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Usability of a Novel Enteral Feeding System: A Summative Study. 一种新型肠内喂养系统的可用性:总结性研究。
IF 1.3 Q2 Medicine Pub Date : 2022-08-05 eCollection Date: 2022-01-01 DOI: 10.2147/MDER.S367100
Osman Mohamed Elfadil, Edel Keaveney, Ankitaben Patel, Marwa G Abdelmagid, Ishani Patel, Jalpan Patel, Ryan T Hurt, Manpreet S Mundi

Background: Utilization of long-term home enteral nutrition (HEN) for nutrition therapy is increasing across the world. However, HEN can be a mobility-limiting experience affecting quality of life (QoL). Improvement of QoL for patients receiving HEN is a universal goal within the nutrition community. This study evaluated usability of Mobility+®, a novel enteral feeding system (EFS).

Methods: A summative study evaluating usability of the novel EFS was conducted with novices (NV), non-novices (NN), and healthcare professionals (HCP). Subjects in NV and NN groups received familiarization training where they were introduced to the novel EFS and walked through steps to fill pouch, simulate feeding, flush (rinse), and wear the system, using the Instructions for Use (IFU) booklet, followed by a testing session where they simulated system use on their own. HCP self-trained using the IFU and instructional videos. A fill from ready-to-hang (RTH) formula bag method was also tested in HCP. Participants' ability to loosely coil the tubing and sit, stand, and move around wearing a filled feeding pouch inside a crossbody bag was also evaluated.

Results: Forty-five participants completed the study. All participants successfully and safely simulated use of the novel EFS, with 97.8% (44/45) doing so on first attempt. All participants could wear the novel EFS in crossbody bag and move around without any use errors or safety issues.

Conclusion: The examined novel EFS can be safely used in intended use population, with or without previous experience with enteral nutrition, on provision of basic familiarization training and written IFU. Additionally, HCP can successfully self-train on this system with instructional videos.

背景:长期家庭肠内营养(HEN)在营养治疗中的应用在世界范围内正在增加。然而,HEN可能是一种影响生活质量(QoL)的行动受限体验。改善HEN患者的生活质量是营养学界的普遍目标。本研究评估了一种新型肠内喂养系统(EFS) Mobility+®的可用性。方法:对新手(NV)、非新手(NN)和医疗保健专业人员(HCP)进行了一项评估新型EFS可用性的总结性研究。NV组和NN组的受试者接受了熟悉培训,在培训中,他们被介绍给新的EFS,并按照使用说明(IFU)小册子完成填充袋、模拟喂食、冲洗(漂洗)和佩戴系统的步骤,随后是一个测试阶段,他们自己模拟系统的使用。HCP使用IFU和教学视频进行自我培训。在HCP中还测试了即用型(RTH)配方袋填充法。参与者的能力松散线圈管和坐,站,四处走动穿着一个充满喂食袋内斜挎包。结果:45名参与者完成了研究。所有参与者都成功并安全地模拟了新型EFS的使用,97.8%(44/45)的参与者在第一次尝试时就成功了。所有参与者都可以在斜挎包中佩戴新型EFS,并且在没有任何使用错误或安全问题的情况下四处走动。结论:在提供基本熟悉培训和书面IFU的情况下,所研究的新型EFS可安全用于预期使用人群,无论是否有肠内营养经验。此外,HCP可以通过教学视频成功地在该系统上进行自我训练。
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引用次数: 1
Use of a Portable Electronic Interface Improves Clinical Handoffs and Adherence to Lung Protective Ventilation. 使用便携式电子界面可改善临床交接和坚持肺保护性通气。
IF 1.3 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2022-08-05 eCollection Date: 2022-01-01 DOI: 10.2147/MDER.S372333
Neil R Euliano, Paul Stephan, Konstantinos Michalopoulos, Michael A Gentile, A Joseph Layon, Andrea Gabrielli

Background: Mechanical ventilation (MV) is used to support patients with respiratory impairment. Evidence supports the use of lung-protective ventilation (LPV) during MV to improve outcomes. However, studies have demonstrated poor adherence to LPV guidelines. We hypothesized that an electronic platform adapted to a hand-held tablet receiving real-time ventilatory parameters could increase clinician awareness of key LPV parameters. Furthermore, we speculated that an electronic shift-change tool could improve the quality of clinician handoffs.

Methods: Using a specially designed Wi-Fi dongle to transmit data from three ventilators and a respiratory monitor, we implemented a system that displays data from all ventilators under the care of a Respiratory Care Practitioner (RCP) on an electronic tablet. In addition, the tablet created a handoff checklist to improve shift-change communication. In a simulated ICU environment, we monitored the performance of eight RCPs at baseline and while using the system.

Results: Using the system, the time above guideline Pplat decreased by 74% from control, and the time outside the VT range decreased by 60% from control, p = 0.007 and 0.015, respectively. The handoff scores improved quality significantly from 2.8 to 1.6 on a scale of 1 to 5 (1 being best), p = 0.03.

Conclusion: In a simulated environment, an electronic RT tool can significantly improve shift-change communication and increase the RCP's level of LPV adherence.

背景:机械通气(MV)用于支持呼吸功能受损的患者。有证据支持在机械通气过程中使用肺保护通气(LPV)来改善治疗效果。然而,研究表明,对 LPV 指南的遵守情况很差。我们假设,一个可接收实时通气参数的手持平板电脑电子平台可提高临床医生对关键 LPV 参数的认识。此外,我们还推测电子换班工具可以提高临床医生的交接班质量:我们使用专门设计的 Wi-Fi 加密狗传输来自三台呼吸机和一台呼吸监护仪的数据,并在电子平板电脑上显示呼吸护理医师 (RCP) 所护理的所有呼吸机的数据。此外,平板电脑还创建了一份交接清单,以改善换班沟通。在模拟的重症监护室环境中,我们监测了八名呼吸护理执业医师在基线和使用该系统时的表现:结果:使用该系统后,高于指导 Pplat 的时间比对照组减少了 74%,超出 VT 范围的时间比对照组减少了 60%,p = 0.007 和 0.015。在 1 到 5 的评分中,交接评分从 2.8 显著提高到 1.6(1 为最佳),p = 0.03:结论:在模拟环境中,电子 RT 工具可显著改善交班沟通,提高 RCP 的 LPV 依从性水平。
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引用次数: 0
Biomechanical and Physiological Evaluation of Respiratory Protective Equipment Application. 呼吸防护装备应用的生物力学与生理学评价。
IF 1.3 Q2 Medicine Pub Date : 2022-07-26 eCollection Date: 2022-01-01 DOI: 10.2147/MDER.S370142
Silvia Caggiari, Dan L Bader, Finn Foxell, Nicholas Pipe, Seana Couch, Abbie Turner, Peter R Worsley

Purpose: Respiratory protective equipment is widely used in healthcare settings to protect clinicians whilst treating patients with COVID-19. However, their generic designs do not accommodate the variability in face shape across genders and ethnicities. Accordingly, they are regularly overtightened to compensate for a poor fit. The present study aims at investigating the biomechanical and thermal loads during respirator application and the associated changes in local skin physiology at the skin-device interface.

Materials and methods: Sixteen healthy volunteers were recruited and reflected a range of gender, ethnicities and facial anthropometrics. Four single-use respirators were evaluated representing different geometries, size and material interfaces. Participants were asked to wear each respirator in a random order while a series of measurements were recorded, including interface pressure, temperature and relative humidity. Measures of transepidermal water loss and skin hydration were assessed pre- and post-respirator application, and after 20 minutes of recovery. Statistical analysis assessed differences between respirator designs and associations between demographics, interface conditions and parameters of skin health.

Results: Results showed a statistically significant negative correlation (p < 0.05) between the alar width and interface pressures at the nasal bridge, for three of the respirator designs. The nasal bridge site also corresponded to the highest pressures for all respirator designs. Temperature and humidity significantly increased (p < 0.05) during each respirator application. Significant increases in transepidermal water loss values (p < 0.05) were observed after the application of the respirators in females, which were most apparent at the nasal bridge.

Conclusion: The results revealed that specific facial features affected the distribution of interface pressures and depending on the respirator design and material, changes in skin barrier function were evident. The development of respirator designs that accommodate a diverse range of face shapes and protect the end users from skin damage are required to support the long-term use of these devices.

目的:在医疗机构中广泛使用呼吸防护设备,以保护临床医生治疗COVID-19患者。然而,他们的通用设计并不能适应不同性别和种族的脸型差异。因此,他们经常过度收紧,以弥补不合适的。本研究旨在探讨呼吸器使用过程中的生物力学和热负荷以及皮肤-装置界面局部皮肤生理的相关变化。材料和方法:招募了16名健康志愿者,反映了一系列性别、种族和面部人体测量学。评估了代表不同几何形状、尺寸和材料界面的四种一次性呼吸器。参与者被要求按随机顺序佩戴每个呼吸器,同时记录一系列测量数据,包括界面压力、温度和相对湿度。在使用呼吸器前后和恢复20分钟后,评估经皮失水和皮肤水化的测量。统计分析评估了呼吸器设计之间的差异以及人口统计学、界面条件和皮肤健康参数之间的关联。结果:三种呼吸器的鼻翼宽度与鼻梁界面压力呈显著负相关(p < 0.05)。鼻桥部位也与所有呼吸器设计的最高压力相对应。每次使用时,温度和湿度均显著升高(p < 0.05)。女性患者在使用呼吸器后,经皮失水值显著升高(p < 0.05),且以鼻梁部位最为明显。结论:特定的面部特征影响了界面压力的分布,根据呼吸器的设计和材料,皮肤屏障功能的变化是明显的。为了支持这些设备的长期使用,需要开发适应各种脸型并保护最终用户免受皮肤损伤的呼吸器设计。
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引用次数: 3
Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series. 骶髂关节后路间位异体结构固定外侧多孔钛植入物的改良:一个多中心病例系列。
IF 1.3 Q2 Medicine Pub Date : 2022-07-20 eCollection Date: 2022-01-01 DOI: 10.2147/MDER.S369808
Andy Kranenburg, Gabriel Garcia-Diaz, Judson H Cook, Michael Thambuswamy, Whitney James, David Stevens, Adam Bruggeman, Ying Chen, Robyn Capobianco, W Carlton Reckling, Joel D Siegal

Background: Distraction arthrodesis (DA) and stabilization of the sacroiliac (SI) joint by placing standalone structural allograft (SA) into the joint from a posterior trajectory has recently been introduced as a surgical procedure for chronic SI joint pain refractory to non-operative care.

Methods: Retrospective case series of patients with recurrent and/or persistent pain after placement of one or more interpositional/intraarticular standalone SAs between the ilium and sacrum using a posterior procedure to treat SI joint pain/dysfunction. Patients subsequently underwent surgical revision with porous titanium fusion implants using a lateral transfixing procedure. The demographic, clinical, and radiographic features of these cases are described.

Results: Data were available for 37 patients. The average (SD) age was 57 (13) years, 62% were female, and the average BMI was 31 (5.4). On average, two SA implants were placed per joint; 46% of cases were bilateral. At follow-up, two common themes were identified: lucencies around the implants and suboptimal implant position. None of the cases showed radiographic fusion of the SI joint prior to revision. One patient had an inflammatory reaction to the SA. All patients presented for revision due to either continued (49%) or recurrence (51%) of pain. In one revision case, the SA was forced ventrally, resulting in a sacral fracture, which was treated conservatively without sequelae.

Conclusions: The popularity of standalone SA for SI joint stabilization/fusion with a posterior procedure is increasing. This case series demonstrates that clinical failures from this procedure may require surgical revision. The proposed fusion strategy (DA) for these products is unproven in the SI joint, and, therefore, properly conducted prospective randomized clinical trials with long-term clinical and radiographic follow-up are important to establish the safety and efficacy of this approach. In the meantime, the placement of lateral titanium implants appears to be an effective revision strategy.

背景:骶髂(SI)关节的牵拉关节融合术(DA)和稳定通过放置独立的同种异体结构移植物(SA)从后方进入关节最近被引入作为慢性SI关节疼痛难治性非手术治疗的外科手术。方法:采用后路手术治疗髂关节疼痛/功能障碍后,在髂骨和骶骨之间放置一个或多个插入性/关节内独立sa后复发和/或持续疼痛的患者的回顾性病例系列。患者随后接受了多孔钛融合植入物外侧穿刺手术翻修。本文描述了这些病例的人口学、临床和放射学特征。结果:37例患者资料可查。平均(SD)年龄为57(13)岁,62%为女性,平均BMI为31(5.4)。平均每个关节放置两个SA植入物;46%的病例为双侧。在随访中,确定了两个常见的主题:种植体周围透明和次优种植体位置。所有病例均未在翻修前显示骶髂关节的x线片融合。一名患者对SA有炎症反应。所有患者因疼痛持续(49%)或复发(51%)而接受翻修。在一个翻修病例中,SA被强制向腹侧,导致骶骨骨折,该病例被保守治疗,无后遗症。结论:独立SA用于后路SI关节稳定/融合的普及程度越来越高。本病例系列表明,临床失败的手术可能需要手术修正。这些产品的拟议融合策略(DA)在骶髂关节中尚未得到证实,因此,适当进行前瞻性随机临床试验,并进行长期临床和影像学随访,对于确定该方法的安全性和有效性非常重要。同时,放置外侧钛种植体似乎是一种有效的翻修策略。
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引用次数: 1
Clinical Proof of Concept for Stabilization of Tracheostomy Tubes Using Novel DYNAtraq Device. 新型DYNAtraq装置稳定气管切开术导管概念的临床证明。
IF 1.3 Q2 Medicine Pub Date : 2022-07-13 eCollection Date: 2022-01-01 DOI: 10.2147/MDER.S366829
Mauricio Orozco-Levi, Carlos Reyes, Neikel Quintero, Diana Tiga-Loza, Mabel Reyes, Sandra Sanabria, Camilo Pizarro, Juan De Hoyos, Norma Serrano, Victor Castillo, Alba Ramírez-Sarmiento

Introduction: Tracheostomy is one of the most common surgical strategies in intensive care units (ICU) and provides relevant clinical benefit for multiple indications. However, the complications associated with its use range from 5 to 40% according to different series. The risk of these complications could be reduced if fixation strategies and alignment of the tracheostomy tube with respect to the tracheal axis are improved.

Aim: To build a functional device of technological innovation in respiratory medicine for the fixation and alignment of tracheostomy cannula (acronym DYNAtraq) and to evaluate its feasibility and safety in a pilot study in mechanically ventilated patients.

Methods: Study carried out in four phases: (1) design engineering and functional prototyping of the device; (2) study of cytotoxicity and tolerance to the force of traction and push; (3) pilot study of feasibility and safety of its use in tracheostomized and mechanically ventilated patients; and (4) health workers satisfaction study.

Results: The design of the innovative DYNAtraq device included, on the one hand, a connector with very little additional dead space to be inserted between the cannula and the ventilation tubes, and, on the other hand, a shaft with two supports for adhesion to the skin of the thorax with very high tolerance (several kilograms) to pull and push. In patients, the device corrected the malpositioned tracheostomy tubes for the latero-lateral (p < 0.001) and cephalo-caudal angles (p < 0.001). Its effect was maintained throughout the follow-up time (p < 0.001). The use of DYNAtraq did not induce serious adverse events and showed a 70% protective effect for complications (RR = 0.3, p < 0.001) in patients.

Conclusion: DYNAtraq is a new device for respiratory medicine that allows the stabilization, alignment and fixation of tracheostomy tubes in mechanically ventilated patients. Its use provides additional benefits to traditional forms of support as it corrects misalignment and increases tolerance to habitual or forced movements. DYNAtraq is a safe element and can reduce the complications of tracheostomy tubes.

简介:气管切开术是重症监护病房(ICU)最常见的手术策略之一,可为多种适应症提供相关的临床益处。然而,根据不同的系列,与使用相关的并发症从5%到40%不等。如果固定策略和气管造口管相对于气管轴的对齐得到改善,这些并发症的风险可以降低。目的:建立一种用于气管造口插管固定和对准的呼吸医学技术创新功能装置(简称DYNAtraq),并在机械通气患者中进行初步研究,评估其可行性和安全性。方法:研究分四个阶段进行:(1)设备的设计工程和功能原型;(2)细胞毒性和对牵引力和推力的耐受性研究;(3)气管造口和机械通气患者使用的可行性和安全性的初步研究;(4)卫生工作者满意度研究。结果:创新的DYNAtraq装置的设计,一方面包括一个连接器,在套管和通气管之间插入很少的额外死区,另一方面,一个带有两个支撑物的轴,用于粘附在胸部皮肤上,具有非常高的耐受性(几公斤)拉和推。在患者中,该装置矫正了气管造口管在侧侧角(p < 0.001)和头尾角(p < 0.001)的错位。其效果在整个随访期间保持不变(p < 0.001)。使用DYNAtraq未引起严重不良事件,对患者并发症的保护作用为70% (RR = 0.3, p < 0.001)。结论:DYNAtraq是一种新型的呼吸内科设备,可用于机械通气患者气管造口管的稳定、对准和固定。它的使用为传统形式的支撑提供了额外的好处,因为它纠正了错位,增加了对习惯性或强迫运动的容忍度。DYNAtraq是一种安全的元素,可以减少气管造口管的并发症。
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引用次数: 0
Preference Testing in Medical Devices: Current Framework and Regulatory Gaps. 医疗器械偏好测试:当前框架和监管缺口。
IF 1.3 Q2 Medicine Pub Date : 2022-07-06 eCollection Date: 2022-01-01 DOI: 10.2147/MDER.S368420
Amy Lewis, Despoina Douka, Angeliki Koukoura, Vasiliki Valla, Amie Smirthwaite, Susanne Holm Faarbaek, Efstathios Vassiliadis

Preference testing is a valuable source of information that can be provided by both healthcare professionals (HCPs) and patients (users). It can be used to improve the design and development of medical devices by feeding into device usability and, ultimately, risk management. Furthermore, it can aid with selecting the most appropriate clinical endpoints to be used in the clinical evaluation of a device and increase patient engagement by incorporating patient-relevant outcomes. Preference testing is widely conducted in the food industry but is not widespread in the medical field due to limited guidelines and a lack of regulatory framework. As such, manufacturers may be unaware of the benefits of preference testing and fail to take full advantage of it, or conversely, may use inappropriate methodology and/or analyses and consequently fail to collect meaningful data. In this position paper, we aim to highlight the benefits and uses of preference testing, along with potential methods that could be used for preference testing of medical devices. A key step towards the wider implementation of preference testing in medical devices is for the publication of international standards and guidelines for the collection, assessment, and implementation of preference data into the life cycle of a medical device.

偏好测试是医疗保健专业人员(HCPs)和患者(用户)都可以提供的有价值的信息来源。它可用于改善医疗设备的设计和开发,为设备可用性提供信息,并最终改善风险管理。此外,它可以帮助选择最合适的临床终点用于设备的临床评估,并通过纳入患者相关结果来提高患者参与度。偏好测试在食品行业广泛进行,但由于指导方针有限和缺乏监管框架,在医疗领域并不普遍。因此,制造商可能没有意识到偏好测试的好处,未能充分利用它,或者相反,可能使用不适当的方法和/或分析,从而未能收集到有意义的数据。在本立场文件中,我们旨在强调偏好测试的好处和用途,以及可用于医疗设备偏好测试的潜在方法。在医疗器械中更广泛地实施偏好测试的一个关键步骤是出版在医疗器械生命周期中收集、评估和实施偏好数据的国际标准和指南。
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引用次数: 1
Nonclinical Bench Performance Testing of a Very Low-Cost Nonelectric Bubble Continuous Positive Airway Pressure (bCPAP) and Blenders Device Designed for Newborn Respiratory Support. 对专为新生儿呼吸支持设计的超低成本无电气泡持续气道正压(bCPAP)和混合器设备进行非临床台架性能测试。
IF 1.3 Q4 ENGINEERING, BIOMEDICAL Pub Date : 2022-06-27 eCollection Date: 2022-01-01 DOI: 10.2147/MDER.S318218
Patricia S Coffey, Alec Wollen

Purpose: Bubble continuous positive airway pressure (bCPAP) is often used to treat respiratory distress experienced by some 15 million preterm infants born globally every year. In low- and middle-income countries, improvised bCPAP devices are used, often without a blender that protects the infant from the sequelae of excessive oxygen exposure.

Materials and methods: The aim of this bench testing was to assess the mechanical safety and performance of the PATH bCPAP and blenders device, which provides a stable and reliable source of pressurized blended gas without the requirement for a source of compressed medical air or electricity. The device includes two fixed ratio blenders: a "low" blend that provides 37% oxygen and a "high" blend that provides 60% oxygen. We performed bench testing to characterize the performance of the bCPAP and blenders, including respiratory circuit verification, blender verification, conditioned humidity testing, and sound measurement.

Results: Test results for all performance variables met the acceptance criteria of our product requirement specification. The device provides a fixed ratio of air and oxygen that is consistent over the entire range of clinically relevant pressures (4 to 8 cmH2O) and remains consistent despite changes in flow (2 to 7 liters per minute). The blend is stable within ± 5% of the blenders' nominal blend ratio when used with a 100% oxygen source, irrespective of the flow and pressure from the oxygen source or the flow and pressure of the blended gas delivered to the neonate. Sound and humidity test results were within specifications.

Conclusion: This very low-cost nonelectric bCPAP and blenders device is optimally designed to deliver a stable and reliable source of pressurized blended gas.

目的:气泡持续气道正压(bCPAP)通常用于治疗全球每年约 1500 万早产儿的呼吸窘迫。在中低收入国家,使用的是简易的 bCPAP 设备,通常没有搅拌器来保护婴儿免受过量氧气暴露的后遗症:该装置可提供稳定可靠的加压混合气体源,无需压缩医用空气源或电力。该装置包括两个固定比例的混合器:提供 37% 氧气的 "低 "混合器和提供 60% 氧气的 "高 "混合器。我们对 bCPAP 和混合器的性能进行了台架测试,包括呼吸回路验证、混合器验证、条件湿度测试和声音测量:结果:所有性能变量的测试结果均符合我们的产品要求规范的验收标准。设备提供的固定空气和氧气比例在整个临床相关压力范围(4 至 8 cmH2O)内保持一致,并且在流量变化(每分钟 2 至 7 升)时也保持一致。在与 100% 氧气源一起使用时,无论氧气源的流量和压力如何,也无论输送给新生儿的混合气体的流量和压力如何,混合气体都能稳定在混合器标称混合比率的 ± 5% 范围内。声音和湿度测试结果均符合规范:这款成本极低的非电动 bCPAP 和混合器设备经过优化设计,可提供稳定可靠的加压混合气体源。
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引用次数: 0
Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers. 推进医疗设备周围的患者安全:唯一设备标识符在卫生系统实施中的障碍、策略和下一步。
IF 1.3 Q2 Medicine Pub Date : 2022-06-21 eCollection Date: 2022-01-01 DOI: 10.2147/MDER.S364539
Natalia A Wilson, James E Tcheng, Jove Graham, Joseph P Drozda

Background: The requirement for medical device manufacturers to label their devices with a unique device identifier (UDI) was formalized by the 2013 US Food and Drug Administration Unique Device Identification System Rule. However, parallel regulatory requirement for US health systems to use UDIs, particularly the electronic documentation of UDIs during patient care is lacking. Despite the lack of regulation, some health systems have implemented and are using UDIs. To assess the current state, we studied representative health system UDI implementation experiences, including barriers and the strategies to overcome them, and identified next steps to advance UDI adoption.

Methods: Semi-structured interviews were performed with health system personnel involved in UDI implementation in their cardiac catheterization labs or operating rooms. Interviews were transcribed and analyzed using the framework methodology of Ritchie and Spencer. An expert panel evaluated findings and informed barriers, strategies, and next steps.

Results: Twenty-four interviews at ten health systems were performed. Identified barriers were internal (lack of organizational support, information technology gaps, clinical resistance) and external (information technology vendor resistance, limitations in manufacturer support, gaps in reference data, lack of an overall UDI system). Identified strategies included relationship building, education, engagement, and communication. Next steps to advance UDI adoption focus on education, research, support, and policy.

Conclusions and implications: Delineation of UDI implementation barriers and strategies provides guidance and support for health systems to adopt the UDI standard and electronically document UDIs during clinical care. Next steps illuminate critical areas for attention to advance UDI adoption and achieve a comprehensive UDI system in health care to strengthen patient care and safety.

背景:2013年美国食品和药物管理局唯一设备标识系统规则正式规定了医疗器械制造商使用唯一设备标识符(UDI)标记其设备的要求。然而,美国卫生系统使用UDIs的平行监管要求,特别是在患者护理期间UDIs的电子文档缺乏。尽管缺乏监管,但一些卫生系统已经实施并正在使用udi。为了评估现状,我们研究了具有代表性的卫生系统UDI实施经验,包括障碍和克服这些障碍的策略,并确定了推进UDI采用的下一步措施。方法:对在心导管实验室或手术室参与UDI实施的卫生系统人员进行半结构化访谈。访谈记录和分析使用里奇和斯宾塞的框架方法。一个专家小组评估了调查结果,并通报了障碍、战略和下一步措施。结果:在10个卫生系统进行了24次访谈。确定的障碍是内部(缺乏组织支持、信息技术差距、临床阻力)和外部(信息技术供应商阻力、制造商支持限制、参考数据差距、缺乏整体UDI系统)。确定的策略包括建立关系、教育、参与和沟通。推进UDI采用的下一步工作重点是教育、研究、支持和政策。结论和意义:UDI实施障碍和策略的描述为卫生系统在临床护理中采用UDI标准和电子文档UDI提供了指导和支持。接下来的步骤阐明了需要关注的关键领域,以推进UDI的采用,并在卫生保健领域实现全面的UDI系统,以加强患者护理和安全。
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引用次数: 2
Cervix Type and Cervical Cancer Classification System Using Deep Learning Techniques. 使用深度学习技术的子宫颈类型和宫颈癌分类系统。
IF 1.3 Q2 Medicine Pub Date : 2022-06-16 eCollection Date: 2022-01-01 DOI: 10.2147/MDER.S366303
Lidiya Wubshet Habtemariam, Elbetel Taye Zewde, Gizeaddis Lamesgin Simegn

Purpose: Cervical cancer is the 4th most common cancer among women, worldwide. Incidence and mortality rates are consistently increasing, especially in developing countries, due to the shortage of screening facilities, limited skilled professionals, and lack of awareness. Cervical cancer is screened using visual inspection after application of acetic acid (VIA), papanicolaou (Pap) test, human papillomavirus (HPV) test and histopathology test. Inter- and intra-observer variability may occur during the manual diagnosis procedure, resulting in misdiagnosis. The purpose of this study was to develop an integrated and robust system for automatic cervix type and cervical cancer classification using deep learning techniques.

Methods: 4005 colposcopy images and 915 histopathology images were collected from different local health facilities and online public datasets. Different pre-trained models were trained and compared for cervix type classification. Prior to classification, the region of interest (ROI) was extracted from cervix images by training and validating a lightweight MobileNetv2-YOLOv3 model to detect the transformation region. The extracted cervix images were then fed to the EffecientNetb0 model for cervix type classification. For cervical cancer classification, an EffecientNetB0 pre-trained model was trained and validated using histogram matched histopathological images.

Results: Mean average precision (mAP) of 99.88% for the region of interest (ROI) extraction, and test accuracies of 96.84% and 94.5% were achieved for the cervix type and cervical cancer classification, respectively.

Conclusion: The experimental results demonstrate that the proposed system can be used as a decision support tool in the diagnosis of cervical cancer, especially in low resources settings, where the expertise and the means are limited.

目的:宫颈癌是全球第四大最常见的女性癌症。发病率和死亡率持续上升,特别是在发展中国家,原因是缺乏筛查设施、熟练专业人员有限以及缺乏认识。宫颈癌是在应用醋酸(VIA)、巴氏(Pap)试验、人乳头瘤病毒(HPV)试验和组织病理学试验后使用目视检查进行筛查的。在人工诊断过程中,可能会发生观察者之间和观察者内部的变异,从而导致误诊。本研究的目的是利用深度学习技术开发一个集成的、强大的自动子宫颈癌类型和子宫颈癌分类系统。方法:收集来自不同地方卫生机构和在线公共数据集的4005张阴道镜图像和915张组织病理学图像。对不同的预训练模型进行训练和比较,用于宫颈类型分类。在分类之前,通过训练和验证轻量级的MobileNetv2-YOLOv3模型来检测转换区域,从子宫颈图像中提取感兴趣区域(ROI)。然后将提取的子宫颈图像输入到effecentnetb0模型中进行子宫颈类型分类。对于宫颈癌的分类,使用直方图匹配的组织病理学图像训练和验证了一个EffecientNetB0预训练模型。结果:感兴趣区域(ROI)提取的平均精密度(mAP)为99.88%,宫颈类型和宫颈癌分类的检测准确率分别为96.84%和94.5%。结论:实验结果表明,该系统可作为宫颈癌诊断的决策支持工具,特别是在资源匮乏、专业知识和手段有限的情况下。
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引用次数: 7
Safety and Efficacy of Inflatable Penile Prostheses for the Treatment of Erectile Dysfunction: Evidence to Date. 充气阴茎假体治疗勃起功能障碍的安全性和有效性:迄今为止的证据。
IF 1.3 Q2 Medicine Pub Date : 2022-02-10 eCollection Date: 2022-01-01 DOI: 10.2147/MDER.S251364
Vinson M Wang, Laurence A Levine

Erectile dysfunction (ED) is a common problem, and prevalence rates are expected to rise as life expectancy increases worldwide. In more severe cases of ED, penile prosthesis implantation has been an excellent option for patients. Over the past few decades, significant design improvements have been made to the penile prosthesis and modifications to surgical technique to improve clinical outcomes. The purpose of this review is to summarize the safety and efficacy of FDA-approved penile implants in the US market. Design modifications have greatly improved the safety and reliability of the implant. Development of improved surgical techniques has decreased intraoperative injuries and reservoir-related complications. With its high overall satisfaction rates and low risk of complications, the inflatable penile prosthesis remains an excellent option for patients with erectile dysfunction.

勃起功能障碍(ED)是一个常见的问题,随着世界范围内预期寿命的增加,患病率预计会上升。在更严重的ED病例中,阴茎假体植入对患者来说是一个很好的选择。在过去的几十年里,阴茎假体的设计得到了显著的改进,手术技术也得到了改进,以改善临床效果。本综述的目的是总结fda批准的阴茎植入物在美国市场的安全性和有效性。设计上的改进大大提高了种植体的安全性和可靠性。改进手术技术的发展减少了术中损伤和与储层相关的并发症。由于其高的总体满意度和低的并发症风险,充气阴茎假体仍然是勃起功能障碍患者的一个很好的选择。
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引用次数: 5
期刊
Medical Devices-Evidence and Research
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