Zeitschriftenartikel: „Electromedical Devices and Radiological Health“

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Pertiwi, Yeni, M. Febry Rhomadhon, Nur Hadziqoh, Nani Lasiyah und Rino Ferdian. „Pelatihan Inspection Preventive Maintenance (IPM) Alat Cath Lab“. Abdimas Universal 4, Nr. 1 (15.08.2022): 133–38. http://dx.doi.org/10.36277/abdimasuniversal.v4i1.213.

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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 und Rino Ferdian. „Pelatihan Inspection Preventive Maintenance (IPM) MRI“. Abdimas Universal 4, Nr. 2 (23.08.2022): 211–17. http://dx.doi.org/10.36277/abdimasuniversal.v4i2.219.

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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., und V. A. Drobyshev. „On the question of electrical safety in physiotherapy rooms: protective grounding of electrical equipment“. Fizioterapevt (Physiotherapist), Nr. 3 (11.05.2024): 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 und Muhammad Alpian Hadi. „Pelayanan Kesehatan Melalui Standarisasi Peralatan Kesehatan Di Puskesmas Barabai Kabupaten Hulu Sungai Tengah“. Lumbung Inovasi: Jurnal Pengabdian kepada Masyarakat 8, Nr. 2 (11.06.2023): 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, und Ernia Susana. „Pengembangan Aplikasi Mobile Health Berbasis Android untuk Monitoring dan Evaluasi Stunting“. Jurnal Sehat Mandiri 15, Nr. 1 (12.06.2020): 24–32. http://dx.doi.org/10.33761/jsm.v15i1.188.

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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, Nr. 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, Nr. 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, Nr. 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, Nr. 2 (1992): 111–13. http://dx.doi.org/10.1016/0958-3947(92)90024-a.

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

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Payasan, Lalu Guntur, Arhtur J. S. Runturambi und Iqrak Sulhin. „Doctors Say “Not Only Me”: Medical Malpractice as a Professional Crime in the Internet Medical Era“. International Journal of Science and Healthcare Research 7, Nr. 4 (26.12.2022): 326–33. http://dx.doi.org/10.52403/ijshr.20221046.

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The entry internet of medical things affects the basic concept of medical practice. Its impact on who will be responsible in the event of medical malpractice. The inclusion of technical elements that have dominance, tends to be the same as the position of doctors in determining the success of an action. Therefore, it is important to discuss this. The authors conceptualize medical malpractice in the internet era of medical things as a professional crime. In the pre-IoMT era, it focused on doctors. The author uses a conceptual approach to typology of crime from Clinard & Quinney. Using this method, the researchers conceptualize medical malpractice as a professional crime in this era. It can be addressed to other health workers who are directly responsible for the practice of medicine or the medical devices used. In the context of robotic surgery, electromedical/medical engineering is a health profession. It is then responsible for ensuring the reliability of robotic surgery before it is used by doctors in the practice of robotic medicine. But it is different if it is in radiotherapy medicine. In radiotherapy medicine, in addition to doctors, there are electromedics / medical engineering and medical physicists. More details are found in the discussion Keywords: medical malpractice, internet of medical things, typology of crime, professional crime

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Zafeirakis, Athanasios, und Ioannis Galatas. „Major radiological threats and emergencies requiring public health preparedness (the example of Greece)“. Romanian Journal of Military Medicine 125, Nr. 1 (01.02.2022): 102–8. http://dx.doi.org/10.55453/rjmm.2022.125.1.14.

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Radiological emergencies carry the potential for major disruptions to public health care provision, due to their infrequency, unpredicted nature, delay in appearance of adverse effects and the grave psychological impact on sufferers and society. This study aims to describe and analyze the main categories of radiological hazards and emergencies that require hospital response and preparedness at a nation-wide level, taking into specific account the example of Greece. These radiological threats are either accidental, like reactor emergencies and accidents in hospital or industrial units implementing radiological sources of high activities, or deliberate, like detonation of nuclear devices and malicious use of various radionuclides.

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Cabrera, Suzanne Lobaton, und Randal D. Beaton. „The Role of Occupational Health Nurses in Terrorist Attacks Employing Radiological Dispersal Devices“. AAOHN Journal 57, Nr. 3 (März 2009): 112–19. http://dx.doi.org/10.3928/08910162-20090301-03.

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Cabrera, Suzanne Lobaton, Randal D. Beaton, Phyllis Berryman und Eileen Lukes. „The Role of Occupational Health Nurses in Terrorist Attacks Employing Radiological Dispersal Devices“. AAOHN Journal 57, Nr. 3 (März 2009): 112–21. http://dx.doi.org/10.1177/216507990905700306.

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Blumenthal, Daniel J., und Stephen V. Musolino. „International Outdoor Experiments and Models for Outdoor Radiological Dispersal Devices“. Health Physics 110, Nr. 5 (Mai 2016): 401–2. http://dx.doi.org/10.1097/hp.0000000000000507.

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Guarnieri, Biancamaria, Michelangelo Maestri, Federico Cucchiara, Annalisa Lo Gerfo, Alessandro Schirru, Dario Arnaldi, Pietro Mattioli et al. „Multicenter Study on Sleep and Circadian Alterations as Objective Markers of Mild Cognitive Impairment and Alzheimer’s Disease Reveals Sex Differences“. Journal of Alzheimer's Disease 78, Nr. 4 (08.12.2020): 1707–19. http://dx.doi.org/10.3233/jad-200632.

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Background: Circadian and sleep disturbances are associated with increased risk of mild cognitive impairment (MCI) and Alzheimer’s disease (AD). Wearable activity trackers could provide a new approach in diagnosis and prevention. Objective: To evaluate sleep and circadian rhythm parameters, through wearable activity trackers, in MCI and AD patients as compared to controls, focusing on sex dissimilarities. Methods: Based on minute level data from consumer wearable devices, we analyzed actigraphic sleep parameters by applying an electromedical type I registered algorithm, and the corresponding circadian variables in 158 subjects: 86 females and 72 males (42 AD, 28 MCI, and 88 controls). Moreover, we used a confusion-matrix chart method to assess accuracy, precision, sensitivity, and specificity of two decision-tree models based on actigraphic data in predicting disease or health status. Results: Wake after sleep onset (WASO) was higher (p < 0.001) and sleep efficiency (SE) lower (p = 0.003) in MCI, and Sleep Regularity Index (SRI) was lower in AD patients compared to controls (p = 0.004). SE was lower in male AD compared to female AD (p = 0.038) and SRI lower in male AD compared to male controls (p = 0.008), male MCI (p = 0.047), but also female AD subjects (p = 0.046). Mesor was significantly lower in males in the overall population. Age reduced the dissimilarities for WASO and SE but demonstrated sex differences for amplitude (p = 0.009) in the overall population, controls (p = 0.005), and AD subjects (p = 0.034). The confusion-matrices showed good predictive power of actigraphic data. Conclusion: Actigraphic data could help identify disease or health status. Sex (possibly gender) differences could impact on neurodegeneration and disease trajectory with potential clinical applications.

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Campbell, Gregory. „The experience in the FDA's Center for Devices and Radiological Health with Bayesian strategies“. Clinical Trials: Journal of the Society for Clinical Trials 2, Nr. 4 (August 2005): 359–63. http://dx.doi.org/10.1191/1740774505cn093oa.

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Webber, Christina M., Allen L. Chen, David J. Gebben, Anindita Saha und Michelle E. Tarver. „Measuring Patient Preferences at the FDA Center for Devices and Radiological Health: Reflections and Projections“. Value in Health 24, Nr. 7 (Juli 2021): 1024–29. http://dx.doi.org/10.1016/j.jval.2021.01.009.

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Regens, James L., James T. Gunter und Claire E. Beebe. „Estimating Total Effective Dose Equivalents from Terrorist Use of Radiological Dispersion Devices“. Human and Ecological Risk Assessment: An International Journal 13, Nr. 5 (18.09.2007): 929–45. http://dx.doi.org/10.1080/10807030701506165.

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Dennis, Jerome E. „Amendments to the Center for Devices and Radiological Health Federal Performance Standard for laser products“. Journal of Laser Applications 9, Nr. 6 (Dezember 1997): 301–5. http://dx.doi.org/10.2351/1.4745474.

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Zhuang, Chen, und Frank E. Block. „Building Medical Device Supply Chain Resilience With the US Food and Drug Administration“. Journal of Clinical Engineering 49, Nr. 2 (April 2024): 48–51. http://dx.doi.org/10.1097/jce.0000000000000635.

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Medical device supply chain shortages have the potential to negatively impact patient care when patients and caregivers are unable to obtain the medical devices they need. The US Food and Drug Administration (FDA), specifically the Center for Devices and Radiological Health, received expanded authorities requiring medical device manufacturers to notify the FDA of any interruption or discontinuance of medical devices during or in advance of a public health emergency. The clinical community, in particular, healthcare technology managers, can provide additional information and perspective to the FDA by voluntarily reporting any device availability concerns. This will provide the FDA with more data about the current supply chain landscape and drive communication about the issue. Ultimately, improved information sharing will help ensure devices are available when and where they are needed to protect the health of the nation's patients and healthcare workers into the future.

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Evans, Clifford D. „Center for Devices and Radiological Health Problem Reporting Program for Radiation Therapy Devices. Summary Reports Received from July 1990 to December 1990“. Medical Dosimetry 16, Nr. 2 (1991): 93–95. http://dx.doi.org/10.1016/0958-3947(91)90052-4.

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Clark, Phoebe, Jayne Kim und Yindalon Aphinyanaphongs. „Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices“. JAMA Network Open 6, Nr. 7 (05.07.2023): e2321792. http://dx.doi.org/10.1001/jamanetworkopen.2023.21792.

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ImportanceThe marketing of health care devices enabled for use with artificial intelligence (AI) or machine learning (ML) is regulated in the US by the US Food and Drug Administration (FDA), which is responsible for approving and regulating medical devices. Currently, there are no uniform guidelines set by the FDA to regulate AI- or ML-enabled medical devices, and discrepancies between FDA-approved indications for use and device marketing require articulation.ObjectiveTo explore any discrepancy between marketing and 510(k) clearance of AI- or ML-enabled medical devices.Evidence ReviewThis systematic review was a manually conducted survey of 510(k) approval summaries and accompanying marketing materials of devices approved between November 2021 and March 2022, conducted between March and November 2022, following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Analysis focused on the prevalence of discrepancies between marketing and certification material for AI/ML enabled medical devices.FindingsA total of 119 FDA 510(k) clearance summaries were analyzed in tandem with their respective marketing materials. The devices were taxonomized into 3 individual categories of adherent, contentious, and discrepant devices. A total of 15 devices (12.61%) were considered discrepant, 8 devices (6.72%) were considered contentious, and 96 devices (84.03%) were consistent between marketing and FDA 510(k) clearance summaries. Most devices were from the radiological approval committees (75 devices [82.35%]), with 62 of these devices (82.67%) adherent, 3 (4.00%) contentious, and 10 (13.33%) discrepant; followed by the cardiovascular device approval committee (23 devices [19.33%]), with 19 of these devices (82.61%) considered adherent, 2 contentious (8.70%) and 2 discrepant (8.70%). The difference between these 3 categories in cardiovascular and radiological devices was statistically significant (P &lt; .001).Conclusions and RelevanceIn this systematic review, low adherence rates within committees were observed most often in committees with few AI- or ML-enabled devices. and discrepancies between clearance documentation and marketing material were present in one-fifth of devices surveyed.

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Kufel, Jakub, Katarzyna Bargieł, Maciej Koźlik, Łukasz Czogalik, Piotr Dudek, Aleksander Jaworski, Mikołaj Magiera et al. „Usability of Mobile Solutions Intended for Diagnostic Images—A Systematic Review“. Healthcare 10, Nr. 10 (15.10.2022): 2040. http://dx.doi.org/10.3390/healthcare10102040.

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Despite the growing popularity of mobile devices, they still have not found widespread use in medicine. This is due to the procedures in a given place, differences in the availability of mobile devices between individual institutions or lack of appropriate legal regulations and accreditation by relevant institutions. Numerous studies have been conducted and compared the usability of mobile solutions designed for diagnostic images evaluation on various mobile devices and applications with classic stationary descriptive stations. This study is an attempt to compare the usefulness of currently available mobile applications which are used in the medical industry, focusing on imaging diagnostics. As a consequence of the healthcare sector’s diversity, it is also not possible to design a universal mobile application, which results in a multitude of software available on the market and makes it difficult to reliably compile and compare studies included in this systematic review. Despite these differences, it was possible to identify both positive and negative features of portable methods analyzing radiological images. The mobile application of the golden mean in hospital infrastructure should be widely available, with convenient and simple usage. Our future research will focus on development in the use of mobile devices and applications in the medical sector.

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Inchingolo, Alessio Danilo, Assunta Patano, Giovanni Coloccia, Sabino Ceci, Angelo Michele Inchingolo, Grazia Marinelli, Giuseppina Malcangi et al. „The Efficacy of a New AMCOP® Elastodontic Protocol for Orthodontic Interceptive Treatment: A Case Series and Literature Overview“. International Journal of Environmental Research and Public Health 19, Nr. 2 (16.01.2022): 988. http://dx.doi.org/10.3390/ijerph19020988.

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Background: Elastodontics is a specific interceptive orthodontic treatment that uses removable elastomeric appliances. They are functional appliances that produce neuromuscular, orthopedic and dental effects. Thus, these devices are useful in the developmental age, when skeletal structures are characterized by important plasticity and adaptation capacity, allowing to remove factors responsible for malocclusions. Elastomeric devices are generally well tolerated by patients requiring simple collaboration and management. This work can be useful to update all orthodontists already adopting these appliances or for those who want to approach them for the first time. This study aimed to describe four cases treated with new elastomeric devices called AMCOP Bio-Activators and to provide an overview of elastodontics, its evolution, indications and limits. Methods: A total of four clinical cases were presented after a treatment period of 16–20 months to evaluate the clinical and radiological effects of the elastodontic therapy. Results: The effectiveness of Bio-Activators on clinical cases was evidenced with a significant improvement in skeletal and dentoalveolar relationship, and malocclusion correction in a limited treatment period (16–20 months). Conclusions: The Bio-Activators showed clinical effectiveness to achieve therapeutic targets according to a low impact on the patient’s compliance.

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Yadav, Lakshmi, Navreet Boora und Raushan Kumar. „Assessment of Knowledge of Radiographic Students about Radiation Protection Devices, Their Use and Handling“. International Journal of Research and Review 8, Nr. 6 (29.06.2021): 277–82. http://dx.doi.org/10.52403/ijrr.20210634.

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Aim: The aim of this study to assess the knowledge of radiographic students about radiation protection devices, their use and handling. Methods: A prospective, questionnaire-based study was carried out in Department of Radiological and Imaging Techniques. A validated questionnaire was circulated among undergraduate and postgraduate Radiographic students. Result: Out of 169 participants was 150(88.7%) of undergraduate, postgraduate and diploma students of radiological and imaging techniques filled questionnaire in this study. To assess knowledge about radiation protection devices, their use and handling, which they gain during theory classes and from hospital posting. There were 58(38.7%) were female and 92 (61.3%) were male. Conclusion: Study concluded that there should be proper theory classes for the conduction of knowledge about radiation protection devices, their use and handling in radiology department. Training session and teaching standards should be taken in account for not only the number of hours required to obtain the knowledge with the equipment required to run the classes in the simulation-based learning environment. This questionnaire-based survey demonstrates that up-to-date radiation protection devices, their use and handling skill in among radiography students of college of paramedical sciences were not sufficient, this should be improved by the well-designed training and theoretical sessions. From this study, we suggest that all members of the health care community should attend the webinars, guest lectures and training sessions about knowledge of radiation protection devices, their use and handling in radiology department. Keywords: Radiation protection devices, Lead equivalent, X-ray, Radiology department.

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Yang, Xiting, Laura Thompson, Jianxiong Chu, Sherry Liu, Hong Lu, Jie Zhou, Shanti Gomatam et al. „Adaptive Design Practice at the Center for Devices and Radiological Health (CDRH), January 2007 to May 2013“. Therapeutic Innovation & Regulatory Science 50, Nr. 6 (November 2016): 710–17. http://dx.doi.org/10.1177/2168479016656027.

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Logan, Mary K. „A Roundtable Discussion: Home Healthcare—Not A Hospital in the Home“. Biomedical Instrumentation & Technology 47, s1 (01.01.2013): 10–15. http://dx.doi.org/10.2345/0899-8205-47.s1.10.

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Home healthcare is vital for a large percentage of the population. According to data from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), 7 million people in the United States receive home healthcare annually. The use of medical devices in the home and other nonclinical environments is increasing dramatically. By the year 2050, an estimated 27 million people will need continuing care in the home or in the community and not in a controlled clinical environment.1 The FDA recently announced its Home Use Devices Initiative and issued the document, “Draft Guidance for Industry and FDA Staff—Design Considerations for Devices Intended for Home Use” on Dec. 12, 2012.2 The Center for Devices and Radiological Health (CDRH) regulates medical devices, but that regulatory authority alone is not enough to ensure safe and effective use of devices in the home. To address these and other issues, AAMI and FDA will co-host a summit on healthcare technology in nonclinical settings Oct. 9–10, 2013.

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Sreekumar, K., S. K. Jha, Jaison T. John und M. Harikumar. „Application of Internet of Things Technologies for Automation and Quality Enhancement in Radiological Metrology“. Current Natural Sciences and Engineering 1, Nr. 4 (26.07.2024): 261–77. http://dx.doi.org/10.63015/6h-2424.1.4.

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Automation refers to the application of technology that reduces the need for human involvement1.It is being implemented in all aspects of modern life. Automation is also feasible in occupational radiation safety and surveillance programmes. One kind modern automation is Internet of Things (IoT), defined as technologies with which devices with sensors, data processing units and software are linked together over internet or any other network2. Health Physics Units attached to various nuclear or radiological facilities all over the world are associated with radiological surveillance and protection of workers and environment. This paper briefs about application of various IoT techniques for automation in environmental and occupational radiologicalmonitoring and surveillance programmes.

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Simerl, Nathanael, Jace Beavers, Jacob Milburn, Miranda Dodson, Ryan Strahler, Richard Kroeger, Ivan Ulloa-Garcia et al. „Contamination Measurements from Simultaneous Activated Potassium Bromide Radiological Dispersal Devices with a Collimated Vehicular Sensor“. Health Physics 120, Nr. 6 (11.02.2021): 618–27. http://dx.doi.org/10.1097/hp.0000000000001390.

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O'Dowd, W. J. „Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety“. Physics in Medicine and Biology 47, Nr. 2 (04.01.2002): 349. http://dx.doi.org/10.1088/0031-9155/47/2/701.

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Zari, Giulia, Sara Condino, Fabrizio Cutolo und Vincenzo Ferrari. „Magic Leap 1 versus Microsoft HoloLens 2 for the Visualization of 3D Content Obtained from Radiological Images“. Sensors 23, Nr. 6 (11.03.2023): 3040. http://dx.doi.org/10.3390/s23063040.

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The adoption of extended reality solutions is growing rapidly in the healthcare world. Augmented reality (AR) and virtual reality (VR) interfaces can bring advantages in various medical-health sectors; it is thus not surprising that the medical MR market is among the fastest-growing ones. The present study reports on a comparison between two of the most popular MR head-mounted displays, Magic Leap 1 and Microsoft HoloLens 2, for the visualization of 3D medical imaging data. We evaluate the functionalities and performance of both devices through a user-study in which surgeons and residents assessed the visualization of 3D computer-generated anatomical models. The digital content is obtained through a dedicated medical imaging suite (Verima imaging suite) developed by the Italian start-up company (Witapp s.r.l.). According to our performance analysis in terms of frame rate, there are no significant differences between the two devices. The surgical staff expressed a clear preference for Magic Leap 1, particularly for the better visualization quality and the ease of interaction with the 3D virtual content. Nonetheless, even though the results of the questionnaire were slightly more positive for Magic Leap 1, the spatial understanding of the 3D anatomical model in terms of depth relations and spatial arrangement was positively evaluated for both devices.

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Thilmany, Jean. „The Model of Good Health“. Mechanical Engineering 140, Nr. 04 (01.04.2018): 32–37. http://dx.doi.org/10.1115/1.2018-apr-2.

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This article explores the innovative ways of using advanced modeling, simulation, and analysis software in medical field. In order to meet design requirements, engineers who work for medical device makers have been putting advanced modeling, simulation, and analysis software to use in innovative ways, such as creating models of the human anatomy that can be used to virtually test potential medical technologies. They have also put new tools such as 3D printers to work building model prototypes for real-world testing. The Food and Drug Administration’s Center for Devices and Radiological Health is now creating a simulated human capable of serving as an in-silico guinea pig. The center is building a library of computer regulatory testing models and a family of ‘virtual patients’ for product design and testing. The article also describes that medical device developers can use cinematic rendering, such as an image of the blood vessels in the skull created in Syngio via Frontier, an application enabling the realistic depiction of volume datasets, to help create better treatments.

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Sperandio, L., G. Antonacci, P. Battisti, L. Ciciani, A. Rizzo und I. Vilardi. „IN VIVO public monitoring in emergency exposure scenarios by means of spectrometric and non-spetrometric devices“. Radiation Protection Dosimetry 199, Nr. 15-16 (Oktober 2023): 2015–19. http://dx.doi.org/10.1093/rpd/ncac217.

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Abstract In a nuclear or radiological accident scenario, when potentially members of the public can undergo internal contamination by anthropogenic radionuclides released in the atmosphere, effective methods that can be used directly in the field to perform a fast scan for internal contamination on a large number of individuals can play a major role to undertake appropriate countermeasures. Specific attention should be paid to the individual monitoring of children since they constitute the sensitive population group with the highest risk of developing cancer. At the ENEA Casaccia Research Center in Rome (Italy), monitoring procedures based on a portable HPGe detector and ratemeters were tested in the field. A total of 170 acquisitions of uncontaminated volunteers for the blank measurements were collected, 105 acquisitions on adult and 65 acquisitions on 10-y/o children. The detection limit calculation, in terms of activity taken up (Bq), was carried out according to the Standard ISO’s 11929 and 28218, whereas the corresponding ‘minimum effective dose’ (mSv) was calculated based on international commission on radiological protection (ICRP) Publications 134, 137 and 141. Results and evaluations of the measurement campaign are presented and discussed in respect to the aspects reported in the current literature.

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El Younoussi, Laila, Brahim Benaji, Mohammed Azougagh, Souad Lebbar, Lekbir El hamidi, Abdelmajid Soulaymani und Abdelrhani Mokhtari. „Radiodiagnostic Equipment: Regulations and Materiovigilance“. E3S Web of Conferences 319 (2021): 01090. http://dx.doi.org/10.1051/e3sconf/202131901090.

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The use of medical devices (MDs) in the field of medical imaging has always been governed by rigorous regulations, in particular the authorizations and compliance of radiological installations and premises in view of the risks generated by the ionizing radiation produced by these MDs. The regulatory bases that deal with equipment emitting ionizing radiation are diversified between those specific to the protection of the public and users of ionizing radiation and those relating to medical devices. In addition, radio-diagnostic equipment must provide all the guarantees in terms of the balance between benefits and risks. Although radiation protection is essential, materiovigilance is one of the key elements of technological monitoring and surveillance of the risks that may result from the use of these medical devices after they have been placed on the market. The Moroccan legislation has a legal arsenal in accordance with the model of the World Health Organization’s global regulatory framework for medical devices. It outlines regulations and adheres to international guidelines in the field of vigilance against ionizing radiation. However, it is necessary to move on to the specification of procedures in order to remove any ambiguity.

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Regnault, William F., und Grace Lee Picciolo. „Review of Medical Biosensors and Associated Materials Problems“. Journal of Biomedical Materials Research 21, S2 (August 1987): 163–80. http://dx.doi.org/10.1002/j.1097-4636.1987.tb00016.x.

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Developers of biosensors as medical devices are using emerging technologies that incorporate chemical assays with fiber optics and semiconductors. These biosensors will eventually become indwelling catheters for monitoring blood analyte concentrations as well as functioning as controlled feedback elements for artificial organs. Materials used in these devices are subject to problems of manufacture and reliability as well as those induced by the human body's response to these “foreign agents.” The Division of Mechanics and Materials Science in the Center for Devices and Radiological Health at the Food and Drug Administration has initiated a program to investigate factors that effect sensitivity, selectivity and reliability of sensors used in biological applications. Our group's principle focus is on sensors of chemical processes. This article is an outgrowth of our research efforts and is a review of some of the technologies that are currently available or becoming available for these applications. The goal of our research is to identify factors that will have an impact on the reliability of long‐term implanted medical devices with particular attention to sensors used in feedback‐controlled therapeutic systems.

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Talbot, A., M. Kragsholm, A. Månsson und S. S. Nielsen. „Medical Devices Quality Assurance Services“. Radiation Protection Dosimetry 57, Nr. 1-4 (01.01.1995): 195–98. http://dx.doi.org/10.1093/rpd/57.1-4.195.

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Barthe, J., J. M. Bordy, M. Mourgues, T. Lahaye, B. Boutruche und P. Ségur. „New Devices for Individual Neutron Dosimetry“. Radiation Protection Dosimetry 54, Nr. 3-4 (01.07.1994): 365–68. http://dx.doi.org/10.1093/oxfordjournals.rpd.a082366.

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Abstract This paper deals with the design and fabrication of three new dosimetric sensors to be used in personal radiation monitoring. The first two sensors, double diode and streamer chamber, are based on the same particle detection principle, the last is a multicellular tissue-equivalent proportional counter. Each dosimetric sensor has a preferential range of applications. The double diode dosemeter, called DIAC, is the least sensitive, but can be reduced to the size of an 'electronic credit card' weighing a few 10s of grams. Two versions of the streamer chamber have been developed, the first corresponding to a personal device called DINE and the second to an ambient device called DANE. These two sensors are much more sensitive than the DIAC. The last sensor, studied in the SDOS laboratory, is a multicellular proportional counter called MC-TEPC. Giving both the dose and the dose equivalent quantities, it is more suitable for a good evaluation of the radiation risk but many problems due to gas aging have to be solved.

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Barthe, J., J. M. Bordy, M. Mourgues, T. Lahaye, B. Boutruche und P. Ségur. „New Devices for Individual Neutron Dosimetry“. Radiation Protection Dosimetry 54, Nr. 3-4 (01.07.1994): 365–68. http://dx.doi.org/10.1093/rpd/54.3-4.365.

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Dambal, Akash, Harrison Michael Zaphrey, M. P. Venkatesh, Kaushik Devaraju und T. M. Pramod Kumar. „Comparative Study of Pre-Market Approval Process and Denovo Process for Medical Devices“. International Journal of Pharmaceutical Quality Assurance 11, Nr. 01 (25.01.2013): 74–82. http://dx.doi.org/10.25258/ijpqa.11.1.29.

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FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Regulatory control increases from Class I to Class III. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Pre-market Notification 510(k); and most Class III devices require Pre-market Approval.The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a “not substantially equivalent” determination in response to a pre-market notification [510(k)] submission.Class III Devices are those considered as high risk along these lines requiring the regularly lengthier Pre-market Approval (PMA) process. The new De Novo process was designed to usher through any new device that was both Unprecedented (novel) and Low to moderate risk (or with a risk that was easily mitigated). The most inventive gadgets are considered high-hazard due to the non-attendance of equivalent items and follow either the De Novo or PMA path. Truly high-risk devices, in which deficient data exists to decide if general and special controls are sufficient to give sensible attestation of the item’s safety and effectiveness, follow the PMA pathway. Novel devices that do not have a predicate are classified in the highest risk class,despite the level of genuine risk it postures or the capacity of general and special controls to guarantee safety and effectiveness. The De Novo process allows these novel devices with low to moderate risk to be reclassified from a high-risk class, which requires a PMA.

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Rollinger, F., J. Lochard und T. Schneider. „Lessons learnt by IRSN about the involvement of experts towards the population in contaminated areas in Fukushima Prefecture“. Annals of the ICRP 45, Nr. 2_suppl (03.10.2016): 99–104. http://dx.doi.org/10.1177/0146645316666497.

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Since November 2011, Institut de radioprotection et de sûreté nucléaire (IRSN) experts have participated in the International Commission on Radiological Protection’s (ICRP) dialogue initiative for the rehabilitation of living conditions after the Fukushima accident. In 2013, IRSN and Centre d’étude sur l’Evaluation de la Protection dans le domaine Nucléaire (CEPN) launched a study to identify the main lessons that can be learned from these dialogues, and benefit French IRSN experts in the event of a postaccident situation. The main lesson is that in order to protect the inhabitants of contaminated areas efficiently, experts must work in cooperation with local actors to develop a co-expertise process. The availability of measurement devices for inhabitants is crucial to allow them to assess their own radiological situation. Measuring radioactivity makes it visible, and allows individuals to discuss the results in their communities and develop local projects to improve their daily life. Eventually, inhabitants create a practical radiological protection culture to manage their situation. However, helping people to protect themselves does not mean that authorities and experts have no responsibilities, and this calls for strong ethical principles such as not making decisions for people about their future. To be helpful, scientists need to understand that, as necessary as radiation protection is, it is not the only problem that inhabitants are facing and it cannot control people's lives. Radiation protection experts must commit themselves to be at the service of individuals and the community, and the issues they want to address.

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Long, Cynthia, James E. Tcheng, Danica Marinac-Dabic, Andrea Iorga, Mitchell Krucoff und Deborah Fisher. „Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN)“. BMJ Surgery, Interventions, & Health Technologies 4, Suppl 1 (November 2022): e000118. http://dx.doi.org/10.1136/bmjsit-2021-000118.

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Obesity continues to be a major public health issue, with more than two-thirds of adults in the USA categorized as overweight or obese. Bariatric surgery is effective and yields durable weight loss; however, few qualified candidates choose to undergo surgical treatment. Less-invasive alternatives to bariatric surgery are being developed to bridge the treatment gap. Recognizing the burden of conducting pivotal clinical trials and traditional post-approval studies for medical devices, the Food and Drug Administration (FDA) Center for Devices and Radiological Health has encouraged the development of real-world data content and quality that is sufficient to provide evidence for Total Product Life Cycle medical device evaluation. A key first step is to establish a minimum core data structure that provides a common lexicon for endoscopic obesity devices and its corresponding interoperable data elements. Such a structure would facilitate data capture across existing workflow with a ‘coordinated registry network’ capability. On July 29, 2016, a workshop entitled, ‘GI Coordinated Registry Network: A Case for Obesity Devices’ was held at the FDA White Oak Campus by the Medical Device Epidemiology Network public–private partnership and FDA to initiate the work of developing a common lexicon and core data elements in the metabolic device space, which marked the inauguration of the Gastrointestinal Coordinated Registry Network project. Several work groups were subsequently formed to address clinical issues, data quality issues, registry participation, and data sharing.

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Trzcińska, Sandra, Michał Kuszewski und Kamil Koszela. „Analysis of Posture Parameters in Patients with Idiopathic Scoliosis with the Use of 3D Ultrasound Diagnostics—Preliminary Results“. International Journal of Environmental Research and Public Health 19, Nr. 8 (14.04.2022): 4750. http://dx.doi.org/10.3390/ijerph19084750.

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(1) Background: Idiopathic scoliosis occurs in 2 to 4% of children between 10 and 16 years of age. Due to the harmfulness of radiological examination, non-invasive devices, including the 3D ultrasound technology and Scolioscan apparatus, are more and more frequently used for postural diagnostics. The aim of the study was to analyze the parameters of posture in patients with idiopathic scoliosis with the use of 3D ultrasound diagnostics. (2) Methods: The study included 20 girls, aged 10 to 16 years, with double-curve idiopathic scoliosis (the value of primary curve ranged from 25–50°), types I and II according to King–Moe classification. On the basis of X-ray scan, the Cobb angle of primary and secondary curves was assessed, the skeletal maturity was evaluated with the Risser test, and the type of scoliosis was determined. The girls participated in a 3-week rehabilitation program. The examinations were performed before and after therapy. A scoliometer was used for measurements. Each of the participants underwent individual therapy. The three-plane approach to asymmetric exercises was based largely on positions that included primary curve correction with hypercorrection of the secondary curve. (3) Results: After the therapy, values of trunk rotation angles and the angle of scoliotic curvature of secondary curve were significantly lower than before the therapy, except for the value of the primary curve angle. The parameters measured by X-ray were significantly and positively related to the results obtained with the scoliometer and the scolioscan. (4) Conclusions: The application of therapy that takes into account summing parameters may prevent the deterioration of the secondary curve when treating patients with idiopathic scoliosis. The observed correlations between the parameters of the radiological examination, the scoliometer, and the scolioscan prove the possibility of their interchangeable application in the assessment of effects of the therapy. Three-dimensional ultrasound diagnostics may become an alternative to radiological examination in assessing the treatment effects of patients with idiopathic scoliosis.

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Epistatu, Dragos, Andreea Ciolacu, Aikaterina Kitsou, Ioanina Părlătescu, Octavian Dincă, Cristian Vlădan, Florin Dogioiu, Valentin Varlas und Paula Perlea. „A radiological study method of vertical alveolar resorptions using immediate dental implants“. Romanian Journal of Stomatology 67, Nr. 3 (30.09.2021): 177–82. http://dx.doi.org/10.37897/rjs.2021.3.8.

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Dental extraction is followed by decreases in alveolar volume, vertically and horizontally. This retrospective study measured vertical alveolar resorption after insertion of immediate implants, using OPG, without CBCT or additional radiographs. Patients were randomly split in two groups A (57 implants) and B (47 implants). Measurements were made by two independent observers. The types of implants were: Exacta (Biaggini Medical Devices), Nova, Dentix Millenium and Surcam. The method was based on the size of the implant and another common element of the two radiographs. It used an optimal radiologic exposure. It can be generalized to other studies. Similar results measured in the two groups showed that alveolar remodeling does not depend on the type of the implant. Half of the alveoli did not have any resorption. Another quarter showed barely perceptible clinical resorption (1-2 mm). In the last quarter were registered all the notable resorptions that were associated with various factors (temporary mobile prosthesis, surgical flap, medication and some health problems, smoking, etc.) showing real situations, not ideal conditions. Maximum resorption was unique (7.63 mm).

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Valentin, J. „Protecting people against radiation exposure in the event of a radiological attack“. Annals of the ICRP 35, Nr. 1 (Januar 2005): iii—iv. http://dx.doi.org/10.1016/j.icrp.2005.01.001.

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This report responds to a widely perceived need for professional advice on radiological protection measures to be undertaken in the event of a radiological attack. The report, which is mainly concerned with possible attacks involving “radioactive dispersion devices”, re-affirms the applicability of existing ICRP recommendations to such situations, should they ever occur. Many aspects of the emergency scenarios expected to arise in the event of a radiological attack may be similar to those that experience has shown can arise from radiological accidents, but there may also be important differences. For instance, a radiological attack would probably be targeted at a public area, possibly in an urban environment, where the presence of radiation is not anticipated and the dispersion conditions commonly assumed for a nuclear or radiological emergency, such as at a nuclear installation, may not be applicable. First responders to a radiological attack and other rescuers need to be adequately trained and to have the proper equipment for identifying radiation and radioactive contamination, and specialists in radiological protection must be available to provide advice. It may be prudent to assume that radiological, chemical, and/or biological agents are involved in an attack until it is proven otherwise. This calls for an “all-hazard” approach to the response. In the aftermath of an attack, the main aim of radiological protection must be to prevent the occurrence of acute health effects attributable to radiation exposure (termed “deterministic” effects) and to restrict the likelihood of late health effects (termed “stochastic” effects) such as cancers and some hereditable diseases. A supplementary aim is to minimise environmental contamination from radioactive residues and the subsequent general disruption of daily life. The report notes that action taken to avert exposures is a much more effective protective measure than protective measure the provision of medical treatment after exposure has occurred. Responders involved in recovery, remediation and eventual restoration should be subject to the usual international standards for occupational radiological protection, which are based on ICRP recommendations, including the relevant requirements for occupational dose limitation established in such standards. These restrictions may be relaxed for informed volunteers undertaking urgent rescue operations, and they are not applicable for voluntary life-saving actions. However, specific protection measures are recommended for female workers who may be pregnant or nursing an infant. The immediate countermeasures to protect the public in the rescue phase are primarily caring for people with traumatic injuries and controlling access. Subsequent actions include respiratory protection, personal decontamination, sheltering, iodine prophylaxis (if radioiodines are involved), and temporary evacuation. In the recovery phase, the relocation and resettlement of people may be needed in extreme cases. This phase may require remedial action, including cleanup, management of the resulting radioactive waste, management of any human remains containing significant amounts of radioactive substances, and dealing with remaining radioactive residues. The guidance given in relation to public protection is based solely on radiological protection considerations and should be seen as a decision-aiding tool to prepare for the aftermath of a radiological attack. It is expected to serve as input to a final decision-making process that may include other societal concerns, consideration of lessons learned in the past (especially these involving the public perception of the risks posed by radioactive contamination) and the participation of interested parties. A radiological attack could also be the cause of radioactive contamination of water, food, and other widely consumed commodities. This possible outcome is considered unlikely to lead to significant internal contamination of a large number of people owing to the large amounts of radioactive material that would be required to cause high levels of contamination of water, food, and other commodities. Nonetheless, the report recommends radiological criteria for restricting the use of commodities under such circumstances. The report concludes by reiterating that the response to radiological attacks should be planned beforehand following the customary processes for optimisation of radiological protection recommended by ICRP, and that optimised measures should be prepared in advance. Such plans should result in a systematic approach that can be modified if necessary to take into account the prevailing conditions and to invoke actions as warranted by the circumstances. Many potential scenarios clearly cannot induce immediate severe radiation injuries. Therefore, in order to prevent over-reaction, response measures prepared in advance should reflect the real expected gravity of the various possible scenarios.

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Hampshire, Victoria A., und Samuel H. Gilbert. „Refinement, Reduction, and Replacement (3R) Strategies in Preclinical Testing of Medical Devices“. Toxicologic Pathology 47, Nr. 3 (01.10.2018): 329–38. http://dx.doi.org/10.1177/0192623318797289.

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The U.S. Food and Drug Administration Center for Devices and Radiological Health (FDA/CDRH) has recently published several in vivo test guidance documents that mention refinements, reductions, or replacement animal testing strategies to facilitate the leveraging of data from large animal safety tests for conventional rodent testing. In response to the recently enacted Food and Drug Administration Safety and Innovation Act Section 907, which facilitates expedited access to novel therapies commonly described as Breakthrough Therapy Designation, FDA/CDRH has discussed efficient regulatory strategies for first-in-human investigation, including early feasibility study guidance. Large gains in humane care and translational research could also be attained by examples in FDA’s Guidance for the Use of International Organization for Standardization 10993-1, which states that large animal safety studies may be considered as replacement rodent tests if the scientific principles, methods, and end points (SPME) are considered and applied. This article discusses SPME for the replacement of conventional rodent testing by the inclusion and integration of clinical, diagnostic, and pathologic data obtained from well-designed large animal studies. The recommendations include consideration for study designs that utilize methods for an overall more comprehensive interrogation of animal systems.

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Yadav, Dev Kumar, Janifer Raj Xavier, Om Prakash Chauhan, Prakash Eknath Patki und Rakesh Kumar Sharma. „Nutritional Intervention during Chemical, Biological, Radiological, Nuclear Environments A Dietary Perspective“. Defence Life Science Journal 4, Nr. 2 (11.04.2019): 122–29. http://dx.doi.org/10.14429/dlsj.4.12766.

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The future war scenario is based on use and applications of various conventional and non-convectional agents which includes weaponised or non-weaponised chemical, biological, radiological, nuclear (CBRN), toxic industrial materials, direct energy devices/ weapons, and or high yield explosives. These include nerve agents, blood agents, vesicants or skin blistering agents, lung irritants, asphyxiants or choking agents. Biological weapons are basically disease causing microorganisms and other replicating entities including viruses, infectious nucleic acids and prions. These agents have ability to infect host and are highly virulent, pathogenic and dangerous in nature. The interface between ammunitions and above agents is soldier whose physical and mental health is affected as enough precautionary measures are not adopted. The reducing environment thus created has various agents which enter into exposed body and lead to mild to serious damage to various vital parts of the human body. As food is important component for survival and intrinsic to basic human nutrition and health, therefore, it is imperative to develop certain kind of a wholesome meal system which can be consumed by the soldiers tasked with combating CBRN situations during such operations. Such meals can be in the form of solid or liquid type and packaged in suitable delivery system, compatible and amenable with the CBRN suit. Food can be contaminated during CBRN conditions by coming in direct or indirect contact with CBRN agents. Therefore, the food materials to be used under such conditions need to be protected in suitable coverings as consumption of contaminated food can be lethal. Designer meal for CBRN environment is not only suitable for soldiers but also to all human interface dealing with similar scenario viz. the low intensity conflicts and surgical operations, nuclear submarines, cosmonauts, pilots, individuals handling radiation equipment and patient undergoing chemotherapy for cancer.

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McDonnell, Gerald. „Alternative AOAC Sporicidal Test Carrier for Evaluating Peracetic Acid-Based Sterilants (Modification of AOAC Official Method 966.04)“. Journal of AOAC INTERNATIONAL 86, Nr. 2 (01.03.2003): 407–11. http://dx.doi.org/10.1093/jaoac/86.2.407.

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Abstract Dacron suture loops were demonstrated to be inert, consistent carriers in the presence of peracetic acid-based sterilants, whereas black silk sutures had a variable preparation process and interacted with peracetic acid. In addition, Dacron suture loops provided comparable spore loading to black silk suture loops and an HCl resistance of ≥2 min. These results indicate that black silk suture loops are not appropriate carriers for assessing peracetic acid-based sterilants, and Dacron loops are an acceptable alternative. This finding is consistent with the Office of Science and Technology Laboratory (Center for Devices and Radiological Health) study which determined that “polyester suture material is a viable alternative to silk for the AOAC sporicidal test for liquid disinfectants.”

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Torosyan, Yelizaveta, Yuzhi Hu, Sarah Hoffman, Qianlai Luo, Bruce Carleton und Danica Marinac-Dabic. „An in silico framework for integrating epidemiologic and genetic evidence with health care applications: ventilation-related pneumothorax as a case illustration“. Journal of the American Medical Informatics Association 23, Nr. 4 (23.04.2016): 711–20. http://dx.doi.org/10.1093/jamia/ocw031.

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Abstract Objective To illustrate an in silico integration of epidemiologic and genetic evidence that is being developed at the Center for Devices and Radiological Health/US Food and Drug Administration as part of regulatory research on postmarket device performance. In addition to using conventional epidemiologic evidence from registries, this innovative approach explores the vast potential of open-access omics databases for identifying genetic evidence pertaining to devices. Material and methods A retrospective analysis of Agency for Healthcare Research and Quality (AHRQ)/Healthcare Cost and Utilization Project (HCUPNet) data (2002–2011) was focused on the ventilation-related iatrogenic pneumothorax (Vent-IP) outcome in discharges with mechanical ventilation (MV) and continuous positive airway pressure (CPAP). The derived epidemiologic evidence was analyzed in conjunction with pre-existing genomic data from Gene Expression Omnibus/National Center for Biotechnology Information and other databases. Results AHRQ/HCUPNet epidemiologic evidence showed that annual occurrence of Vent-IP did not decrease over a decade. While the Vent-IP risk associated with noninvasive CPAP comprised about 0.5%, the Vent-IP risk due to longer-term MV reached 2%. Along with MV posing an independent risk for Vent-IP, female sex and white race were found to be effect modifiers, resulting in the highest Vent-IP risk among mechanically ventilated white females. The Vent-IP risk was also potentiated by comorbidities associated with spontaneous pneumothorax (SP) and fibrosis. Consistent with the epidemiologic evidence, expression profiling in a number of animal models showed that the expression of several collagens and other SP/fibrosis-related genes was modified by ventilation settings. Conclusion Integration of complementary genetic evidence into epidemiologic analysis can lead to a cost- and time-efficient discovery of the risk predictors and markers and thus can facilitate more efficient marker-based evaluation of medical product performance.

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Hackel, Meredith A., Joseph P. Iaconis, James A. Karlowsky und Daniel F. Sahm. „Analysis of Potential β-Lactam Surrogates To Predict In Vitro Susceptibility and Resistance to Ceftaroline for Clinical Isolates of Enterobacteriaceae“. Journal of Clinical Microbiology 56, Nr. 4 (07.02.2018): e01892-17. http://dx.doi.org/10.1128/jcm.01892-17.

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ABSTRACT Ceftaroline fosamil was approved by the United States Food and Drug Administration in 2010 and by the European Medicines Agency in 2012. As of April 2017, only one commercial antimicrobial susceptibility testing device offered a Gram-negative panel that included ceftaroline. This circumstance is unfortunate, as many clinical microbiology laboratories rely solely on commercial devices to generate in vitro antimicrobial susceptibility testing results for common bacterial pathogens. In lieu of device-based testing of clinical isolates of Enterobacteriaceae, laboratories wishing to test ceftaroline must either opt for disk diffusion testing or use a gradient strip; however, both alternatives interrupt laboratory workflow and require additional labor and expense. Identification of a reliable surrogate β-lactam to predict in vitro susceptibility to ceftaroline may offer another interim solution as laboratories await availability of ceftaroline for testing on their commercial devices. We tested six β-lactams (aztreonam, ceftazidime, ceftriaxone, cefotaxime, cefoxitin, and cefpodoxime) as potential surrogates for ceftaroline against a collection of 543 clinical isolates of Enterobacteriaceae selected to approximate the distribution of ceftaroline MICs observed in AWARE global surveillance studies conducted in 2013. All six potential surrogates generated very major error rates of 16.3% to 56.6%, far exceeding the accepted limit of 1.5% set by the Clinical and Laboratory Standards Institute (CLSI) and the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health. Failure to identify a reliable surrogate to predict in vitro susceptibility and resistance to ceftaroline for clinical isolates of Enterobacteriaceae underscores the need for expedited addition of newer antimicrobial agents to commercial antimicrobial susceptibility testing devices.

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