Prevent Potential Hazards Caused by Medical Device Time Differences in Integrated Clinical Environments

2019 ◽  
Author(s):  
Zhenyu Zhang ◽  
Chunhui Guo ◽  
Zhicheng Fu ◽  
Shangping Ren ◽  
Nalini Venkatasubramanian
Keyword(s):  
Medical Device ◽  
Clinical Environments

scholarly journals Getting Better Hospital Alarm Sounds Into a Global Standard

2018 ◽  
Vol 26 (4) ◽  
pp. 4-13 ◽  
Author(s):  
Judy Reed Edworthy ◽  
Richard R. McNeer ◽  
Christopher L. Bennett ◽  
Roman Dudaryk ◽  
Siné J. P. McDougall ◽  
...  
Keyword(s):  
Medical Device ◽  
End Users ◽  
Safety Standard ◽  
Constant Attention ◽  
Alarm Signals ◽  
Audible Alarm ◽  
Clinical Environments ◽  
Testing Potential ◽  
Further Development ◽  
Alarm Sounds

The reserved set of audible alarm signals embodied within the global medical device safety standard, IEC 60601-1-8, is known to be problematic and in need of updating. The current alarm signals are not only suboptimal, but there is also little evidence beyond learnability (which is known to be poor) that demonstrates their performance in realistic and representative clinical environments. In this article, we describe the process of first designing and then testing potential replacement audible alarm signals for IEC 60601-1-8, starting with the design of several sets of candidate sounds and initial tests on learnability and localizability, followed by testing in simulated clinical environments. We demonstrate that in all tests, the alarm signals selected for further development significantly outperform the current alarm signals. We describe the process of collecting considerably more data on the performance of the new sounds than exists for the current sounds, which ultimately will be of use to end users. We also reflect on the process and practice of working with the relevant committees and other practical issues beyond the science, which also need constant attention if the alarms we have developed are to be included successfully in an updated version of the standard.

An analysis of home and hospital medical device incidents in the Maude database

2004 ◽  
Author(s):  
Ibraheem S. Al-Tarawneh ◽  
Walter J. Stevens ◽  
Steven R. Arndt
Keyword(s):  
Medical Device ◽  
Hospital Medical

Thrombosis of Surgical Bioprosthetic Heart Valves-Insights from Reports to International Medical Device Vigilance Systems

2017 ◽  
Vol 65 (S 01) ◽  
pp. S1-S110
Author(s):  
C. Gestrich ◽  
J.E. Klein ◽  
B. Toctam ◽  
G.D. Dürr ◽  
J.M. Sinning ◽  
...  
Keyword(s):  
Medical Device ◽  
Heart Valves ◽  
International Medical ◽  
Bioprosthetic Heart Valves

Europäischer Medizinproduktemarkt: Wie sich Einkauf und Logistik auf die europäische MDR vorbereiten müssen

2019 ◽  
Vol 01 (04) ◽  
pp. 74-77
Author(s):  
Thomas Gallmann
Keyword(s):  
Medical Device ◽  
Medical Device Regulation

Nicht lieferbare Medizinprodukte sind für Kliniken ein Albtraum – mitunter müssen sogar geplante OPs abgesagt werden. Die Folge: Die mit den Kostenträgern vereinbarten Leistungszahlen sind schwieriger zu erfüllen und es könnte zu schwer kompensierbaren Erlöseinbußen für die Leistungserbringer kommen. Die Medical Device Regulation (MDR) wird die Liefersituation von Medizinprodukten ab 2020 wahrscheinlich noch weiter verschärfen.

The study for constant force characteristic of C-shaped superelastic SMA

2020 ◽  
Vol 64 (1-4) ◽  
pp. 1253-1259
Author(s):  
Minghui Wang ◽  
Hongliu Yu
Keyword(s):  
Shape Memory Alloys ◽  
Shape Memory ◽  
Medical Device ◽  
Soft Tissues ◽  
Computational Simulation ◽  
Force Characteristic ◽  
Constant Force ◽  
Curve Shape ◽  
Artificial Sphincter ◽  
Round Bar

Clamping devices with constant force or pressure are desired in medical device, such as hemostatic forceps and the artificial sphincter, to prevent soft tissues from injures due to overloading. It is easily obtained by stretching an SMA wire. However, studies with SMA bending round bar have seldom been reported before. This paper studied constant force characteristic of C-shaped round bar with shape memory alloys. Optimization designs of the components were carried out with computational simulation. Numerical results show that the phenomenon of constant force strongly depends on contour curve shape and geometric dimensions of the C-shaped round bar of SMA component.

Attrarre la produzione e la ricerca di imprese farmaceutiche e di medical device

MECOSAN ◽  
2017 ◽  
pp. 103-108
Author(s):  
Patrizio Armeni ◽  
Giuditta Callea ◽  
Rosanna Tarricone ◽  
Aleksandra Torbica
Keyword(s):  
Medical Device

Development of Wafer Level Chip Size Packaging Process and its Application to the CMOS Image Sensor Module for Medical Device

2017 ◽  
Vol 137 (2) ◽  
pp. 48-58
Author(s):  
Noriyuki Fujimori ◽  
Takatoshi Igarashi ◽  
Takahiro Shimohata ◽  
Takuro Suyama ◽  
Kazuhiro Yoshida ◽  
...  
Keyword(s):  
Medical Device ◽  
Cmos Image Sensor ◽  
Image Sensor ◽  
Wafer Level ◽  
Packaging Process ◽  
Sensor Module ◽  
Chip Size

A Fluidic Vibrational Energy Harvester for Implantable Medical Device Applications

2017 ◽  
Vol 137 (6) ◽  
pp. 152-158
Author(s):  
Satoshi Inoue ◽  
Takuya Takahashi ◽  
Momoko Kumemura ◽  
Kazunori Ishibashi ◽  
Hiroyuki Fujita ◽  
...  
Keyword(s):  
Medical Device ◽  
Energy Harvester ◽  
Vibrational Energy ◽  
Implantable Medical Device ◽  
Device Applications

Long-term efficacy of a new medical device containing Fernblock® and DNA repair enzyme complex in the treatment and prevention of cancerization field in patients with actinic keratosis.

2019 ◽  
Vol 2 (02) ◽  
pp. 80-89
Author(s):  
Blanca De Unamuno Bustos ◽  
Natalia Chaparr´´o Aguilera ◽  
Inmaculada Azorín García ◽  
Anaid Calle Andrino ◽  
Margarita Llavador Ros ◽  
...  
Keyword(s):  
Dna Damage ◽  
Dna Repair ◽  
Medical Device ◽  
Actinic Keratosis ◽  
Statistical Significance ◽  
Dna Lesions ◽  
Enzyme Complex ◽  
Repair Enzyme ◽  
P53 Expression ◽  
Cancerization Field

Actinic keratosis (AKs) are part of the cancerization field, a region adjacent to AKs containing subclinical and histologically abnormal epidermal tissue due to Ultraviolet (UV)-induced DNA damage. The photoproducts as consequence of DNA damage induced by UV are mainly cyclobutane pyrimidine dimers (CPDs). Fernblock® demonstrated in previous studies significant reduction of the number of CPDs induced by UV radiation. Photolyases are a specific group of enzymes that remove the major UV-induced DNA lesions by a mechanism called photo-reactivation. A monocentric, prospective, controlled, and double blind interventional study was performed to evaluate the effect of a new medical device (NMD) containing a DNA-repair enzyme complex (photolyases, endonucleases and glycosilases), a combination of UV-filters, and Fernblock® in the treatment of the cancerization field in 30 AK patients after photodynamic therapy. Patients were randomized into two groups: patients receiving a standard sunscreen (SS) andpatients receiving the NMD. Clinical, dermoscopic, reflectance confocal microscopy (RCM) and histological evaluations were performed. An increase of AKs was noted in all groups after three months of PDT without significant differences between them (p=0.476). A significant increase in the number of AKs was observed in SS group after six (p=0.026) and twelve months of PDT (p=0.038); however, this increase did not reach statistical significance in the NMD group. Regarding RCM evaluation, honeycomb pattern assessment after twelve months of PDT showed significant differences in the extension and grade of the atypia in the NMD group compared to SS group (p=0.030 and p=0.026, respectively). Concerning histopathological evaluation, keratinocyte atypia grade improved from baseline to six months after PDT in all the groups, with no statistically significant differences between the groups. Twelve months after PDT, p53 expression was significantly lower in the NMD group compared to SS group (p=0.028). The product was well-tolerated, with no serious adverse events reported. Our results provide evidence of the utility of this NMD in the improvement of the cancerization field and in the prevention of the development of new AKs.  

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