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Article ; Online: Dynamic X-ray elastography using a pulsed photocathode source.

Kamezawa, Chika / Cramer, Avilash / Krull, Wolfgang / Yashiro, Wataru / Hyodo, Kazuyuki / Gupta, Rajiv

2021 Volume 11, Issue 1, Page(s) 24128

Abstract: X-ray absorption of breast cancers and surrounding healthy tissue can be very similar, a situation that sometimes leads to missed cancers or false-positive diagnoses. To increase the accuracy of mammography and breast tomosynthesis, we describe dynamic X- ...

Abstract	X-ray absorption of breast cancers and surrounding healthy tissue can be very similar, a situation that sometimes leads to missed cancers or false-positive diagnoses. To increase the accuracy of mammography and breast tomosynthesis, we describe dynamic X-ray elastography using a novel pulsed X-ray source. This new imaging modality provides both absorption and mechanical properties of the imaged material. We use a small acoustic speaker to vibrate the sample while a synchronously pulsed cold cathode X-ray source images the mechanical deformation. Using these stroboscopic images, we derive two-dimensional stiffness maps of the sample in addition to the conventional X-ray image. In a breast phantom composed of ZrO
Language	English
Publishing date	2021-12-16
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-021-03221-y
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Assessment of the Qualitative Fit Test and Quantitative Single-Pass Filtration Efficiency of Disposable N95 Masks Following Gamma Irradiation.

Cramer, Avilash / Tian, Enze / Galanek, Mitchell / Lamere, Edward / Li, Ju / Gupta, Rajiv / Short, Mike

JAMA network open

2020 Volume 3, Issue 5, Page(s) e209961

MeSH term(s)	Disposable Equipment/standards ; Filtration ; Gamma Rays ; Humans ; Masks/standards ; Masks/statistics & numerical data ; Sterilization/methods ; Sterilization/standards
Keywords	covid19
Language	English
Publishing date	2020-05-01
Publishing country	United States
Document type	Journal Article
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2020.9961
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic.

Antonini, Marc-Joseph / Plana, Deborah / Srinivasan, Shriya / Atta, Lyla / Achanta, Aditya / Yang, Helen / Cramer, Avilash K / Freake, Jacob / Sinha, Michael S / Yu, Sherry H / LeBoeuf, Nicole R / Linville-Engler, Ben / Sorger, Peter K

Frontiers in digital health

2021 Volume 3

Abstract: The disruption of conventional manufacturing, supply, and distribution channels during the COVID-19 pandemic caused widespread shortages in personal protective equipment (PPE) and other medical supplies. These shortages catalyzed local efforts to use ... ...

Abstract	The disruption of conventional manufacturing, supply, and distribution channels during the COVID-19 pandemic caused widespread shortages in personal protective equipment (PPE) and other medical supplies. These shortages catalyzed local efforts to use nontraditional, rapid manufacturing to meet urgent healthcare needs. Here we present a crisis-responsive design framework designed to assist with product development under pandemic conditions. The framework emphasizes stakeholder engagement, comprehensive but efficient needs assessment, rapid manufacturing, and modified product testing to enable accelerated development of healthcare products. We contrast this framework with traditional medical device manufacturing that proceeds at a more deliberate pace, discuss strengths and weakness of pandemic-responsive fabrication, and consider relevant regulatory policies. We highlight the use of the crisis-responsive framework in a case study of face shield design and production for a large US academic hospital. Finally, we make recommendations aimed at improving future resilience to pandemics and healthcare emergencies. These include continued development of open source designs suitable for rapid manufacturing, education of maker communities and hospital administrators about rapidly-manufactured medical devices, and changes in regulatory policy that help strike a balance between quality and innovation.
Language	English
Publishing date	2021-03-22
Publishing country	Switzerland
Document type	Journal Article
ISSN	2673-253X
ISSN (online)	2673-253X
DOI	10.3389/fdgth.2021.617106
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE.

Cramer, Avilash K / Plana, Deborah / Yang, Helen / Carmack, Mary M / Tian, Enze / Sinha, Michael S / Krikorian, David / Turner, David / Mo, Jinhan / Li, Ju / Gupta, Rajiv / Manning, Heather / Bourgeois, Florence T / Yu, Sherry H / Sorger, Peter K / LeBoeuf, Nicole R

Scientific reports

2021 Volume 11, Issue 1, Page(s) 2051

Abstract: The COVID-19 pandemic has led to widespread shortages of personal protective equipment (PPE) for healthcare workers, including of N95 masks (filtering facepiece respirators; FFRs). These masks are intended for single use but their sterilization and ... ...

Abstract	The COVID-19 pandemic has led to widespread shortages of personal protective equipment (PPE) for healthcare workers, including of N95 masks (filtering facepiece respirators; FFRs). These masks are intended for single use but their sterilization and subsequent reuse has the potential to substantially mitigate shortages. Here we investigate PPE sterilization using ionized hydrogen peroxide (iHP), generated by SteraMist equipment (TOMI; Frederick, MD), in a sealed environment chamber. The efficacy of sterilization by iHP was assessed using bacterial spores in biological indicator assemblies. After one or more iHP treatments, five models of N95 masks from three manufacturers were assessed for retention of function based on their ability to form an airtight seal (measured using a quantitative fit test) and filter aerosolized particles. Filtration testing was performed at a university lab and at a National Institute for Occupational Safety and Health (NIOSH) pre-certification laboratory. The data demonstrate that N95 masks sterilized using SteraMist iHP technology retain filtration efficiency up to ten cycles, the maximum number tested to date. A typical iHP environment chamber with a volume of ~ 80 m
MeSH term(s)	COVID-19/epidemiology ; COVID-19/prevention & control ; Equipment Reuse/statistics & numerical data ; Humans ; Hydrogen Peroxide/pharmacology ; N95 Respirators/supply & distribution ; N95 Respirators/virology ; Pandemics/prevention & control ; Personal Protective Equipment/supply & distribution ; Personal Protective Equipment/virology ; Respiratory Protective Devices ; SARS-CoV-2/isolation & purification ; Sterilization/methods ; United States/epidemiology
Chemical Substances	Hydrogen Peroxide (BBX060AN9V)
Language	English
Publishing date	2021-01-21
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-021-81365-7
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE

Avilash K. Cramer / Deborah Plana / Helen Yang / Mary M. Carmack / Enze Tian / Michael S. Sinha / David Krikorian / David Turner / Jinhan Mo / Ju Li / Rajiv Gupta / Heather Manning / Florence T. Bourgeois / Sherry H. Yu / Peter K. Sorger / Nicole R. LeBoeuf

Scientific Reports, Vol 11, Iss 1, Pp 1-

2021 Volume 10

Abstract: Abstract The COVID-19 pandemic has led to widespread shortages of personal protective equipment (PPE) for healthcare workers, including of N95 masks (filtering facepiece respirators; FFRs). These masks are intended for single use but their sterilization ... ...

Abstract	Abstract The COVID-19 pandemic has led to widespread shortages of personal protective equipment (PPE) for healthcare workers, including of N95 masks (filtering facepiece respirators; FFRs). These masks are intended for single use but their sterilization and subsequent reuse has the potential to substantially mitigate shortages. Here we investigate PPE sterilization using ionized hydrogen peroxide (iHP), generated by SteraMist equipment (TOMI; Frederick, MD), in a sealed environment chamber. The efficacy of sterilization by iHP was assessed using bacterial spores in biological indicator assemblies. After one or more iHP treatments, five models of N95 masks from three manufacturers were assessed for retention of function based on their ability to form an airtight seal (measured using a quantitative fit test) and filter aerosolized particles. Filtration testing was performed at a university lab and at a National Institute for Occupational Safety and Health (NIOSH) pre-certification laboratory. The data demonstrate that N95 masks sterilized using SteraMist iHP technology retain filtration efficiency up to ten cycles, the maximum number tested to date. A typical iHP environment chamber with a volume of ~ 80 m3 can treat ~ 7000 masks and other items (e.g. other PPE, iPADs), making this an effective approach for a busy medical center.
Keywords	Medicine ; R ; Science ; Q
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic

Marc-Joseph Antonini / Deborah Plana / Shriya Srinivasan / Lyla Atta / Aditya Achanta / Helen Yang / Avilash K. Cramer / Jacob Freake / Michael S. Sinha / Sherry H. Yu / Nicole R. LeBoeuf / Ben Linville-Engler / Peter K. Sorger

Frontiers in Digital Health, Vol

2021 Volume 3

Abstract	The disruption of conventional manufacturing, supply, and distribution channels during the COVID-19 pandemic caused widespread shortages in personal protective equipment (PPE) and other medical supplies. These shortages catalyzed local efforts to use nontraditional, rapid manufacturing to meet urgent healthcare needs. Here we present a crisis-responsive design framework designed to assist with product development under pandemic conditions. The framework emphasizes stakeholder engagement, comprehensive but efficient needs assessment, rapid manufacturing, and modified product testing to enable accelerated development of healthcare products. We contrast this framework with traditional medical device manufacturing that proceeds at a more deliberate pace, discuss strengths and weakness of pandemic-responsive fabrication, and consider relevant regulatory policies. We highlight the use of the crisis-responsive framework in a case study of face shield design and production for a large US academic hospital. Finally, we make recommendations aimed at improving future resilience to pandemics and healthcare emergencies. These include continued development of open source designs suitable for rapid manufacturing, education of maker communities and hospital administrators about rapidly-manufactured medical devices, and changes in regulatory policy that help strike a balance between quality and innovation.
Keywords	personal protective equipment (PPE) ; COVID-19 ; manufacturing ; prototyping ; biocompatibility ; 3D printing ; Medicine ; R ; Public aspects of medicine ; RA1-1270 ; Electronic computers. Computer science ; QA75.5-76.95
Subject code	670
Language	English
Publishing date	2021-03-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: De novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response.

Kothakonda, Akshay / Atta, Lyla / Plana, Deborah / Ward, Ferrous / Davis, Chris / Cramer, Avilash / Moran, Robert / Freake, Jacob / Tian, Enze / Mazor, Ofer / Gorelik, Pavel / Van, Christopher / Hansen, Christopher / Yang, Helen / Sinha, Michael S / Li, Ju / Yu, Sherry H / LeBoeuf, Nicole R / Sorger, Peter K

medRxiv : the preprint server for health sciences

2021

Abstract: The rapid spread of COVID-19 and disruption of normal supply chains resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information ... ...

Abstract	The rapid spread of COVID-19 and disruption of normal supply chains resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information describing design and performance criteria represents a substantial barrier to new approaches to address these shortages. We sought to apply open-source product development to PAPRs to enable alternative sources of supply and further innovation. We describe the design, prototyping, validation, and user testing of locally manufactured, modular, PAPR components, including filter cartridges and blower units, developed by the Greater Boston Pandemic Fabrication Team (PanFab). Two designs, one with a fully custom-made filter and blower unit housing, and the other with commercially available variants (the "Custom" and "Commercial" designs respectively) were developed. Engineering performance of the prototypes was measured and safety validated using NIOSH-equivalent tests on apparatus available under pandemic conditions, at university laboratories. Feedback on designs was obtained from four individuals, including two clinicians working in an ambulatory clinical setting and two research technical staff for whom PAPR use is a standard part of occupational PPE. Respondents rated the PanFab Custom PAPR a 4 to 5 on a 5 Likert-scale 1) as compared to current PPE options, 2) for the sense of security with use in a clinical setting, and 3) for comfort. The three other versions of the designs (with a commercial blower unit, filter, or both) performed favorably, with survey responses consisting of scores ranging from 3-5. Engineering testing and clinical feedback demonstrate that the PanFab designs represents favorable alternative PAPRs in terms of user comfort, mobility, and sense of security. A nonrestrictive license promotes innovation in respiratory protection for current and future medical emergencies.
Language	English
Publishing date	2021-03-29
Publishing country	United States
Document type	Preprint
DOI	10.1101/2021.03.25.21252076
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Assessing the filtration efficiency and regulatory status of N95s and nontraditional filtering face-piece respirators available during the COVID-19 pandemic.

Plana, Deborah / Tian, Enze / Cramer, Avilash K / Yang, Helen / Carmack, Mary M / Sinha, Michael S / Bourgeois, Florence T / Yu, Sherry H / Masse, Peter / Boyer, Jon / Kim, Minjune / Mo, Jinhan / LeBoeuf, Nicole R / Li, Ju / Sorger, Peter K

BMC infectious diseases

2021 Volume 21, Issue 1, Page(s) 712

Abstract: Background: The COVID-19 pandemic has severely disrupted supply chains for many types of Personal Protective Equipment (PPE), particularly surgical N95 filtering facepiece respirators (FFRs; "masks"). As a consequence, an Emergency Use Authorization ( ... ...

Abstract	Background: The COVID-19 pandemic has severely disrupted supply chains for many types of Personal Protective Equipment (PPE), particularly surgical N95 filtering facepiece respirators (FFRs; "masks"). As a consequence, an Emergency Use Authorization (EUA) from the FDA has allowed use of industrial N95 respirators and importation of N95-type masks manufactured to international standards; these include KN95 masks from China and FFP2 masks from the European Union. Methods: We conducted a survey of masks in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer or supplier. We then assembled a testing apparatus at a university laboratory and performed a modified test of filtration performance using KCl and ambient particulate matter on masks from hospital inventories; an accompanying website shows how to build and use the testing apparatus. Results: Over 100 different makes and models of traditional and nontraditional filtering facepiece respirators (N95-type masks) were in the inventory of surveyed U.S. teaching hospitals as opposed to 2-5 models under normal circumstances. A substantial number of unfamiliar masks are from unknown manufacturers. Many are not correctly labelled and do not perform to accepted standards and a subset are obviously dangerous; many of these masks are likely to be counterfeit. Due to the absence of publicly available information on mask suppliers and inconsistent labeling of KN95 masks, it is difficult to distinguish between legitimate and counterfeit products. Conclusions: Many FFRs available for procurement during the COVID-19 pandemic do not provide levels of fit and filtration similar to those of N95 masks and are not acceptable for use in healthcare settings. Based on these results, and in consultation with occupational health officers, we make six recommendations to assist end users in acquiring legitimate products. Institutions should always assess masks from non-traditional supply chains by checking their markings and manufacturer information against data provided by NIOSH and the latest FDA EUA Appendix A. In the absence of verifiable information on the legitimacy of mask source, institutions should consider measuring mask fit and filtration directly. We also make suggestions for regulatory agencies regarding labeling and public disclosure aimed at increasing pandemic resilience.
MeSH term(s)	COVID-19 ; Humans ; Masks ; Occupational Exposure ; Pandemics/prevention & control ; Respiratory Protective Devices ; SARS-CoV-2 ; Ventilators, Mechanical
Language	English
Publishing date	2021-07-29
Publishing country	England
Document type	Journal Article
ZDB-ID	2041550-3
ISSN	1471-2334 ; 1471-2334
ISSN (online)	1471-2334
ISSN	1471-2334
DOI	10.1186/s12879-021-06008-8
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Article ; Online: Disposable N95 Masks Pass Qualitative Fit-Test But Have Decreased Filtration Efficiency after Cobalt-60 Gamma Irradiation

Cramer, Avilash / Tian, Enze / Yu, Sherryl H / Galanek, Mitchell / Lamere, Edward / Li, Ju / Gupta, Rajiv / Short, Michael P

medRxiv

Abstract: The current COVID-19 pandemic has led to a dramatic shortage of masks and other personal protective equipment (PPE) in hospitals around the globe. One component of PPE that is in particular demand are disposable N95 face masks. To alleviate this, many ... ...

Abstract	The current COVID-19 pandemic has led to a dramatic shortage of masks and other personal protective equipment (PPE) in hospitals around the globe. One component of PPE that is in particular demand are disposable N95 face masks. To alleviate this, many methods of N95 mask sterilization have been studied and proposed with the hope of being able to safely reuse masks. Two major considerations must be made when re-sterilizing masks: (1) the sterilization method effectively kills pathogens, penetrating into the fibers of the mask, and (2) the method does not degrade the operational integrity of the N95 filters. We studied Cobalt-60 gamma irradiation as a method of effective sterilization without inducing mask degradation. Significant literature exists supporting the use of gamma radiation as a sterilization method, with viral inactivation of SARS-CoV reported at doses of at most 10 kGy, with other studies supporting 5 kGy for many types of viruses. However, concerns have been raised about the radiation damaging the fiber material within the mask, specifically by causing cross-linking of polymers, leading to cracking and degradation during fitting and/or deployment. A set of 3M 8210 and 9105 masks were irradiated using MIT9s Co-60 irradiator. Three masks of each type received 0 kiloGray (kGy), 10 kGy and 50 kGy of approximately 1.3 MeV gamma radiation from the circular cobalt sources, at a dose rate of 2.2 kGy per hour. Following this sterilization procedure, the irradiated masks passed a OSHA Gerson Qualitative Fit Test QLFT 50 (saccharin apparatus) when donned correctly, performed at the Brigham and Women9s Hospital, in a blinded study repeated in triplicate. However, the masks9 filtration of 0.3 um particles was significantly degraded, even at 10 kGy. These results suggest against gamma, and possibly all ionizing radiation, as a method of disposable N95 sterilization. Even more importantly, they argue against using the qualitative fit test alone to assess mask integrity.
Keywords	covid19
Language	English
Publishing date	2020-03-30
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2020.03.28.20043471
Database	COVID19

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Article ; Online: Analysis of SteraMist ionized hydrogen peroxide technology as a method for sterilizing N95 respirators and other personal protective equipment

Avilash Cramer / Deborah Plana / Helen L Yang / Mary Carmack / Enze Tian / Michael S Sinha / David Krikorian / David Turner / Jinhan Mo / Ju Li / Rajiv Gupta / Heather Manning / Florence T. Bourgeois / Sherry H Yu / Peter Sorger / Nicole L LeBoeuf

Abstract: The COVID-19 pandemic has led to widespread shortages of personal protective equipment (PPE) for healthcare workers, including filtering facepiece respirators (FFRs) such as N95 masks. These masks are normally intended for single use, but their ... ...

Abstract	The COVID-19 pandemic has led to widespread shortages of personal protective equipment (PPE) for healthcare workers, including filtering facepiece respirators (FFRs) such as N95 masks. These masks are normally intended for single use, but their sterilization and subsequent reuse could substantially mitigate a world-wide shortage. In this study, we investigate PPE sterilization using ionized hydrogen peroxide (iHP), generated by SteraMist® equipment (TOMI; Frederick, MD), in a sealed environment chamber installed in the animal facility of an academic medical center. Following one to five sterilization cycles, five N95 mask models from three manufacturers were evaluated using three criteria: efficiency of iHP in sterilization (measured with bacterial spores in standard biological indicator assemblies), ability of sterilized masks to efficiently filter particles down to 0.3μm, and a quantitative fit test. Filtration efficiency was measured using ambient particulate matter at a university lab and an aerosolized NaCl challenge at a National Institute for Occupational Safety and Health (NIOSH) pre-certification laboratory. The data demonstrate that N95 masks sterilized using SteraMist iHP technology retain function up to five cycles, the maximum number tested. Some but not all PPE could also be sterilized in the same manner, and pre-treatment with a handheld iHP generator was required for semi-enclosed surfaces such as respirator hoses. A typical environment chamber with a volume of ~80 m3 can treat ~7000 masks per day, and as well as other items of PPE, making this an effective approach for a busy medical center.
Keywords	covid19
Publisher	medrxiv
Document type	Article ; Online
DOI	10.1101/2020.04.19.20069997
Database	COVID19

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