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Received November 11, 2023, accepted January 22, 2024, date of publication March 6, 2024

Sustainable Procurement of Medical Devices in an 
International Context - Part 3
Assessment of Local and Lifelong Use Conditions
By Valerio Di Virgilio1, Alexia Bouchard Saindon2, Francisco Becerra Posada2

1 Università degli studi La Sapienza, Roma
2 United Nations Office for Project Services (UNOPS)

ABSTRACT

Background and Objectives: This article is the third in a series of three manuscripts published in this journal. It aims to describe 
how sustainable procurement of medical devices (MDs) can be implemented in operational projects in the context of developing 
countries. It also further details how the biomedical/clinical engineer lead (BCEL) in charge of technical support during the MD 
procurement process can apply sustainability principles and concepts of value-based procurement.
Material and Methods: Based on the authors’ experience of more than 20 years in procurement projects and implementation of 
MDs, the role of the BCEL will be developed from a theoretical point of view with the description of the second and third pillars of 
a sustainable purchase following the needs assessment: the assessment of existing conditions along with local capacities and the 
evaluation of the use conditions during the lifetime of the medical equipment. The application of these principles in operational 
projects will be further discussed by analyzing literature and lessons learned from projects implemented in developing countries.
Results/Proposal: The BCEL has a key role in the sustainable procurement of MDs to design the technical specifications of the 
goods, related services, and post-sales conditions to maximize the benefit of the investment. As the specialist can analyze the 
local existing conditions and capacities while ensuring efficient use of the MDs during their lifespan, they can contribute to a 
sustainable implementation of MDs in developing countries. 
The BCEL shall also be able to analyze the local and international markets to find all possible technological solutions that meet 
the needs, local conditions, and capacities and ensure quality use during the lifespan of the purchased MD. The BCEL shall have 
competencies in identifying all the risks related to the use of the MD from the safety risks linked to its installation, use, and main-
tenance to the sustainability risks linked to obtaining the conditions that guarantee the use of the device and maintaining them 
as long as possible. Examples of these conditions include the presence of qualified and trained users, availability of maintenance 
and consumable budgets, availability and maintenance of infrastructure conditions (access, electrical power, water, drainage, 
medical gasses, etc.), and last but not least, presence of patients requiring a diagnosis or treatment using the purchased MD who 
were identified during the evaluation of the first pillar: a sound needs assessment.
Conclusion: As an evolution of the BCEL’s traditional biomedical and clinical engineering work, he/she shall assume the re-
sponsibility to guarantee the sustainability of the MD purchase. This quality assurance and control role is achieved by a sound 
theoretical background knowledge based on the three sustainable procurement pillars: the needs, existing and lifetime use 
conditions assessments, the analysis of the local and international markets, and a broad understanding of sustainability risks.

Keywords – Medical device procurement, sustainable procurement, technical specifications, local conditions, local capacities, 
lifetime use of MDs, total cost of ownership, health services in developing countries, quality assurance, sustainability, clinical 
engineer role, international health procurement, value-based procurement.

Copyright © 2024. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY): Creative Commons - Attribu-
tion 4.0 International - CC BY 4.0. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) 
are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is 
permitted which does not comply with these terms.



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Di Virgilio, Bouchard Saindon, Becerra Posada: Sustainable Procurement of Medical Devices in an International Context - Part 3 

INTRODUCTION
In a previous article,1 sustainability principles and 

their importance in MD procurement projects, especially 
in developing countries, has been described. A theoretical 
concept with three fundamental pillars was proposed to 
improve the sustainability in MD procurement projects and 
address the risk of purchasing MDs that will not be used 
by local clinical personnel. This concept suggests focus-
ing the technical work of the BCEL on three assessments: 
(1) the needs, (2) the local conditions and capacities, and 
(3) the conditions for the lifetime use of the MD. All ac-
tions performed during the project are recommended to 
be coherent with the results of these three assessments 
linked to the project’s objective to facilitate the sustain-
able outcome of the purchased MDs.

Without specific attention to the sustainable conditions 
of use, an investment in health technology, including MD 
purchases, has a high risk of becoming a burden for the 
local health system.

This article aims to further detail how these pillars 
for sustainability can be implemented in MD procure-
ment projects within the environment of developing 
countries. This article will focus on assessing the MDs’ 
local and lifetime use conditions since the needs assess-
ment was already developed in a previous article.2 The 
responsibility and recommended actions that the BCEL 
can take to perform these assessments are discussed and 
analyzed using examples from implemented projects. 
In this framework, a convenient approach is to focus on 
value-based procurement, a novel approach to purchas-
ing that evaluates potential new MDs to maximize overall 
value for money (including their economy, effectiveness, 
efficiency, equity, and sustainability), rather than focusing 
only on the lowest purchase price will also be explored.3,4

THE ASSESSMENT OF EXISTING CONDITIONS AND 
CAPACITIES

The second pillar of sustainability is the assessment of 
existing conditions and capacities where the MD will be 
used. This includes the analysis of the following conditions: 

• The delivery logistics required to get to the installa-
tion site and the installation room from the nearest 
port/airport and the manufacturing site;

• The customs rules and regulations; 
• The installation site infrastructure and installation 

conditions according to the technical requirements 
of the MDs to be implemented;

• The local and international rules and regulations on 
MDs, construction, electrical, fire prevention, health 
and safety, etc.

• The local capacities are clinical, technical, logistics, 
financial, etc. 

• The availability of the MDs, services, and consumables 
on the local and international markets is needed to 
guarantee sustainability.

The result of these analyses is the development of de-
tailed technical specifications for the MDs to be procured, 
starting from the technological level defined in the needs 
assessment in line with the analysis of the intended use 
of the MD, together with an adequate delivery and instal-
lation plan translated into requirements to be included 
in the tender documents. 

The technical specifications of the MDs shall be tai-
lored to consider local clinical and technical capacities 
as well as their working method, standards, and cultural 
environment. Therefore, a dialogue with the MDs’ clinical 
and technical beneficiaries is essential during assessing 
the existing conditions and capacities for defining the 
technical specifications.

EG1 MDs required to equip a delivery room can be 
selected in very different ways depending on cultural 
aspects, including delivery positions and the presence of 
accompanying relatives. Depending on the local culture, 
the use of birthing balls, stools, supports from the ceilings 
together or instead of the classical delivery bed have to be 
discussed and considered when designing the equipment 
list and their technical specifications.5,6

Linked to the Incoterms used in the tender and pur-
chasing contract, shipment conditions shall consider the 
logistics and safety of the sites. Sometimes, due to urgency 
or specific logistic complexity, the delivery costs may 
become higher than the costs of the goods. To minimize 
the carbon footprint and reduce costs, local suppliers 
shall be encouraged to participate in the tender processes 
since ‘’goods sourced locally have a positive sustainability 



Di Virgilio, Bouchard Saindon, Becerra Posada: Sustainable Procurement of Medical Devices in an International Context - Part 3

J Global Clinical Engineering Vol.6 Issue 2: 2024  18

impact, e.g., eliminating transportation costs.’’7 In most 
cases, the National Regulatory Authority certification is 
mandatory to import the goods, and relevant customs 
bureaucracy shall be managed. 

The design of pre-installation requirements represents, 
for complex equipment, a critical issue since the installation 
shall comply with the manufacturer’s recommendations 
and local rules and regulations. In most cases, interna-
tional practices and safety standards for the installation 
shall be added to local rules and regulations depending 
on the maturity level of the beneficiary country. 

The result of the assessment of the existing condi-
tions are:

1. Detailed technical specification of the MDs; 
2. Complete delivery conditions and specifications;
3. Exhaustive organization of the pre-installation 

responsibilities;
4. Pre-installation requirements;
5. Training requirements for the tender process;
6. Installation requirements for the tender process.

The role of BCEL in the assessment of existing local 
conditions and capacities

Based on the assessment of the existing conditions: 
infrastructure, electromechanical installations, clinical and 
technical capacities, installed and available technologies, 
local market, intranet-internet connections, etc. the BCEL 
along with the local stakeholders and within the scope 
of the project agreement, will design, as summarized in 
Figure 1:

1. The technical specifications are the detailed require-
ments for the MD; In this process, the BCEL shall consider 
the technological level8 and the clinical objectives defined 
in the needs assessment as well as the installation condi-
tions and, most notably, the local clinical and technical 
capacities, as well as the lessons learned in previous 
projects and the local and international market. This 
process implies a consistent workload depending on how 
the market analysis can be performed depending on the 
availability of lessons learned from previous projects. If an 
up-to-date database of previous successful projects with 
the same specific technology required for the project is 

available, the market analysis can be reduced. Suppose 
a new technology has to be purchased. In that case, the 
market analysis may require a larger technical effort 
and contact with potential suppliers and manufacturers, 
requiring several additional weeks for the specifications 
design of a single technology. Typically, this process is 
outsourced by the BCEL to other biomedical engineers 
who can work remotely while the BCEL focuses on the 
next steps.

According to the United Nations Office for Project 
Services (UNOPS)9 and the United Nations International 
Children’s Emergency Fund (UNICEF),10 the BCEL could 
also perform additional sustainability considerations in 
the planning phase of the project:

○ Plan a market analysis to understand and determine:
• Sustainable solutions that might already exist in 

the local market;
• Sustainable solutions that have been implemented 

internationally;
• The economic, social and environmental risks/

opportunities related to that specific MD;
• Standards and regulations requirements available 

for the MD.
○ Assess the sustainability risks of the MD and adjust 

the procurement strategy consequently.
2. The delivery requirements, including temporary 

storage and transport conditions, safety rules for ma-
nipulation and transportation, possibly considering, 
during tender evaluation, the carbon footprint. For larger 
equipment, these requirements shall include the access 
pathway inside the beneficiary’s infrastructure to the 
final installation site, considering the size and weight of 
the good’s packages: the rigging plan. This includes on-
site transportation that can become relevant for heavy 
or large equipment requiring a detailed plan, including 
health and safety considerations for the workers. Also, 
the disposal, recycling, or storage of equipment packag-
ing can also be an important aspect to integrate into the 
technical specification preparation.

3. The pre-installation responsibilities are linked to the 
installation site and MD’s specific chosen brand and model. 
The BCEL shall design how to organize the contractual 



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Di Virgilio, Bouchard Saindon, Becerra Posada: Sustainable Procurement of Medical Devices in an International Context - Part 3 

responsibilities between the beneficiary hospital, the 
supplier, and the international purchasing organization, 
including, when relevant, the hospital’s constructor. The 
exchange and approval of progressively more detailed 
technical drawings and the definition of responsibilities 
for the pre-installation work between all the stakehold-
ers is essential to the success of the implementation. This 
process shall consider the standards and regulations 
applicable to the different installation aspects, such as 
structural capacities, radiation protection, hazardous 
material management, waste management, etc.

4. The pre-installation requirements which include 
all technical requirements for a safe installation and use 
of MDs that need to be specified by the BCEL to support 
hospital architects and engineers in designing new in-
frastructures or renovating existing sites3; They can be 
organized as shown in Table 1.

These requirements are specified when the equipment 
type is defined and adjusted with the manufacturer’s docu-
mentation when the specific brand and model is awarded.

5. Human resources (clinical and technical) training 
requirements. The design of the training requirements is 
a critical issue, and the BCEL shall consider all available 
options from simple written instruction of use and main-
tenance to online training and tutorials or even in-person 
training by the manufacturer’s certified instructor. The 
BCEL can also consider the possibility of longer train-
ing when introducing new technology. For example, the 
clinical and technical personnel could travel to a clinical 
or training center where the same equipment model is 
installed for several weeks of hands-on training. A good 
practice is to identify the trained personnel and restrict 
the use and maintenance of the MD only to trained staff. 

Another recommended strategy is training local techni-
cians to maintain essential MDs, such as hospital furniture 
and simple equipment commonly found in primary care 
institutions that benefit a larger population.11

6. Detailed installation requirements in charge of the 
supplier to be included in the tender document. As the 
last step of the installation design, the BCEL will prepare 
the final installation requirements to be tendered with 
the equipment. These requirements shall match the on-
site conditions, and the pre-installation works that the 
beneficiary or a third party eventually takes care of. It 
is a good practice to include the specific installation re-
quirements in a framework considering environmental 
protection, health and safety of the installers, as well as 
human rights and gender equality policies. After installa-
tion completion, the supplier may be required to imple-
ment a communication plan to enhance the visibility of 
the project. If so, this activity shall be implemented under 
the strict supervision of the beneficiary.

The BCEL shall consider the impact of pre-installation 
works and installation activities on the hospital’s clini-
cal workflow and discuss it with the beneficiary before 
starting the purchasing process. In some instances, the 
impact can be so unacceptable for the beneficiary that the 
purchase of the new equipment is rejected, and a different 
technological solution shall be pursued.

To improve the quality of procurement processes, 
a standard template of technical specifications for the 
procurement of MDs with standards, regulations, and 
sustainability principles is recommended to be available 
for BCELs within an implementation agency. A peer-review 
mechanism of technical specifications, delivery, installa-
tion, and lifetime use plan by BCELs is also recommended 
to be incorporated into the procurement processes of 
MDs. The outcome of the project’s implementation can 
be monitored, and lessons learned can be gathered to 
benefit future projects.

EG2 A purchasing project for a few computed tomog-
raphy (CT) scanners installed in specific hospitals where 
the clinical engineer has also designed their sustainable 
use can be further investigated and improved if analyzed 
nationally. The national distribution of imaging equipment 
in a network scheme that minimizes the distance to the 

Electrical supply Temperature and humidity
Water hot/cold Weight
Drainage Radiation shielding
Medical gasses Magnetic shielding
Other gasses Biohazards containment
Network connections

TABLE 1 Pre-installation Requirements, Which Include All 
Technical Requirements for the Safe Installation and Use Of MDs



Di Virgilio, Bouchard Saindon, Becerra Posada: Sustainable Procurement of Medical Devices in an International Context - Part 3

J Global Clinical Engineering Vol.6 Issue 2: 2024  20

nearest CT scanner for the population, their connections, 
and their interactions through local and national PACS/RIS 
systems allows a broader assessment that can suggest some 
adjustments to the technical specifications for purchasing 
the CT scanner in the benefit of its future optimized use.

FIGURE 1. The role of BCEL in assessing existing local conditions and capacities.

The sustainability risks of a weak assessment of 
existing conditions

A incomplete or absent assessment of the local con-
ditions is, together with a weak needs assessment, the 
main cause for an unsuccessful project: the equipment 
is delivered but not used. The opportunity to improve 
the health system’s quality and the investment are lost, 



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and the equipment becomes a burden to be removed 
and disposed of. The World Health Organization states, 
“According to one estimate, only 10–30% of donated 
equipment becomes operational in developing countries. 
Reasons for unused equipment include mismanagement 
in the technology acquisition process, lack of user train-
ing, and lack of effective technical support.’’12 Other risks 
associated with a poor assessment of existing conditions 
can include the following examples.

• An impossibility to deliver, install, test the equipment 
or train personnel due to poor road conditions, war 
zones, etc.;

• A lack of services for the safe and effective use of 
the device: absence of a reliable electrical power 
source, unavailability of medical gasses, inadequate 
water quality, insufficient mechanical structure, no 
protection against radiation or bio risks exposure, 
lack of information technology, etc.;

• A lack or absence of training and qualified clinical 
and technical resources to use and maintain the MD;

• A lack or absence of proper accessories and consum-
ables to make effective use of the device;

• Non-compliance of the device to local standards and 
regulations.3

The BCEL shall avoid additional examples of frequent 
pitfalls and derived lessons learned during the design phase:

1. Absent, insufficient, or wrong pre-installation 
conditions when the installation works are supposed to 
start. To prevent this situation, it is possible and useful 
in some cases to delegate the pre-installation works to 
the beneficiary hospital even when the beneficiary has a 
weak technical capacity. In these cases, the supervision 
of the works and the final approval shall be assumed by 
the BCEL and the equipment supplier. Only a close fol-
low up of the execution of the pre-installation works can 
guarantee that the proper pre-installation conditions will 
meet the requirements.

2. A lack of personnel to be trained: The BCEL shall 
ensure that the beneficiary users are available and pre-
pared to receive the appropriate training at the planned 
time. The final users and the final responsibility for main-
tenance shall be formally designated by the beneficiary 

authority to receive the training and be available during 
the training days. Furthermore, recording the training 
sessions to guide new users and creating a formal docu-
ment to register who has been trained and is habilitated 
to use and maintain the equipment correctly is advisable.

3. A lack of specific tools and consumables on the lo-
cal market. The BCEL shall verify in advance and search 
for alternatives when a particular tool or consumable is 
unavailable on the local market. 

4. The local supplier representative lacks capacities 
for installation and post-sales services delivery. The 
BCEL shall confirm that the local representative of the 
supplier/manufacturer has been properly trained to 
install the equipment. The BCEL shall require appropri-
ate certification of local technical people delegated for 
equipment installation from the manufacturer. In past 
projects, situations where local representatives could 
not install the equipment properly and damaged the new 
equipment during the installation attempt happened. The 
presence of the BCEL and close supervision of the instal-
lation process is recommended, especially for sensitive 
and high-technology equipment. In case of doubt, a video 
record of the installation can be useful.

5. During the installation planning, especially in large 
projects with tens or hundreds of installations, the cli-
mate factor has to be considered. The BCEL shall know 
the difference between the dry and wet seasons in the 
beneficiary country since some critical delivery opera-
tions of managing important loads from trucks to rural 
sites may be affected by heavy rains.

Working in a developing country environment requires 
additional flexibility and problem-solving capacities to 
face some unforeseen issues that arise during the instal-
lation. These issues can also be much more complex in a 
fragile environment.

EG3 During the installation of a MD in a remote hospital 
in Haiti, a broken specialized tool represented an issue: the 
nearest market in the capital was far away, and most prob-
ably the specific tool was not available there. An overseas 
purchase was needed, adding a delay of at least 3-5 days 
on the overall installation.



Di Virgilio, Bouchard Saindon, Becerra Posada: Sustainable Procurement of Medical Devices in an International Context - Part 3

J Global Clinical Engineering Vol.6 Issue 2: 2024  22

However, it’s not all about risks, many opportunities 
can be analyzed and pursued during the project’s design 
and implementation. A relevant approach recommended 
to the BCEL is to constantly seek opportunities to improve 
the sustainability of the health system through the intro-
duction of technologies.

EG4 In Jamaica, nurses use most of their work time to 
manually measure patient vital signs and copy them on 
paper registers. They report that up to 90% of their time 
is used to perform similar paperwork. A simple device to 
monitor and record vital signs in a database can abruptly 
reduce nurse routine work and help nurses spend more 
time attending to patient’s needs.

Examples of local conditions assessments
Figure 2 shows the workflow for the pre-installation 

requirements responsibilities as designed by the BCEL in 
charge of the procurement project of 32 CT scanners in 2022 
in the Philippines. Four main actors were involved: UNOPS 

organization, the Philippines Department of Health at a 
national level, the supplier, and the beneficiary hospitals.

Constraints at the beginning of this project were that 
installation site plans were not all available for every 
hospital, and it was urgent to implement the project ac-
cording to certain emergency response programs. Based 
on the decision that each hospital had to be responsible 
for complying with the pre-installation requirements, 
the following operational workflow was designed by the 
BCEL in charge during the project launch.

In 2008, during a project in Uruguay, a communication 
plan was proposed by the BCEL and implemented by the 
project team to inform the recipient health units and the 
general population of the equipment to be delivered and 
of their schedule so that the units were prepared for the 
immediate inclusion of the new technologies in the clinical 
activities.13 The Ministry of Health (MSP) implemented a 
component of the plan through radio messages and local 
newspaper advertisements. Each supplier implemented 

FIGURE 2. Workflow of 32 CTs Installation Process: From the Analysis of Local Conditions to the Definition of the Requirements, 
Implementation and Use (Klappenbach F. With The Permission Of The Author)



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a second component under the strict supervision of the 
MSP. Tender requirements detailed the services required to 
the suppliers: national television advertisements, national 
written press advertisements, and labels while establish-
ing that the Ministry of Health will keep the rights to all 
information managed by the supplier, being the supplier 
forbidden to use it without written authorization.

In many cases, citizens, after a communication cam-
paign on local radios and newspapers, went to the health 
units to see the new technologies. This process of local 
conditions assessment to implement the Italian loan for 
MDs purchase was successfully presented by the Ministry 
of Health to the Health Commission of the Uruguayan 
parliament on February 26th, 2008.

ASSESSMENT OF THE LIFETIME USE CONDITIONS
The third pillar of sustainability is the assessment 

of the lifetime use conditions of the MD. The result 
of this analysis is an adequate lifetime use plan. A key 
factor is to plan the duration of the useful life of the MD. 
The manufacturers are not used to expose the planned 
life duration of their goods, but this might change since 
“manufacturers are required to provide definite expected 
lifetime for the certification of their product under the new 
EU medical device regulations (EU MDR 2017/745).’’14 
However, the US Food and Drug Administration does 
not require manufacturers to establish an expected life 
for a device.15 The expected minimal life duration of the 
equipment is an essential element of any purchase since 
it is relevant to evaluate the total cost of ownership and is 
the basis of any asset management plan for existing and 
future technologies.

The role of BCEL in the assessment of lifetime use 
conditions

While considering the project’s constraints such as 
the available budget, the local conditions, and resources, 
the BCEL shall explore their awareness and interest with 
the stakeholders on the purchase’s mid- and long-term 
benefits. The BCEL shall also promote all the actions 
needed to maintain the equipment during its lifespan and 
keep the benefits and positive impact of the investment 
as long as possible. 

The BCEL in accordance with the beneficiary, will 
design and propose, as summarized in Figure 3:

1. The planned lifetime use duration of the equipment. 
One of the impacts of the life expectancy definition is in 
the specifications for the materials of the goods. Certain 
kinds of steel or plastic can increase or reduce the life 
expectancy of medical furniture or a medical device 
while simultaneously increasing or reducing its value 
and purchasing cost. Once the expected duration of the 
equipment is determined, the BCEL shall revise the tech-
nical specifications of the MD to adjust and adapt them 
consequently to the available technologies on the market.

2. The post-sale services requirements, including 
warranties, maintenance, consumables contracts, and 
documentation, are to be provided with the MD. 

3.  For certain types of equipment, it is recommended 
to use the financial planning of the total cost of owner-
ship. This costing methodology considers the total cost of 
a product over its lifetime. In addition to the initial pro-
curement costs, transportation, maintenance, operations, 
utilities, training, consumables, and waste management 
costs are also evaluated based on the expected lifetime 
of the purchased equipment.16 If the cost of post-sales 
services or consumables is substantial compared to the 
cost of the equipment, it is recommended to consider 
the total cost of ownership during the financial analysis 
of the purchasing process.

4. When the consumable and maintenance costs are 
comparable with the equipment cost, other options be-
sides the purchase can be considered by the BCEL such as 
leasing or renting the equipment by purchasing a certain 
amount of consumables. These types of contracts may 
represent a valid strategy alternative to the purchase 
depending on the market and on the contracting rules 
of the beneficiary and donors.17

5. How to manage the technical documentation ac-
companying the equipment from the commissioning to 
the disposal, including all user and maintenance manuals, 
training and maintenance actions, measures and tests, 
calibrations etc., shall be planned by the BCEL.

6.  Designing the maintenance requirements, including 
the in-warranty and post-warranty preventive and corrective 
maintenance requirements according to the complexity of 



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J Global Clinical Engineering Vol.6 Issue 2: 2024  24

The sustainability risks of a weak assessment of 
lifetime use conditions

The risks associated with a poor or absent assessment 
of the lifetime use conditions may render the MD unus-
able after some time and thus threaten the sustainability 
of the project: 

• Insufficient planning or lack of financial resources 
needed to purchase consumables and spare parts 
to maintain the MD throughout its life expectancy;

• A lack of properly trained clinical and technical staff 
during the lifetime of the MD;

• An absence of the equipment documentation: con-
tractual warranty, user and service manuals, etc. 
probably caused by the lack of hand-over of the 
project’s contractual documents regarding warranty 
and post-sales services to the beneficiary;

• Absent, inadequate, or inappropriate warranty 
requirements in the tender documents. The manu-
facturer’s default warranty conditions may require 
to send the equipment to the production site in case 
of malfunctioning or to demonstrate that the mal-
functioning is not due to improper use;

• A lack of managerial capacities to follow up with 
the supplier regarding maintenance, repairs, and 
upgrades included in the warranty;

• Unavailability of consumables or spare parts on the 
local market, which does not allow or makes the use 
or the repair of the equipment too expensive;

• A premature failure of the purchased MD due to 
materials inappropriate to the hospital environment 
where aggressive cleaning agents are frequently used;

• A lack or insufficient program of continuous training 
on how to use the MD for new users; 

SUSTAINABLE RISK ASSESSMENT
The recommended approach to sustainability is to 

start the project with a proper risk analysis involving the 
different project’s stakeholders. Sustainable risk assess-
ment is performed at the start of the purchasing projects, 
in the evaluation of the three pillars -needs, existing and 
lifetime use conditions, and capacities - allows the BCEL 
to identify the challenges and evaluate the potential risks 

the equipment and the local needs, is an essential duty of 
the BCEL. Indeed, procuring MDs without a maintenance 
plan can be wasteful and reduce the device’s lifetime.18 
It is also advisable to include the software updates in the 
maintenance requirements. 

7. It is part of the BCEL role to analyze the availability 
of spare parts and consumables on the local market and 
to include appropriate requirements in the purchasing 
tender conditions to encourage the availability of such 
goods. The BCEL also needs to confirm with the benefi-
ciaries the availability of a budget for these consumables 
and their capacity to manage efficiently the purchase of 
spare parts and consumables.

8. Ideally, when a BCEL plans the lifetime use of the 
MDs, he/she shall include a plan for its decommissioning 
and consider the expenses associated when calculating 
the total cost of ownership.19

All the requirements mentioned above, excluding 
decommissioning, will be included by the BCEL in the 
tender documents and act as relevant contractual con-
ditions once the device has been received, installed, and 
commissioned properly.

FIGURE 3. The role of BCEL in the assessment of lifetime use 
conditions.



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related to sustainability that could have an impact on the 
outcome of the project. 

Once the sustainable risk assessment is performed and 
the specific risks of the procurement project have been 
identified, a mitigation plan can be prepared. Different 
risk mitigation strategies to ensure sustainable procure-
ment practices of MD implementation can be applied to 
different projects, including:
1. Openly discuss the sustainability risk of scarce or 

improper use of the purchased MDs with the different 
project stakeholders.

2. Openly discuss sustainability challenges with manu-
facturers or distributors of MDs during the market 
analysis.

3. Center the procurement process on the added value 
of the intended use of the MDs rather than on their 
possession.

4. Give relevance to the requirements on the supporting 
services of the goods that can guarantee proper and 
long-term use of the device.

5. When applicable, choose a procurement process that 
allows an evaluation of the quality and performance 
of the MD during the selection phase, discarding the 
minimum price approach and considering alternatives 
to the purchase. 

6. Ask for a list of reference centers during the selection 
phase to validate the quality and performance of the 
bided MD in the mid and long term.

7. Discuss and share experiences with other health 
technology assessment experts from UN agencies or 
international institutions on evidence-based procure-
ment of MD.

8. Build within the implementation organization a record 
of the performances of the MDs and suppliers to build 
a knowledge database.

CONCLUSION
Sustainable procurement of MDs, especially in develop-

ing countries, is of utmost importance.1 The BCEL has a 
key role and responsibility in assuring the implemented 
MDs’ quality and sustainability. This article further detailed 
the proposed theoretical background of two fundamental 

pillars besides assessing the needs2: local and lifetime 
use conditions and capacities analyzes that the BCEL 
can follow as a guideline to achieve sustainable projects.

It also emphasizes the role of the BCEL as the techni-
cal expert conscious of the project’s sustainability and 
responsible for the quality assurance process, raising 
awareness on the possible issues and discussing solu-
tions with the rest of the team, the beneficiary, and the 
project’s stakeholders to minimize the risks.

Since the BCEL has to work in a multidisciplinary team20 
and be able to dialogue with different stakeholders from 
various backgrounds, they require expertise to cover all 
the aspects of the project, from public health to project 
management, while also considering clinical aspects, 
hospital design, infrastructure, installation, MDs design 
and technology.21

The assessment of the local capacities and conditions 
is a key element in the work of the BCEL to:

• Ensure that the technology level is adequate to the 
site conditions which in developing countries may 
be challenging because of the lack of adequate infra-
structure, stable electrical power supply, controlled 
working temperature and humidity, accessibility, and

• Ensure that the MD is adequate to the local capacities 
of use and of maintenance since, in most developing 
countries those capacities are scarce. Expert profes-
sionals, when available, have a high turnover because 
they are constantly searching for better conditions.

Once the BCEL confirms that the technology design 
is fit for purpose and adequate to local conditions and 
capacities, including the design of the support services 
for delivery, installation, and training, they have to ensure 
that these sustainable conditions will last during the 
device’s lifetime.

This can be done by planning the intended lifespan 
of the MD and verifying that the main conditions will 
remain stable: availability of trained personnel, planned 
maintenance by trained technical personnel, availability 
of consumables, adequate electrical supply, etc.

The focus on the lifespan of the MD will bring the total 
cost of ownership criteria in the evaluation and add the 
analysis of alternative ways of procuring the goods, such 



Di Virgilio, Bouchard Saindon, Becerra Posada: Sustainable Procurement of Medical Devices in an International Context - Part 3

J Global Clinical Engineering Vol.6 Issue 2: 2024  26

CONFLICT OF INTEREST
The authors declare no conflict of interest regarding 

the publication of this paper.

ACKNOWLEDGMENTS
The authors would like to thank Federico Klappenbach 

and Oscar Marenco for contributing to the examples and 
figures presented in this article and for the constructive 
technical discussions during project implementation.

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contract. The benefit procured by using the purchased 
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experience and guidance from peer-review processes and 
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to express their imagination, creativity, and experience 
during the process.



27 J Global Clinical Engineering Vol.6 Issue 2: 2024

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