Concept of ASME V&V 40 : Simulation Standard for Medical Devices of American Society of Mechanical Engineers

2021 ◽  
Vol 91 (4) ◽  
pp. 363-366
Author(s):  
貴博 山田
2021 ◽  
Vol 55 (4) ◽  
pp. 118-120
Author(s):  
Rotem Naftalovich ◽  
Marko Oydanich ◽  
Tolga Berkman ◽  
Andrew John Iskander

Abstract Mechanical respirators typically use a plastic circuit apparatus to pass gases from the ventilator to the patient. Structural integrity of these circuits is crucial for maintaining oxygenation. Anesthesiologists, respiratory therapists, and other critical care professionals rely on the circuit to be free of defects. The American Society for Testing and Materials maintains standards of medical devices and had a standard (titled Standard Specification for Anesthesia Breathing Tubes) that included circuits. This standard, which was last updated in 2008, has since been withdrawn. Lack of a defined standard can invite quality fade—the phenomenon whereby manufacturers deliberately but surreptitiously reduce material quality to widen profit margins. With plastics, this is often in the form of thinner material. A minimum thickness delineated in the breathing circuit standard would help ensure product quality, maintain tolerance to mechanical insults, and avert leaks. Our impression is that over the recent years, the plastic in many of the commercially available breathing circuits has gotten thinner. We experienced a circuit leak in the middle of a laminectomy due to compromised plastic tubing in a location that evaded the safety circuit leak check that is performed prior to surgery. This compromised ventilation and oxygenation in the middle of a surgery in which the patient is positioned prone and hence with a minimally accessible airway; it could have resulted in anoxic brain injury or death. The incident led us to reflect on the degree of thinness of the circuit's plastic.


Sexual Health ◽  
2013 ◽  
Vol 10 (5) ◽  
pp. 408 ◽  
Author(s):  
Michael Cecil ◽  
Lee Warner ◽  
Aaron J. Siegler

Background Across studies, 35–50% of men describe condoms as fitting poorly. Rates of condom use may be inhibited in part due to the inaccessibility of appropriately sized condoms. As regulated medical devices, condom sizes conform to national standards such as those developed by the American Society for Testing and Materials (ASTM) or international standards such as those developed by the International Organisation for Standardisation (ISO). We describe the initial online sales experience of an expanded range of condom sizes and assess uptake in relation to the current required standard dimensions of condoms. Methods: Data regarding the initial 1000 sales of an expanded range of condom sizes in the United Kingdom were collected from late 2011 through to early 2012. Ninety-five condom sizes, comprising 14 lengths (83–238 mm) and 12 widths (41–69 mm), were available. Results: For the first 1000 condom six-pack units that were sold, a total of 83 of the 95 unique sizes were purchased, including all 14 lengths and 12 widths, and both the smallest and largest condoms. Initial condom purchases were made by 572 individuals from 26 countries. Only 13.4% of consumer sales were in the ASTM’s allowable range of sizes. Conclusions: These initial sales data suggest consumer interest in an expanded choice of condom sizes that fall outside the range currently allowable by national and international standards organisations.


Author(s):  
Delma P. Thomas ◽  
Dianne E. Godar

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.


Author(s):  
B.D. Tall ◽  
K.S. George ◽  
R. T. Gray ◽  
H.N. Williams

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.


Author(s):  
John J. Friel

Committee E-04 on Metallography of the American Society for Testing and Materials (ASTM) conducted an interlaboratory round robin test program on quantitative energy dispersive spectroscopy (EDS). The test program was designed to produce data on which to base a precision and bias statement for quantitative analysis by EDS. Nine laboratories were sent specimens of two well characterized materials, a type 308 stainless steel, and a complex mechanical alloy from Inco Alloys International, Inconel® MA 6000. The stainless steel was chosen as an example of a straightforward analysis with no special problems. The mechanical alloy was selected because elements were present in a wide range of concentrations; K, L, and M lines were involved; and Ta was severely overlapped with W. The test aimed to establish limits of precision that could be routinely achieved by capable laboratories operating under real world conditions. The participants were first allowed to use their own best procedures, but later were instructed to repeat the analysis using specified conditions: 20 kV accelerating voltage, 200s live time, ∼25% dead time and ∼40° takeoff angle. They were also asked to run a standardless analysis.


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