Expert review of medical devices最新文献_第2页

Innovations in protective mechanical ventilation for acute respiratory distress syndrome management. 用于急性呼吸窘迫综合征管理的保护性机械通气的创新。

Expert review of medical devices Pub Date : 2024-08-19 DOI: 10.1080/17434440.2024.2393773

Denise Battaglini, Sergio Lassola, Marcus J Schultz, Patricia Rm Rocco

引用次数: 0

Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana. 翻新医疗器械的监管情况、风险和解决方案：美国、欧盟、马来西亚和加纳的比较分析。

Expert review of medical devices Pub Date : 2024-08-11 DOI: 10.1080/17434440.2024.2390581

Ann Merin Pinheiro, Bijaya Chettri, Anjali Mehra, Isha Deepti, Ramya Ravi

{"title":"Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana.","authors":"Ann Merin Pinheiro, Bijaya Chettri, Anjali Mehra, Isha Deepti, Ramya Ravi","doi":"10.1080/17434440.2024.2390581","DOIUrl":"10.1080/17434440.2024.2390581","url":null,"abstract":"Introduction: Refurbished medical devices are previously owned equipment that undergo a process of restoration to ensure they meet quality standards and function effectively. The utilization of refurbished medical devices, coupled with the integration of software, poses intricate challenges in terms of regulatory compliance, risk management, and patient safety.Areas covered: This article explores the regulatory frameworks governing refurbished medical devices in the United States (US), the European Union (EU), Malaysia, and Ghana. Included information from a range of primary and secondary sources. Additionally, it aims to identify and analyze the risks associated with refurbished medical devices, with a specific focus on the implications of software integration, and recommend practical solutions for mitigating these risks.Expert opinion: The landscape of refurbished medical devices presents challenges in terms of regulatory compliance, risk management, and patient safety. Addressing these challenges requires careful consideration and strategies to ensure that refurbished devices meet stringent quality standards. By focusing on these areas, policymakers and healthcare professionals can enhance the safe utilization of refurbished medical devices, thereby improving access to quality healthcare, particularly in underserved regions.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908627","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}

引用次数: 0

A pilot study of optical coherence tomography-guided transbronchial biopsy in peripheral pulmonary lesions. 光学相干断层扫描引导下经支气管活组织检查外周肺部病变的试点研究。

Expert review of medical devices Pub Date : 2024-08-06 DOI: 10.1080/17434440.2024.2389235

Guanghong Zhou, Yan Yang, Yi Liao, Lijuan Chen, Yang Yang, Jun Zou

{"title":"A pilot study of optical coherence tomography-guided transbronchial biopsy in peripheral pulmonary lesions.","authors":"Guanghong Zhou, Yan Yang, Yi Liao, Lijuan Chen, Yang Yang, Jun Zou","doi":"10.1080/17434440.2024.2389235","DOIUrl":"https://doi.org/10.1080/17434440.2024.2389235","url":null,"abstract":"Background: The diagnosis of peripheral pulmonary lesions (PPLs) remains challenging. Despite advancements in guided transbronchial biopsy (TBB) techniques, diagnostic yields haven't reached ideal levels. Optical coherence tomography (OCT) has been developed for application in pulmonary diseases, yet no data existed evaluating effectiveness in diagnosing PPLs.Research design and methods: This study included patients who underwent OCT and radial endobronchial ultrasound (R-EBUS)-guided TBB. OCT and R-EBUS imaging features were analyzed to differentiate between benign and malignant PPLs and subtypes of lung cancer.Results: A total of 89 patients were included in this study. The diagnostic yield of OCT-guided TBB stood at 56.18%, R-EBUS-guided TBB was 83.15% (P<0.01). The accuracy of OCT to judge the nature of lesions was 92.59%, while R-EBUS was 77.92%. The accuracy of OCT in predicting squamous carcinoma (SCC) and adenocarcinoma were both 91.30%.Conclusions: Although the diagnostic yield of OCT-guided TBB fell short of that achieved by R-EBUS, OCT possessed the capability to judge the nature of lesions and guide the pathological classification of malignant lesions. Further extensive prospective studies are necessary to thoroughly assess the characteristics of this procedure.Clinical trial registration: https://register.clinicaltrials.gov/ identifier is NCT06419114.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141899229","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}

引用次数: 0

Insertional effect following deep brain stimulation electrode implants. 脑深部刺激电极植入后的插入效应。

Expert review of medical devices Pub Date : 2024-08-05 DOI: 10.1080/17434440.2024.2388135

Ana Carolina Pinheiro Campos, Clement Hamani

引用次数: 0

Electrical neuromodulation for the treatment of chronic pain: derivation of the intrinsic barriers, outcomes and considerations of the sustainability of implantable spinal cord stimulation therapies. 治疗慢性疼痛的电神经调控：植入式脊髓刺激疗法的内在障碍、结果和可持续性考虑因素的推导。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-23 DOI: 10.1080/17434440.2024.2382234

Mark N Malinowski, Brandon E Gish, Alexandra M Moreira, Marcin Karcz, Lucas A Bracero, Timothy R Deer

{"title":"Electrical neuromodulation for the treatment of chronic pain: derivation of the intrinsic barriers, outcomes and considerations of the sustainability of implantable spinal cord stimulation therapies.","authors":"Mark N Malinowski, Brandon E Gish, Alexandra M Moreira, Marcin Karcz, Lucas A Bracero, Timothy R Deer","doi":"10.1080/17434440.2024.2382234","DOIUrl":"10.1080/17434440.2024.2382234","url":null,"abstract":"Introduction: For over 60 years, spinal cord stimulation has endured as a therapy through innovation and novel developments. Current practice of neuromodulation requires proper patient selection, risk mitigation and use of innovation. However, there are tangible and intangible challenges in physiology, clinical science and within society.Areas covered: We provide a narrative discussion regarding novel topics in the field especially over the last decade. We highlight the challenges in the patient care setting including selection, as well as economic and socioeconomic challenges. Physician training challenges in neuromodulation is explored as well as other factors related to the use of neuromodulation such as novel indications and economics. We also discuss the concepts of technology and healthcare data.Expert opinion: Patient safety and durable outcomes are the mainstay goal for neuromodulation. Substantial work is needed to assimilate data for larger and more relevant studies reflecting a population. Big data and global interconnectivity efforts provide substantial opportunity to reinvent our scientific approach, data analysis and its management to maximize outcomes and minimize risk. As improvements in data analysis become the standard of innovation and physician training meets demand, we expect to see an expansion of novel indications and its use in broader cohorts.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141753567","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}

引用次数: 0

Haemodynamic support with percutaneous devices in patients with cardiogenic shock: the current evidence of mechanical circulatory support. 心源性休克患者经皮装置的血液动力学支持：机械循环支持的现有证据。

Expert review of medical devices Pub Date : 2024-08-01 DOI: 10.1080/17434440.2024.2380330

Fatima Kayali, Tiffany Agbobu, Thurkga Moothathamby, Yousif F Jubouri, Matti Jubouri, Amr Abdelhaliem, Samuel N S Ghattas, Samuel S S Rezk, Damian M Bailey, Ian M Williams, Wael I Awad, Mohamad Bashir

{"title":"Haemodynamic support with percutaneous devices in patients with cardiogenic shock: the current evidence of mechanical circulatory support.","authors":"Fatima Kayali, Tiffany Agbobu, Thurkga Moothathamby, Yousif F Jubouri, Matti Jubouri, Amr Abdelhaliem, Samuel N S Ghattas, Samuel S S Rezk, Damian M Bailey, Ian M Williams, Wael I Awad, Mohamad Bashir","doi":"10.1080/17434440.2024.2380330","DOIUrl":"10.1080/17434440.2024.2380330","url":null,"abstract":"Introduction: Cardiogenic shock (CS) is a complex life-threatening condition that results from primary cardiac dysfunction, leading to persistent hypotension and systemic hypoperfusion. Among the therapeutic options for CS are various percutaneous mechanical circulatory support (MCS) devices that have emerged as an increasingly effective hemodynamic support option. Percutaneous therapies can act as short-term mechanical circulatory assistance and can be split into intra-aortic balloon pump (IABP) and non-IABP percutaneous mechanical devices.Areas covered: This review will evaluate the MCS value while considering the mortality rate improvements. We also aim to outline the function of pharmacotherapies and percutaneous hemodynamic MCS devices in managing CS patients to avoid the onset of end-organ dysfunction and improve both early and late outcomes.Expert opinion: Given the complexity, acuity and high mortality associated with CS, and despite the availability and efficacy of pharmacological management, MCS is required to achieve hemodynamic stability and improve survival. Various percutaneous MCS devices are available with varying indications and clinical outcomes. The rates of early mortality and complications were found to be comparable between the four devices, yet, IABP seemed to show the most optimal clinical profile whilst ECMO demonstrated its more long-term efficacy.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141861922","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}

引用次数: 0

Promoting the widespread adoption of videolaryngoscopy: addressing resistance to change. 促进视频喉镜的广泛应用：应对变革阻力。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-24 DOI: 10.1080/17434440.2024.2383376

Manuel Ángel Gómez-Ríos, Teresa López, Alfredo Abad-Gurumeta, José A Sastre

引用次数: 0

Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform. 介入放射学中的混合现实技术：聚焦 XR90 增强现实可视化和导航平台的首次临床应用。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-25 DOI: 10.1080/17434440.2024.2379925

Kyle Finos, Sanjit Datta, Art Sedrakyan, Jeffrey W Milsom, Bradley B Pua

{"title":"Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform.","authors":"Kyle Finos, Sanjit Datta, Art Sedrakyan, Jeffrey W Milsom, Bradley B Pua","doi":"10.1080/17434440.2024.2379925","DOIUrl":"10.1080/17434440.2024.2379925","url":null,"abstract":"Introduction: Augmented reality (AR) and virtual reality (VR) are emerging tools in interventional radiology (IR), enhancing IR education, preprocedural planning, and intraprocedural guidance.Areas covered: This review identifies current applications of AR/VR in IR, with a focus on studies that assess the clinical impact of AR/VR. We outline the relevant technology and assess current limitations and future directions in this space. We found that the use of AR in IR lags other surgical fields, and the majority of the data exists in case series or small-scale studies. Educational use of AR/VR improves learning anatomy, procedure steps, and procedural learning curves. Preprocedural use of AR/VR decreases procedure times, especially in complex procedures. Intraprocedural AR for live tracking is accurate within 5 mm live patients and has up to 0.75 mm in phantoms, offering decreased procedure time and radiation exposure. Challenges include cost, ergonomics, rapid segmentation, and organ motion.Expert opinion: The use of AR/VR in interventional radiology may lead to safer and more efficient procedures. However, more data from larger studies is needed to better understand where AR/VR is confers the most benefit in interventional radiology clinical practice.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141763486","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}

引用次数: 0

Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols. 临床研究期间的医疗设备可用性评估：临床研究协议的范围审查。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-09 DOI: 10.1080/17434440.2024.2378093

Laura Douze, Jessica Schiro, Louise Heyndels, Lionel Pazart, Sylvia Pelayo

{"title":"Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols.","authors":"Laura Douze, Jessica Schiro, Louise Heyndels, Lionel Pazart, Sylvia Pelayo","doi":"10.1080/17434440.2024.2378093","DOIUrl":"10.1080/17434440.2024.2378093","url":null,"abstract":"Objective: Combining clinical investigations with usability studies provides valuable information for medical devices evaluation. But both types of study are very different in terms of objectives and methodologies. How are usability studies integrated into clinical investigations in practice?Methods: We searched the ClinicalTrials.gov database for clinical investigation protocols that included usability outcome(s) and analyzed them.Results: 77 study protocols were identified for the analysis, including 102 outcomes related to usability in total. The most frequently assessed outcomes were satisfaction (53/102) and ease of use (33/102). The questionnaire was the most frequently planned technique (85/102) followed by interviews (24/102). Other methods were used, such as observation (9/102), mostly when the end users was a healthcare professional, and diary (6/102), mostly with patients.Conclusion: Our study results showed that the collection of usability data can be included in a clinical investigation, with various levels of investment. Resource-light, rapid integration via a questionnaire will enable the collection of subjective data on the users' perceptions. When more resources are available, observation in accessible environments can be set up (especially during use by healthcare professionals in hospital) or interviews and/or diaries for home-based environments (especially by patients).","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141565409","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}

引用次数: 0

Thoracic endovascular aortic repair completion following frozen elephant trunk: how it's done and device selection. 冷冻大象躯干后完成胸腔内血管主动脉修补术：手术方法和器械选择。

Expert review of medical devices Pub Date : 2024-08-01 Epub Date: 2024-07-31 DOI: 10.1080/17434440.2024.2380801

André N Capitain, Bartosz Rylski, Tim Berger, Stoyan Kondov, Philipp Discher, Tim Walter, Nikola Batinkov, Magdalena Bork, Matthias D'Inka, Martin Czerny, Maximilian Kreibich

{"title":"Thoracic endovascular aortic repair completion following frozen elephant trunk: how it's done and device selection.","authors":"André N Capitain, Bartosz Rylski, Tim Berger, Stoyan Kondov, Philipp Discher, Tim Walter, Nikola Batinkov, Magdalena Bork, Matthias D'Inka, Martin Czerny, Maximilian Kreibich","doi":"10.1080/17434440.2024.2380801","DOIUrl":"10.1080/17434440.2024.2380801","url":null,"abstract":"Introduction: Since its introduction in the mid-1990s the frozen elephant trunk (FET) technique has quickly evolved into an effective hybrid treatment option for patients with various thoracic aortic pathologies, acute and chronic. However, a notable incidence of and risk for distal aortic reinterventions persists after the implementation of the FET device. In this review, the authors analyze the indications and outcomes of thoracic endovascular aortic repair completion following FET.Areas covered: For this review, we looked not only at our own data but also searched PubMed for relevant studies, comments, and current recommendations of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society for Vascular Surgery (ESVS). Additionally, we outline our approach in this 2-stage-treatment plan.Expert opinion: The treatment of acute or chronic aortic pathologies involving the aortic arch frequently requires a 2-stage treatment approach. Sometimes, a tertiary procedure is needed to fix the entire aortic pathology. Thoracic endovascular aortic repair completion following FET requires careful planning to achieve the excellent clinical outcomes that we and numerous other aortic centers have shown. Only a dedicated aortic clinic provides the long-term continuous follow-up required to identify the few patients in need of a tertiary procedure.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141794288","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}

引用次数: 0