Expert review of medical devices最新文献_第6页

Study on the impact of sensitization on materiovigilance programme among pharmacy and dental postgraduate students. 研究药剂学和牙科学研究生对药物警戒计划宣传的影响。

Expert review of medical devices Pub Date : 2024-06-06 DOI: 10.1080/17434440.2024.2364821

Adusumilli Pramod Kumar, Jyothi S, Kavya A V, Jeesa George

{"title":"Study on the impact of sensitization on materiovigilance programme among pharmacy and dental postgraduate students.","authors":"Adusumilli Pramod Kumar, Jyothi S, Kavya A V, Jeesa George","doi":"10.1080/17434440.2024.2364821","DOIUrl":"10.1080/17434440.2024.2364821","url":null,"abstract":"Background: Medical devices play a crucial role in patient care but entail inherent risks, necessitating the presence of materiovigilance to monitor and prevent medical device adverse events (MDAEs). The primary objective of our study is to evaluate the impact of an awareness and sensitization program regarding medical devices among participants.Methods: A self-administered, validated knowledge, attitude, and practice (KAP) questionnaire consisting of 15 questions was distributed to study participants, and their responses were collected. The data were analyzed using SPSS software version 18.Results: Out of the 182 responses received, 56% were from the Pharmacy, while 44% were from the Dental field. 64.8% of the participants were unaware of the Materiovigilance Programme of India (MvPI). However, an overwhelming 97.5% displayed a positive attitude towards reporting MDAEs. Only 5% of the participants had received training on how to report MDAEs. Furthermore, 85.71% of participants had not seen the MDAE reporting form.Conclusion: To improve the reporting of MDAEs, it is essential to implement educational interventions and provide training to Pharmacy and Dental postgraduate students. These measures will increase awareness and promote better understanding and implementation of materiovigilance practices.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141249100","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 comparative study of medical device regulation between countries based on their economies. 根据各国经济情况对各国医疗器械监管进行比较研究。

Expert review of medical devices Pub Date : 2024-06-04 DOI: 10.1080/17434440.2024.2360979

Bijaya Chettri, Ramya Ravi

{"title":"A comparative study of medical device regulation between countries based on their economies.","authors":"Bijaya Chettri, Ramya Ravi","doi":"10.1080/17434440.2024.2360979","DOIUrl":"https://doi.org/10.1080/17434440.2024.2360979","url":null,"abstract":"Introduction: Medical devices play a crucial role in healthcare, addressing the diagnosis, treatment, and monitoring of various medical conditions. This study conducts a comprehensive analysis of medical device regulations across nations, considering the economic contexts of diverse countries.Areas covered: The research involves a comparative examination of medical device regulations, dissecting unique frameworks in countries like the United States (US), European Union (EU), India, and Africa. These nations were chosen based on economic significance, market influence, and regulatory structures. The study aims to achieve a nuanced understanding of global medical device regulation, develop strategies to enhance guidelines, especially in developing nations, and provide recommendations for improvements in relevant regions.Expert opinion: Through this study, valuable insights are gained into the diverse regulatory frameworks governing medical devices globally. The analysis identifies areas within these frameworks that require improvement, as well as strategies to enhance regulatory guidelines, particularly addressing the specific needs of developing economies. Ultimately, the research provides significant recommendations for policymakers and industry stakeholders. By offering a deeper understanding of regulatory intricacies, this study establishes pragmatic approaches to address challenges within the medical device industry and improve the regulatory landscape on a global scale.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141238732","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

Comparison of the HugeMed video laryngoscope with the Macintosh direct laryngoscope for nasotracheal tracheal intubation in children undergoing dental treatment: a randomized controlled clinical study. 比较 HugeMed 视频喉镜和 Macintosh 直接喉镜对接受牙科治疗的儿童进行鼻气管插管：一项随机对照临床研究。

Expert review of medical devices Pub Date : 2024-06-03 DOI: 10.1080/17434440.2024.2363289

Ozlem Kocaturk, Sultan Keles

{"title":"Comparison of the HugeMed video laryngoscope with the Macintosh direct laryngoscope for nasotracheal tracheal intubation in children undergoing dental treatment: a randomized controlled clinical study.","authors":"Ozlem Kocaturk, Sultan Keles","doi":"10.1080/17434440.2024.2363289","DOIUrl":"https://doi.org/10.1080/17434440.2024.2363289","url":null,"abstract":"Objectives: The aim of this study was to compare the performance of the HugeMed® videolaryngoscope with a direct Macintosh laryngoscope for nasotracheal intubation.Methods: Eighty-eight children aged 4-10 years were randomly assigned to either the HugeMed® videolaryngoscope (HVL) or the Macintosh direct laryngoscope (MDL) group. Intubation difficulty, glottic view grade, time-to-intubation, number of tracheal intubation attempts, use of external laryngeal manipulation and Magill forceps, recovery time, pediatric-anesthesia-delirium-scale (PAEDS) scores, pain due to tracheal intubation, and laryngeal bleeding were evaluated.Results: Easy tracheal intubation incidence was higher in the HVL group than that in the MDL group (p = 0.001). Glottic view was better in the HVL group as compared to the MDL group (p = 0.027). There was no difference between the groups in terms of time-to-tracheal intubation, number of tracheal intubation attempts, Magill forceps usage, pain, and bleeding due to tracheal intubation. The need for external laryngeal manipulation (p = 0.004) and PAEDS scores (p = 0.006) were higher in the MDL group than those in the HVL group.Conclusion: HugeMed® videolaryngoscope may provide easier tracheal intubation, create a better glottic view, and significantly reduce the need for additional manipulation compared to the Macintosh direct laryngoscope, for nasotracheal intubation.Clinical trial registration: www.clinicaltrial.gov identifier is NCT05121597.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141201617","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

Use of patent term extensions to restore regulatory time for medical devices in the United States. 利用专利期延长恢复美国医疗器械的监管时间。

Expert review of medical devices Pub Date : 2024-06-03 DOI: 10.1080/17434440.2024.2363298

C Benson Kuo, Frances Richmond

{"title":"Use of patent term extensions to restore regulatory time for medical devices in the United States.","authors":"C Benson Kuo, Frances Richmond","doi":"10.1080/17434440.2024.2363298","DOIUrl":"https://doi.org/10.1080/17434440.2024.2363298","url":null,"abstract":"Background: Medical devices can seek patent term extensions (PTEs), which extend market exclusivity to compensate for delays related to clinical trials and regulatory review. Pharmaceutical companies commonly use PTEs, but their use by medical device companies has not been clear.Research design and methods: We examined the use of PTEs by medical device companies between 1984 and 2024 using a database published in the Federal Register and a list published by the Patent and Trademark Office.Results: Only 178 medical device submissions were linked to a PTE application. They were mostly concentrated in 116 product codes associated with 15 medical specialties; nearly half were associated with cardiovascular devices. Numbers increased significantly in the past decade. Successful applications restored 987 days on average.Conclusions: The patent restoration opportunity appears underutilized. It is unclear whether some companies do not recognize the opportunity it promises, or whether it does not meet their needs. Different business features and marketing strategies in device versus pharmaceutical industries may decrease the usefulness of the PTE program for these types of medical products. However, the finding that a small subset of manufacturers operating in competitive markets adopted patent extension strategies more commonly suggests a significant competitive advantage when competition increases.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141238735","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

Paired associative stimulation to enhance motor outcome in spinal cord injury: a systematic review of first evidence. 通过配对联想刺激提高脊髓损伤患者的运动能力：对初步证据的系统回顾。

Expert review of medical devices Pub Date : 2024-05-30 DOI: 10.1080/17434440.2024.2358048

Alex Martino Cinnera, Mirjam Bonanno, Rocco Salvatore Calabrò, Alessio Bisirri, Martina D'Arienzo, Alessia D'Acunto, Irene Ciancarelli, Giovanni Morone, Giacomo Koch

{"title":"Paired associative stimulation to enhance motor outcome in spinal cord injury: a systematic review of first evidence.","authors":"Alex Martino Cinnera, Mirjam Bonanno, Rocco Salvatore Calabrò, Alessio Bisirri, Martina D'Arienzo, Alessia D'Acunto, Irene Ciancarelli, Giovanni Morone, Giacomo Koch","doi":"10.1080/17434440.2024.2358048","DOIUrl":"10.1080/17434440.2024.2358048","url":null,"abstract":"Introduction: Spinal cord injuries (SCI) often result in motor impairment and lifelong disability.Methods: This systematic review, conducted in agreement with PRISMA guidelines, aimed to evaluate the effects of cortico-spinal paired associative stimulation (PAS) on motor outcomes in individuals with SCI. PubMed, Scopus/EMBASE, Pedro, and Cochrane databases were consulted from inception to 2023/01/12.Results: In 1021 articles, 10 studies involving 84 patients meet the inclusion criteria, 7 case series/study, and 3 clinical trials. Despite light differences, the included studies performed a cortico-peripheral PAS using a single transcranial magnetic stimulation and high frequency electrical peripheral nerve stimulation for a consistent number of sessions (>20). All included studies reported improvement in motor outcomes recorded via clinical and/or neurophysiological assessment.Conclusion: Available evidence showed an increase in motor outcomes after PAS stimulation. Indeed, both clinical and neurophysiological outcomes suggest the effectiveness of a high number of PAS sessions in chronic individuals with SCI. Due to a limited number of studies and an unsatisfactory study design, well-designed RCTs are needed to confirm the potentiality of these approaches and clarify the adequate dose-response of PAS in the SCI population.Registration id: The protocol was registered on the PROSPERO database (CRD42023485703).","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141072472","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

Design, evolution, and experience with the candy plug device for endovascular false lumen occlusion of chronic aortic dissections. 用于慢性主动脉夹层血管内假腔闭塞的糖果塞装置的设计、演变和使用经验。

Expert review of medical devices Pub Date : 2024-05-27 DOI: 10.1080/17434440.2024.2360987

Alessandro Grandi, Mario D'Oria, Giuseppe Panuccio, Fiona Rohlffs, Ahmed Eleshra, Jose Torrealba, Petroula Nana, Sandro Lepidi, Andrea Melloni, Luca Bertoglio, Tilo Kölbel

{"title":"Design, evolution, and experience with the candy plug device for endovascular false lumen occlusion of chronic aortic dissections.","authors":"Alessandro Grandi, Mario D'Oria, Giuseppe Panuccio, Fiona Rohlffs, Ahmed Eleshra, Jose Torrealba, Petroula Nana, Sandro Lepidi, Andrea Melloni, Luca Bertoglio, Tilo Kölbel","doi":"10.1080/17434440.2024.2360987","DOIUrl":"https://doi.org/10.1080/17434440.2024.2360987","url":null,"abstract":"Introduction: The management of the false lumen (FL) when dealing with aortic dissection is a crucial aspect since inducing its thrombosis is necessary in order to achieve aortic remodeling. One of the pitfalls of endovascular treatment of aortic dissection (AD) is retrograde distal FL perfusion and pressurization, which prevents FL thrombosis and thus aortic remodeling, while being associated with aneurysmal degeneration of the FL and poor long-term outcomes.Areas covered: Currently, there is no CE/FDA approved device for FL closure, however different techniques and devices have been proposed to overcome this challenge, the most known of which is the Candy Plug (CP). This review aims to describe the CP device, its implantation technique, and the available data in the literature (PubMed, Cochrane, and EMBASE databases; last queried, December 31, 2023).Expert opinions: While the treatment of AD remains technically challenging, the use of the CP technique to close any distal FL reperfusion proved to be feasible and safe with excellent rates of both technical and clinical success. Furthermore, recent studies have shown a quick learning curve with this technique.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141159297","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

Economic evaluation of automated external defibrillator deployment in public settings for out-of-hospital cardiac arrest: a systematic review. 针对院外心脏骤停在公共场所部署自动体外除颤器的经济评估：系统综述。

Expert review of medical devices Pub Date : 2024-05-17 DOI: 10.1080/17434440.2024.2354472

Jalal Arabloo, Elaheh Ahmadizadeh, Aziz Rezapour, Seyed Jafar Ehsanzadeh, Vahid Alipour, Mohammad Mehdi Peighambari, Ali Sarabi Asiabar, Aghdas Souresrafil

{"title":"Economic evaluation of automated external defibrillator deployment in public settings for out-of-hospital cardiac arrest: a systematic review.","authors":"Jalal Arabloo, Elaheh Ahmadizadeh, Aziz Rezapour, Seyed Jafar Ehsanzadeh, Vahid Alipour, Mohammad Mehdi Peighambari, Ali Sarabi Asiabar, Aghdas Souresrafil","doi":"10.1080/17434440.2024.2354472","DOIUrl":"10.1080/17434440.2024.2354472","url":null,"abstract":"Background: Out-of-hospital cardiac arrest (OHCA) is a major issue in aging populations. The use of automatic external defibrillators (AEDs) in public places improves cardiac arrest survival rates. The purpose of this study is to review economic evaluation studies of the use of AED technology in public settings for cardiac arrest resuscitation.Methods: Our search covered 1990-2021 and included PubMed, Cochrane Library, Embase, Scopus, and Web of Science. We included studies that analyzed cost-effectiveness, cost-utility and cost-benefit of the AED technology. Also, we performed the quality assessment of the studies through the checklist of quality assessment standard of health economic studies (QHES).Results: Our inclusion criteria were met by 25 studies. AEDs are found to be cost-effective in places with a high occurrence of cardiac arrest. In addition, proper integration of drones with AEDs into existing systems has the potential to significantly improve OHCA survival rates.Conclusion: The present study found that putting AEDs in high-cardiac arrest and crowded areas reduces average costs. Despite this, the costs associated with acquiring and maintaining AEDs prevent their widespread use. Further research is needed to evaluate feasibility and explore innovative strategies for AED maintenance and accessibility.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140913608","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

Phosphorus-32 microparticles for locally advanced pancreatic cancer: how and when? 磷-32微粒子治疗局部晚期胰腺癌：如何治疗，何时治疗？

Expert review of medical devices Pub Date : 2024-05-07 DOI: 10.1080/17434440.2024.2352009

Luca Urso, Luca Filippi

引用次数: 0

Randomized comparative study of negative pressure wound therapy versus compression dressing on split-thickness skin grafts of the lower limbs in an elderly population. 负压伤口疗法与压力敷料对老年人下肢分层植皮的随机比较研究。

Expert review of medical devices Pub Date : 2024-05-07 DOI: 10.1080/17434440.2024.2350494

Vivien Moris, Sarra Cristofari, Leslie Ann See, David Guillier, Narcisse Zwetyenga, Isabelle Pluvy

{"title":"Randomized comparative study of negative pressure wound therapy versus compression dressing on split-thickness skin grafts of the lower limbs in an elderly population.","authors":"Vivien Moris, Sarra Cristofari, Leslie Ann See, David Guillier, Narcisse Zwetyenga, Isabelle Pluvy","doi":"10.1080/17434440.2024.2350494","DOIUrl":"https://doi.org/10.1080/17434440.2024.2350494","url":null,"abstract":"Introduction: Failure to adequately secure the skin graft to the lower limbs recipient bed can result in loss of the graft. Our objective was to compare the healing of split-thickness skin grafts three weeks postoperatively, using either negative pressure wound therapy (NPWT) or conventional compression bandaging.Methods: In this multicenter randomized controlled study, patients with tissue loss ranging from 50 cm2 to 600 cm2 on the lower limbs and treated with split-thickness skin grafts were included in three French hospitals. A digital photographic evaluation was performed at 3 weeks.Results: During 9 years, 70 patients were included in the study and allocated to a treatment group. The grafted area was similar in both groups. Loss of graft was significantly reduced in the NPWT group with 14.6 cm2 compared to 29 cm2 in the control group (p = 0.0003). The hospital stay was also significantly reduced in the NPWT group, at 4 days versus 6.5 days in the control group (p = 0.0284). In the NPWT group, 60% reported pain compared to 22.9% in the control group (p = 0.0048).Conclusions: The use of NPWT dressings improves skin graft take by reducing necrosis, improving the graft's adherence to the recipient site, and reducing hospital length-of-stay.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140854861","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

Therapeutic biliary stents: applications and opportunities. 治疗性胆道支架：应用与机遇。

Expert review of medical devices Pub Date : 2024-05-01 Epub Date: 2024-05-08 DOI: 10.1080/17434440.2024.2341960

Matthew Ledenko, Beau Toskich, Christine Mehner, Hakan Ceylan, Tushar Patel

{"title":"Therapeutic biliary stents: applications and opportunities.","authors":"Matthew Ledenko, Beau Toskich, Christine Mehner, Hakan Ceylan, Tushar Patel","doi":"10.1080/17434440.2024.2341960","DOIUrl":"10.1080/17434440.2024.2341960","url":null,"abstract":"Introduction: Biliary stents are used to optimize ductal patency and enable bile flow in the management of obstruction or injury related to biliary tract tumors, strictures, stones, or leaks. Although direct therapeutic applications of biliary stents are less well developed, stents can be used to deliver drugs, radioisotopes, and photodynamic therapy.Areas covered: This report provides an in-depth overview of the clinical indications, and therapeutic utility of biliary stents. Unique considerations for the design of biliary stents are described. The properties and functionalities of materials used for stents such as metal alloys, plastic polymers, or biodegradable materials are described, and opportunities for design of future stents are outlined. Current and potential applications of stents for therapeutic applications for biliary tract diseases are described.Expert opinion: Therapeutic biliary stents could be used to minimize inflammation, prevent stricture formation, reduce infections, or provide localized anti-cancer therapy for biliary tract cancers. Stents could be transformed into therapeutic platforms using advanced materials, 3D printing, nanotechnology, and artificial intelligence. Whilst clinical study and validation will be required for adoption, future advances in stent design and materials are expected to expand the use of therapeutic biliary stents for the treatment of biliary tract disorders.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140878209","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