2. PAGE 1
Global Clinical Engineering Summit
Success Story Resource
Global CE Advisory Board, Dr. Yadin David, Chair, May 1, 2016
Situation
Health Technology (HT) is vital to global healthcare. The dependence of health, rehabilitation, and wellnessprograms
on technologyforthe deliveryof theirserviceshasneverbeengreater. Itisthereforeessentialthathealthtechnologybe
managed in the most optimal way, to better contribute to the response to the burden of disease, to utilize digital care
delivery tools, and to confront reemerging and new epidemics like Ebola and Zika.
“The Sixtieth World Health Assembly: recognizingthat health technologies (HT) equip health-careproviders with tools that
are indispensable for effective and efficient prevention, diagnosis, treatment and rehabilitation and attainment of
internationally agreed health-related development goals,includingthosecontained in the MillenniumDeclaration;… noting
the need to expand expertise in the field of HT in particular medical devices; … urges Member States to formulate as
appropriate national strategies and plans for the establishment of systems for the assessment, planning, procurement and
management of health technologies.” (WHO 2007 www.who.int/medical_devices/resolution_wha60_29-en1.pdf)
This global collaborative initiative of the International Federation of Medical and Biological Engineering – Clinical
Engineering Division (IFMBE – CED, see http://cedglobal.org/) has compiled over 150 success stories from 90 countries
demonstratinghowHThasimprovedkeyhealth care processesandoutcomessince 2007. CED andWHO have partnered
in this work for nearly 40 years, leading up to the 2007 Resolution, but have accelerated efforts in the past ten years.
This resource will be presented to the World Health Organization World Health Assembly in May 2016, demonstrating
progress over the past10 years,and seekingdevelopingcountry Ministries of Health endorsement, recognition,and adoption
of these global health technologies’ best practices and methodologies presented in the success stories.
Background
At the 1st
International ClinicalEngineeringandHealthTechnologyManagementCongress andSummitheldatHangzhou,
China in October 2015 (www.icehtmc.com), a resolution was adopted by the global Clinical Engineering (CE) country
participants present to identify and promote the unique qualifications of clinical engineers, and to record the many
contributions of these professionals to the improvement of world health and wellness status.
Followingthis meeting, an action plan was adopted (http://global.icehtmc.com) thatled to establishinga group of experts from
every global region for this Global Clinical Engineering initiative (http://global.icehtmc.com/aboutus/aboutus_letter). The group
has collected successstories thatexemplify theoutcomes achieved due to the interventions of members of the CE profession.
In the short period of time, between February and April 2016, members of the Global CE Initiative reached out to
colleagues on each continent. As a result, over 150 submissions were collected from 90 countries, grouped in six
categories of impact. Each category consists of over 10 success stories with health related statistics from the specific
region,size of populationinvolved,prominenthealthsystem,anddetailsaboutthe successstory. The HT successstory
categories include the following; see glossary for definitions:
Innovation
Through provision of new HT solutions,adaptation of existing,or a combination to address several issues.
ImprovedAccess
Ease in reachingHT-related health services or facilitiesin terms of location,time, and ease of approach.
Health Systems
Positiveimpactfrom more efficient and effective deployment of HT at national or policy level.
Healthcare TechnologyManagement(HTM)
Establishingor improvingHTM methodology resultingin improved population health or wellness.
Safety & Quality
HT’s positiveimpacton health services safety or quality outcomes, or through HT human resourcedevelopment.
e-Technology
Improvements achieved due to deployment of internet-based health technology tools.
3. PAGE 2
Glossary
Clinical Engineer (CE)
A professional who is qualifiedbyeducationand/or registrationto practice engineering in the health care environment where technology
is created, deployed, taught, regulated, managed or maintained related to health services. Other related terms used for the CE role in
developing countries includes biomedical engineer, andrehabilitation engineer. (Clinical Engineering Global Summit 2015, http://global.icehtmc.com/)
Efficacy & Effectiveness
Efficacy:The extent to whicha specific intervention, procedure, regimenor service, produces the intendedresult 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 intendedfor a specified population. (WHO 2011, Glossary, http://www.who.int/healthsystems/Glossary_January2011.pdf)
Efficiency
The capacity to produce the maximum output for a given input. (WHO 2011, Glossary, ibid)
Health systems
(i) All activities whose purpose is to promote, restore and/or maintain health;(ii) people, institutions, resources, arranged withestablished
policies, to improve the health ofthe populationserved, meetinglegitimate expectations, andprotecting against cost of ill‐health through
activities whose primary intent is to improve health. (WHO 2011, Glossary, ibid)
Health technology (HT)
Application of organized knowledge andskills 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).
Medical device
An article, instrument, apparatus or machine that is usedinthe prevention, diagnosis or treatment of illnessor 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 achievedbypharmacological, immunological, or metabolic means. (http://www.who.int/medical_devices/definitions/en/)
HT management (HTM)
To ensure access toappropriate medicaldevices, proper management and use ofmedical equipment over its life cycle must be considered,
beginning withunderstandingthe needs of the country, region, community, or facilityand ending withdecommissioning. 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/)
Appropriate health technologies (AHT)
Methods, procedures, techniques & equipment are: (i) scientificallyvalid;(ii) adaptedto 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)
Impact
(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)
Innovation
Serves to fill existing gaps in the availability of HT to vulnerable populations through provision of new solutions to health problems, the
adaptationof an existingHT to a particular setting or for a new use, and the combination of HT to address several healthissues at once.
(WHO 2016, http://www.who.int/medical_devices/innovation/en/)
Life Sciences & Digital Health
Life Sciences1 research and biotechnology, includes genetic engineering, synthetic biology, genomics and proteomics leading to specific,
personalizedbiologics andcare. (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 healthon their terms, further defining the patient-caregiver relationship, in all settings of care. (2WHO 2015: IFMBECED Global
CEProfile of BiomedicalEngineering preparedfor WHO’s December 2015presentation to the International Labour Organization http://www.ilo.org/)
Quality
Care delivery structure, processes, and outcomes meeting established norms through ongoing measurement; quality of care features
typicallyinclude effectiveness, safety, patient‐centeredness, comprehensiveness, continuity, integration.1 Qualityof care given bya health
professional can be judgedbyits outcome, the technical performance of the care, andbyinterpersonal relationships.2 Care qualityavoids
underuse, misuse, andoveruse; service qualityis measuredbythe satisfactionwith experience of patients andtheir familymembers with
their care.3 (1
WHO 2011, Glossary, ibid; 2
Donabedian 1988 http://post.queensu.ca/~hh11/assets/applets/The_Quality_of_Care__How_Can_it_Be_Assess ed_ -
_Donabedian.pdf. 3
NCQA 2006 The Essential Guide to Healthcare Quality www.ncqa.org/portals/0/publications/resource%20library/ncqa_primer_web.pdf)
Safety
The reductionof riskof unnecessaryharmassociated withhealthcare to anacceptable minimum1. And medical device qualityandsafety
regulations.2 (1
WHO-ICPS 2009 www.who.int/patientsafety/implementation/taxonomy/icps_technical_report_en.pdf) 2
WHO 2016 www.who.int/medical_devices/safety/en)
HT outcome indicators
Technologytotal life cycle impact canbe measuredusing indicators suchas improvements inpopulationhealth 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 inthese indicators and, significantly, inthe abilityof a health system to provide a highqualityandefficient basket of health
services. (Dr. Yadin David 2016)
4. PAGE 3
Assessment
Biomedical and clinical engineers (BME-CEs) are qualified and competent to practicein the health and rehabilitation services sector,
and to facilitatethe achievements of goals as measured by these HT outcome indicators.For example, improved Quality & Safety can
be driven by engagement of an adequate number of qualified HT professionals (BME-CEs) in a country. This white paper illustrates
many, but certainly not all,of the examples of how BME-CEs have made a significantdifference, and thus have improved the role of
appropriate, safe, and efficient technology for the population where they practice.
Here is a quick summary of compellingevidence from over 60 stories selected below (most with extensive peer-reviewed data available):
Innovations for existing andemerging diseaseburden (e.g., Ebola best practicehealth technologies); alsobeginning toaddress LifeSciences & DigitalHealth
Access toservices for specialty care(e.g., for cancer), chronicdisease(e.g., for dialysis anddiabetes), and hard-to-reach populations
Health systems/policy/managementstories that demonstrate raising awareness and engagement ofdecision-makers (e.g., medicaldevicelegislation1.)
Financialmodels of how CEand Health Technology Management strategies area wiseinvestmentfor Ministries ofHealth
Creativeuses of e-Technology for management, MaternalChildHealth(MCH) care,electronic health record (EHR) medical deviceinterface, design, training
Governance, process,policy, and academicapproaches for improving Quality &Safety,whilereducing risk in care delivery using appropriate HT
Population and
Health Issues
Impacted by
Stories
370 Million
Surgery, Respiratory, Trauma, Primary
Care, Hospitals, Device Manufacturing,
Point of care diagnostics, Ebola care
1.5 Billion
Mobile health, Diagnostics,
Dialysis, Telemedicine, and
Chronic Disease care
850M
Professional certification &
societies, Medical device
maintenance, Donations
2.3B
Medical device planning,
investment & legislation, MoH HT
Unit strategies, Product tracking
1.6B
MCH care, device clinical
data & EHRs, ICT & on-line
training, Cybersecurity
1.6B
Improved Q&S from policy,
governance, regulation,
processes, human factors
Story
Category
Innovation Access Management Health Systems e-Technology Quality & Safety (Q&S)
Total Number
of Stories
/ Countries
17
/ 12
12
/ 13
42
/ 41
36
/ 24
22
/ 18
25
/ 30
Selected
Stories
(countries)
-Best
evidence
(extensive
data)
-Good
evidence
(data
provided)
2016: Rapid Clinical Evaluation
of Robotic Surgery, Stefano
Gidaro & Luca Radice (Italy)
2016: Provincial Respiratory
Outreach Program, Anthony
Chan, Esther Khor (Canada)
2016: Blood/fluid warmer for
roadside trauma, Anne-Louise
Smith, Mark McEwen (Australia)
2016: Biomechanics, long
distance cycling patients, Azman
Hamid (Malaysia)
CE driving new public hospital
design & construction, Franco
Simini (Uruguay)
2
WHO 2011-2014 HT
Innovations for Low Resource
Countries, Adriana Velazquez (LRC)
2016: MoH "Andhra Med Tech
Zone" new medical devices
manufacturing park, Jitendar
Sharma (India)
2
2014: WHO medical device list
for Ebola care, Adriana Velazquez
(Global)
2
2015: WHO Specifications for
Oxygen Concentrators, Adriana
Velazquez (Global)
2015: HT enhancing rural
Primary Care and eHealth
Ahmed Raihan Abir (Bangladesh)
2016: Heavy-Metals HT Point of
Care Detection, Herb Voigt, Fred
Hosea (Peru)
2015: Business Opportunities in
HT Projects Mario Castañeda
(Colombia/USA)
High technology diag-
nostics access, 2016,
data - Ledina Picari (Albania)
2015: Ministry of Health
mobile medical units,
Jitendar Sharma (India)
2015: Ministry of Health
(MoH) free essential
diagnostics, Sharma (India)
2016: MoH National
Dialysis Program, Jitendar
Sharma (India)
2016: Using Telehealth to
improve Diabetes care,
Elliot Sloane, Nilmini
Wickramasinghe, Steve
Goldberg (Australia/ Canada)
2016: Global Health
Telemedicine, Michele
Bartolo (Italy/Africa)
2
2016: WHO cancer care
global initiative, Adriana
Velazquez (LRC)
2015: The Rise of
Telehealth , Yadin David et
al (Global)
2015: HT improves
provincial care access,
German Giles (Argentina)
2015: A Telemedicine
System for Chronic Disease
Follow-up, Gonzalez-
Fernandez (Cuba)
Impact of national CE
Certification on HT,
2016, Zhou Dan (China)
Internal Endoscopy
support, Anne-Louise
Smith (Australia)
Medical device tech-
nician training, Worm,
Mpamije Tonkin, Mol,
Kasaro (Rwanda, Zambia)
Creation of HT
Technical E-Library,
Salah Alkhallagi (Saudi
Arabia)
Medical Research Council
HTM Unit, Anna Kah, Ebrima
Nyassi (The Gambia)
MoH ophthalmic equip-
ment support & Device
HydroCarbon Training
Philip Anyango, Mary Nguri &
Joseph Rugut (Kenya)
HT Donations Study,
2015, Bradley, Yoon,
Zahedi, Adusei-poku,
Gentles (Ghana / Canada)
THET NGO & South
Africa enhancing 15
African HTM societies,
Anna Worm & Mladen
Poluta (Africa, UK, THET3
)
2015: MoH HTM
Programs (Botswana,
Cuba, Bhutan, Uganda)
HTM as key health
planning discipline, Guanxin
Gao (Inner Mongolia, China)
MoH HT list driving
national investment, Murilo
Conto (Brazil)
MoH HT Unit creates
nation-wide HTM capacity,
Roberto Ayala (Mexico)
MoH HT Unit product
tracking/surveillance/
pricing & Country-wide
HTM, data, Ugur Cunedioglu
& Bilal Beceren (Turkey)
2016: Model national CE
society and impact on
legislation, Paolo Lago,
Lorenzo Leogrande (Italy)
MoH & NIH HT Unit care
improvement strategies ,
Rossana Rivas, Luis
Vilcahuaman (Peru)
2016: MoH HT Unit device
legislation, Ledina Picari
(Albania)
2013: Medical Equipment
Maintenance: Manage-
ment and Oversight book,
Binseng Wang (Global)
MoH HT Units national
impact (Nigeria, Ethiopia,
Suriname, Colombia)
Using ICE4
data for
HTM, Tracy Rausch,
Tom Judd (India/USA)
Designing MoH HTM IT
systems in Developing
Countries, Jitendar
Sharma, Prabhat Arora
(India)
Evidence-based
MCH5
care enabled
by HT, Tom Judd, Lee
Jacobs, Brian Birch, and
Matt Jansen (Haiti)
CE: from Devices to
Systems, Roberto
Miniati, Ernesto
Iadanza, Fabrizio Dori,
Italy, 2015 (Global)
2015: IHE6
begun in
LA&C Vladimir
Quintero, (Colombia,
Latin America)
2015: ICT7
training
for HT, Elliot Sloane
(Global)
2015: On-Line HTM
Training,, Tobey Clark
et al (Latin America)
2016: Medical
Device Cyber
security, Steve Grimes
(Global)
2015: Trends on IT &
HT, Antonio Hernandez
(Latin America, Global)
2016: Shanghai
Region Medical
Equipment Q&S, Libin
(China)
2016: User Care of
Medical Equipment,
Nehal Kapadia & Sunema
Talapusi (Samoa-Fiji)
2016: Impact of State
CE Directorate, Ignacio
Macias (Mexico)
2016: MoH HTM
Regulations, Andrea
Garcia-Ibarra (Colombia)
2016: Medical Air Mis-
connections, Anne-Louise
Smith, Mark McEwen
(Australia)
2014: Pediatric and
Neonatal equipment
QI (Papua New Guinea)
2009: Developing
national HT policy J
Riha (Cameroon)
2012: Profile of BME
Education in Latin
America , SJ Calil et al
(Latin America, Global)
2015: Human Factors for
HT Safety, IFMBE book
Tony Easty et al (Global)
2015: Managing the
medical equipment
lifecycle resource, THET,
Anna Worm (Global)
CE Risk Management,
Frank Painter (Global)
Notes:
1Design and implementation of Medical Device legislation: helps in national approach for
conformity evaluation, certifications, market surveillance, and for smaller health care facilities.
Strategies and plans - without a good legislative framework that obliges the health care
providers to follow rules and regulations - often end up by not being used or neglected,
especially because of hospital leaders’ focus on other financial and resource challenges.
2Also includes global stories, e.g., from World Health Organization (WHO), and other sources
3The Tropical Health & Education Trust (THET) www.thet.org; see Making It Work: Managing
medical equipment in low-resource settings, www.youtube.com/watch?v=kpPdhYZlbsA&nohtml5=False
4ICE – Integrated Clinical Environment, see http://www.mdpnp.org/mdice.html, part of the
Medical Device Plug and Play Program, Boston MA, USA
5
Evidence-based Maternal Child Health (MCH) care based on WHO clinical practice guidelines
& Essential HT List for MCH Care, www.thepermanentejournal.org/issues/2016/spring/6061-haiti.html
6IHE – Integrating the Healthcare Enterprise, see http://www.ihe.net/, an initiative by
healthcare professionals and industry to improve the way computer systems (and medical
devices) share information.
7ICT (WHO): eHealth is the use of information and communication technologies (ICT) for
health. Examples include treating patients, conducting research, educating the health
workforce, tracking diseases and monitoring public health; activities increasingly supported
and led by clinical engineers. See http://www.who.int/topics/ehealth/en/
5. PAGE 4
Recommendations
For Ministries of Health in WHO Member States
The success stories described should help in the formulation of national strategies and plans for the establishmentor
enhancement of health technology life-cycle management programs in collaboration with clinical and biomedical
engineering professionals. In several countries,this has best been achieved by developing a Health Technology Unit at
Ministry of Healthlevel. More storydetailsare available on the Global CE Success Story website - http://global.icehtmc.com.
“Understanding that health technologies - in particular medical devices - represent an economic as well as a technical
challenge to the health systems of many Member States, and concerned about the waste of resources resulting from
inappropriate investments in health technologies - in particular medical devices - that do not meet high-priority needs, are
incompatible with existing infrastructures, are irrationally or incorrectly used, or do not function efficiently.
Acknowledging the need for Member States and donors to contain burgeoningcosts by establishingprioritiesin theselection
and acquisition of health technologies in particular medical devices on thebasis of their impacton the burden of disease,and
to ensure the effective use of resources through proper planning, assessment, acquisition and management;
Noting the need to expand expertise in the field of health technologies in particular medical devices …” (WHO 2007
http://www.who.int/medical_devices/resolution_wha60_29-en1.pdf?ua=1)
The storiescollected,notedabove,andincludedatthe websiteprovide clearevidence thathealthtechnologyisbeneficial,
yetat timespresentscomplexsystemsthatmustbe effectively guided and managed for optimal impact to be realized.
Adequate planningisneededtoaddresschallengespresentedatdifferentlevelsof desiredhealthservices. Thisdocument
focusesontheirdependence onsafe,integrated,andsustainabletechnologies. Requirementsof healthservices’priorities
and supportsystems varyfrom one regiontoanother;therefore manysuccessstoriesare providedtoshare howdiverse
situations benefit from life-cycle management from innovation to deployment. In each of the storiesattached the early
and on-goingengagementof biomedical/clinical engineeringexpertise wasakeytoachievingsuccess.Three briefclosing
examples follow:
A Ministry of Health HT Unit-led project in Albania thateffectively doubled availableaccess to critical diagnosticservices, e.g., CT
Scan, MRI, and angiography, while reducing equipment downtime to zero, and significantly reducing cost.
Coordination between the multiple stakeholders in the National Public Health Laboratory and its connected laboratories in
Colombia, led by Ministry of Health clinical engineers (CEs) who partner with other experts from academia and industry.
A CE-led 122-hospital Quality & Safety program in the Shanghai region that cooperates with official, industry and academic
entities, resultingin improved device user satisfaction,trackingof emerging technologies, and closer partnerships with industry.
We hope that you will find that the sharing of the information collected is beneficial and invite you to direct your i nquiries through
our website - http://global.icehtmc.com/contactus.
Respectfully submitted,
Yadin David
Chairman, Global Clinical Engineering Advisory Group
Board Member, IFMBE - CED
