Ocular irritation and photo-irritation testing of medical devices and extracts using 3D reconstructed human cornea-like tissue models.

2021 ◽  
Vol 350 ◽  
pp. S252-S253
Author(s):  
P. Pôbis ◽  
H. Kandarova
Keyword(s):  
Medical Devices ◽  
Human Cornea ◽  
Ocular Irritation ◽  
Tissue Models

Safety Assessment of Modified Terephthalate Polymers as Used in Cosmetics

2014 ◽  
Vol 33 (3_suppl) ◽  
pp. 36S-47S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Medical Devices ◽  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Bulking Agents ◽  
Ocular Irritation ◽  
Cosmetic Ingredients ◽  
Animal Safety ◽  
Use Studies

The safety of 6 modified terephthalate polymers as cosmetic ingredients was assessed. These ingredients mostly function as exfoliants, bulking agents, hair fixatives, and viscosity-increasing agents—nonaqueous. Polyethylene terephthalate (PET) is used in leave-on products up to 100% and in rinse-off products up to 2%. The Cosmetic Ingredient Review Expert Panel (Panel) considered that the PET used in cosmetics is chemically equivalent to that used in medical devices. The Panel determined that the Food and Drug Administration’s determination of safety of PET in several medical devices, which included human and animal safety data, can be used as the basis for the determination of safety of PET and related polymers used in cosmetics. Use studies of cosmetic eye products that contain PET demonstrated no ocular irritation or dermal sensitization. The Panel concluded that modified terephthalate polymers were safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment.

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.

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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