visible the domain knowledge and assumptions that support the validity of a specific requirement, noting the value of making this available for subsequent analysis on a requirement change or reuse across a system family [2]. Among the objectives of the CIMIT MD PnP Program is to develop one or more instances of systems that, using the same family of systems components and interfaces, satisfies the functional and non-functional needs of four distinct clinical scenarios [4] according to the criteria set forth ...
Objective: In this study, we built a mobile continuous Blood Oxygen Saturation (SpO2) monitor, an... more Objective: In this study, we built a mobile continuous Blood Oxygen Saturation (SpO2) monitor, and for the first time, explored key design principles towards daily applications. Methods: We firstly built a customized wearable computer that can sense two-channel photoplethysmogram (PPG) signals, and transmit the signals wirelessly to smartphone. Afterwards, we explored many SpO2 model building principles, focusing on linear/nonlinear models, different PPG parameter calculation methods, and different finger types. Moreover, we further compared PPG sensor placement principles by comparing different hand configurations and different finger configurations. Finally, a dataset collected from eleven human subjects was used to evaluate the mobile health monitor and explore all of the above design principles. Results: The experimental results show that the root mean square error of the SpO2 estimation is only 1.8, indicating the effectiveness of the system. Conclusion: These results indicate ...
Many surgeons believe that long turnover times between cases are a major impediment to their prod... more Many surgeons believe that long turnover times between cases are a major impediment to their productivity. We hypothesized that redesigning the operating room (OR) and perioperative-staffing system to take advantage of parallel processing would improve throughput and lower the cost of care. A state of the art high tech OR suite equipped with augmented data collection systems served as a living laboratory to evaluate both new devices and perioperative systems of care. The OR suite and all the experimental studies carried out in this setting were designated as the OR of the Future Project (ORF). Before constructing the ORF, modeling studies were conducted to inform the architectural and staffing design and estimate their benefit. In phase I a small prospective trial tested the main hypothesized benefits of the ORF: reduced patient intra-operative flow-time, wait-time and operative procedure time. In phase II a larger retrospective study was conducted to explore factors influencing the...
2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability (HCMDSS-MDPnP 2007), 2007
... Bob Wilson Glenn Himes, PhD The MITRE Corporation [email protected] The MITRE Corporation ghi... more ... Bob Wilson Glenn Himes, PhD The MITRE Corporation [email protected] The MITRE Corporation [email protected] ... listing [1]. The medical device listing database is updated monthly and contains information submitted by device manufacturers about the generic categories of ...
Background New operating room (OR) design focuses more on the surgical environment than on the pr... more Background New operating room (OR) design focuses more on the surgical environment than on the process of care. The authors sought to improve OR throughput and reduce time per case by goal-directed design of a demonstration OR and the perioperative processes occurring within and around it. Methods The authors constructed a three-room suite including an OR, an induction room, and an early recovery area. Traditionally sequential activities were run in parallel, and nonsurgical activities were moved from the OR to the supporting spaces. The new workflow was supported by additional anesthesia and nursing personnel. The authors used a retrospective, case- and surgeon-matched design to compare the throughput, cost, and revenue performance of the new OR to traditional ORs. Results For surgeons performing the same case mix in both environments, the new OR processed more cases per day than traditional ORs and used less time per case. Throughput improvement came from superior nonoperative per...
Our goal is to improve patient outcomes and safety through medical device interoperability. To ac... more Our goal is to improve patient outcomes and safety through medical device interoperability. To achieve this, it is not enough to build a technically perfect system. We present here our work toward the validation of middleware for use in interoperable medical cyber-physical systems. This includes clinical requirements, together with our methodology for collecting them, and a set of eighteen `design pillars' that document the non-functional requirements and design goals that we believe are necessary to build a successful interoperable medical device system. We discuss how the clinical requirements and design pillars are involved in the selection of a middleware for our OpenICE implementation.
Technology in Anesthesiology: Opportunities for Innovation o Updated equipment procurement langua... more Technology in Anesthesiology: Opportunities for Innovation o Updated equipment procurement language that may reduce device vulnerabilities The CSTF proposes to liaise with experts in the FDA, the ASA Committee on Equipment and Facilities, the APSF Committee on Technology, the Society for Technology in Anesthesia, and standards bodies such as ISO Technical Committee 121, IEC 62, AAMI A/R, and UL, to reach technical and clinical subject matter experts. In addition, the CSTF could collaborate with labs that test and evaluate cybersecurity solutions to facilitate sharing the results with hospitals for implementation.
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Papers by Julian Goldman