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HTA of MDs
Health Technology Assessment of Medical Devices


HTA is multi-disciplinary field of policy analysis that examines the medical, economic, social and ethical implications of the incremental value, diffusion and use of a health technology in health care.

The term Health Technology refers to application of organised knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life.



Library of Assessments on MDs (1999-2020)

50 Entries into category "other"

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WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices

The Model recommends guiding principles, harmonized definitions and specifies the attributes of effective and efficient regulation, to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF).

WHO technical specifications of neonatal resuscitation devices

The WHO technical specifications of Neonatal Resuscitation Devices was developed under the framework of the World Health Assembly Resolution WHA66.7, (5) which is at the foundation of the United Nations Commission on Life-Saving Commodities (UNCLSC) for Women and Children (Annex 10). The mandate of the UNCLSC is to promote and assure the availability of 13 safe, […]

Conceptual model for early health technology assessment of current and novel heart valve interventions

The future promises many technological advances in the field of heart valve interventions, like tissue-engineered heart valves (TEHV). Prior to introduction in clinical practice, it is essential to perform early health technology assessment. We aim to develop a conceptual model (CM) that can be used to investigate the performance and costs requirements for TEHV to become cost-effective.

Health Technology Implementation Roadmap in Central and Eastern European Countries

The opportunity cost of inappropriate health policy decisions is greater in Central and Eastern European (CEE) compared with Western European (WE) countries because of poorer population health and more limited healthcare resources. Application of health technology assessment (HTA) prior to healthcare financing decisions can improve the allocative efficiency of scarce resources. However, few CEE countries have a clear roadmap […]

Total hip replacement and surface replacement for the treatment of pain and disability resulting from end-stage arthritis of the hip (review of technology appraisal guidance 2 and 44): systematic review and economic evaluation

Total hip replacement (THR) involves the replacement of a damaged hip joint with an artificial hip prosthesis. Resurfacing arthroplasty (RS) involves replacement of the joint surface of the femoral head with a metal surface covering. The objective of this review was to undertake clinical effectiveness and cost-effectiveness analysis of different types of THR and RS for the treatment of pain […]

Interagency List of Medical Devices for Essential Interventions for Reproductive, Maternal, Newborn and Child Health

The objective of this project was to list the medical devices required to provide the essential reproductive, maternal, newborn and child health interventions defined by existing WHO guidelines and publications, in order to improve access to these devices in low- and middle-income countries, support quality of care, and strengthen health-care system. The medical devices are allocated […]

Systematic review of needs for medical devices for ageing populations

This report provides a literature-based review of medical devices needed by older people. The results have been used to create lists of devices categorized in terms of whether they are preventive, diagnostic or therapeutic. Broad clinical safety and effectiveness information has also been provided when available.

Mitral Valve Clip for Treatment of Mitral Regurgitation: An Evidence-Based Analysis

Many of the 500,000 North American patients with chronic mitral regurgitation may be poor candidates for mitral valve surgery. The objective of this study was to investigate the comparative effectiveness, harms, and cost-effectiveness of percutaneous mitral valve repair using mitral valve clips in candidates at prohibitive risk for surgery. Primary studies were sought from existing systematic reviews that […]

Harmonization of HTA-based reimbursement and regulatory activities

 ABSTRACT  Background  Regulatory approval and reimbursement are necessary to bring health technologies to market. As both are distinct processes, the lack of interaction between regulators and payers has been criticized for resulting in health system inefficiencies.  Objectives  This study describes the experiences of health system stakeholders on the development and implementation of initiatives to better harmonize […]

Colon Capsule Endoscopy for the Detection of Colorectal Polyps: An Evidence-Based Analysis

Colorectal cancer, a leading cause of mortality and morbidity in Ontario, can be prevented through early diagnosis and removal of precancerous polyps. Colon capsule endoscopy is a relatively new, minimally invasive test for detecting colorectal polyps.  The objectives of this analysis were to evaluate the diagnostic accuracy and safety of colon capsule endoscopy for the detection of […]