scholarly journals ANALYSIS ON THE HALAL STATUS OF A MEDICAL DEVICE: A STUDY ON THE SURGICAL SUTURE

2021 ◽  
Vol 1 (1) ◽  
pp. 01-07
Author(s):  
Nur Farhani Zarmani ◽  
Mohd Anuar Ramli ◽  
Shaikh Mohd Saifuddeen Shaikh Mohd Salleh ◽  
Mohd Zaid Daud ◽  
Mohd Amzari Tumiran
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Field Studies ◽  
The Body ◽  
Healthcare Sector ◽  
Medical Practitioners ◽  
Library Research ◽  
Surgical Suture ◽  
The Status ◽  
Depth Interviews

There is a recent demand for halal certification from another healthcare sector which is medical devices, which cover all types of medical equipment used in hospitals from simple equipment such as bandages to complex equipment such as ventilators. This matter has been raised by the industry as halal labelling is a requirement to penetrate the market of Islamic countries such as Saudi Arabia, Turkey, and Pakistan. Even it seems critical to proving halal status for the medical devices that incorporate animal tissues, in contact with or invasive to the body, and produce a reaction to the body, this does not deny the demand for other types of devices. This study will focus on the halal issues related to medical devices which are widely used to stitch and close the wounds of patients after surgery or injury, namely sutures. This study seeks to identify the status of suture usage from the perspective of Islamic ruling. To achieve this objective, a qualitative research method through library research, as well as field studies involving in-depth interviews with the industry players, both medical device and religious authorities, Islamic scholars, and medical practitioners. The interviews were recorded, transcribed, translated, coded, and reconciled with the aid of Atlas.ti software (version 7) to identify themes and subthemes for this study. The results show that with regard to the status of resources and processes, and the application of al-darurah (necessity) concept.

A Platform and Multi-sided Market for Translational, Software-defined Medical Research in the Operation Room: OP 4.1 (Preprint)

2021 ◽  
Author(s):  
Magdalena Görtz ◽  
Michael Byczkowski ◽  
Mathias Rath ◽  
Viktoria Schütz ◽  
Philipp Reimold ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Heterogeneous Data ◽  
Healthcare Sector ◽  
Successful Development ◽  
Software Developers ◽  
Intelligent Support ◽  
Operation Room ◽  
Central Platform ◽  
Medical Device Manufacturers

BACKGROUND While digital and data-based technologies are widespread in various industries in the context of Industry 4.0, the use of smart, connected devices in healthcare is still in its beginnings. Innovative solutions for the medical environment suffer from difficult access to medical device data and high barriers for market entry due to proprietary systems. OBJECTIVE In the proof-of-concept project OP 4.1, we show the business viability of connecting and augmenting medical devices and data through software add-ons by giving companies a technical and commercial platform for the development, implementation, distribution, and billing of innovative software solutions. METHODS The creation of a central platform prototype requires the collaboration of several independent market contenders, amongst them medical users, software developers, medical device manufacturers, and platform providers. A dedicated consortium of clinical and scientific partners as well as industry partners was established. RESULTS We demonstrate the successful development of the prototype of a user-centric, open, and extensible platform for the intelligent support of processes starting with the operation room. By connecting heterogeneous data sources and medical devices from different manufacturers and making them accessible for software developers and medical users, the cloud-based platform OP 4.1 enables the augmentation of medical devices and procedures through software-based solutions. The platform also allows for the demand-oriented billing of applications and medical devices, thus permitting software-based solutions to fast-track their economic development and become commercially successful. CONCLUSIONS The technology and business platform OP 4.1 creates a multi-sided market for the successful development, implementation, distribution, and billing of new software solutions in the operation room and in the healthcare sector in general. Consequently, software-based medical innovation can be translated into clinical routine fast, efficiently, and cost-effectively, optimizing the treatment of patients through smartly assisted procedures.

Software-as-a-Medical Device: demystifying Connected Health regulations

2016 ◽  
Vol 18 (2) ◽  
pp. 186-215 ◽  
Author(s):  
Noel Carroll ◽  
Ita Richardson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Healthcare Service ◽  
Healthcare Sector ◽  
Future Research ◽  
Extensive Literature ◽  
Comprehensive Overview ◽  
Content Type ◽  
Connected Health ◽  
The Impact

Purpose Connected Health is an emerging and rapidly developing field never before witnessed across the healthcare sector. It has the potential to transform healthcare service systems by increasing its safety, quality and overall efficiency. However, as healthcare technologies or medical devices continuously rely more on software development, one of the core challenges is examining how Connected Health is regulated – often impacting Connected Health innovation. The purpose of this paper is to present an understanding of how Connected Health is regulated. Many of these regulatory developments fall under “medical devices”, giving rise to Software-as-a-Medical Device (SaaMD). Design/methodology/approach Through an extensive literature review, this paper demystifies Connected Health regulation. It presents the outcome of expert discussions which explore the key regulatory developments in the context of Connected Health to provide a practical guide to understanding how regulation can potentially shape healthcare innovation. Findings Several key issues are identified, and the authors present a comprehensive overview of regulatory developments relating to Connected Health with a view to support the continued growth of IT-enabled healthcare service models. The authors also identify the key challenges in Connected Health and identify areas for future research. Originality/value A key outcome of this research is a clearer understanding of the opportunities and challenges that regulation and standards present to Connected Health. Furthermore, this research is of critical importance in a first attempt towards recognising the impact of regulation and standards compliance in Connected Health.

scholarly journals Biocompatibility of Medical Devices - A Review

2021 ◽  
Vol 10 (36) ◽  
pp. 3152-3158
Author(s):  
Ramya Shree Gangadhar ◽  
Balamuralidhara V ◽  
Rajeshwari S.R.
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Human Body ◽  
The Body ◽  
Biological Responses ◽  
Medical Device Manufacturers ◽  
Biocompatibility Testing ◽  
Biological Environment ◽  
Key Words Biocompatibility

BACKGROUND Biomaterial is defined as "any substance or combination of medicine, artificial or natural origin, which can be used at any time, in whole or part by a system that controls, adds to, or restores any tissue, organ or function". ISO 10993-1: 2018 standard defines bio compliance law as "the ability of a medical device or tool to perform a selected program with the acceptable response of experts". Incompatible factors cause chemical reactions in patients, with little or no side effects. The body can respond in a sort of way after the installation of medical devices, so testing and improvement is important here. Therefore, testing and improvement in this field are important. Biocompatibility is required for any significant use of components or materials in medical devices. Inconsistent factors create negative biological responses in patients, which may have serious consequences. Biomaterials are substances utilized in medical devices, especially in applications where the device is touched, temporarily embedded, or permanently implanted within the body. Because of the significant impact of biocompatibility, many countries have imposed regulations on medical device manufacturers to meet biocompatibility specifications. Here is a brief explanation about the biocompatibility and incompatibility parameters of medical devices with a human body and its need for biocompatibility of medical devices with the human body. Medical devices have improved doctors' ability to diagnose and treat disease, which has led to significant improvements in health and quality of life. Thus, medical devices are prone to various incompatibility issues and procedures that affect the biological environment must be followed. KEY WORDS Biocompatibility, Material Interactions, Sterilization, Medical devices, Biocompatibility Testing, Incompatibility Factors.

Regulation of Medical Devices and their Clinical Trials Studies in the USA: An Update

2020 ◽  
Vol 13 (2) ◽  
pp. 94-109
Author(s):  
Manita ◽  
Aakash Deep ◽  
Vikram ◽  
A.C. Rana ◽  
Monu Yadav ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Studies ◽  
Healthcare Sector ◽  
Regulatory Body ◽  
Class Iii ◽  
General Control ◽  
Dental Floss ◽  
The Usa

Background: Need for Medical devices is very important in the healthcare sector and related processes for global regulation. Medical devices are the apparatus or instruments which are specifically used for diagnostics and therapeutic applications. In the USA, a regulatory body known as FDA (Food and Drug Administration) has its unit called CDRH which looks the manufacture, packaging and use of medical devices in the USA. Objective: In USA, Medical devices are classified into 3 classes: class I which look for the medical devices used for the general control as dental floss and bandages, etc., class II which regulate the medical devices used for the general control as well as special control as powered wheelchairs and pregnancy kits. Class III medical devices look the general control. PMA (Premarket Approval) and Premarket Notification application has been filed to FDA for seeking the market authorization of medical devices. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. These trials are performed on various age groups such as on paediatrics, adult and old age group commonly called phase 1,2,3,4. Regulatory approval of high-risk medical device is based on clinical studies submitted with pre-market approval. The main objective of this article is to make the researcher aware of the regulation and clinical trials of medical devices in the USA. Conclusion: Every medical device should comply with FDA, QMS and QSR for marketing in the USA. The present article has focused on the regulation of medical devices, clinical trial phases and clinical studies on medical devices.

Retractable Anti-Buckling Support Systems for Flexible Medical Devices

2018 ◽  
Author(s):  
Brandon S. Sargent ◽  
Spencer P. Magleby ◽  
Brian D. Jensen ◽  
Larry L. Howell
Keyword(s):  
Medical Device ◽  
Support System ◽  
Medical Devices ◽  
Support Systems ◽  
The Body ◽  
Lateral Stiffness ◽  
Flexible Device

This work presents two novel support systems used to help mitigate flexible device buckling during insertion such as the insertion of medical device into the body. These systems are collapsible to accommodate the changing length of the flexible device as it is inserted. They use tension in wires or geometry to provide systems with lateral stiffness used to support the device. Through modeling, the performance of these systems can be predicted and they can be designed to a desired performance. This was validated in the geometry-based support system. They provide systems with small operating volumes and part counts.

scholarly journals Challenges for the Implantation of Symbiotic Nanostructured Medical Devices

2020 ◽  
Vol 10 (8) ◽  
pp. 2923 ◽  
Author(s):  
Jean-Pierre Alcaraz ◽  
Gauthier Menassol ◽  
Géraldine Penven ◽  
Jacques Thélu ◽  
Sarra El Ichi ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
The Body ◽  
Biofuel Cells ◽  
Implantable Medical Devices ◽  
Enzymatic Biofuel Cells ◽  
Starting Point ◽  
Implanted Medical Devices ◽  
Biomimetic Approach ◽  
Implanted Device

We discuss the perspectives of designing implantable medical devices that have the criterion of being symbiotic. Our starting point was whether the implanted device is intended to have any two-way (“duplex”) communication of energy or materials with the body. Such duplex communication extends the existing concepts of a biomaterial and biocompatibility to include the notion that it is important to consider the intended functional use of the implanted medical device. This demands a biomimetic approach to design functional symbiotic implantable medical devices that can be more efficient in mimicking what is happening at the molecular and cellular levels to create stable interfaces that allow for the unfettered exchanges of molecules between an implanted device and a body. Such a duplex level of communication is considered to be a necessary characteristic of symbiotic implanted medical devices that are designed to function for long periods of time inside the body to restore and assist the function of the body. We illustrate these perspectives with experience gained from implanting functional enzymatic biofuel cells.

scholarly journals Technology, Productivity, and Costs in Healthcare

2018 ◽  
Author(s):  
Albert A. Okunade ◽  
Ahmad Reshad Osmani
Keyword(s):  
Information And Communication Technologies ◽  
Healthcare Cost ◽  
Medical Devices ◽  
Technological Progress ◽  
Healthcare Systems ◽  
The Body ◽  
Healthcare Sector ◽  
Lower Productivity ◽  
The World ◽  
The Government

Healthcare cost encompasses expenditures on the totality of scarce resources (implicit and explicit) given up (or allocated) to produce healthcare goods (e.g., drugs and medical devices) and services (e.g., hospital care and physician office services are major components). Healthcare cost accounting components (sources and uses of funds) tend to differ but can be similar enough across most of the world countries. The healthcare cost concept usually differs for consumers, politicians and health policy decision-makers, health insurers, employers, and the government. All else given, inefficient healthcare production implies higher economic cost and lower productivity of the resources deployed in the process. Healthcare productivity varies across health systems of the world countries, the production technologies used, regulatory instruments, and institutional settings. Healthcare production often involves some specific (e.g., drugs and medical devices, information and communication technologies) or general technology for diagnosing, treating, or curing diseases in order to improve or restore human health conditions. In the last half century, the different healthcare systems of the world countries have undergone fundamental transformations in the structural designs, institutional regulations, and socio-economic and demographic dimensions. The nations have allocated a rising share of total economic resources or incomes (i.e., Gross National Product, or GDP) to the healthcare sector and are consequently enjoying substantial increases in population health status and life expectancies. There are complex and interacting linkages among escalating healthcare costs, longer life expectancies, technological progress (or “the march of science”), and sectoral productivities in the health services sectors of the advanced economies. Healthcare policy debates often concentrate on cost-containment strategies and search for improved efficient resource allocation and equitable distribution of the sector’s outputs. Consequently, this contribution is a broad review of the body of literature on technological progress, productivity, and cost: three important dimensions of the evolving modern healthcare systems. It provides a logical integration of three strands of work linking healthcare cost to technology and research evidence on sectoral productivity measurements. Finally, some important aspects of the existing study limitations are noted to motivate new research directions for future investigations to explore in the growing health sector economies.

scholarly journals EFEKTIVITAS PENGELOLAAN ALOKASI DANA DESA DALAM PEMBANGUNAN FISIK DI DESA BATUJAJAR TIMUR KABUPATEN BANDUNG BARAT

2019 ◽  
Vol 3 (1) ◽  
pp. 45-69
Author(s):  
Dzenta Mashita ◽  
Yamardi Yamardi ◽  
Toto Kushartono
Keyword(s):  
Field Studies ◽  
Physical Development ◽  
Research Field ◽  
Qualitative Approach ◽  
Government Regulations ◽  
Fund Allocation ◽  
Descriptive Research ◽  
Library Research ◽  
The Village ◽  
Depth Interviews

The problems that occur in Batujajar Timur Village are the mismatch of village fund allocations received according to the realization, the delay in disbursing village fund allocations, the uneven physical development in Batujajar Timur Village. The management of village fund allocations cannot be said to be effective, if it is reviewed correctly, quickly, economically, and safely. This study uses a descriptive research method with a qualitative approach. The data obtained through the results of library research, field studies through in-depth interviews and observations, and documentation. The results showed that the management of Village Fund Allocation in Physical Development in Batujajar Timur Village, Batujajar Subdistrict, West Bandung Regency, cannot be said to be effective, due to the lack of community participation in musrenbangdes, the village fund allocation received is not by government regulations which in theory were obtained in January. and it was reported in December, the facilities for infrastructure funds were not yet supported, the allocation of village funds obtained did not match the realization. Keywords: Effectiveness, Management, Village Fund Allocation, Development

scholarly journals “Made in India”: How’s that for an indigenous medical device?

2013 ◽  
Vol 02 (02) ◽  
pp. 151-153 ◽  
Author(s):  
Ganne Umamaheswara Rao
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Developmental Process ◽  
Medical Profession ◽  
Medical Practitioners ◽  
Device Development ◽  
Regulatory Processes ◽  
Skilled Manpower ◽  
Good Standard ◽  
Made In

Abstract With increasing costs of imported equipment, there is a need for Indigenization of medical devices in India. The resources including skilled manpower to develop equipment of a good standard are available in the country. What plagues the developmental process is the lack of adequate interaction between the medical profession and the technologists and reluctance of the industry to venture into the medical device manufacturing. A much bigger and more serious road-block is the lack of formal certification and regulatory processes for these devices. Medical practitioners should be open to evaluating and accepting indigenous equipment that pass the requisite standards. Formal mechanisms should be developed to orient both physicians and engineers to the technical and commercial issues of device development.

Regulation and Clinical Investigation of Medical Device in the European Union

2019 ◽  
Vol 6 (3) ◽  
pp. 163-181
Author(s):  
Manita ◽  
Aakash Deep ◽  
Vikram ◽  
Avtar C. Rana ◽  
Prabodh C. Sharma
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Investigation ◽  
Controlled Trial ◽  
Healthcare Sector ◽  
World Population ◽  
The European Union

Background:: Medical devices are the machine, tool, instrument, apparatus, implant, calibrator in vitro, software, the similar or related object intended for use by the manufacturer alone or in combination becoming increasingly important in the healthcare sector as these are used to diagnosis, control, prevention or treatment of an illness. Safety of the world population is the highest priority in order to launch new medical devices for the treatment and diagnostic of several diseases. New innovation in industries and regulations work together to provide devices for different world market and to improve quality and safety of exiting devices in the market. The main key for devices is to classify the determination of actual regulatory pathway which ensures the safety standards and other regulatory requirements in a specific country. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. For any high-risk devices, the new EU law states that the manufacturer has to prepare a complete summary for their evidence. The clinical trials regulation provides more transparency on clinical trials data. Complete transparency is required for the maximum possibility of informed decisions in order to use new medical devices. Objective:: The current manuscript will provide the information regarding the regulatory framework for the approval of medical devices and clinical investigation of medical device in European Union and comparison of approval process of medical device in USA, EU and India. The aim of this paper is to provide an overview of the most suitable and emerging requirements that manufacturers need for introducing their medical devices in the market in compliance with the MDR regulations. Conclusion:: The proposal for a modified regulation of medical devices aims to ensure more robust clinical data in support of the CE marking applications of the medical device. The clinical investigation requirements will be mandatory, and there will be an obligation to demonstrate the clinical benefits of the device and provide a rigorous equivalence test if the assessment is based on comparison devices. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.

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