Health technology assessment of medical devices

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1 IntroductionHealth systems throughout the world,whether in developed or developingcountries, are struggling with the challengeof how to manage health-care delivery inconditions of resource constraint. Healthcarepolicy, practice and decisions areneeded to maximize the positive impactof health-care interventions on populationhealth, while maximizing the value fromthe cost of providing the interventions.This document explores how healthtechnology assessment can be adoptedand adapted in developing and emergingcountries in an attempt to foster healthequity.2 PurposeHealth technology assessment of medicaldevices provides a background to theconcept and programme of healthtechnology assessment (HTA) aroundthe world, and highlights the contributionthat HTA can make to informed policyanddecision-making, particularly fordeveloping and emerging countries. Itaims to describe strategic actions foradvancing HTA into developing andemerging countries, and to support informeddecision-making on the introductionof HTA into the health systems of thesecountries.This document was commissioned byWHO for the advancement of health technologyassessment in developing andemerging countries.3 ApproachThis document builds on the work of theWHO Department of Essential HealthTechnologies, the Global Initiative onHealth Technologies (GIHT), the GlobalNetwork of WHO Collaborating Centres forHealth Technology Assessment, HealthTechnology Assessment international(HTAi), the International Networkof Agencies for Health TechnologyAssessment (INAHTA), and otherscommitted to the use of high-qualityevidence to inform health-care policy anddecision-making. The authors have basedtheir work on a personal knowledge of theinternational literature on the conceptsand practice of health technologyassessment (HTA) as well as on theavailable literature and past experiencesof introducing HTA into developing andemerging countries. Consultations withkey groups and international experts inHTA have contributed to the text.10Health technology assessment of medical devices
4 Definition of health technology assessmentThe paradigm of HTA emerged as aresponse to decision-makers’ questionsabout the uncontrolled diffusion of costlymedical equipment. HTA began in theearly 1970s, when the rapid demandfor computer-assisted tomography (CTscans)became a public policy issue dueto the very high cost per unit, often inexcess of US$ 300 000 (3).In February 1975 the US SenateCommittee on Labor and Public Welfare(on behalf of its Subcommittee on Health)invited the recently established Officeof Technology Assessment to conducta study of the justifications requiredbefore the implementation of costly newmedical technologies and procedures.The concepts of health technologies andHTA have developed very broadly since.A health technology is “any interventionthat may be used to promote health, toprevent, diagnose or treat disease or forrehabilitation or long-term care” (4). It thusencompasses medical devices rangingfrom simple wooden tongue depressorsand assistive devices, to the mostsophisticated implants, medical imagingsystems, drugs, medical and surgicalprocedures, and the organizational andsupportive systems within which suchcare is provided.HTA is “the systematic evaluation ofproperties, effects, and/or impacts ofhealth-care technology. It may addressthe direct, intended consequences oftechnologies as well as their indirect,unintended consequences. Its mainpurpose is to inform technology-relatedpolicy-making in health care. HTA isconducted by interdisciplinary groupsusing explicit analytical frameworksdrawing from a variety of methods”(4).Depending on the issues involved, thetime frame of decision-making, and theavailability of resources, HTAs can takedifferent forms such as a full-scale HTAreport, contextualization of HTA reportsproduced elsewhere, rapid reviews,health technology information services orhorizon scanning reports. HTA is alwayspolicy-oriented, context-embedded andmethodologically sound (5).As outlined in a document from theOrganisation for Economic Co-operationand Development (6), countries cansuccessfully manage the opportunitiesand challenges arising from healthrelatedtechnology by optimizing decisionmakingprocesses, recognizing the valueof innovation, dealing with uncertainty,and producing and coordinating HTA.WHO Medical device technical series11
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Health technology assessment of medical devices

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