Moving toward Meaningful Standards for Preclinical Performance Testing of Medical Devices and Combination Products with Antimicrobial Effects

2020 ◽  
pp. 17-25
Author(s):  
Hao Wang ◽  
Aprajita Garg ◽  
Mehdi Kazemzadeh-Narbat ◽  
Kenneth L. Urish ◽  
K. Scott Phillips
Keyword(s):  
Medical Devices ◽  
Performance Testing ◽  
Antimicrobial Effects

scholarly journals Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical Devices

Micromachines ◽  
2020 ◽  
Vol 11 (10) ◽  
pp. 886
Author(s):  
Rucha Natu ◽  
Suvajyoti Guha ◽  
Seyed Ahmad Reza Dibaji ◽  
Luke Herbertson
Keyword(s):  
Medical Devices ◽  
Failure Modes ◽  
Channel Model ◽  
Standardized Test ◽  
Performance Testing ◽  
Test Methods ◽  
Device Performance ◽  
Related Factors ◽  
Rigid Particles ◽  
The Impact

The development of new standardized test methods would allow for the consistent evaluation of microfluidic medical devices and enable high-quality products to reach the market faster. A comprehensive flow characterization study was conducted to identify regulatory knowledge gaps using a generic inertia-based spiral channel model for particle sorting and facilitate standards development in the microfluidics community. Testing was performed using 2–20 µm rigid particles to represent blood elements and flow rates of 200–5000 µL/min to assess the effects of flow-related factors on overall system performance. Two channel designs were studied to determine the variability associated with using the same microchannel multiple times (coefficient of variation (CV) of 27% for Design 1 and 18% for Design 2, respectively). The impact of commonly occurring failure modes on device performance was also investigated by simulating progressive and complete channel outlet blockages. The pressure increased by 10–250% of the normal channel pressure depending on the extent of the blockage. Lastly, two common data analysis approaches were compared—imaging and particle counting. Both approaches were similar in terms of their sensitivity and consistency. Continued research is needed to develop standardized test methods for microfluidic systems, which will improve medical device performance testing and drive innovation in the biomedical field.

Ultrastructural changes in murine lymphoma cells exposed to ultraviolet-A radiation

1991 ◽  
Vol 49 ◽  
pp. 104-105
Author(s):  
Delma P. Thomas ◽  
Dianne E. Godar
Keyword(s):  
Medical Devices ◽  
Blood Cells ◽  
White Blood Cells ◽  
Consumer Products ◽  
Ultrastructural Changes ◽  
Ultraviolet A ◽  
Uv Spectrum ◽  
Lymphoma Cells ◽  
Murine Lymphoma ◽  
Transmission Electron

Ultraviolet radiation (UVR) from all three waveband regions of the UV spectrum, UVA (320-400 nm), UVB (290-320 nm), and UVC (200-290 nm), can be emitted by some medical devices and consumer products. Sunlamps can expose the blood to a considerable amount of UVR, particularly UVA and/or UVB. The percent transmission of each waveband through the epidermis to the dermis, which contains blood, increases in the order of increasing wavelength: UVC (10%) < UVB (20%) < UVA (30%). To investigate the effects of UVR on white blood cells, we chose transmission electron microscopy to examine the ultrastructure changes in L5178Y-R murine lymphoma cells.

Bacterial biofilm behavior in water-supply lines of dental units

1992 ◽  
Vol 50 (1) ◽  
pp. 882-883
Author(s):  
B.D. Tall ◽  
K.S. George ◽  
R. T. Gray ◽  
H.N. Williams
Keyword(s):  
Water Supply ◽  
Medical Devices ◽  
Biofilm Formation ◽  
Bacterial Biofilm

Studies of bacterial behavior in many environments have shown that most organisms attach to surfaces, forming communities of microcolonies called biofilms. In contaminated medical devices, biofilms may serve both as reservoirs and as inocula for the initiation of infections. Recently, there has been much concern about the potential of dental units to transmit infections. Because the mechanisms of biofilm formation are ill-defined, we investigated the behavior and formation of a biofilm associated with tubing leading to the water syringe of a dental unit over a period of 1 month.

The use of videotape technology to train administrators of walk-through performance testing

1988 ◽  
Author(s):  
Jerry W. Hedge ◽  
Terry L. Dickinson ◽  
Sheryl A. Bierstedt
Keyword(s):  
Performance Testing

Musculoskeletal Performance Testing and Profiling of Elite Competitive Fencers

1984 ◽  
Vol 3 (1) ◽  
pp. 231-244
Author(s):  
Alexander A. Sapega ◽  
Jeffrey Minkoff ◽  
Marius Valsamis ◽  
James A. Nicholas
Keyword(s):  
Performance Testing ◽  
Musculoskeletal Performance

Patients with chronic diseases: tomorrow, all sentinels?

2020 ◽  
Vol 12 (1) ◽  
pp. 10502
Author(s):  
Jean-David Cohen ◽  
Cyril Crozet ◽  
Jean-François d’Ivernois ◽  
Rémi Gagnayre
Keyword(s):  
Chronic Diseases ◽  
Experimental Research ◽  
Medical Devices ◽  
Clinical Experiences ◽  
Very Old ◽  
Quasi Experimental ◽  
External Measure

Very old studies and clinical experiences of physicians already signal the ability of some patients to feel subclinical signs. These patients are called sentinel patients because they can anticipate crisis very early and therefore intervene quickly to prevent them. Studies have shown that these patients develop these skills from their own experience, in steps which are similar to quasi-experimental research. They test and adjust their competence all the more easily as they have an objective external measure available. This faculty of patients suggests the possibility of using medical devices as a means of learning for patients to tutor themselves in support of this singular skill.

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