CE & HTM Definitions

The World Health Organization (WHO) noted in 2018 that it is critical that “trained and qualified medical engineering professionals are required to design, evaluate, regulate, maintain and manage medical devices, and train on their safe use in health systems around the world. This role is referred to as clinical engineering (CE), biomedical engineering (BE), and/or health-care technology management (HTM) dependent on regional terminology.”

WHO often uses the term 'Biomedical Engineer' as one who practices Clinical Engineering.

Efficacy: The extent to which a specific intervention, procedure, regimen or service, produces the intended result under ideal conditions. Effectiveness: The extent to which a specific intervention, procedure, regimen or service, deployed in the field in routine circumstances, does what it is intended for a specified population. (WHO 2011, Glossary, http://www.who.int/healthsystems/Glossary_January2011.pdf)

The capacity to produce the maximum output for a given input. (WHO 2011, Glossary, ibid)

(i) All activities whose purpose is to promote, restore and/or maintain health; (ii) people, institutions, resources, arranged with established policies, to improve the health of the population served, meeting legitimate expectations, and protecting against cost of ill‐health through activities whose primary intent is to improve health. (WHO 2011, Glossary, ibid)

Application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives. (WHO 2007, www.who.int/medical_devices/resolution_wha60_29-en1.pdf).

An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological, or metabolic means. (http://www.who.int/medical_devices/definitions/en/)

To ensure access to appropriate medical devices, proper management and use of medical equipment over its life cycle must be considered, beginning with understanding the needs of the country, region, community, or facility and ending with decommissioning. In between, the process consists of good procurement practices, appropriate donation solicitation and provision, logistics of delivery and installation, inventory management, maintenance, safe use and training, and measurement of clinical effectiveness. HTM is conducted alongside HT assessment (HTA) and HT regulatory and performance compliance. (WHO 2016, www.who.int/medical_devices/management_use/en/)

Methods, procedures, techniques & equipment are: (i) scientifically valid; (ii) adapted to local needs; (iii) acceptable to users & recipients; & (iv) maintainable with local resources. (WHO, 1989 www.cugh.org/sites/default/files/9_Appropriate_Health_Technologies_Concepts_Criteria_And_Uses_FINAL.pdf)

(i) The total, direct and indirect, effects of a program, service, or institution on health status and overall health and socio‐economic development. (ii) Positive or negative, long‐term or medium‐term effects produced by a program or intervention. (iii) Degree of achievement of an ultimate health objective. (WHO 2011, Glossary, ibid)

Serves to fill existing gaps in the availability of HT to vulnerable populations through provision of new solutions to health problems, the adaptation of an existing HT to a particular setting or for a new use, and the combination of HT to address several health issues at once. (WHO 2016, http://www.who.int/medical_devices/innovation/en/)

Life Sciences1 research and biotechnology, includes genetic engineering, synthetic biology, genomics and proteomics leading to specific, personalized biologics and care. (1WHO 2016: http://www.who.int/csr/bioriskreduction/lifescience_project/en/). Digital Health2: care where you are, enabling efficiency, convenience, and continuous patient engagement. Convergence of capabilities that empower consumers to manage their health on their terms, further defining the patient-caregiver relationship, in all settings of care. (2WHO 2015: IFMBE CED Global CE Profile of Biomedical Engineering prepared for WHO’s December 2015 presentation to the International Labour Organization http://www.ilo.org/)

Care delivery structure, processes, and outcomes meeting established norms through ongoing measurement; quality of care features typically include effectiveness, safety, patient‐centeredness, comprehensiveness, continuity, integration.1 Quality of care given by a health professional can be judged by its outcome, the technical performance of the care, and by interpersonal relationships.2 Care quality avoids underuse, misuse, and overuse; service quality is measured by the satisfaction with experience of patients and their family members with their care.3 (1WHO 2011, Glossary, ibid; 2Donabedian 1988 http://post.queensu.ca/~hh11/assets/applets/The_Quality_of_Care__How_Can_it_Be_Assessed_-_Donabedian.pdf. 3NCQA 2006 The Essential Guide to Healthcare Quality www.ncqa.org/portals/0/publications/resource%20library/ncqa_primer_web.pdf)

The reduction of risk of unnecessary harm associated with health care to an acceptable minimum1. And medical device quality and safety regulations.2 (1WHO-ICPS 2009 www.who.int/patientsafety/implementation/taxonomy/icps_technical_report_en.pdf) 2WHO 2016 www.who.int/medical_devices/safety/en)

Technology total life cycle impact can be measured using indicators such as improvements in population health outcomes, health services access, cost per procedure or patient-day, and change in the volume of adverse events. Appropriate life cycle HTM translates to improvement in these indicators and, significantly, in the ability of a health system to provide a high quality and efficient basket of health services. (Dr. Yadin David 2016)

WHO is developing CE-HTM Indicators to measure the progress of their 194 Member States in growing their Clinical Engineering capability.