Biomedical Instrumentation and Technology最新文献_第9页

The Ethylene Oxide Product Test of Sterility: Limitations and Interpretation of Results. 环氧乙烷产品无菌试验:限制和结果解释。

Biomedical Instrumentation and Technology Pub Date : 2021-03-01 DOI: 10.2345/0899-8205-55.s3.45

Michael Sadowski, Clark Houghtling, Sopheak Srun, Tim Carlson, Jason Hedrick, Andrew Porteous, Ken Gordon

{"title":"The Ethylene Oxide Product Test of Sterility: Limitations and Interpretation of Results.","authors":"Michael Sadowski, Clark Houghtling, Sopheak Srun, Tim Carlson, Jason Hedrick, Andrew Porteous, Ken Gordon","doi":"10.2345/0899-8205-55.s3.45","DOIUrl":"https://doi.org/10.2345/0899-8205-55.s3.45","url":null,"abstract":"The ethylene oxide (EO) product test of sterility (ToS) can be conducted to comply with ANSI/AAMI/ISO 11135:2014 for the generation of data to demonstrate the appropriateness of the biological indicator (BI) that is used to develop and qualify the EO sterilization process. Clause D.8.6 of 11135 provides an option to perform a sublethal EO process, followed by conducting a product ToS, performing sterility testing of BIs from the process challenge device, and comparing the test results. Certain limitations for the EO product ToS should be considered when conducting studies that feature the use of this test, in order to support compliance with this requirement. Limitations for any sterility test include sample size, testing frequency, detection sensitivity, and/or the potential for false-positive/false-negative results, each of which must be recognized and well understood in order to support compliance with the standard. In addition, the experimental design of any study featuring the use of a sterility test should be carefully developed to ensure the generation of scientifically sound results and conclusions to support the study objective.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655700/pdf/i0899-8205-55-s3-45.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39259653","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}

引用次数: 1

Application of Processing Guidance: Case Study of Cleaning Validations on Flexible Endoscopes. 加工指南的应用:柔性内窥镜清洗验证案例研究。

Biomedical Instrumentation and Technology Pub Date : 2021-03-01 DOI: 10.2345/0899-8205-55.s3.12

Nupur Jain, S Darbi Chavez, Alpa Patel

引用次数: 0

Enhancing Service Capabilities by Adding Electron-Beam Irradiator to Gamma Irradiation Facility. 在伽玛辐照设施增加电子束辐照器，以提高服务能力。

Biomedical Instrumentation and Technology Pub Date : 2021-03-01 DOI: 10.2345/0899-8205-55.s3.27

Gilmara C de Luca, John Schlecht, Bart Croonenborghs

{"title":"Enhancing Service Capabilities by Adding Electron-Beam Irradiator to Gamma Irradiation Facility.","authors":"Gilmara C de Luca, John Schlecht, Bart Croonenborghs","doi":"10.2345/0899-8205-55.s3.27","DOIUrl":"https://doi.org/10.2345/0899-8205-55.s3.27","url":null,"abstract":"In 2013, Sterigenics undertook the addition of a 10-MeV electron beam (e-beam) accelerator at its facility in Jarinu, Brazil. A gamma irradiator was already located at this facility, which processed materials and provided irradiation services in Brazil. The decision to implement an e-beam accelerator at the same facility was made in order to diversify the technology that could be offered and to rapidly increase the overall capacity of the facility. In addition, the e-beam technology was complementary to the existing gamma pallet irradiator and thus provided an internal backup for some processes. The main challenge for staff at the Brazil facility was cross-validating processes carried out by the existing gamma irradiator with processes performed with the new e-beam accelerator. The overall success rate in the cross-validation of processes between the two modalities was positive. Products for healthcare, laboratory testing, and other low-bulk-density products that basically consisted of commonly used polymeric materials were most suitable for cross-validation. Products of higher bulk density, greater heterogeneity, or variability between packaging systems and products with dose specifications for a tote rather than a pallet gamma irradiator presented limitations in the cross-validation success rate. This article focuses on the transition approach, discusses the types of products that were successfully cross-validated in e-beam from gamma, and presents examples where such cross-validation was not pursued.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655706/pdf/i0899-8205-55-s3-27.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39259652","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}

引用次数: 0

Regulatory Approach for Transitioning from Gamma Ray to X-ray Radiation Sterilization. 从伽马射线到x射线辐射灭菌过渡的监管方法。

Biomedical Instrumentation and Technology Pub Date : 2021-03-01 DOI: 10.2345/0899-8205-55.s3.58

Alan Montgomery, Romain Bolle-Reddat, Shari Formica, Bradley Lundahl, Gerald McDonnell

{"title":"Regulatory Approach for Transitioning from Gamma Ray to X-ray Radiation Sterilization.","authors":"Alan Montgomery, Romain Bolle-Reddat, Shari Formica, Bradley Lundahl, Gerald McDonnell","doi":"10.2345/0899-8205-55.s3.58","DOIUrl":"https://doi.org/10.2345/0899-8205-55.s3.58","url":null,"abstract":"When investing in X-ray irradiation facilities around the world, an opportunity exists for defining a regulatory framework for assessing the transition from current gamma irradiation processes. Historically, regulatory strategies for changing the radiation source for routine processing has consisted of repeating the majority, if not all, of the validation activities performed as part of an initial validation and associated submission. Although not a new concept, performing a risk assessment has the potential to be leveraged more fully by increasing the rigor of determining what is changing when product moves from a gamma to an X-ray irradiator, then determining how these differences may affect product characteristics. During these steps, differences can be identified and quantified between radiation sources and potential impacts, if any, to product quality can be elucidated. Based on these risk assessments, the level of action required, or not required, in terms of empirical product testing can be examined and a determination can be made regarding whether a substantial change has occurred.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655707/pdf/i0899-8205-55-s3-58.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39259654","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}

引用次数: 5

Change in Radiation Sterilization Process from Gamma Ray to X-ray. 从伽玛射线到x射线辐射灭菌过程的变化。

Biomedical Instrumentation and Technology Pub Date : 2021-03-01 DOI: 10.2345/0899-8205-55.s3.78

Christiane Beerlage, Bjoern Wiese, Annemie Rehor Kausch, Milorad Arsenijevic

引用次数: 3

Sterilization Modality Selection: Role of Sterility Assurance Subject Matter Expert. 灭菌方式选择:无菌保证主题专家的作用。

Biomedical Instrumentation and Technology Pub Date : 2021-03-01 DOI: 10.2345/0899-8205-55.s3.67

Jami McLaren, Joyce M Hansen, Vu Le

{"title":"Sterilization Modality Selection: Role of Sterility Assurance Subject Matter Expert.","authors":"Jami McLaren, Joyce M Hansen, Vu Le","doi":"10.2345/0899-8205-55.s3.67","DOIUrl":"https://doi.org/10.2345/0899-8205-55.s3.67","url":null,"abstract":"Selection of a sterilization modality for a medical device is a critical decision that requires sterility assurance subject matter experts (SME)s to work collaboratively with various company functions. The sterility assurance SME is responsible and accountable for the sterilization modality decision for a product. The modality selection process starts with the sterility assurance SME partnering with research and development to ensure that the sterilization modality allows the device to deliver its intended function in patient care. After the sterilization modality is selected, the sterility assurance SME needs to work with other partners, including quality, supply chain/logistics, operations, and regulatory, to ensure that the selected sterilization modality is appropriately integrated into the end-to-end process. Collaborative partnerships between sterility assurance experts and key partners regarding sterilization modality selection reduce the potential for negative impacts within the end-to-end sterility assurance process, including impacts on product functionality, increased regulatory approval timelines, and inefficiencies and risks throughout the supply chain. This article describes aspects of a comprehensive approach to sterilization modality selection, including critical information necessary to address each of the key considerations.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655698/pdf/i0899-8205-55-s3-67.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39259650","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}

引用次数: 1

Advancing the Sustainable Use of Ethylene Oxide through Process Validation. 通过工艺验证推进环氧乙烷的可持续利用。

Biomedical Instrumentation and Technology Pub Date : 2021-03-01 DOI: 10.2345/0899-8205-55.s3.35

Brian McEvoy, Stacy Bohl Wiehle, Ken Gordon, Gerry Kearns, Paulo Laranjeira, Nicole McLees

{"title":"Advancing the Sustainable Use of Ethylene Oxide through Process Validation.","authors":"Brian McEvoy, Stacy Bohl Wiehle, Ken Gordon, Gerry Kearns, Paulo Laranjeira, Nicole McLees","doi":"10.2345/0899-8205-55.s3.35","DOIUrl":"https://doi.org/10.2345/0899-8205-55.s3.35","url":null,"abstract":"Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward optimization of EO processes, whereby only necessary amounts of sterilant are used in routine processing. EO sterilization of medical devices is validated in accordance with AAMI/ANSI/ISO 11135:2014 via a manner in which a sterility assurance level (SAL) of 10-6 is typically achieved, with multiple layers of conservativeness delivered, using \"overkill\" approaches to validation. Various optimization strategies are being used throughout the medical device industry to deliver the required SAL while utilizing only necessary amounts of sterilant. This article presents relevant experiences and describes challenges and considerations encountered in delivering EO process optimization. Thus far, the results observed by the authors are encouraging in demonstrating how EO processing can be optimized in the delivery of critical single-use medical devices for patient care.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655701/pdf/i0899-8205-55-s3-35.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39253189","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}

引用次数: 3

Potential Induced Radioactivity in Materials Processed with X-ray Energy Above 5 MeV. 用5兆电子伏特以上的x射线处理材料的电位诱导放射性。

Biomedical Instrumentation and Technology Pub Date : 2021-03-01 DOI: 10.2345/0899-8205-55.s3.17

Hervé Michel, Thomas Kroc, Brian J McEvoy, Deepak Patil, Pierre Reppert, Mark A Smith

引用次数: 2

Lessons from the Glass Cockpit: Innovation in Alarm Systems to Support Cognitive Work. 玻璃座舱的教训:支持认知工作的报警系统创新。

Biomedical Instrumentation and Technology Pub Date : 2021-01-01 DOI: 10.2345/0899-8205-55.1.29

Randall J Mumaw, Emilie M Roth, Emily S Patterson

{"title":"Lessons from the Glass Cockpit: Innovation in Alarm Systems to Support Cognitive Work.","authors":"Randall J Mumaw, Emilie M Roth, 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":"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.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"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}

引用次数: 3

Overview of a Robust Human Factors Engineering Process. 稳健的人因工程过程概述。

Biomedical Instrumentation and Technology Pub Date : 2021-01-01 DOI: 10.2345/0899-8205-55.1.16

Tressa Daniels, Tim Goldsmith, Anindya Basu

引用次数: 0