scholarly journals PARAMETER UTAMA DAN KESIAPAN LEMBAGA PENILAIAN KESESUAIAN KURSI RODA MANUAL DALAM PENGEMBANGAN STANDAR DI INDONESIA

2021 ◽  
Vol 23 (1) ◽  
pp. 33
Author(s):  
Meilinda Ayundyahrini ◽  
Suprapto Suprapto ◽  
Fahrina Fahma ◽  
Wahyudi Sutopo ◽  
Eko Pujiyanto ◽  
...  
Keyword(s):  
Medical Device ◽  
National Differences

<p>Berdasarkan ketentuan <em>A</em><em><ins cite="mailto:Author">SEAN</ins></em><em><del cite="mailto:Author">sean</del> Medical Device Directive</em> (AMDD) kursi roda yang termasuk dalam klasifikasi penggunaan risiko rendah. Sehingga Kementerian Kesehatan tidak menjadikan SNI (Standar Nasional Indonesia) sebagai persyaratan dalam pengajuan izin edar. Sebab, produk kursi roda yang paling banyak ditemui di Indonesia memang tidak berkualitas, apalagi produk impor. Kondisi ini tentunya bertentangan dengan Undang-Undang Nomor 36 Tahun 2009 Pasal 42. Penelitian ini bertujuan untuk mendapatkan parameter utama dan kesiapan CAB jika standar diterapkan. Parameter utama terdiri dari 7 parameter dan 30 sub parameter. Parameter tersebut adalah: stabilitas, kemampuan manuver, mobilitas dan penyimpanan produk, dimensi, kekuatan, daya tahan, dan informasi produk. Sedangkan sub parameter yang dapat diusulkan menjadi <em><ins cite="mailto:Author">National Differences</ins></em><del cite="mailto:Author">Beda Nasional</del> adalah: dimensi dengan antropometri harus mampu menampung segmen persentil Indonesia, uji fatik dilakukan lebih dari 200.000 putaran, uji jatuh dilakukan lebih dari 6.666 siklus, uji ujung tajam<del cite="mailto:Author"> </del>, uji sisi halus, dan koefisien gesekan. Dalam persiapan penerapan SNI kursi roda manual, diperlukan Badan Penilai Kesesuaian (CAB). Mengidentifikasi 6 laboratorium penguji, 4 badan sertifikasi produk. Waktu yang dibutuhkan untuk mempersiapkan infrastruktur pengujian diperkirakan 6-12 bulan.</p>

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

Modernization, Globalization, Trends, and Convergence in Health Expenditure in Latin America and the Caribbean

2015 ◽  
Vol 1 (2) ◽  
pp. 321-346 ◽  
Author(s):  
Shiri Noy ◽  
Patricia A. McManus
Keyword(s):  
Health Care ◽  
Latin America ◽  
Health Care Systems ◽  
Health Care Financing ◽  
Health Spending ◽  
Modernization Theory ◽  
The Public ◽  
National Differences ◽  
Care Systems ◽  
Public Private Mix

Are health care systems converging in developing nations? We use the case of health care financing in Latin America between 1995 and 2009 to assess the predictions of modernization theory, competing strands of globalization theory, and accounts of persistent cross-national differences. As predicted by modernization theory, we find convergence in overall health spending. The public share of health spending increased over this time period, with no convergence in the public-private mix. The findings indicate robust heterogeneity of national health care systems and suggest that globalization fosters human investment health policies rather than neoliberal, “race to the bottom” cutbacks in public health expenditures.

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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