Biomedical Instrumentation and Technology最新文献

{"title":"Potential Induced Radioactivity in Materials Processed with X-ray Energy Above 5 MeV.","authors":"Hervé Michel,&nbsp;Thomas Kroc,&nbsp;Brian J McEvoy,&nbsp;Deepak Patil,&nbsp;Pierre Reppert,&nbsp;Mark A Smith","doi":"10.2345/0899-8205-55.s3.17","DOIUrl":"https://doi.org/10.2345/0899-8205-55.s3.17","url":null,"abstract":"<p><p>Section 5.1.2 of ANSI/AAMI/ISO 11137-1 states that \"the potential for induced radioactivity in product shall be assessed.\" This article describes how compliance with this requirement may be achieved using qualified test methods. Materials of consideration are conceptually discussed, and results of testing conducted on products processed with a 7.5-MeV X-ray irradiation process are provided. As X-ray becomes more widely used in healthcare sterilization, having standard assessment protocols for activation coupled with a shared database of material test results will benefit manufacturers seeking to utilize this innovative technology.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 s3","pages":"17-26"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655703/pdf/i0899-8205-55-s3-17.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39253190","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":"Lessons from the Glass Cockpit: Innovation in Alarm Systems to Support Cognitive Work.","authors":"Randall J Mumaw,&nbsp;Emilie M Roth,&nbsp;Emily S Patterson","doi":"10.2345/0899-8205-55.1.29","DOIUrl":"https://doi.org/10.2345/0899-8205-55.1.29","url":null,"abstract":"<p><p>Nurses working in the hospital setting increasingly have become overburdened by managing alarms that, in many cases, provide low information value regarding patient health. The current trend, aided by disposable, wearable technologies, is to promote patient monitoring that does not require entering a patient's room. The development of telemetry alarms and middleware escalation devices adds to the continued growth of auditory, visual, and haptic alarms to the hospital environment but can fail to provide a more complete understanding of patient health. As we begin to innovate to both address alarm overload and improve patient management, perhaps using fundamentally different integration architectures, lessons from the aviation flight deck are worth considering. Commercial jet transport systems and their alarms have evolved slowly over many decades and have developed integration methods that account for operational context, provide multiple response protocol levels, and present a more integrated view of the airplane system state. We articulate three alarm system objectives: (1) supporting hazard management, (2) establishing context, and (3) supporting alarm prioritization. More generally, we present the case that alarm design in aviation can spur directions for innovation for telemetry monitoring systems in hospitals.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 1","pages":"29-40"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641425/pdf/i0899-8205-55-1-29.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25436835","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":"Overview of a Robust Human Factors Engineering Process.","authors":"Tressa Daniels,&nbsp;Tim Goldsmith,&nbsp;Anindya Basu","doi":"10.2345/0899-8205-55.1.16","DOIUrl":"https://doi.org/10.2345/0899-8205-55.1.16","url":null,"abstract":"All medical device companies perform human factors engineering (HFE) in some capacity. Human factors validation often is required for a medical product to reach market. The type of human factors validation that each device undergoes can be based on the medical device regulatory risk classification, severity of harm associated with the use of the device, or product complexity. Some companies treat the human factors validation process as a check box at the end of product development rather than using the HFE process throughout the product life cycle, which can lead to costly validation tests that generate a multitude of usability issues that need to be fixed, thereby delaying timelines and launch dates and harming a company’s bottom line. Companies that incorporate a robust HFE process into the entire product life cycle find that they have increased product safety and decreased development time. It also results in a competitive advantage in the marketplace. This article provides an overview and introduction to what a robust HFE process looks like.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 1","pages":"16-20"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641423/pdf/i0899-8205-55-1-16.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25335623","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":"Hey You, Get On the Cloud: Safe and Compliant Use of Cloud Computing with Medical Devices.","authors":"Clay Anselmo,&nbsp;Mike Attili,&nbsp;Randy Horton,&nbsp;Bernhard Kappe,&nbsp;Josh Schulman,&nbsp;Pat Baird","doi":"10.2345/0899-8205-55.1.1","DOIUrl":"https://doi.org/10.2345/0899-8205-55.1.1","url":null,"abstract":"Numerous well-established principles, standards, and best practices serve as a robust framework for hardware-based medical device development, manufacturing, and maintenance, with the goal of ensuring ongoing safety and effectiveness. These range from broad frameworks (e.g., the Food and Drug Administration’s [FDA’s] Total Product Life Cycle) to specific standards, guidelines, and broadly accepted best practices (e.g., the ubiquitous ISO 13485 and corresponding implementation in the FDA Quality System Regulation requirements [21 CFR 820]). Because of the origin of medical devices in hardware, sections of these standards/regulations were clearly written with hardware in mind. The advent of devices that are exclusively software (Software as a Medical Device [SaMD]) created challenges for the medical device industry, ranging from development methodologies to manufacturing and postmarket maintenance and upgrades. These continue to be addressed via the adaptation of existing medical device frameworks for the SaMD life cycle in the creation of new standards and best practices (e.g., developing practices outlined in IEC 62304 and the quality principles promulgated by the International Medical Devices Regulator Forum [IMDRF]). Most recently, the execution of software has increasingly moved away from local storage and processing toward a cloud-based paradigm. This presents new challenges and opportunities throughout the development and product life cycle. However, frameworks for a cloud-based life cycle have not been fully defined. This article seeks to address the current lack of a consensus framework/guidance/ initial best practices and regulatory uncertainty around the use of cloud technology as a component in the operation of regulated medical devices. The authors believe that this issue can best be addressed by creating a well-understood and repeatable pathway, which this article can help kickstart, followed by progression to a consensus report. After that, if there is collective value for the ecosystem to take this pathway further, this work could evolve into an AAMI Technical Information Report (TIR) or approved standard. The objective of developing new standards or guidance is to provide the industry with a clearly marked path to move forward to a “medical device cloud framework” that takes into account the following: • Use of cloud technology in a sustained, compliant manner • A large collection of available cloud technology currently exists that is well established, reliable, and being used in the regulated industry • The existence of established, highly competent cloud technology providers for cloud computing • Certain aspects of cloud technology actually can be less risky compared with traditional medical device computing models This article will discuss the following topics: • History of the cloud • The National Institute of Standards and Technology’s (NIST’s) definition of the cloud • Current obstacles and compliance issues related to cloud ","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 1","pages":"1-15"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641424/pdf/i0899-8205-55-1-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38839068","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":"Nurse and Pharmacist Knowledge of Intravenous Smart Pump System Setup Requirements.","authors":"K. Giuliano, Jeannine W C Blake","doi":"10.2345/0890-8205-55.1.51","DOIUrl":"https://doi.org/10.2345/0890-8205-55.1.51","url":null,"abstract":"OBJECTIVE\u0000The primary purpose of this research was to describe nurse and pharmacist knowledge of setup requirements for intravenous (IV) smart pumps that require head height differentials for accurate fluid flow.\u0000\u0000\u0000METHODS\u0000A secondary analysis of anonymous electronic survey data using a database of prerecruited clinicians was conducted. A survey was sent by email to 173 pharmacists and 960 nurses. The response rate for pharmacists was 58% (100 of 173), and the response rate for nurses was 52% (500 of 960). After removing respondents who did not provide direct care and who did not use a head height differential IV infusion system, the final sample for analysis was 186 nurses and 25 pharmacists.\u0000\u0000\u0000RESULTS\u0000Overall, less than one-half of respondents (40%) were aware that manufacturer guidelines for positioning the primary infusion bag relative to the infusion pump were available. Slightly more (49.5%) were aware of the required head height differentials for secondary infusion. Only five respondents selected the correct primary head height, eight respondents selected the correct secondary head height, and one respondent selected both the correct primary and secondary head heights.\u0000\u0000\u0000CONCLUSION\u0000The results of this study identify a substantial lack of knowledge among frontline clinicians regarding manufacturer recommendations for accurate IV administration of primary and secondary infusions for head height differential infusion systems. Both increased clinician education and innovative technology solutions are needed to improve IV smart pump safety and usability.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 1 1","pages":"51-58"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45528697","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":"Balancing Patient Safety, Clinical Efficacy, and Cybersecurity with Clinician Partners.","authors":"Joseph Schneider,&nbsp;Axel Wirth","doi":"10.2345/0899-8205-55.1.21","DOIUrl":"https://doi.org/10.2345/0899-8205-55.1.21","url":null,"abstract":"Where We Stand Today Cybersecurity events affecting healthcare organizations are in the news with increasing frequency, indicating their growing impact and expanse. We have seen incidents ranging from breaches affecting millions of patient records to attacks shutting down hospitals across the country, with at least one of them tragically contributing to the death of a patient. Most recently, the Cybersecurity and Infrastructure Security Agency, Federal Bureau of Investigation, and Department of Health & Human Services (HHS) issued a joint warning about the healthcare industry being a target of expanding ransomware activity. Meanwhile, ransom financial demands are rising and adversaries are resorting to increasingly brazen methods, including exfiltrating data and extorting patients. COVID-19 has accelerated the trend toward connectivity in healthcare. We have added remote workers and remote patients using telehealth services and are placing devices in patients’ homes, offering a wide range of attack opportunities as critical data are transmitted across home and public networks. Healthcare is now taking place in a much more complex and highly accessible space, offering rich data and a growing attack surface. With the rapidly evolving, increasingly connected information technology (IT) infrastructure and growth of cyberthreats, healthcare is facing a perfect storm. The danger is exacerbated by the fact that we are no longer dealing solely with individual hackers but mainly with well-resourced cybercriminal organizations, as well as politically and economically motivated adversaries (e.g., nation-states, cyber terrorists). Global economic losses due to cyber incidents are estimated to be in the $3-trillion range and are expected to reach $6 trillion in 2021 and $10.5 trillion by 2025. Healthcare organizations are expected to spend $125 billion on cybersecurity over the next 5 years. It is imperative that healthcare improve its cyber defenses and “cyber culture.” This includes expanding our understanding of cyber risks, better defining what we must protect, learning how to protect it in ways that support efficient workflows and safety, and instilling good user cyber behavior. IT security and clinical engineering cannot do this alone. To develop a safe and effective path forward, we also need cyber-savvy clinicians working as partners to ensure that clinical needs are met in security decisions. This article proposes an approach and explores how we might achieve this.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 1","pages":"21-28"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641426/pdf/i0899-8205-55-1-21.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25335624","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":"Even the Simplest Devices May Malfunction: Split Septum Design Revisited.","authors":"R. Naftalovich, S. Char, Andrew Iskander, D. Naftalovich","doi":"10.2345/0890-8205-55.1.41","DOIUrl":"https://doi.org/10.2345/0890-8205-55.1.41","url":null,"abstract":"Split septum medical devices are used in tubing for intravenous (IV) fluid administration-an extremely common clinical task. These tubing caps contain a needleless, valveless system that allows fluid to flow directly through the lumen of the catheter but prevents backflow of fluid or blood when the tubing extension is not connected. We experienced complete failure of a needle-free connector extension set with a Luer-access split septum device in multiple patients due to the split septum remaining fused and essentially unsplit despite being connected on both ends. This led to an adverse event in a patient due to repeated unnecessary IV insertion attempts. This case shows how even the simplest of devices can malfunction and highlights the need for vigilance in clinical practice.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 1 1","pages":"41-43"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43279393","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":"Even the Simplest Devices May Malfunction: Split Septum Design Revisited.","authors":"Rotem Naftalovich,&nbsp;Steven Char,&nbsp;Andrew J Iskander,&nbsp;Daniel Naftalovich","doi":"10.2345/0899-8205-55.1.41","DOIUrl":"https://doi.org/10.2345/0899-8205-55.1.41","url":null,"abstract":"<p><p>Split septum medical devices are used in tubing for intravenous (IV) fluid administration-an extremely common clinical task. These tubing caps contain a needleless, valveless system that allows fluid to flow directly through the lumen of the catheter but prevents backflow of fluid or blood when the tubing extension is not connected. We experienced complete failure of a needle-free connector extension set with a Luer-access split septum device in multiple patients due to the split septum remaining fused and essentially unsplit despite being connected on both ends. This led to an adverse event in a patient due to repeated unnecessary IV insertion attempts. This case shows how even the simplest of devices can malfunction and highlights the need for vigilance in clinical practice.</p>","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"55 1","pages":"41-43"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641422/pdf/i0899-8205-55-1-41.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25453724","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":"Reading Room: Reading Room.","authors":"Nathan Lynch","doi":"10.2345/0899-8205-54.6.450","DOIUrl":"https://doi.org/10.2345/0899-8205-54.6.450","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"54 6","pages":"450"},"PeriodicalIF":0.0,"publicationDate":"2020-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38730648","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":"Bright Ideas: Picturing a Future for Diagnostic Imaging Apprentices.","authors":"Brian Stallard","doi":"10.2345/0899-8205-54.6.434","DOIUrl":"https://doi.org/10.2345/0899-8205-54.6.434","url":null,"abstract":"","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":"54 6","pages":"434-437"},"PeriodicalIF":0.0,"publicationDate":"2020-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38730647","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}