Clinical Engineering Definitions

Clinical Engineer (CE)

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.”¹

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

Besides, the American College of Clinical Engineering (ACCE) defines a clinical engineer as “a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology”, and has delimited the clinical engineer role as the “engineering professional who focuses on healthcare technology planning, evaluation, management, analysis, education, support, and regulatory compliance”.²

However, it is important to remember that the responsibilities carried out by this role could vary between countries.

References

[1] World Health Organization. Human resources for medical devices [Internet]. WHO; 2024 [cited 2024 Apr 1]. Available from: https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/human-resources

[2] American College of Clinical Engineering. About ACCE: Clinical Engineer [Internet]. American College of Clinical Engineering; [cited 2024 Apr 1]. Available from: https://accenet.org/about/Pages/ClinicalEngineer.aspx

Efficacy & Effectiveness

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, when deployed in the field in routine circumstances, does what it is intended to do for a specified population.

References

World Health Organization. Health Systems Strengthening – Glossary [Internet]. Geneva: WHO; 2011 [cited 2024 Apr 1]. Available from: https://cdn.who.int/media/docs/default-source/documents/health-systems-strengthening-glossary.pdf

Efficiency

The capacity to produce the maximum output for a given input.

References

World Health Organization. Health Systems Strengthening – Glossary [Internet].

Geneva: WHO; 2011 [cited 2024 Apr 1]. Available from: https://cdn.who.int/media/docs/default-source/documents/health-systems-strengthening-glossary.pdf

Health Systems

All activities whose purpose is to promote, restore and/or maintain health
The people, institutions and resources, arranged together in accordance with established policies, to improve the health of the population they serve, while responding to people’s legitimate expectations and protecting them against the cost of ill-health through a variety of activities whose primary intent is to improve health.¹

The World Health Organization propose a framework to describe health systems in terms of six core components or “building blocks”: (i) service delivery, (ii) health workforce, (iii) health information systems, (iv) access to essential medicines, (v) financing, and (vi) leadership/governance. The six building blocks contribute to the strengthening of health systems in different ways.²

References

[1] World Health Organization. Global patient safety action plan 2021–2030: towards eliminating avoidable harm in health care [Internet]. Geneva: WHO; 2021 [cited 2024 Apr 1]. Available from: https://www.who.int/publications/i/item/9789240032705

[2] World Health Organization. Monitoring the building blocks of health systems: a handbook of indicators and their measurement strategies [Internet]. Geneva: WHO; 2010 [cited 2024 Apr 2]. Available from: https://iris.who.int/bitstream/handle/10665/258734/9789241564052-eng.pdf

Health Technology (HT)

As defined by the World Health Organization, HT is the 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.

A synonym frequently used for this term is health-care technology.

References

World Health Organization. Health products policy and standards – Medical devices [Internet]. WHO; 2024 [cited 2024 Apr 1]. Available from: https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices

Medical Device

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.

References

Medical Equipment

Used for the specific purposes of diagnosis and treatment of disease or rehabilitation following disease or injury; it can be used either alone or in combination with any accessory, consumable or other medical equipment. Medical equipment excludes implantable, disposable or single-use medical devices. Medical equipment is a capital asset and usually requires professional installation, calibration, maintenance, user training and decommissioning, which are activities usually managed by clinical engineers

References

WHO Medical device technical series. Human resources for medical devices, the role of biomedical engineers [Internet]. Geneva: World Health Organization; 2017 [cited 2024 Apr 1]. Available from: https://www.who.int/publications/i/item/9789241565479

Health Technology Management (HTM)

Health technology management comprises the domains of planning, needs assessment, selection, procurement, donations, inventory, installation and maintenance of medical equipment, training for safe use and finally decommissioning. Each of these domains encompasses a wide range of activities, including “providing technical advice, planning and costing work, monitoring contracts, supply chain, decommissioning and disposal, managing workshop facilities, managing staff, record-keeping, managing the inventory, stock control of parts, consumables, managing waste, and implementing safety protocols”.

Health technology management should be carried out on all levels of health care and ideally should be coordinated by a designated health technology management unit within the ministry of health that dictates policies on planning of medical equipment allocation, development of technical specifications for procurement purposes, application/ user training or other related elements. It should relate to other government agencies like the regulatory agency or the health technology assessment or similar units in the ministry of health.

References

WHO medical devices technical series. Global atlas of medical devices [Internet]. Geneva: World Health Organization; 2017 [cited 2024 Apr 1]. Available from: https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/global-atlas-of-medical-devices

Appropriate Health Technologies (AHT)

Methods, procedures, techniques and equipment that are scientifically valid, adapted to local needs and acceptable to those who use them and to those for whom they are used, and that can be maintained and utilized with resources the community or country can afford.

References

Andrews G, Faulkner D, Andrews M. A Glossary of Terms for Community Health Care and Services for Older Persons. Japan: World Health Organization; 2004 [cited 2024 Apr 2]. Available from: https://iris.who.int/bitstream/handle/10665/68896/WHO_WKC_Tech.Ser._04.2.pdf

Impact

The total, direct and indirect, effects of a programme, service, or institution on a health status and overall health and socio‐economic development.
Positive or negative, long‐term or medium‐term effects produced by a programme or intervention.
Degree of achievement of an ultimate health objective.

References

Innovation

Fill existing gaps in the availability of health technology (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.¹
World Health Organization (WHO) defines health innovation as a new or improved solution with the transformative ability to accelerate positive health impact. WHO’s Innovation Scaling Framework links three dimensions for innovation scaling: a) the health demands and priorities of countries, b) the supply of ready-to-scale innovations, and c) assessment throughout from incubating (through partners) to implementing and sustaining innovations.²

References

[1] David Y, Judd T. Evidence-based impact by clinical engineers on global patients outcomes. Health Technol (Berl). 2020; 10(2): 517–535. DOI: 10.1007/s12553-019-00345-0

[2] World Health Organization. Health innovation for impact [Internet]. Geneva: WHO; 2024 [cited 2024 Apr 3]. Available from: https://www.who.int/teams/digital-health-and-innovation/health-innovation-for-impact#:~:text=WHO%20defines%20health%20innovation%20as,to%20accelerate%20positive%20health%20impact.

Life Sciences & Digital Health

Life Sciences¹: All sciences that deal with living organisms, including humans, nonhuman animals, plants and agriculture, and the environment, or products of living organisms or that incorporate components derived directly or synthetically from living organisms; the life sciences include but are not limited to biology, biotechnology, genomics, proteomics, bioinformatics, pharmaceutical and biomedical research and technologies.

The term digital health is rooted in eHealth, which is defined as “the use of information and communications technology in support of health and health-related fields”. Mobile health (mHealth) is a subset of eHealth and is defined as “the use of mobile wireless technologies for health”. More recently, the term digital health was introduced as “a broad umbrella term encompassing eHealth (which includes mHealth), as well as emerging areas, such as the use of advanced computing sciences in ‘big data’, genomics and artificial intelligence”.²

Digital health³ is the field of knowledge and practice associated with the development and use of digital technologies to improve health. Digital health expands the concept of eHealth to include digital consumers, with a wider range of smart devices and connected equipment. The following areas are commonly understood as being part of, or related to, digital health: artificial intelligence, big data, blockchain, health data, health information systems, the infodemic, the Internet of Things, interoperability and telemedicine.

References

[1] World Health Organization. Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research [Internet]. Geneva: WHO; 2022 [cited 2024 Apr 1]. Available from: https://www.who.int/publications/i/item/9789240056107

[2] World Health Organization. WHO guideline: recommendations on digital interventions for health system strengthening [Internet]. Geneva: WHO; 2019 [cited 2024 Apr 3]. Available from: https://www.who.int/publications/i/item/9789241550505

[3] World Health Organization – Regional Office for Europe. Health topics – Digital Health [Internet]. Geneva: WHO; 2024 [cited 2024 Apr 3]. Available from: https://www.who.int/europe/health-topics/digital-health#tab=tab_1

Patient Safety

Patient safety is a framework of organized activities that creates cultures, processes, procedures, behaviors, technologies and environments in health care that consistently and sustainably lower risks, reduce the occurrence of avoidable harm, make error less likely and reduce impact of harm when it does occur.

References

World Health Organization. Global patient safety action plan 2021–2030: towards eliminating avoidable harm in health care [Internet]. Geneva: WHO; 2021 [cited 2024 Apr 1]. Available from: https://www.who.int/publications/i/item/9789240032705

Quality of care

A definition for quality of care accepted by the World Health Organization, is the one from the National Academy of Medicine, that defines quality of care as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. According with World Health Organization, quality of care features typically includes 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. 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.²

Quality improvement is the framework used to systematically improve care. Quality improvement seeks to standardize processes and structure to reduce variation, achieve predictable results, and improve outcomes for patients, healthcare systems, and organizations. Structure includes things like technology, culture, leadership, and physical capital; process includes knowledge capital (e.g., standard operating procedures) or human capital (e.g., education and training).³

References

[1] World Health Organization. Health topics – Quality of care [Internet]. WHO; 2024 [cited 2024 Apr 1]. Available from: https://www.who.int/health-topics/quality-of-care#tab=tab_1

[2] Donabedian A. The quality of care. How can it be assessed? JAMA. 1988 Sep; 260(12):1743-8. DOI: 10.1001/jama.260.12.1743

[3] Centers for Medicare & Medicaid Services. Quality Measurement and Quality Improvement [Internet]. CMS.gov; 2023 [cited 2024 Apr 1]. Available from: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Quality-Measure-and-Quality-Improvement-#:~:text=Quality%20is%20defined%20by%20the,used%20to%20systematically%20improve%20care.

Safety

Safety is the reduction of risk of unnecessary harm to an acceptable minimum. An acceptable minimum refers to the collective notions of given current knowledge, resources available and the context in which care was delivered weighed against the risk of non-treatment or other treatment.

References

World Health Organization. Conceptual Framework for the International Classification for Patient Safety – Final Technical Report [Internet]. Geneva: WHO; 2009 [cited 2024 Apr 1]. Available from: https://iris.who.int/bitstream/handle/10665/70882/WHO_IER_PSP_2010.2_eng.pdf?sequence=1