Biomedical Instrumentation and Technology最新文献

{"title":"ISO 4135, Fourth Edition: Two Decades of Progress in ISO/TC 121.","authors":"Debra R Milamed","doi":"10.2345/1943-5967-56.1.29","DOIUrl":"https://doi.org/10.2345/1943-5967-56.1.29","url":null,"abstract":"<p><p>The publication of ISO 4135, Anaesthetic and respiratory equipment-Vocabulary, fourth edition, highlights expansion of the scope of the International Organization for Standardization (ISO) Technical Committee (TC) 121 and its Subcommittees and Working Groups during two decades of work. This document stands alongside ISO 19223:2019, Lung ventilators and related equipment-Vocabulary and semantics, to promote consistency and specificity of terminology across ISO/TC 121 standards.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":" ","pages":"29-32"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39746484","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}

{"title":"Signaling Patient Oxygen Desaturation with Enhanced Pulse Oximetry Tones.","authors":"P. Sanderson, R. Loeb, H. Liley, David Liu, E. Paterson, Kelly Hinckfuss, J. Zestic","doi":"10.2345/1943-5967-56.2.46","DOIUrl":"https://doi.org/10.2345/1943-5967-56.2.46","url":null,"abstract":"Manufacturers could improve the pulse tones emitted by pulse oximeters to support more accurate identification of a patient's peripheral oxygen saturation (SpO2) range. In this article, we outline the strengths and limitations of the variable-pitch tone that represents SpO2 of each detected pulse, and we argue that enhancements to the tone to demarcate clinically relevant ranges are feasible and desirable. The variable-pitch tone is an appreciated and trusted feature of the pulse oximeter's user interface. However, studies show that it supports relative judgments of SpO2 trends over time and is less effective at supporting absolute judgments about the SpO2 number or conveying when SpO2 moves into clinically important ranges. We outline recent studies that tested whether acoustic enhancements to the current tone could convey clinically important ranges more directly, without necessarily using auditory alarms. The studies cover the use of enhanced variable-pitch pulse oximeter tones for neonatal and adult use. Compared with current tones, the characteristics of the enhanced tones represent improvements that are both clinically relevant and statistically significant. We outline the benefits of enhanced tones, as well as discuss constraints of which developers of enhanced tones should be aware if enhancements are to be successful.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"56 2 1","pages":"46-57"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43637579","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}

{"title":"Detecting Unusual Intravenous Infusion Alerting Patterns with Machine Learning Algorithms.","authors":"Marian Obuseh, Denny Yu, P. DeLaurentis","doi":"10.2345/1943-5967-56.2.58","DOIUrl":"https://doi.org/10.2345/1943-5967-56.2.58","url":null,"abstract":"OBJECTIVE\u0000To detect unusual infusion alerting patterns using machine learning (ML) algorithms as a first step to advance safer inpatient intravenous administration of high-alert medications.\u0000\u0000\u0000MATERIALS AND METHODS\u0000We used one year of detailed propofol infusion data from a hospital. Interpretable and clinically relevant variables were feature engineered, and data points were aggregated per calendar day. A univariate (maximum times-limit) moving range (mr) control chart was used to simulate clinicians' common approach to identifying unusual infusion alerting patterns. Three different unsupervised multivariate ML-based anomaly detection algorithms (Local Outlier Factor, Isolation Forest, and k-Nearest Neighbors) were used for the same purpose. Results from the control chart and ML algorithms were compared.\u0000\u0000\u0000RESULTS\u0000The propofol data had 3,300 infusion alerts, 92% of which were generated during the day shift and seven of which had a times-limit greater than 10. The mr-chart identified 15 alert pattern anomalies. Different thresholds were set to include the top 15 anomalies from each ML algorithm. A total of 31 unique ML anomalies were grouped and ranked by agreeability. All algorithms agreed on 10% of the anomalies, and at least two algorithms agreed on 36%. Each algorithm detected one specific anomaly that the mr-chart did not detect. The anomaly represented a day with 71 propofol alerts (half of which were overridden) generated at an average rate of 1.06 per infusion, whereas the moving alert rate for the week was 0.35 per infusion.\u0000\u0000\u0000DISCUSSION\u0000These findings show that ML-based algorithms are more robust than control charts in detecting unusual alerting patterns. However, we recommend using a combination of algorithms, as multiple algorithms serve a benchmarking function and allow researchers to focus on data points with the highest algorithm agreeability.\u0000\u0000\u0000CONCLUSION\u0000Unsupervised ML algorithms can assist clinicians in identifying unusual alert patterns as a first step toward achieving safer infusion practices.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"56 2 1","pages":"58-70"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41341990","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}

{"title":"Assessing Detergent Residuals for Reusable Device Cleaning Validations.","authors":"T. Kremer, D. Olsen, Chad Summers, Alpa Patel, Julie Hoover, M. Cieślak, D. Znamensky, G. Mcdonnell","doi":"10.2345/0890-8205-55.4.165","DOIUrl":"https://doi.org/10.2345/0890-8205-55.4.165","url":null,"abstract":"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 processing cycle, including the risk of device-associated cytotoxicity over the concentration ranges for recommended use and rinsing during cleaning. However, no regulation currently exists requiring manufacturers to demonstrate such safety. Although manufacturers' safety data sheets (SDSs) provide information on the safe use of chemicals for users, this information may not provide sufficient detail to determine the risks of residual chemicals on device surfaces. SDSs are not required to contain a comprehensive list of chemicals used, only those of risk to the user. They should be supplemented with information on the correct concentrations that should be used for cleaning, as well as instructions on the rinsing required to reduce the levels of chemicals to safe (nontoxic) levels prior to further processing. Supporting data, such as toxicity profiles or cytotoxicity data that support the instructions for use, would provide medical device manufacturers and healthcare personnel with the necessary information to make informed decisions about selection and correct use of detergents. In the current work, cytotoxicity profiles for eight commonly used cleaning formulations available internationally were studied. Although all of these products are indicated for use in the cleaning of reusable medical devices, results vary across the serial dilution curves and are not consistent among detergent types. The information presented here can be leveraged by both medical device manufacturers and processing department personnel to properly assess residual detergent risks during processing. This work also serves as a call to cleaning formulation manufacturers to provide this information for all chemistries.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 4 1","pages":"165-170"},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47343779","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}

{"title":"Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices.","authors":"P. Masci, S. Weininger","doi":"10.2345/0890-8205-55.4.132","DOIUrl":"https://doi.org/10.2345/0890-8205-55.4.132","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 1","pages":"132-142"},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42703535","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}

{"title":"Assessing Detergent Residuals for Reusable Device Cleaning Validations.","authors":"Terra A Kremer,&nbsp;Daniel Olsen,&nbsp;Chad Summers,&nbsp;Alpa Patel,&nbsp;Julie Hoover,&nbsp;Marcin Cieslak,&nbsp;Dmitry Znamensky,&nbsp;Gerald McDonnell","doi":"10.2345/0899-8205-55.4.165","DOIUrl":"https://doi.org/10.2345/0899-8205-55.4.165","url":null,"abstract":"<p><p>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 processing cycle, including the risk of device-associated cytotoxicity over the concentration ranges for recommended use and rinsing during cleaning. However, no regulation currently exists requiring manufacturers to demonstrate such safety. Although manufacturers' safety data sheets (SDSs) provide information on the safe use of chemicals for users, this information may not provide sufficient detail to determine the risks of residual chemicals on device surfaces. SDSs are not required to contain a comprehensive list of chemicals used, only those of risk to the user. They should be supplemented with information on the correct concentrations that should be used for cleaning, as well as instructions on the rinsing required to reduce the levels of chemicals to safe (nontoxic) levels prior to further processing. Supporting data, such as toxicity profiles or cytotoxicity data that support the instructions for use, would provide medical device manufacturers and healthcare personnel with the necessary information to make informed decisions about selection and correct use of detergents. In the current work, cytotoxicity profiles for eight commonly used cleaning formulations available internationally were studied. Although all of these products are indicated for use in the cleaning of reusable medical devices, results vary across the serial dilution curves and are not consistent among detergent types. The information presented here can be leveraged by both medical device manufacturers and processing department personnel to properly assess residual detergent risks during processing. This work also serves as a call to cleaning formulation manufacturers to provide this information for all chemistries.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 4","pages":"165-170"},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641418/pdf/i0899-8205-55-4-165.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39600500","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}

{"title":"Quality Fade in Medical Device Manufacturing: Thinness of Airway Breathing Circuit Plastic.","authors":"R. Naftalovich, Marko Oydanich, Tolga Berkman, Andrew Iskander","doi":"10.2345/0890-8205-55.4.118","DOIUrl":"https://doi.org/10.2345/0890-8205-55.4.118","url":null,"abstract":"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 other critical care professionals rely on the circuit to be free of defects. The American Society for Testing and Materials maintains standards of medical devices and had a standard (titled Standard Specification for Anesthesia Breathing Tubes) that included circuits. This standard, which was last updated in 2008, has since been withdrawn. Lack of a defined standard can invite quality fade-the phenomenon whereby manufacturers deliberately but surreptitiously reduce material quality to widen profit margins. With plastics, this is often in the form of thinner material. A minimum thickness delineated in the breathing circuit standard would help ensure product quality, maintain tolerance to mechanical insults, and avert leaks. Our impression is that over the recent years, the plastic in many of the commercially available breathing circuits has gotten thinner. We experienced a circuit leak in the middle of a laminectomy due to compromised plastic tubing in a location that evaded the safety circuit leak check that is performed prior to surgery. This compromised ventilation and oxygenation in the middle of a surgery in which the patient is positioned prone and hence with a minimally accessible airway; it could have resulted in anoxic brain injury or death. The incident led us to reflect on the degree of thinness of the circuit's plastic.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 4 1","pages":"118-120"},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48115768","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}

{"title":"Selecting a Passive Network Monitoring Solution for Medical Device Cybersecurity Management.","authors":"P. Upendra","doi":"10.2345/0890-8205-55.4.121","DOIUrl":"https://doi.org/10.2345/0890-8205-55.4.121","url":null,"abstract":"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 of all the assets in a healthcare system, network security and monitoring are critical to ensuring cyber hygiene of these medical devices. Because of the unique challenges of connected medical devices, a passive network monitoring (PNM) solution is preferred for its overall cybersecurity management. This article is intended to provide guidance on selecting PNM solutions while reinforcing the importance of program assessment, project management, and use of leading practices that facilitate the selection and further implementation of PNM solutions for medical devices. The article provides a detailed introduction to connected medical devices and its role in effective care delivery, an overview of network security types and PNM, an overview of the National Institute of Standards and Technology Cybersecurity Framework and its application for program assessment, essentials of project management for PNM solution selection and implementation, key performance indicators for measuring a solution's ability to meet critical cybersecurity needs for medical devices, and lessons learned from the author's professional experience, selective literature review, and leading practices. Rather than describing a complete list of guidelines for selecting PNM solutions, the current work is intended to provide guidance based on the author's experience and leading practices compiled from successful medical device cybersecurity programs.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 4 1","pages":"121-130"},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46305102","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}

{"title":"Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality.","authors":"G. Mcdonnell, Harold S. Baseman, Lena Cordie-Bancroft","doi":"10.2345/0890-8205-55.4.143","DOIUrl":"https://doi.org/10.2345/0890-8205-55.4.143","url":null,"abstract":"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 process manufacturing), different terms and/or definitions are often used for similar processes or applications internationally. With product innovations (including combination products and cell-based therapy) and global regulatory influences, there is a growing need to harmonize these definitions. The objective of the Kilmer Regulatory Innovation microbiological quality and sterility assurance glossary is to clarify and harmonize the practical use of terms employed by the different parts of regulated healthcare product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled healthcare products internationally. The glossary is expected to continue to evolve, and further industry, academic, and regulatory input is encouraged.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 4 1","pages":"143-164"},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49491865","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}

{"title":"Quality Fade in Medical Device Manufacturing: Thinness of Airway Breathing Circuit Plastic.","authors":"Rotem Naftalovich,&nbsp;Marko Oydanich,&nbsp;Tolga Berkman,&nbsp;Andrew John Iskander","doi":"10.2345/0899-8205-55.4.118","DOIUrl":"https://doi.org/10.2345/0899-8205-55.4.118","url":null,"abstract":"<p><p>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 other critical care professionals rely on the circuit to be free of defects. The American Society for Testing and Materials maintains standards of medical devices and had a standard (titled Standard Specification for Anesthesia Breathing Tubes) that included circuits. This standard, which was last updated in 2008, has since been withdrawn. Lack of a defined standard can invite quality fade-the phenomenon whereby manufacturers deliberately but surreptitiously reduce material quality to widen profit margins. With plastics, this is often in the form of thinner material. A minimum thickness delineated in the breathing circuit standard would help ensure product quality, maintain tolerance to mechanical insults, and avert leaks. Our impression is that over the recent years, the plastic in many of the commercially available breathing circuits has gotten thinner. We experienced a circuit leak in the middle of a laminectomy due to compromised plastic tubing in a location that evaded the safety circuit leak check that is performed prior to surgery. This compromised ventilation and oxygenation in the middle of a surgery in which the patient is positioned prone and hence with a minimally accessible airway; it could have resulted in anoxic brain injury or death. The incident led us to reflect on the degree of thinness of the circuit's plastic.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 4","pages":"118-120"},"PeriodicalIF":0.0,"publicationDate":"2021-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641416/pdf/i0899-8205-55-4-118.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39851014","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}