Bibliografie tematiche / Electromedical Devices and Radiological Health

Letteratura scientifica selezionata sul tema "Electromedical Devices and Radiological Health"

Autore: Grafiati
Pubblicato: 27 luglio 2024
Ultima modifica: 29 luglio 2024

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Articoli di riviste sul tema "Electromedical Devices and Radiological Health"

1

Pertiwi, Yeni, M. Febry Rhomadhon, Nur Hadziqoh, Nani Lasiyah e Rino Ferdian. "Pelatihan Inspection Preventive Maintenance (IPM) Alat Cath Lab". Abdimas Universal 4, n. 1 (15 agosto 2022): 133–38. http://dx.doi.org/10.36277/abdimasuniversal.v4i1.213.

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Abstract (sommario):
Health equipment is a very crucial component in health services. In Indonesian Hospitals, the quality of medical devices is carried out by the Hospital Facility Maintenance Installation, which is abbreviated as IPSRS. Generally, IPSRS staff consists of human resources who have qualifications in Electromedical, Public Health, and Management qualifications. HR who carry out maintenance and repairs, hereinafter referred to as Preventive Maintenance Inspection (IPM) of medical devices, are HR with electromedical qualifications. Cath Lab is the latest technology in the medical world. Therefore, many electromedical technicians do not understand the latest developments in the Cath Lab IPM process. In order to prepare hospital services with quality Cath Lab tools, reliable human resources are needed in carrying out their HDI. For this reason, training on HDI from this Cath Lab equipment is needed. This HDI training was attended by 534 participants from all over Indonesia which was carried out through the Zoom Meetings Application. This training succeeded in increasing the ability of participants by 22.28% from the initial ability of 46.48% to 68.76%. The participants' satisfaction with the reliability of the resource persons, activity themes, communication, committee and media used in the training activities was 86.57% in the very satisfied category.
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Lasiyah, Nani, M. Rio Oktaviano, Yeni Pertiwi, Nurhadziqoh Nurhadziqoh, Romi Mulyadi e Rino Ferdian. "Pelatihan Inspection Preventive Maintenance (IPM) MRI". Abdimas Universal 4, n. 2 (23 agosto 2022): 211–17. http://dx.doi.org/10.36277/abdimasuniversal.v4i2.219.

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Abstract (sommario):
In Indonesia, the quality assurance of medical devices is carried out by the Hospital Facility Maintenance Installation, abbreviated as IPSRS. Generally, IPSRS staff consists of Human Resources (HR) who have qualifications in Electromedical, Public Health, and Management qualifications. Human resources in charge of carrying out maintenance and repairs, hereinafter referred to as Preventive Maintenance Inspections (IPM) of medical devices, are human resources with electromedical qualifications. Magnetic Resonance Imaging (MRI) is an advanced medical device that combines computer technology, high magnetic fields (0.067.0 Tesla) and radio waves to produce cross-sectional images of the muscles of the human body. To prepare patient services in hospitals using an MRI tool, reliable human resources are needed in carrying out their HDI. For this reason, training on the HDI of this MRI equipment is needed. This HDI training was attended by 534 participants from all over Indonesia which was carried out through the Zoom Meeting Application. This training succeeded in increasing the ability of participants by 27.98% while the average satisfaction of training participants was assessed from 5 aspects, namely at 86.65%, so that the training carried out is in the very satisfactory category.
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Abramovich, S. G., e V. A. Drobyshev. "On the question of electrical safety in physiotherapy rooms: protective grounding of electrical equipment". Fizioterapevt (Physiotherapist), n. 3 (11 maggio 2024): 38–43. http://dx.doi.org/10.33920/med-14-2403-05.

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Abstract. The article discusses current issues of electrical safety in medical and preventive organizations. Goal: to attract the attention of physiotherapy specialists to the correct organization of protective grounding as the main means of preventing electrical injuries. Material and research: modern regulatory framework for the technical operation of electrical installations of electrical energy consumers in medical premises, the selection and use of electrical equipment and grounding devices, the frequency of inspections, measurements and tests, passports of grounding devices. Conclusion. It seems important to carry out measures to prevent accidents during the operation of physiotherapeutic equipment in each physiotherapy unit. To increase the level of organization of work on electromedical devices. Exclude the admission of personnel to the work of paramedical personnel without mandatory verification of the implementation of organizational and technical measures in the preparation of workplaces. Health care facilities should regularly hold occupational safety days, during which health care personnel should learn cardiopulmonary resuscitation skills, which today can be done in multidisciplinary accreditation and simulation centers of medical universities and academies.
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Hariyono, Muhammad Akbar, Upik Ari Erlita, Bayu Setyo Wibowo, Galih Persadha, Japeri Japeri, Syukur Yakub, Fatimah Fatimah, Donny Martha e Muhammad Alpian Hadi. "Pelayanan Kesehatan Melalui Standarisasi Peralatan Kesehatan Di Puskesmas Barabai Kabupaten Hulu Sungai Tengah". Lumbung Inovasi: Jurnal Pengabdian kepada Masyarakat 8, n. 2 (11 giugno 2023): 143–53. http://dx.doi.org/10.36312/linov.v8i2.1122.

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Pemeliharaan dan kalibrasi alat kesehatan kecenderungannya hanya dilakukan saat akan menghadapi akreditasi puskesmas saja. Kegiatan ini belum dilakukan secara terencana dan kontinu. Minimnya sosialisasi, terbatasnya sebaran personil dan jumlah laboratorium kalibrasi yang memenuhi syarat, ditambah lagi dengan tidak terpenuhinya anggaran pemeliharaan dan kalibrasi alat kesehatan, membuat upaya kegiatan pemeliharaan dan kalibrasi pada sejumlah alat kesehatan yang ada di sarana pelayanan kesehatan baik pemerintah maupun swasta. Sasaran pengabdian adalah Puskesmas Barabai yang merupakan instansi pelayanan kesehatan masyarakat yang terdampak bencana banjir pada tahun 2021 dimana membutuhkan tindakan berupa perbaikan, perawatan dan kalibrasi internal peralatan kesehatan. Metode kegiatan pengabdian masyarakat dilaksanakan dengan melakukan kegiatan maintenance berupa perbaikan serta kalibrasi peralatan kesehatan dan sosialisasi serta penyuluhan tentang manajemen perawatan dan pemakaian alat kesehatan. Kegiatan merupakan kolaborasi dari berbagai pihak diantaranya adalah Puskemas Barabai, Program Studi DIII Teknik Elektromedik Politeknik Unggulan Kalimantan, Balai Pengujian Fasilitas Kesehatan (BPFK) Banjarbaru, HIMA Teknik Elektromedik Politeknik Unggulan Kalimantan, Ikatan Alumni Teknik Elektromedik Politeknik Unggulan Kalimantan dan pihak DPD Ikatemi Kalimantan Selatan. Setelah dilakukan kegiatan pengabdian masyarakat ditemukan banyak peralatan kesehatan yang perlu dilakukan maintenance karena berbagai kerusakan dan kurangnya pemeriharaan serta pemakaian alat yang tidak sesuai prosedur penggunaan. Berdasarkan hasil kegiatan pengabdian masyarakat ditemukan masih banyaknya puskesmas di daerah Provinsi Kalimantan Selatan dengan kategori wilayah terdampak bencana dan wilayah terpencil yang membutuhkan standarisasi peralatan kesehatan serta edukasi tentang pemeliharaan dan kalibrasi alat kesehatan. Health Services Through Health Equipment Standardization at the Barabai Community Health Center, Hulu Sungai Tengah District Medical equipment is typically only calibrated and maintained when applying for puskesmas accreditation. This action was not conducted in a deliberate and continuous manner. In order to maintain and calibrate a variety of medical devices in healthcare facilities, both public and private, efforts have been made. However, these efforts have been hampered by a lack of outreach, a limited distribution of personnel, and a lack of calibration laboratories that meet the requirements.The dedication is intended for Puskesmas Barabai, a public health care organization that will need to take action to repair, maintain, and internally calibrate its medical equipment as a result of the flood disaster in 2021. The approach of performing community service activities entails engaging in maintenance tasks including repairing and calibrating medical equipment as well as outreach and counseling regarding maintenance administration and the use of medical devices. Puskemas Barabai, Diploma III Electromedical Engineering Study Program at Polytechnic Unggulan Kalimantan, Balai Pengujian Fasilitas Kesehatan Banjarbaru (BPFK), HIMA of Electromedical Engineering at Polytechnic Unggulan Kalimantan, Alumni Association of Electromedical Engineering of the Polytechnic Unggulan Kalimantan, and the DPD IKATEMI South Kalimantan were among the organizations that collaborated on the activity.Following the completion of the community service projects, it was discovered that a significant amount of medical equipment required maintenance due to various damages, lack of maintenance, and the use of instruments that were not in compliance with the recommended process. Based on the outcomes of community service projects, it was discovered that there were still a lot of puskesmas in the province of South Kalimantan that fell into the category of remote areas and disaster-affected areas that needed medical equipment standardization as well as education about the upkeep and calibration of medical devices.
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Hendryani, Atika, e Ernia Susana. "Pengembangan Aplikasi Mobile Health Berbasis Android untuk Monitoring dan Evaluasi Stunting". Jurnal Sehat Mandiri 15, n. 1 (12 giugno 2020): 24–32. http://dx.doi.org/10.33761/jsm.v15i1.188.

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Abstract (sommario):
In 2018 Indonesia still ranked fifth as the country with the highest number of stunting in the world. A better level of a mother’s knowledge can decrease about 4% to 5% in the possibility of stunting in children. Efforts to increase maternal knowledge about the importance of preventing stunting in the first thousand days of life are not only the responsibility of the government, especially the Ministry of Health. The mass media are also responsible for providing knowledge to mothers. One of the most widely used media in accessing news and information is through mobile devices such as mobile phones. From this background the problem of this research can be formulated is how to build an Android-based mobile health application for monitoring and preventing stunting. The purpose of this research is to build an Android-based mobile health for stunting monitoring and prevention. The research method is Research and Development consists of two stages, the Research Phase using qualitative methods and the Development Phase using FAST system development methods. The research was conducted at the Poltekkes of the Ministry of Health Jakarta II, Department of Electromedical Engineering from January to December 2019. The results of the study are android mobile health applications for monitoring and evaluating stunting. From the result of system testing, the mobile health application for monitoring and evaluating stunting could work well.
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D. Evans, Clifford. "Center for Devices and Radiological Health Problem Reporting Program for Radiation Therapy Devices". Medical Dosimetry 14, n. 4 (1989): 285–86. http://dx.doi.org/10.1016/0958-3947(89)90012-5.

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Evans, Clifford D. "Center for Devices and Radiological Health Problem Reporting Program for Radiation Therapy Devices". Medical Dosimetry 14, n. 1 (1989): 27–29. http://dx.doi.org/10.1016/0958-3947(89)90133-7.

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Evans, Clifford D. "Center for Devices and Radiological Health Problem Reporting Program for Radiation Therapy Devices". Medical Dosimetry 17, n. 1 (1992): 43–45. http://dx.doi.org/10.1016/0958-3947(92)90008-4.

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Evans, Clifford D. "Center for Devices and Radiological Health Problem Reporting Program for Radiation Therapy Devices". Medical Dosimetry 17, n. 2 (1992): 111–13. http://dx.doi.org/10.1016/0958-3947(92)90024-a.

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Sohier, Alain, e Frank Hardeman. "Radiological Dispersion Devices: are we prepared?" Journal of Environmental Radioactivity 85, n. 2-3 (gennaio 2006): 171–81. http://dx.doi.org/10.1016/j.jenvrad.2004.04.017.

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Più fonti

Libri sul tema "Electromedical Devices and Radiological Health"

1

South Africa. Directorate: Electromedical Devices and Radiological Health. Electromedical Devices and Radiological Health, 21st anniversary, 1973-1994. Pretoria: Dept. of Health, 1994.

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2

Center for Devices and Radiological Health (U.S.) e Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers, International and Consumer Assistance., a cura di. Division of small manufacturers, international and consumer assistance (DSMICA). Rockville, Md: U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 2002.

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3

Investigations, United States Congress House Committee on Energy and Commerce Subcommittee on Oversight and. Less than the sum of its parts: Reforms needed in the organization, management, and resources of the Food and Drug Administration's Center for Devices and Radiological Health : a report. Washington: U.S. G.P.O., 1993.

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4

Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance. Investigational device exemptions manual. Rockville, MD: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1996.

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5

United States. Food and Drug Administration. Office of Public Affairs., a cura di. Mejor cuidado de la salud con dispositivos médicos de calidad: FDA a la cabeza en tecnología de dispositivos médicos. 2a ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2002.

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United States. Food and Drug Administration. Office of Public Affairs., a cura di. Mejor cuidado de la salud con dispositivos médicos de calidad: FDA a la cabeza en tecnología de dispositivos médicos. 2a ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2002.

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7

FDA's Center for Devices and Radiological Health: A profile. [Washington, D.C.?]: The Center, 1995.

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8

Division of small manufacturers, international and consumer assistance (DSMICA). Rockville, Md: U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 2002.

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9

869013000731. Code of Federal Regulations, Title 21, Food and Drugs: Parts 800-1299, Medical Devices, Radiological and Health and Related Products. United States Government Printing, 1991.

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GOVERNMENT, US. Less than the sum of its parts: Reforms needed in the organization, management, and resources of the Food and Drug Administration's Center for Devices and Radiological Health : A report. For sale by the U.S. G.P.O., Supt. of Docs., Congressional Sales Office, 1993.

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Capitoli di libri sul tema "Electromedical Devices and Radiological Health"

1

Irony, Telba, e Martin Ho. "Benefit–Risk Determinations at the FDA Center for Devices and Radiological Health". In Benefit-Risk Assessment Methods in Medical Product Development, 53–67. Boca Raton : Taylor & Francis, 2016. | Series: Chapman & Hall/CRC biostatistics series: Chapman and Hall/CRC, 2017. http://dx.doi.org/10.1201/b20302-3.

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Atti di convegni sul tema "Electromedical Devices and Radiological Health"

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Rubio, Debora, Sergio Ponce e Francisco Madrid. "ISO/IEC 17025 technical requirements in electrical safety laboratory for electromedical devices". In 2011 Pan American Health Care Exchanges (PAHCE 2011). IEEE, 2011. http://dx.doi.org/10.1109/pahce.2011.5871888.

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2

D’Souza, Gavin A., Suvajyoti Guha, Matthew R. Myers e Prasanna Hariharan. "Evaluation of Aerosol Leakage Sites Through Respirators Using Image-Based Modeling". In 2017 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/dmd2017-3446.

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Abstract (sommario):
Personal protective equipment (PPE) such as respirators will form the first line of defense in the event of a public health emergency including an airborne pandemic or a bio-terror attack. The two major pathways by which virus-carrying aerosols can reach the human lungs through these PPEs are: a) the intrinsic penetration through porous layers of the PPE and b) the leakage through gaps between the PPE and a person’s face [1, 2]. The contribution from the second pathway can be significantly reduced using fit-testing i.e. by choosing the appropriately sized respirator for a specific face. Unfortunately, in case of an emergency, it would not be possible to fit-test the entire US population. In this scenario, excessive leakage can occur through the gaps. [1]. Hence, it is critical to identify the potential anatomical leak sites (gaps) and quantify the amount of aerosol leakage through surgical respirators for the average US population. At the behest of Office of Counterterrorism and Emerging Threats, the Center for Devices and Radiological Health, US Food and Drug Administration (FDA), has been developing a comprehensive risk assessment model for determining the risk to different populations in case of an “off-label” use of such PPEs, i.e. for public emergency scenarios for which these FDA cleared respirators were not intended to be used. In order to develop the risk assessment model, establishing a correlation between the respirator gaps and aerosol leakage between the face and the respirator is critical. A previous study [3] identified the gaps of N95 surgical respirators for a large population and quantified the aerosol leak using computational fluid dynamics. However, the gap surface area, which is a key parameter required for establishing the gap-aerosol leak correlation, has not been quantified before. In this study, gaps were identified and the gap surface areas were quantified for multiple head-respirator combinations under realistic conditions using imaging coupled with computer-aided design and modeling.
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3

Brown, Ronald, Shannon White, Jennifer Goode, Prachi Pradeep e Stephen Merrill. "Use of QSAR Modeling to Predict the Carcinogenicity of Color Additives". In ASME 2013 Conference on Frontiers in Medical Devices: Applications of Computer Modeling and Simulation. American Society of Mechanical Engineers, 2013. http://dx.doi.org/10.1115/fmd2013-16161.

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Patients may be exposed to potentially carcinogenic color additives released from polymers used to manufacture medical devices; therefore, the need exists to adequately assess the safety of these compounds. The US FDA Center for Devices and Radiological Health (CDRH) recently issued draft guidance that, when final, will include FDA’s recommendations for the safety evaluation of color additives and other potentially toxic chemical entities that may be released from device materials. Specifically, the draft guidance outlines an approach that calls for evaluating the potential for the color additive to be released from the device in concert with available toxicity information about the additive to determine what types of toxicity information, if any, are necessary. However, when toxicity data are not available from the literature for the compounds of interest, a scientific rationale can sometimes be provided for omission of these tests. Although the FDA has issued draft guidance on this topic, the Agency continues to explore alternative approaches to understand when additional toxicity testing is needed to assure the safety of medical devices that contain color additives. An emerging approach that may be useful for determining the need for further testing of compounds released from device materials is Quantitative Structure Activity Relationship (QSAR) modeling. In this paper, we have shown how three publically available QSAR models (OpenTox/Lazar, Toxtree, and the OECD Toolbox) are able to successfully predict the carcinogenic potential of a set of color additives with a wide range of structures. As a result, this computational modeling approach may serve as a useful tool for determining the need to conduct carcinogenicity testing of color additives intended for use in medical devices.
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4

Nassau, Christopher J., e Ramesh K. Agarwal. "Shape Optimization of a Trumpet-Tipped LVAD Inflow Cannula to Reduce Blood Damage Using a Genetic Algorithm". In ASME-JSME-KSME 2019 8th Joint Fluids Engineering Conference. American Society of Mechanical Engineers, 2019. http://dx.doi.org/10.1115/ajkfluids2019-4690.

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Abstract Use of computational fluid dynamics (CFD) in the field of blood-contacting medical device design and analysis has been growing in recent years. For example, the U.S. Food and Drug Administration (FDA) Center of Devices and Radiological Health (CDRH) has accelerated interest in industry and academia with nozzle and blood pump benchmarks to uncover best practices and to hopefully elevate the status of CFD to be applied as a safety analysis tool for medical devices. One area, not discussed as often as the pure simulation is the design optimization of hemodynamic devices. A systematic shape “optimization” should be distinguished from a simple “design improvement” by performing many flow field computations and design iterations to improve performance. In this paper, the shape optimization of a trumpet-tipped inflow cannula is presented using a single-objective genetic algorithm (GA) to minimize the blood damage. Many varying accounts in the literature have pointed to the advantages of the trumpet-tipped left ventricular assist device (LVAD) cannula for low blood damage and uniform velocity distribution with little to no backflow when compared to other shapes such as blunt, beveled and caged cannulas.
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Nassau, Christopher J., Timothy J. Wray e Ramesh K. Agarwal. "Computational Fluid Dynamic Analysis of a Blood Pump: An FDA Critical Path Initiative". In ASME/JSME/KSME 2015 Joint Fluids Engineering Conference. American Society of Mechanical Engineers, 2015. http://dx.doi.org/10.1115/ajkfluids2015-26131.

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Computational Fluid Dynamics (CFD) has become a routine tool in recent times for use in blood-contacting medical device design and analysis, such as prosthetic heart valves and ventricular assist devices (VADs). While CFD can aid in design by decreasing the need for expensive prototyping and iterative laboratory testing, standardizations are not currently available for CFD to be used for medical device safety analysis at the preclinical stage. To address this, the U.S. Food and Drug Administration (FDA)’s Center of Devices and Radiological Health (CDRH) has sponsored CFD “round-robins.” This paper focuses on Computational Round Robin #2 – Model Blood Pump. The exact geometries, flow conditions and fluid characteristics for the CFD analysis have been supplied to the participants. In the CFD analysis presented in this paper, a rotating fluid zone around the pump impeller was used to avoid the complexities of a dynamic mesh. The rotating fluid zone was modeled by including the centrifugal and Coriolis forces in the Navier-Stokes equations. The Shear Stress Transport (SST) k-ω turbulence model was used and the steady-state solutions for the desired flow conditions were calculated. Current experimental data is still being collected by FDA for the flow conditions given in the study. However, some of the pump operating characteristics are available from work of other investigators and are used to validate the CFD results.
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Nassau, Christopher J., Timothy J. Wray e Ramesh K. Agarwal. "Computational Fluid Dynamic Analysis of a Blood Pump: An FDA Critical Path Initiative". In ASME 2016 Fluids Engineering Division Summer Meeting collocated with the ASME 2016 Heat Transfer Summer Conference and the ASME 2016 14th International Conference on Nanochannels, Microchannels, and Minichannels. American Society of Mechanical Engineers, 2016. http://dx.doi.org/10.1115/fedsm2016-7611.

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Abstract (sommario):
Computational Fluid Dynamics (CFD) has become a routine tool in recent times for use in blood-contacting medical device design and analysis, such as prosthetic heart valves and ventricular assist devices (VADs). While CFD can aid in design by decreasing the need for expensive prototyping and iterative laboratory testing, standardizations are not currently available for CFD to be used for medical device safety analysis at the preclinical stage. To address this, the U.S. Food and Drug Administration (FDA)’s Center of Devices and Radiological Health (CDRH) has sponsored CFD “round-robins.” This paper focuses on Computational Round Robin #2 - Model Blood Pump. The exact geometries, flow conditions and fluid characteristics for the CFD analysis have been supplied to the participants. In the CFD analysis presented in this paper, a rotating fluid zone around the pump impeller was used to avoid the complexities of a dynamic mesh. The rotating fluid zone was modeled by including the centrifugal and Coriolis forces in the Navier-Stokes equations. The Shear Stress Transport (SST) k-ω turbulence model was used and the steady-state solutions for the desired flow conditions were calculated. Current experimental data is still being collected by FDA for the flow conditions given in the study. However, some of the pump operating characteristics are available from work of other investigators and are used to validate the CFD results.
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7

Dunkers, Joy P., Stefan D. Leigh, Marcus T. Cicerone, Forrest A. Landis, Francis W. Wang e John A. Tesk. "NIST Development of Reference Material Scaffolds for Tissue Engineering". In ASME 2005 International Mechanical Engineering Congress and Exposition. ASMEDC, 2005. http://dx.doi.org/10.1115/imece2005-82012.

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In consultation with ASTM and other stakeholders in Tissue-Engineered Medical Products (TEMPs) industry, the National Institute of Standards and Technology (NIST) initiated a project designed to produce Reference Material scaffolds for tissue engineering. The rationale for Reference Material scaffolds was developed through several NIST/Industry workshops. In brief, Reference Material scaffolds have multiple uses: facilitating the development and the validation of new test methods that measure interactions among various components of a TEMP; comparison with other scaffolds and scaffold materials in terms of cellular responses, biodegradation, and releases of growth factors; and comparisons of responses among various cell lines. The primary customers for Reference Material scaffolds are expected to be the TEMPs industry, academic researchers, regulators, and standards developing organizations. There are many properties of a TEMP that warrant development of multiple Reference Material scaffolds. Currently, NIST is defining a set of Reference Material scaffolds based on geometric descriptors such as permeability, pore volume, pore size distribution, interconnectivity, and tortuosity. In consultation with ASTM, NIST is testing three candidate scaffolds produced by: three dimensional (3-D) printing, stereolithography, and fused deposition modeling (FDM). Scaffolds made by these methods have been obtained from Mayo Clinic (Rochester, MN), Case Western Reserve University (CWRU) (Cleveland, OH), and Osteopore International (Singapore), respectively, for structural characterization. These prototype scaffolds, with well-defined architectures, have been selected to address the following items of interest: 1) establishment of useful functional definitions of porosity content, interconnectivity, and pores; 2) evaluation of testing methods listed in the Standard Guide for the Porosity of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products, which is being drafted by ASTM. Currently, NIST and the Center for Devices and Radiological Health of the Food and Drug Administration, as well as other groups from US and foreign laboratories, are actively carrying out cross-validation test of these prototype scaffolds.
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