Genotoxicity evaluation of medical devices: A regulatory perspective

2021 ◽  
pp. 108407
Author(s):  
Tirukalikundram S. Kumaravel ◽  
Tiruvathipuram Narasimmabarathy Sathya ◽  
Ramalingam Balaje ◽  
Pitchaipillai Pradeepa ◽  
Desikan Yogaraj ◽  
...  
Keyword(s):  
Medical Devices ◽  
Regulatory Perspective

scholarly journals A regulatory perspective on recombinant collagen-based medical devices

2021 ◽  
Author(s):  
Wenbo Liu ◽  
Hai Lin ◽  
Peng Zhao ◽  
Lina Xing ◽  
Jie Li ◽  
...  
Keyword(s):  
Medical Devices ◽  
Regulatory Perspective

scholarly journals Materiovigilance: Concept, Structure and Emerging Perspective for Patient’s Safety in India

Drug Research ◽  
2020 ◽  
Vol 70 (09) ◽  
pp. 429-436
Author(s):  
Farazul Hoda ◽  
Rishabh Verma ◽  
Mawrah Arshad ◽  
Ali Nasir Siddiqui ◽  
Mohammad Ahmed Khan ◽  
...  
Keyword(s):  
Patient Safety ◽  
Adverse Events ◽  
Medical Devices ◽  
Safety Data ◽  
Current Review ◽  
Ensure Patient Safety ◽  
Regulatory Perspective ◽  
Controller General ◽  
Ultimate Objective ◽  
Medical Device Regulation

AbstractThere has been an escalation in the number, diversity, and complexity of medical devices. Regulation of these devices has also advanced due to the requirement of better regulatory perspective induced due to elevation in the number of adverse events associated with medical devices. All over the globe, various measures are undertaken to provide better safety to the patients along with attempts to improve the standard of medical devices. The initial and ultimate objective of the concept happens to be unfailingly to ensure patient safety as well as impart required guidance for both manufacturers and adept authorities enabling them to superintend cases coherently and appropriately. Materiovigilance programme of India (MvPI) was launched by the Drug Controller General of India at the Indian Pharmacopoeia commission (IPC) in Ghaziabad in 2015. The main purpose of this initiative is to monitor adverse events associated with medical devices in order to generate safety data, create awareness among the various stakeholders, and prescribe best practices for patient safety. Whilst the reforms in regulations have proposed policies and designs to elucidate, consolidate and accelerate the processes involved in manufacturing and importing medical devices to India, they consistently carry their challenges and limitations. To eliminate such complications the guidelines and regulations are anticipated to be implemented appropriately with the efficacious conclusion. India has been evident in matching with advancements in the World Medical Device regulation scenario, the current review at hand takes upon the question of ‘how successful has it been so far’?

Summary of Current Regulatory Perspective of Medical Devices

2020 ◽  
pp. 849-879
Author(s):  
Namdev More ◽  
Deepak Ranglani ◽  
Govinda Kapusetti ◽  
Rakesh K. Tekade
Keyword(s):  
Medical Devices ◽  
Regulatory Perspective

Pharmacists in State Government The Regulatory Perspective

1996 ◽  
Vol 9 (4) ◽  
pp. 276-280 ◽  
Author(s):  
Cynthia T. Culmo
Keyword(s):  
Substance Abuse ◽  
Dietary Supplements ◽  
State Government ◽  
Medical Devices ◽  
The State ◽  
State System ◽  
Department Of Health ◽  
Texas Department ◽  
Regulatory Perspective ◽  
Drug Scheduling

Responsibilities encountered as director of the Drugs and Medical Devices Division of the Texas Department of Health are discussed. The author explains how her twelve years of experience in the practice of pharmacy provided a limited background for the responsibilities of a career in state government. Specific challenges in the areas of drug scheduling, substance abuse programs and regulation of dietary supplements are described. Challenges to operating within the state system are detailed.

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.

Medical Devices Needed for Children

2005 ◽  
Author(s):  
Carol Rados ◽  
Keyword(s):  
Medical Devices

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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