clinical engineering
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Author(s):  
Mariana Ribeiro Brandao ◽  
Maria Collier de Mendonça ◽  
Renato Garcia Ojeda ◽  
Richard Perassi ◽  
Francisco Fialho

Objetivo: Analisar estudos baseados na aplicação do Design Thinking envolvendo dispositivos médicos para discutir a importância das necessidades dos usuários na resolução de problemas relacionados às tecnologias em saúde. Design⏐Metodologia⏐Abordagem: Neste artigo é apresentada uma revisão de forma sistemática da literatura, através do método Systematic Search Flow (SSF),  por meio de uma pesquisa nas bases de dados Scopus, IEEE, Pubmed e Scielo. Foram encontradas 161 publicações segundo os critérios de busca e as palavras-chaves definidas. Por fim, foram  selecionados seis artigos para a análise dos resultados. Resultados: Os resultados da revisão de forma sistemática mostraram diversas possibilidades de aplicação do Design Thinking no desenvolvimento de dispositivos médicos, desde em dispositivos de classe de risco mais elevado, até mesmo em equipamentos menos complexos, para uso domiciliar, e software para aporte clínico para melhorar a experiência de recém-nascidos, crianças, quanto também para auxiliar o envelhecimento saudável de idosos. Originalidade⏐Valor: O desenvolvimento de novas soluções tecnológicas centradas  nos usuários e voltadas para a saúde permitem a  aplicação do Design Thinking; especialmente aquelas que envolvem dispositivos médicos para melhorar a segurança e a qualidade das tecnologias de saúde para os usuários, proporcionando melhor usabilidade e compreensão do contexto atual dessas tecnologias na perspectiva dos usuários. Referências  Abookire, S., Plover, C., Frasso, R., & Ku, B. (2020). Health Design Thinking: An Innovative Approach in Public Health to Defining Problems and Finding Solutions. Front Public Health, 8(459). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7484480/ Altman, M., Huang, T. T., & Breland, J. Y. (2018). Design Thinking in Health Care. Prev Chronic Dis. Ayah, R., Ong'ech, J., Mbugua, E. M., Kosgei, R. C., Waller, K., & Gathara, D. (2020). Responding to maternal, neonatal and child health equipment needs in Kenya: a model for an innovation ecosystem leveraging on collaborations and partnerships. BMJ Innov, 6. https://doi.org/10.1136/bmjinnov-2019-000391 Brown, T. (2008). Design Thinking. Harvard Business Review. Brown, T. (2010). Design Thinking - Uma metodologia poderosa para decretar o fim das velhas ideias (Traduzida - 2017 ed.). Starlin Alta. Ferenhof, H. A., & Fernandes, R. F. (2016). Desmistificando a revisão de literatura como base para redação científica: método SFF. Revista ACB, 21(3). https://revista.acbsc.org.br/racb/article/view/1194 Flewwelling, C., Easty, A., Vicente, K., & Cafazzo, J. (2014). The use of fault reporting of medical equipment to identify latent design flaws. J Biomed Inform. Jiang, J., Liu, T., Zhang, Y., Song, Y., Zhou, M., Zheng, X., & Yan, Z. (2017). Design and development of an intelligent nursing bed - a pilot project of "joint assignment". Annu Int Conf IEEE Eng Med Biol Soc, 38–41. https://doi.org/10.1109/EMBC.2017.8036757 Marko-Holguin, M., Cordel, S. L., Voorhees, B., Fogel, J., Sykes, E., Fitzgibbon, M., & Glassgow, A. (2019). A Two-Way Interactive Text Messaging Application for Low-Income Patients with Chronic Medical Conditions: Design-Thinking Development Approach. JMIR Mhealth Uhealth, 7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6658312/ Organização Mundial da Saúde. (2020). Dispositivo Médico - Definição Completa. Organização Mundial da Saúde. https://www.who.int/medical_devices/full_deffinition/en/ Poncette, A.-S., Spies, C., Mosch, L., Schieler, M., Weber-Carstens, S., Krampe, H., & Balzer, F. (2019). Clinical Requirements of Future Patient Monitoring in the Intensive Care Unit: Qualitative Study. JMIR Med Inform, 7. https://doi.org/10.2196/13064 Rodziewicz, T. L., Houseman, B., & Hipskind, J. E. (2020). Medical Error Prevention. StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK499956/ Shepherd, M. (2004). Clinical Engineering Handbook (1st ed.). Elsevier Academic. Sherman, J., Lee, H. C., Weiss, M. E., & Kristensen-Cabrera, A. (2018). Medical Device Design Education: Identifying Problems Through Observation and Hands-On Training. Des Technol Educ, 23, 154-174. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6759072/ Tosi, F., & Rinaldi, A. (2017). Design and Usability of the Next Medical Devices for the Home Care. The Design Journal. https://doi.org/10.1080/14606925.2017.1352722 Van der Cammen, T. J., Albayrak, A., Voûte, E., & Molenbroek, J. F. (2016). New horizons in design for autonomous ageing. Oxford Academic, 46, 11-17. https://doi.org/10.1093/ageing/afw181


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Mee H. ◽  
Greasley S. ◽  
Whiting G. ◽  
Harkin C. ◽  
Oliver G. ◽  
...  

Abstract Background Syndrome of the trephined is a well-recognised phenomenon that occurs in patients following a craniectomy. It is associated with several symptoms, including headaches, motor impairments, cognitive disorders and reduced consciousness. Treatment for the syndrome usually involves replacing the skull defect. Case Study A 71-year-old male underwent a left-sided craniectomy after being diagnosed with biopsy-confirmed invasive squamous cell carcinoma with associated skull erosion. Subsequently, he developed a severe case of syndrome of the trephined (SoT,) resulting in having to lie flat to prevent the motor component of the Glasgow Coma Score (GCS) falling from M5/6 (E3/4 Vt M5/6) to M1 (E3/4 Vt M1) on sitting to 30 degrees. Unfortunately, due to ongoing chest sepsis and physical frailty, he was unable to undergo a cranioplasty. Therefore, to aid in clinical stabilisation, the treating physicians and clinical engineering teams designed and manufactured a prosthesis on-site, allowing rapid patient treatment. The prosthesis led to the patient being able to sit up to 30 degrees without the motor component of the GCS falling from M6 to M1 (E4 VT M6). Conclusion Clinical improvements were demonstrated with definitive neurological improvement after applying the external cranial plate in clinical outcome measures and radiographically. Furthermore, we have shown that rapid prototyping technology provides a flexible solution to synthesise bespoke medical prostheses with the correct expertise and regulatory framework.


Author(s):  
Sushmitha Sankarasubramanian ◽  
Ulrike Pfohl ◽  
Christian R. A. Regenbrecht ◽  
Christoph Reinhard ◽  
Lena Wedeken

Pancreatic cancer is one of the deadliest cancers and remains a major unsolved health problem. While pancreatic ductal adenocarcinoma (PDAC) is associated with driver mutations in only four major genes (KRAS, TP53, SMAD4, and CDKN2A), every tumor differs in its molecular landscape, histology, and prognosis. It is crucial to understand and consider these differences to be able to tailor treatment regimens specific to the vulnerabilities of the individual tumor to enhance patient outcome. This review focuses on the heterogeneity of pancreatic tumor cells and how in addition to genetic alterations, the subsequent dysregulation of multiple signaling cascades at various levels, epigenetic and metabolic factors contribute to the oncogenesis of PDAC and compensate for each other in driving cancer progression if one is tackled by a therapeutic approach. This implicates that besides the need for new combinatorial therapies for PDAC, a personalized approach for treating this highly complex cancer is required. A strategy that combines both a target-based and phenotypic approach to identify an effective treatment, like Reverse Clinical Engineering® using patient-derived organoids, is discussed as a promising way forward in the field of personalized medicine to tackle this deadly disease.


2021 ◽  
Vol 4 (2) ◽  
pp. 26-35
Author(s):  
David Yadin ◽  
Saide Calil ◽  
Nicolas Pallikarakis ◽  
Mladen Poluta ◽  
Stefano Bergamasco ◽  
...  

In this paper, we examine the practice level of engineers and discuss whether Clinical Engineering is a profession or an occupation. Many think that occupation and profession are synonyms, but are they? One must explore the difference, if it exists, between these terms, and to accomplish that, clarification of these terms is being offered and established first. We conducted a review of the terms and proceeded to identify if the tenants that are expected to be associated with professional standing are included in applying clinical engineering practices and to what level if it is. Engineering is a profession that improves the quality of living and for the common good. The professional education of engineers requires the education to contain a body of specialized knowledge, problem-solving skills, ethical behavior, and good analytical judgment in the service of all people. The engineering education domains aim to form individuals who are intellectually trained, practically adept, and ethically accountable for their work. Especially within the healthcare delivery system, engineering work engages problem-solving dependent upon sufficient body of knowledge to deal with practical problems by understanding the why, knowing how and identifying the when. There are various levels of the expected body of knowledge within the clinical engineering field ranging from engineers with formal academic training at undergraduate and graduate levels to clinical engineering technologists and technicians having graduated from between 1-4 years of academic training. Engineers may further select to publicly proclaim their adequate preparation and mastering of knowledge to conduct their work through a credentialing process that can confer the term professional, registered, or certified engineer if successfully achieved. Once the differences of working characteristics and obligations between occupation and profession are understood, it is clear that clinical engineers must continuously commit to pursue and fulfill these obligations. Therefore, every professional engineer is called on to achieve a certain degree of intellectual and technical mastery and acquire practical wisdom that brings together the knowledge and skills that best serve a particular purpose for the good of humanity. Clinical engineers and technologists are critical for sustaining the availability of safe, effective, and appropriate technology for patient care. It is as important for their associations to collaborate on compliance with professional obligations that their jobs require.


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