scholarly journals TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT

2015 ◽  
Vol 31 (5) ◽  
pp. 324-330 ◽  
Author(s):  
Cornelia Henschke ◽  
Dimitra Panteli ◽  
Matthias Perleth ◽  
Reinhard Busse
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Decision Makers ◽  
One Dimension ◽  
Specific Procedure ◽  
Policy Makers ◽  
Classification Schemes ◽  
Different Types ◽  
The Matrix ◽  
Device Classification

Objectives: The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices.Methods: Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model.Results: The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low.Conclusions: Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

scholarly journals Global trade and health: an Indonesian perspective on the asean medical device directive policy

2021 ◽  
Vol 37 (1) ◽  
pp. 1
Author(s):  
Nurul Hidayati ◽  
Dedy Almasdy ◽  
Abdi Setya Putra
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Free Trade Area ◽  
Policy Makers ◽  
Compulsory Licensing ◽  
Parallel Import ◽  
Trade Area ◽  
Strategic Issue ◽  
Asean Countries ◽  
Document Review

Purpose: Health care equipment international trade could serve a new strategic revenue for Indonesia. Since its implementation in 2015, AFTA has been a very strategic issue in creating export opportunities for its member countries. One of the sectors that becomes a priority for ASEAN integration is in the field of medical devices which is regulated in the ASEAN Medical Device Directive (AMDD) policy. Indonesia itself has officially ratified AMDD policy since 2018, but Indonesia will have been facing the problem of quality, innovation and diversification of medical devices. This study examines the competitiveness opportunities for domestic medical devices in ASEAN Free Trade Area. Method: This study used a qualitative method where information was obtained from in-depth interviews and document review. The informants came from policy makers, implementing officers, and stakeholders. Results: Indonesia has harmonized 26 out of 31 standards mandated by AMDD. Conformity assessment bodies in Indonesia that have been certified by the National Accreditation Committee have received international recognition. Indonesia has many potential exporting innovative medical devices to ASEAN countries. Fulfillment of medical devices is carried out through compulsory licensing and parallel import mechanism.

Equipment in anaesthesia

2017 ◽  
Author(s):  
Antony R. Wilkes
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Medical Devices ◽  
Healthcare Workers ◽  
Small Children ◽  
Management Procedures ◽  
Different Types ◽  
First Time ◽  
Work First ◽  
Subsequent Patient

The anaesthetist will routinely use many different types of medical devices during normal working practice, and will have access to many other devices for more challenging use in emergency and other difficult scenarios. The anaesthetist will expect and rely on each medical device to work first time and not to compromise the safety of the user, the patient, their relatives, or other healthcare workers in the vicinity. The equipment will also be expected to be effective, that is, that it will perform as expected when used in a defined population of patients (e.g. small children). Manufacturers and users of equipment use risk management procedures to reduce the risk to patients and others of using the equipment. Following use, the equipment will need to be reprocessed to make it safe for use for a subsequent patient, or disposed of safely.

scholarly journals Exploring the Usage Intentions of Wearable Medical Devices: A Demonstration Study

10.2196/19776 ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. e19776
Author(s):  
Chiao-Chen Chang
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Decision Makers ◽  
Unified Theory ◽  
User Adoption ◽  
Health Consciousness ◽  
Use Of Technology ◽  
The Face ◽  
Research Findings ◽  
Wearable Medical

Background In the face of an aging society, an immediate and preventive medical system urgently needs to be established, and the application of wearable devices is essential. However, the application of smart medical care in Taiwan is still not widespread, and few studies have explored the related issues of wearable medical device usage. Thus, determining the success of a wearable medical device mainly depends on the degree of user adoption and use. Objective The purpose of this study was to examine the factors that influence the intention to use wearable medical devices. Methods This study applied the unified theory of acceptance and use of technology (UTAUT) to build a comprehensive model that explains intentions to use wearable medical devices. Results The research findings showed that health consciousness and trust were the strongest predictors of intentions to use wearable medical devices. Conclusions The results reveal the magnitudes of the impacts of the variables in a well-accepted revised UTAUT model in the context of the medical industry, particularly in the setting of wearable medical devices. Several important implications for academics and industry decision-makers can be formulated from these results.

scholarly journals Exploring the Usage Intentions of Wearable Medical Devices: A Demonstration Study (Preprint)

2020 ◽  
Author(s):  
Chiao-Chen Chang
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Decision Makers ◽  
Unified Theory ◽  
User Adoption ◽  
Health Consciousness ◽  
Use Of Technology ◽  
The Face ◽  
Research Findings ◽  
Wearable Medical

BACKGROUND In the face of an aging society, an immediate and preventive medical system urgently needs to be established, and the application of wearable devices is essential. However, the application of smart medical care in Taiwan is still not widespread, and few studies have explored the related issues of wearable medical device usage. Thus, determining the success of a wearable medical device mainly depends on the degree of user adoption and use. OBJECTIVE The purpose of this study was to examine the factors that influence the intention to use wearable medical devices. METHODS This study applied the unified theory of acceptance and use of technology (UTAUT) to build a comprehensive model that explains intentions to use wearable medical devices. RESULTS The research findings showed that health consciousness and trust were the strongest predictors of intentions to use wearable medical devices. CONCLUSIONS The results reveal the magnitudes of the impacts of the variables in a well-accepted revised UTAUT model in the context of the medical industry, particularly in the setting of wearable medical devices. Several important implications for academics and industry decision-makers can be formulated from these results.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

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