Las normas técnicas para la formación en ingeniería biomédica, tecnología y administración en salud / Technical standards for the training in biomedical engineering, health technology and health management

Introducción: Los documentos normativos establecen el estado del arte relacionado con determinado campo del conocimiento. Existe una gran cantidad de normas relacionadas con los servicios de salud y su gestión, cuya aplicación es relevante en este sector. Objetivo: Exponer la importancia de las normas técnicas en la formación de los profesionales en ingeniería biomédica, tecnología y administración en salud. Desarrollo: Diferentes aspectos relacionados con el desempeño y las funciones de los profesionales en ingeniería biomédica, tecnología de la salud y administración en salud están recogidos en normas técnicas internacionales y en otras de carácter nacional, que resultan pertinentes y de gran utilidad para su formación en el nivel de grado y el posgrado. Conclusiones: Las profesiones abordadas requieren emplear los documentos normativos relacionados con sus funciones para contribuir con la calidad de los servicios de salud; de ahí la pertinencia de su incorporación en los planes de estudio de estas carreras(AU)

Introduction: Normative documents establish the state of the art related to a certain field of knowledge. There is a large number of standards related to health services and their management, whose application is relevant in this sector. Objective: To show the importance of technical standards in the training of professionals from the fields of biomedical engineering, health technology and health management. Development: Different aspects related to the performance and functions of professionals from the fields of biomedical engineering, health technology and health management are gathered in international and other national technical standards, relevant and useful for their training at the undergraduate and postgraduate levels. Conclusions: The addressed professions require the use of normative documents related to their functions in order to contribute to the quality of health services, hence the relevance of their incorporation into the curriculums of these major(AU)

Preliminary Evaluation of 3D Printed Chitosan/Pectin Constructs for Biomedical Applications.

In the present study, chitosan (CS) and pectin (PEC) were utilized for the preparation of 3D printable inks through pneumatic extrusion for biomedical applications. CS is a polysaccharide with beneficial properties; however, its printing behavior is not satisfying, rendering the addition of a thickening agent necessary, i.e., PEC. The influence of PEC in the prepared inks was assessed through rheological measurements, altering the viscosity of the inks to be suitable for 3D printing. 3D printing conditions were optimized and the effect of different drying procedures, along with the presence or absence of a gelating agent on the CS-PEC printed scaffolds were assessed. The mean pore size along with the average filament diameter were measured through SEM micrographs. Interactions among the characteristic groups of the two polymers were evident through FTIR spectra. Swelling and hydrolysis measurements confirmed the influence of gelation and drying procedure on the subsequent behavior of the scaffolds. Ascribed to the beneficial pore size and swelling behavior, fibroblasts were able to survive upon exposure to the ungelated scaffolds.

Bioplatform Fabrication Approaches Affecting Chitosan-Based Interpolymer Complex Properties and Performance as Wound Dressings.

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.

Integrated Security, Safety, and Privacy Risk Assessment Framework for Medical Devices.

The substantial improvements and innovations in communication networks and bio-medical technologies have led to the adoption of networked medical devices due to which the attack surface has increased profoundly. Numerous devices in practice were designed and developed years ago without security measures. In such a scenario, the role of regulatory bodies has become evident. The Food and Drug Administration (FDA) validates and approves devices before commercialization. In contrast, the European Union (EU) follows a decentralized approach and Notified Bodies (NB) for assuring high standards, safety and quality of medical devices being marketed in Europe. Once the device has gone through stringent regulations including good manufacturing practices, Quality Management System (QMS), labeling, clinical tests, performance standards, adequate storage and packaging practices, a declaration of conformity will be granted, which is a legal binding document stating that the device is conformant with applicable European requirements and can be marketed in Europe. However, such regulations lack a systematic methodology to determine unified security, safety and privacy risk that eventually influence the health of patients. To cover these gaps, this research proposes Integrated Safety, Security, and Privacy (ISSP) Risk Assessment Framework to determine the risk level of the device and required security controls. It is, then applied to a case scenario of an infusion pump and further evaluated by comparing it with current standards and practices. The comparison shows that the framework provides a unified approach to consider different types of risks associated with devices.

OQ & PQ protocols development for medical device two-level process validation.

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.

Automation and Process Re-engineering Work Together to Achieve Six Sigma Quality: A 27-Year History of Continuous Improvement.

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.

Australasian recommendations for quality assurance in kilovoltage radiation therapy from the Kilovoltage Dosimetry Working Group of the Australasian College of Physical Scientists and Engineers in Medicine.

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).

Improvement of medical content in the curriculum of biomedical engineering based on assessment of students outcomes.

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.