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1.
Molecules ; 25(1)2020 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-31935794

RESUMO

Chitosan can form interpolymer complexes (IPCs) with anionic polymers to form biomedical platforms (BMPs) for wound dressing/healing applications. This has resulted in its application in various BMPs such as gauze, nano/microparticles, hydrogels, scaffolds, and films. Notably, wound healing has been highlighted as a noteworthy application due to the remarkable physical, chemical, and mechanical properties enabled though the interaction of these polyelectrolytes. The interaction of chitosan and anionic polymers can improve the properties and performance of BMPs. To this end, the approaches employed in fabricating wound dressings was evaluated for their effect on the property-performance factors contributing to BMP suitability in wound dressing. The use of chitosan in wound dressing applications has had much attention due to its compatible biological properties. Recent advancement includes the control of the degree of crosslinking and incorporation of bioactives in an attempt to enhance the physicochemical and physicomechanical properties of wound dressing BMPs. A critical issue with polyelectrolyte-based BMPs is that their effective translation to wound dressing platforms has yet to be realised due to the unmet challenges faced when mimicking the complex and dynamic wound environment. Novel BMPs stemming from the IPCs of chitosan are discussed in this review to offer new insight into the tailoring of physical, chemical, and mechanical properties via fabrication approaches to develop effective wound dressing candidates. These BMPs may pave the way to new therapeutic developments for improved patient outcomes.


Assuntos
Bandagens , Materiais Biocompatíveis , Quitosana , Polímeros , Animais , Materiais Biocompatíveis/química , Engenharia Biomédica/métodos , Engenharia Biomédica/normas , Fenômenos Químicos , Quitosana/química , Humanos , Hidrogéis , Fenômenos Mecânicos , Polímeros/química , Tecidos Suporte , Cicatrização
2.
J Med Eng Technol ; 43(7): 431-442, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31777294

RESUMO

Medical device industry encompasses a wide range of technologies and applications, which makes the process validation approach (IQ/OQ/PQ framework) and OQ/PQ implementation method difficult to be defined in the industry's regulation and process validation guidance documents. Based on two-level (component production level and device assembly level) process validation approach, this article proposes 1) a typical section structure & contents for production equipment/system/process validation OQ/PQ protocols, 2) a typical subsection structure & contents for the protocols' most critical section - Test Plan, and 3) the validation approach and OQ Detailed Test Plan for both common equipment and test equipment.


Assuntos
Equipamentos e Provisões , Controle de Qualidade , Engenharia Biomédica/instrumentação , Engenharia Biomédica/normas , Desenho de Equipamento
4.
Lab Med ; 50(2): e23-e35, 2019 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-30726943

RESUMO

BACKGROUND: In most clinical laboratories, examination quality is considered excellent, whereas pre-/postexamination quality is an area for focused improvement. In our organization, 1 pre-/postexamination quality metric, namely, lost specimens, as tracked continuously for 27 years, has demonstrated steady improvement. During this period, many of our processes transitioned to highly automated effectors. Concurrently, we implemented behavioral controls and reengineered error-prone processes. We believe that this bilateral approach has conclusively lowered our lost specimen rates. METHODS: Using data spanning 27 years, we plotted the correlation between lost specimens and the implementation dates for 8 major phases of automation, as well as 19 process improvements and engineering controls. RESULTS: The lost specimen rate decreased nearly 100-fold. In Six Sigma terms, the 12 month moving average for lost specimens currently hovers at approximately 5.94 sigma, with 11 months at or better than 6 sigma. Although the combination of implementation of process improvements, engineering controls, and automation contributed to the reduction, automation was the most significant contributor. CONCLUSIONS: The custom automation in use by our laboratory has led to improved pre-/postexamination quality. Although this automation may not be possible for all laboratories, our description of 19 behavior and engineering controls may be useful to others seeking to design high quality pre-/postexamination processes.


Assuntos
Automação Laboratorial , Serviços de Laboratório Clínico , Laboratórios , Melhoria de Qualidade , Engenharia Biomédica/organização & administração , Engenharia Biomédica/normas , Serviços de Laboratório Clínico/organização & administração , Serviços de Laboratório Clínico/normas , Humanos , Laboratórios/organização & administração , Laboratórios/normas , Gestão da Qualidade Total
5.
Australas Phys Eng Sci Med ; 41(4): 781-808, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30361918

RESUMO

The Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) Radiation Oncology Specialty Group (ROSG) formed a series of working groups to develop recommendations for guidance of radiation oncology medical physics practice within the Australasian setting. These recommendations provide a standard for safe work practices and quality control. It is the responsibility of the medical physicist to ensure that locally available equipment and procedures are sufficiently sensitive to establish compliance. The recommendations are endorsed by the ROSG, have been subject to independent expert reviews and have also been approved by the ACPSEM Council. For the Australian audience, these recommendations should be read in conjunction with the Tripartite Radiation Oncology Practice Standards and should be read in conjunction with relevant national, state or territory legislation which take precedence over the ACPSEM publication Radiation Oncology Reform Implementation Committee (RORIC) Quality Working Group, RANZCR, 2011a; Kron et al. Clin Oncol 27(6):325-329, 2015; Radiation Oncology Reform Implementation Committee (RORIC) Quality Working Group, RANZCR, 2018a, b).


Assuntos
Saúde do Trabalhador/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Radiometria/normas , Radioterapia/normas , Australásia , Engenharia Biomédica/organização & administração , Engenharia Biomédica/normas , Física Sanitária/organização & administração , Física Sanitária/normas , Humanos , Guias de Prática Clínica como Assunto
14.
BMC Med Educ ; 17(1): 129, 2017 Aug 04.
Artigo em Inglês | MEDLINE | ID: mdl-28778157

RESUMO

BACKGROUND: Improvement of medical content in Biomedical Engineering curricula based on a qualitative assessment process or on a comparison with another high-standard program has been approached by a number of studies. However, the quantitative assessment tools have not been emphasized. The quantitative assessment tools can be more accurate and robust in cases of challenging multidisciplinary fields like that of Biomedical Engineering which includes biomedicine elements mixed with technology aspects. The major limitations of the previous research are the high dependence on surveys or pure qualitative approaches as well as the absence of strong focus on medical outcomes without implicit confusion with the technical ones. The proposed work presents the development and evaluation of an accurate/robust quantitative approach to the improvement of the medical content in the challenging multidisciplinary BME curriculum. METHODS: The work presents quantitative assessment tools and subsequent improvement of curriculum medical content applied, as example for explanation, to the ABET (Accreditation Board for Engineering and Technology, USA) accredited biomedical engineering BME department at Jordan University of Science and Technology. The quantitative results of assessment of curriculum/course, capstone, exit exam, course assessment by student (CAS) as well as of surveys filled by alumni, seniors, employers and training supervisors were, first, mapped to the expected students' outcomes related to the medical field (SOsM). The collected data were then analyzed and discussed to find curriculum weakness points by tracking shortcomings in every outcome degree of achievement. Finally, actions were taken to fill in the gaps of the curriculum. Actions were also mapped to the students' medical outcomes (SOsM). RESULTS: Weighted averages of obtained quantitative values, mapped to SOsM, indicated accurately the achievement levels of all outcomes as well as the necessary improvements to be performed in curriculum. Mapping the improvements to SOsM also helps in the assessment of the following cycle. CONCLUSION: The suggested assessment tools can be generalized and extended to any other BME department. Robust improvement of medical content in BME curriculum can subsequently be achieved.


Assuntos
Acreditação/normas , Educação de Pós-Graduação em Medicina , Avaliação Educacional/normas , Estudantes de Medicina , Engenharia Biomédica/normas , Currículo , Educação de Pós-Graduação em Medicina/normas , Humanos , Competência Profissional , Melhoria de Qualidade
19.
J Biopharm Stat ; 27(6): 1089-1103, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28281931

RESUMO

Evaluation of medical devices via clinical trial is often a necessary step in the process of bringing a new product to market. In recent years, device manufacturers are increasingly using stochastic engineering models during the product development process. These models have the capability to simulate virtual patient outcomes. This article presents a novel method based on the power prior for augmenting a clinical trial using virtual patient data. To properly inform clinical evaluation, the virtual patient model must simulate the clinical outcome of interest, incorporating patient variability, as well as the uncertainty in the engineering model and in its input parameters. The number of virtual patients is controlled by a discount function which uses the similarity between modeled and observed data. This method is illustrated by a case study of cardiac lead fracture. Different discount functions are used to cover a wide range of scenarios in which the type I error rates and power vary for the same number of enrolled patients. Incorporation of engineering models as prior knowledge in a Bayesian clinical trial design can provide benefits of decreased sample size and trial length while still controlling type I error rate and power.


Assuntos
Engenharia Biomédica/estatística & dados numéricos , Ensaios Clínicos como Assunto/estatística & dados numéricos , Equipamentos e Provisões/estatística & dados numéricos , Modelos Estatísticos , Teorema de Bayes , Engenharia Biomédica/normas , Ensaios Clínicos como Assunto/normas , Equipamentos e Provisões/normas , Humanos , Processos Estocásticos
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