Medical Devices-Evidence and Research最新文献

{"title":"Design of Abnormal Heart Sound Recognition System Based on HSMM and Deep Neural Network.","authors":"Hai Yin,&nbsp;Qiliang Ma,&nbsp;Junwei Zhuang,&nbsp;Wei Yu,&nbsp;Zhongyou Wang","doi":"10.2147/MDER.S368726","DOIUrl":"https://doi.org/10.2147/MDER.S368726","url":null,"abstract":"<p><strong>Introduction: </strong>Heart sound signal is an important physiological signal of human body, and the identification and research of heart sound signal is of great significance.</p><p><strong>Methods: </strong>For abnormal heart sound signal recognition, an abnormal heart sound recognition system, combining hidden semi-Markov models (HSMM) with deep neural networks, is proposed. Firstly, HSMM is used to build a heart sound segmentation model to accurately segment the heart sound signal, and then the segmented heart sound signal is subjected to feature extraction. Finally, the trained deep neural network model is used for recognition.</p><p><strong>Results: </strong>Compared with other methods, this method has a relatively small amount of input feature data and high accuracy, fast recognition speed.</p><p><strong>Discussion: </strong>HSMM combined with deep neural network is expected to be deployed on smart mobile devices for telemedicine detection.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"285-292"},"PeriodicalIF":1.3,"publicationDate":"2022-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/16/b7/mder-15-285.PMC9398456.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33438578","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}

{"title":"Cold Plasmamed Beam as a Supporting Treatment of Soft Tissue Injuries in Severe Covid-19 Patients: A Preliminary Report.","authors":"Thanh Xuan Nguyen,&nbsp;Duc Hanh Nguyen,&nbsp;Truong Phu Ho-Man,&nbsp;Vinh Duc An Bui,&nbsp;Phuoc Ngoc Phan","doi":"10.2147/MDER.S372916","DOIUrl":"https://doi.org/10.2147/MDER.S372916","url":null,"abstract":"<p><strong>Background: </strong>Cold plasma has many characteristics that allow for effective wound healing. Due to its efficacy, we have applied it in treating patients with severe Covid-19 who have soft tissue skin lesions and diseases including burns, pressure ulcers, shingles, and contact or atopic dermatitis. This study aims to assess the general characteristics of Covid-19 patients with soft tissue lesions and to conduct a fundamental evaluation of the efficacy of cold plasmamed beams in treating soft tissue wounds in patients with severe Covid-19.</p><p><strong>Methods: </strong>This prospective study was conducted on 20 severe Covid-19 patients with soft tissue lesions at the Intensive Care Center for Covid-19 of Hue Central Hospital in Ho Chi Minh City from September 25 to November 11, 2021. These patients was performed cold plasma irradiation at any stage of wound progression, including new injuries and chronic wounds.</p><p><strong>Results: </strong>Among 915 severe Covid-19 patients treated at our center, 20 patients had soft tissue lesions. Grade I, II, and III pressure ulcers accounted for 70% of the 20 cases of soft tissue lesions and 1.53% of the total patients at the time of the survey. Pressure ulcers were present in only 0.55% of patients (5/915 patients). Eleven out of 20 patients (55.0%) had lesions before admission, and 9 (45.0%) had lesions that appeared after admission. After 14 days of treatment, 14/20 patients had complete epithelialization (70%), and in 18/20 patients, wound exudation had ceased. The wounds became painless; after 3 weeks, the rashes had completely disappeared.</p><p><strong>Conclusion: </strong>The study emphasizes that irradiation with cold plasma contributes to the wound healing process.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"277-283"},"PeriodicalIF":1.3,"publicationDate":"2022-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3c/29/mder-15-277.PMC9394517.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40413538","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}

{"title":"Usability of a Novel Enteral Feeding System: A Summative Study.","authors":"Osman Mohamed Elfadil,&nbsp;Edel Keaveney,&nbsp;Ankitaben Patel,&nbsp;Marwa G Abdelmagid,&nbsp;Ishani Patel,&nbsp;Jalpan Patel,&nbsp;Ryan T Hurt,&nbsp;Manpreet S Mundi","doi":"10.2147/MDER.S367100","DOIUrl":"https://doi.org/10.2147/MDER.S367100","url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"253-262"},"PeriodicalIF":1.3,"publicationDate":"2022-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c2/41/mder-15-253.PMC9362904.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40690124","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}

{"title":"Use of a Portable Electronic Interface Improves Clinical Handoffs and Adherence to Lung Protective Ventilation.","authors":"Neil R Euliano, Paul Stephan, Konstantinos Michalopoulos, Michael A Gentile, A Joseph Layon, Andrea Gabrielli","doi":"10.2147/MDER.S372333","DOIUrl":"10.2147/MDER.S372333","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>In a simulated environment, an electronic RT tool can significantly improve shift-change communication and increase the RCP's level of LPV adherence.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"263-275"},"PeriodicalIF":1.3,"publicationDate":"2022-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/33/48/mder-15-263.PMC9362905.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40690125","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}

{"title":"Biomechanical and Physiological Evaluation of Respiratory Protective Equipment Application.","authors":"Silvia Caggiari,&nbsp;Dan L Bader,&nbsp;Finn Foxell,&nbsp;Nicholas Pipe,&nbsp;Seana Couch,&nbsp;Abbie Turner,&nbsp;Peter R Worsley","doi":"10.2147/MDER.S370142","DOIUrl":"https://doi.org/10.2147/MDER.S370142","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"241-252"},"PeriodicalIF":1.3,"publicationDate":"2022-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9343257/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40682770","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}

{"title":"Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series.","authors":"Andy Kranenburg,&nbsp;Gabriel Garcia-Diaz,&nbsp;Judson H Cook,&nbsp;Michael Thambuswamy,&nbsp;Whitney James,&nbsp;David Stevens,&nbsp;Adam Bruggeman,&nbsp;Ying Chen,&nbsp;Robyn Capobianco,&nbsp;W Carlton Reckling,&nbsp;Joel D Siegal","doi":"10.2147/MDER.S369808","DOIUrl":"https://doi.org/10.2147/MDER.S369808","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"229-239"},"PeriodicalIF":1.3,"publicationDate":"2022-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/51/f6/mder-15-229.PMC9309279.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40639949","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}

{"title":"Clinical Proof of Concept for Stabilization of Tracheostomy Tubes Using Novel DYNAtraq Device.","authors":"Mauricio Orozco-Levi,&nbsp;Carlos Reyes,&nbsp;Neikel Quintero,&nbsp;Diana Tiga-Loza,&nbsp;Mabel Reyes,&nbsp;Sandra Sanabria,&nbsp;Camilo Pizarro,&nbsp;Juan De Hoyos,&nbsp;Norma Serrano,&nbsp;Victor Castillo,&nbsp;Alba Ramírez-Sarmiento","doi":"10.2147/MDER.S366829","DOIUrl":"https://doi.org/10.2147/MDER.S366829","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Aim: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"215-227"},"PeriodicalIF":1.3,"publicationDate":"2022-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bf/46/mder-15-215.PMC9289456.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40540086","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}

{"title":"Preference Testing in Medical Devices: Current Framework and Regulatory Gaps.","authors":"Amy Lewis,&nbsp;Despoina Douka,&nbsp;Angeliki Koukoura,&nbsp;Vasiliki Valla,&nbsp;Amie Smirthwaite,&nbsp;Susanne Holm Faarbaek,&nbsp;Efstathios Vassiliadis","doi":"10.2147/MDER.S368420","DOIUrl":"https://doi.org/10.2147/MDER.S368420","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"199-213"},"PeriodicalIF":1.3,"publicationDate":"2022-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5b/d7/mder-15-199.PMC9271283.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40584895","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}

{"title":"Nonclinical Bench Performance Testing of a Very Low-Cost Nonelectric Bubble Continuous Positive Airway Pressure (bCPAP) and Blenders Device Designed for Newborn Respiratory Support.","authors":"Patricia S Coffey, Alec Wollen","doi":"10.2147/MDER.S318218","DOIUrl":"10.2147/MDER.S318218","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>This very low-cost nonelectric bCPAP and blenders device is optimally designed to deliver a stable and reliable source of pressurized blended gas.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"187-197"},"PeriodicalIF":1.3,"publicationDate":"2022-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/76/f2/mder-15-187.PMC9249094.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40468820","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}

{"title":"Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers.","authors":"Natalia A Wilson,&nbsp;James E Tcheng,&nbsp;Jove Graham,&nbsp;Joseph P Drozda","doi":"10.2147/MDER.S364539","DOIUrl":"https://doi.org/10.2147/MDER.S364539","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and implications: </strong>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.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"177-186"},"PeriodicalIF":1.3,"publicationDate":"2022-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f8/14/mder-15-177.PMC9233486.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40406674","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}