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T Judd et al.: Clinical Engineering/Health Technology Management 2015 Global Update


              personnel involved in health technology assess-   the medical, social, economic and ethical issues related
              ment (HTA) and biomedical engineering” (BME);     to the use of a health technology in a systematic, trans-

           3.  “to draw up national or regional guidelines for   parent, unbiased, robust manner. Its aim is to inform
              good manufacturing and regulatory practices, to   the formulation of safe, effective, health policies that are
              establish surveillance systems and other measures   patient focused and seek to achieve best value. Despite
              to ensure the quality, (risk,) safety and efficacy   its policy goals, HTA must always be firmly rooted in
              of devices and where appropriate participate in   research and the scientific method. 5–7  HTA provides the
              international harmonization” (HTR, Risk & Safety   foundation for successful planning and subsequent use
              or R&S);                                          of health technologies.

           4.  “to establish where necessary national and regional
              institutions of health technology, and to collaborate         HTM GAPS AND PROGRESS
              and build partnerships with health care providers,                                     1
                                                                   Earlier HTM Study: Our prior article  described prog-
              industry, patients’ associations and professional,   ress in HTM in 51 countries, including Africa (11 countries)
              scientific and technical organizations;” (e.g., MOH   Asia (11 countries), Latin America & the Caribbean (19

              HT units); and
           5.  “to collect information that interrelates medical devices   countries), and other (10 countries). In that article, the
              which deal with priority public health conditions at   following gaps in HTM were identified:
              different levels of care and in various settings and   •  A lack of competent staff (Human Resource develop-
              environments, with the required infrastructure, pro-   ment - HR)
              cedures and reference tools;” (to improve Maternal   •  Limited access to technical documentation & spare
              Child Health (MCH), such as HT improving MCH           parts (HTM)
              care outcomes).
                                                                   •  Poor planning and lack of commitment (HTM)
           To illustrate these points, we include a figure from our   •  Irrational HT incorporation and deployment (HTM)
        previous article, which is a graphical representation of
                                                                   •  Limited influence with decision makers (e.g., <10
        the main elements of Health Technology Management,
                                                                     countries then had designated Ministry of Health,
        and how it relates to other areas of the health system
                                                                     Health Technology-HT Units)
        (see Figure 1).
                                                                   •  Donations provided that do not align with Ministry
           As a capital investment, equipment needs to be man-       of Health (MOH) priorities
        aged from deployment (strategic planning, acquisition,
                                                                   In addition, the article identified the following root
        installation / acceptance) until retirement, guided by a
                                                                causes of HTM challenges:
        country’s health technology policy (HTP).
                                                                   •  Lack of: training to develop human resources-HR;
           During its useful life, proper maintenance and manage-
                                                                     experience; awareness; and influence with decision
        ment are essential to ensure safe, efficient, and cost-effective
                                                                     makers regarding HTM
        patient care. Often neglected, feedback provided by users
        and maintainers is essential to continually improve HTM    •  Equipment is often considered a status symbol in-
        within the country or system, and avoid mistakes made        stead of a service production tool
        previously.                                                •  Greed and short-sightedness of manufacturers and
           HTM is intimately related to but distinct from health     distributors

        technology regulation (HTR, and Risk & Safety), as the     •  Selfishness of some “aid,” “cooperation,” and “do-
        latter is focused on safety and efficacy, with little concern   nation” programs that are actual sales-promoting
        on costs and management challenges.                          schemes or publicity stunts
           Health Technology Assessment (HTA) is a multidis-       •  Lack of vision and courage among HTM professionals
        ciplinary process that summarizes information about






        J Global Clinical Engineering Special Issue 1: 4-14; 2018                                               6
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