Biomedical Instrumentation and Technology最新文献_第3页

Clinician Perspectives on Specifications for Metrics to Inform Pediatric Alarm Management. 临床医生对儿科警报管理指标规范的看法。

Biomedical Instrumentation and Technology Pub Date : 2023-01-01 Epub Date: 2023-04-21 DOI: 10.2345/0899-8205-57.1.18

Halley Ruppel, Erin Pohl, Carolina Rodriguez-Paras, Elizabeth Froh, Kim Perry, Meghan McNamara, Naveen Muthu, Daria Ferro, Irit Rasooly, Christopher P Bonafide

{"title":"Clinician Perspectives on Specifications for Metrics to Inform Pediatric Alarm Management.","authors":"Halley Ruppel, Erin Pohl, Carolina Rodriguez-Paras, Elizabeth Froh, Kim Perry, Meghan McNamara, Naveen Muthu, Daria Ferro, Irit Rasooly, Christopher P Bonafide","doi":"10.2345/0899-8205-57.1.18","DOIUrl":"10.2345/0899-8205-57.1.18","url":null,"abstract":"Background: Ongoing management of monitor alarms is important for reducing alarm fatigue among clinicians (e.g., nurses, physicians). Strategies to enhance clinician engagement in active alarm management in pediatric acute care have not been well explored. Access to alarm summary metrics may enhance clinician engagement. Objective: To lay the foundation for intervention development, we sought to identify functional specifications for formulating, packaging, and delivering alarm metrics to clinicians. Methods: Our team of clinician scientists and human factors engineers conducted focus groups with clinicians from medical-surgical inpatient units in a children's hospital. We inductively coded transcripts, developed codes into themes, and grouped themes into \"current state\" and \"future state.\" Results: We conducted five focus groups with 13 clinicians (eight registered nurses and five doctors of medicine). In the current state, information exchanged among team members about alarm burden is initiated by nurses on an ad hoc basis. For a future state, clinicians identified ways in which alarm metrics could help them manage alarms and described specific information, such as alarm trends, benchmarks, and contextual data, that would support decision-making. Conclusion: We developed four recommendations for future strategies to enhance clinicians' active management of patient alarms: (1) formulate alarm metrics for clinicians by categorizing alarm rates by type and summarizing alarm trends over time, (2) package alarm metrics with contextual patient data to facilitate clinicians' sensemaking, (3) deliver alarm metrics in a forum that facilitates interprofessional discussion, and (4) provide clinician education to establish a shared mental model about alarm fatigue and evidence-based alarm-reduction strategies.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10512991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9415085","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

ISO 14698 or EN 17141: Is There a Choice for Cleanroom Compliance? ISO 14698或EN 17141：洁净室合规性有选择吗？

Biomedical Instrumentation and Technology Pub Date : 2023-01-01 Epub Date: 2023-05-05 DOI: 10.2345/0899-8205-57.s1.15

Gordon Ely

引用次数: 0

ANSI/AAMI SW96: Raising the Bar for Medical Device Security Risk Management. ANSI/AAMI SW96：提高医疗器械安全风险管理标准。

Biomedical Instrumentation and Technology Pub Date : 2023-01-01 Epub Date: 2023-05-02 DOI: 10.2345/0899-8205-57.2.40

Charles S Farlow, Michelle L Jump, Michael S Seeberger, Brian J Fitzgerald

引用次数: 0

Affinity and Inactivation of Bacterial Endotoxins for Medical Device Materials. 细菌内毒素对医疗器械材料的亲和力和灭活作用。

Biomedical Instrumentation and Technology Pub Date : 2023-01-01 Epub Date: 2024-01-03 DOI: 10.2345/0899-8205-57.4.153

Allan Kimble, James Hauschild, Gerald McDonnell

引用次数: 0

Effects of Electron Beam Sterilization on Polytetrafluoroethylene: Design of Experiments Study. 电子束灭菌对聚四氟乙烯的影响：实验设计研究。

Biomedical Instrumentation and Technology Pub Date : 2023-01-01 Epub Date: 2024-01-03 DOI: 10.2345/0899-8205-57.4.117

Rishabh Jain

{"title":"Effects of Electron Beam Sterilization on Polytetrafluoroethylene: Design of Experiments Study.","authors":"Rishabh Jain","doi":"10.2345/0899-8205-57.4.117","DOIUrl":"10.2345/0899-8205-57.4.117","url":null,"abstract":"Polytetrafluoroethylene (PTFE) is a common polymer used in medical devices due to its exceptional properties (e.g., biocompatibility, inertness, chemical stability, low coefficient of friction). However, as a result of molecular weight reduction caused by the process of chain scission, it is known to be susceptible to radiation exposure and can rapidly lose strength and integrity. In this design of experiments study, the goal was to determine whether an operating window of conditions exist for electron beam (E-beam) radiation sterilization in which the degradation of PTFE is acceptably low. PTFE was tested for yield stress after exposure to radiation under different parameters (total dose [15-60 kGy], packaging atmosphere [air/nitrogen], and poststerilization accelerated aging [real-time equivalent of 1 and 3 years]). The results showed that total dose and packaging atmosphere were significant factors and indicated that the use of modified atmosphere packaging (vacuum sealing with nitrogen gas purge) can be a useful approach in increasing the stability of PTFE toward E-beam sterilization.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10764064/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139088868","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

Principles of Parametric Release: Emphasis on Data Collection and Interpretation. 参数发布原理：强调数据收集和解释。

Biomedical Instrumentation and Technology Pub Date : 2023-01-01 Epub Date: 2024-01-03 DOI: 10.2345/0899-8205-57.4.163

Brian McEvoy, Ana Maksimovic, Daniel Howell, Hervé Michel

{"title":"Principles of Parametric Release: Emphasis on Data Collection and Interpretation.","authors":"Brian McEvoy, Ana Maksimovic, Daniel Howell, Hervé Michel","doi":"10.2345/0899-8205-57.4.163","DOIUrl":"10.2345/0899-8205-57.4.163","url":null,"abstract":"Parametric release, which relies on use of process data for product release, provides many benefits. However, adoption by the sterilization industry has been slow, with release typically involving biological indicator (BI) growth responses/ dosimetry readings. The current article highlights how the data provided by the process (described through examples for ethylene oxide [EO], vaporized hydrogen peroxide [VHP], and radiation) may be better used to inform parametric release implementation. The examples involving EO and VHP demonstrated the ability of the sterilization equipment to deliver validated parameters repeatedly after the load presented was validated. For instances in which load variability has not been addressed in performance qualification, BI testing or even measurement of EO concentration cannot reliably or fully inform the impact of such variance on the validated process. \"Direct\" monitoring of EO concentration is a current requirement in ISO 11135:2014. Nonetheless, the findings presented here show that EO and VHP concentrations can be determined by the calculated method, rendering the use of a concentration measurement probe somewhat superfluous. In alignment with European Union good manufacturing practice Annex 17, a key requirement of parametric release is to have sufficient data to demonstrate the repeatability of the validated process. Similar to gas technologies, radiation processing strives to implement parametric release but is limited by the currently available means of measuring all critical parameters, such as photon delivery.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10764061/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139088872","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

Test Soil and Material Affinity for Reusable Device Cleaning Validations. 测试可重复使用设备清洁验证的土壤和材料亲和性。

Biomedical Instrumentation and Technology Pub Date : 2023-01-01 Epub Date: 2024-01-03 DOI: 10.2345/0899-8205-57.4.136

Terra A Kremer, Christopher H Ratanski

{"title":"Test Soil and Material Affinity for Reusable Device Cleaning Validations.","authors":"Terra A Kremer, Christopher H Ratanski","doi":"10.2345/0899-8205-57.4.136","DOIUrl":"10.2345/0899-8205-57.4.136","url":null,"abstract":"While selecting the test variables for a cleaning validation for reusable medical devices, the manufacturer must provide a simulative and clinically representative challenge for the device. An appropriate challenge must be identified with care so as not to overchallenge the cleaning process by selecting the worst case for every variable, thus leading to an impossible validation or unrealistic processing requirements. To appropriately select the testing variables, an understanding of the challenge to the cleaning process is important. The relationship among device material, test soil, and application method was investigated by testing 140 variable combinations, including seven materials (stainless steel, polyoxymethylene, polyether ether ketone, nitinol, aluminum, titanium, and silicone), four test soils (defibrinated blood soil, coagulated blood, modified coagulated blood, and Miles soil), and five soil application methods (pipetting neat, pipetting spreader, painting, handling with soiled gloves, and immersion). Stainless steel was the only material that showed consistent soil application in a thickness (at ~6 μL/cm2) that fully covered the test surface without some element of pooling, cracking, flaking, or soil migration with all test soils and application methods. The data collected using solubility testing indicated that a complex relationship for material adherence may exist between device materials and test soil. Stainless steel was the most challenging material tested.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10764060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139088873","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

Validation of the Device Feature Approach for Reusable Medical Device Cleaning Evaluations. 验证可重复使用医疗器械清洁评估的设备特征方法。

Biomedical Instrumentation and Technology Pub Date : 2023-01-01 Epub Date: 2024-01-03 DOI: 10.2345/0899-8205-57.4.143

Terra A Kremer, Jeff Felgar, Neil Rowen, Gerald McDonnell

{"title":"Validation of the Device Feature Approach for Reusable Medical Device Cleaning Evaluations.","authors":"Terra A Kremer, Jeff Felgar, Neil Rowen, Gerald McDonnell","doi":"10.2345/0899-8205-57.4.143","DOIUrl":"10.2345/0899-8205-57.4.143","url":null,"abstract":"The identification of worst-case device (or device set) features has been a well-established validation approach in many areas (e.g., terminal sterilization) for determining process effectiveness and requirements, including for reusable medical devices. A device feature approach for cleaning validations has many advantages, representing a more conservative approach compared with the alternative compendial method of testing the entirety of the device. By focusing on the device feature(s), the most challenging validation variables can be isolated to and studied at the most difficult-to-clean feature(s). The device feature approach can be used to develop a design feature database that can be used to design and validate device cleanliness. It can also be used to commensurately develop a quantitative cleaning classification system that will augment and innovate the effectiveness of the Spaulding classification for microbial risk reduction. The current study investigated this validation approach to verify the efficacy of device cleaning procedures and mitigate patient risk. This feature categorization approach will help to close the existing patient safety gap at the important interface between device manufacturers and healthcare facilities for the effective and reliable processing of reusable medical devices. A total of 56,000 flushes of the device features were conducted, highlighting the rigor associated with the validation. Generating information from design features as a critical control point for cleaning and microbiological quality will inform future digital transformation of the medical device industry and healthcare delivery, including automation.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10764062/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139088874","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

Sterilization-Related Challenges of Off-Site Transportation of Medical Equipment. 医疗设备场外运输的灭菌相关挑战。

Biomedical Instrumentation and Technology Pub Date : 2023-01-01 Epub Date: 2023-05-05 DOI: 10.2345/0899-8205-57.s1.11

Rodney Parker, Greg Baumgardner, Susan G Klacik

引用次数: 0

Power of Parametric: Methods to Validate Ethylene Oxide Sterilization Parametric Release. 参数的力量：验证环氧乙烷灭菌参数发布的方法。

Biomedical Instrumentation and Technology Pub Date : 2023-01-01 Epub Date: 2024-01-03 DOI: 10.2345/0899-8205-57.4.129

Elise Coakley, Liliana De Alba Nunez, Abigail Honetschlager, Daniel Howell, Scott Jelley, Nicole McLees, Rosa I Vale Mercado

{"title":"Power of Parametric: Methods to Validate Ethylene Oxide Sterilization Parametric Release.","authors":"Elise Coakley, Liliana De Alba Nunez, Abigail Honetschlager, Daniel Howell, Scott Jelley, Nicole McLees, Rosa I Vale Mercado","doi":"10.2345/0899-8205-57.4.129","DOIUrl":"10.2345/0899-8205-57.4.129","url":null,"abstract":"When approaching an ethylene oxide (EO) sterilization validation, medical device manufacturers traditionally have two choices. They can use biological indicators (BIs) to monitor each production run or establish a parametric release process in which sterile release is based on the monitoring and control of physical process parameters that ensure process specifications are met. In ISO 11135:2014, parametric release was brought to the forefront as an acceptable release method; however, a perception exists that implementing parametric release is challenging and time consuming. This article will demonstrate that the opposite is true. It presents a streamlined approach in which parametric release is addressed through the various stages of validation: product definition, process definition, performance qualification, routine release, and process control. Considerations for establishing specifications directly from validation versus \"run and record\" and trending critical process parameters (e.g., relative humidity, temperature, EO concentration) are discussed. In addition, the benefits of parametric release (active monitoring) over BI release (passive monitoring), including improvements to turnaround time, process control, risk mitigation, reduction of resource investment, and elimination of microbiological release testing, are highlighted. With multiple benefits, parametric release should be the gold standard for EO sterilization processes. It is not novel and has been widely accepted by regulatory agencies globally and notified bodies. The article further describes how the data collection and process capability that is central to process control and parametric release is more powerful than the information provided by a BI, which is merely a catastrophic indicator when used in routine processing.","PeriodicalId":35656,"journal":{"name":"Biomedical Instrumentation and Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10764058/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139088871","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