Sustainable procurement of medical devices in an international context - Part 2

Main Article Content

Valerio Di Virgilio
Alexia Bouchard Saindon
Francisco Becerra Posada

Keywords

Medical device procurement, sustainable procurement, needs assessment, health services in developing countries, quality assurance, sustainability, Biomedical/Clinical Engineer role, international health procurement

Abstract

Background and Objectives: This article describes how sustainable procurement of medical devices (MDs) can be implemented in operational projects in developing countries. It also further details how sustainability principles and the needs assessment can be applied by the biomedical/clinical engineer lead (BCEL) responsible for the technical and quality aspects of the procurement process of MDs. It also emphasizes the importance of the BCEL considering the country’s or region’s specific healthcare context when working on MD procurement projects in developing countries.
Material and Methods: This article describes how sustainable procurement of medical devices (MDs) can be implemented in operational projects in developing countries. It also further details how sustainability principles and the needs assessment can be applied by the biomedical/clinical engineer lead (BCEL) responsible for the technical and quality aspects of the procurement process of MDs. It also emphasizes the importance of the BCEL considering the country’s or region’s specific healthcare context when working on MD procurement projects in developing countries.
Results: The BCEL has a key role in the sustainable procurement of MDs as an integrator able to understand clinical needs and translate them into requirements while being aware of the sustainability and safety risks linked to technology implemented in the fragile environment of a developing country with limited resources.
This context also creates additional challenges that can be managed if the BCEL is conscious of the country’s health expenditure, geopolitical, healthcare, model of care, regulatory, infrastructure, and logistical conditions in which the MDs will be installed. Many equipment may remain unused if the technology implementation is not in line with the needs of the beneficiaries. Therefore, a thorough needs assessment performed by the BCEL to obtain the detailed list of MDs, their technological level and estimated budget is of utmost importance to increase the project’s sustainability and mitigate the risk of unused MDs.
Conclusion: Besides traditional disciplines in biomedical and clinical engineering, the BCEL shall also learn at least basic principles in public health, healthcare planning, project management, health infrastructure, and development aid to facilitate the dialogue with stakeholders based on knowledge, flexibility, and capacity to anticipate and solve practical issues on the ground. To this extent, it is advisable for a BCEL new to the environment of developing countries to have progressive exposure to more complex projects and to extensively use the peer review mechanism to assure sustainability and quality during project implementation. A theoretical background based on sustainable procurement principles, analysis of the local and national health context and regulations, and knowledge of lessons learned from past projects should guide the BCEL’s approach to performing the needs assessment while implementing a new project.

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References

Di Virgilio, V., Bouchard Saindon, A., & Becerra Posada, F. C. G. (2023). Sustainable procurement of medical devices in an international context : Part 1 - background and definitions. Global Clinical Engineering Journal, 5(3), 29–39. https://doi.org/10.31354/globalce.v5i3.159
WHO. Sustainable Procurement. WHO; April 2022. Available at: https://apps.who.int/gb/MSPI/pdf_files/2022/04/Item5_11-04.pdf.
UNICEF. UNICEF Implements Sustainable Procurement. UNICEF Supply Division; September 2018. Available at: https://www.unicef.org/supply/sites/unicef.org.supply/files/2019-06/sustainable-procurement-information-note.pdf.
UNDP. Practitioner’s Guide to Sustainable Procurement. Available at: https://popp.undp.org/UNDP_POPP_DOCUMENT_LIBRARY/Public/PSU_Procurement%20Overview_Sustainable%20Procurement.docx#:~:text=Several%20of%20factors%20influence%20sustainable,line%20with%20good%20financial%20management.
United Nations Office for Project Services Procurement Group. Sustainable Procurement Framework - Annex 1 to the Procurement Manual. UNOPS. 2021, July 1. Available at: https://content.unops.org/service-Line-Documents/Procurement/UNOPS-Procurement-Manual-Annex-1-2021_EN.pdf.
WHO. Guidelines for Healthcare Equipment Donations. Organization of Health Services Delivery. March 2000. Available at: https://apps.who.int/iris/bitstream/handle/10665/70806/WHO_ARA_97.3_eng.pdf?sequence=1&isAllowed=y.
Perry L, Malkin R. Effectiveness of medical equipment donations to improve health systems: How much medical equipment is broken in the developing world? Med Biol Engineer Comput 2011;49(7):719-722. Available at: https://doi.org/10.1007/s11517-011-0786-3.
The World Bank. Current Health Expenditure Per Capita. April 7th, 2023. Available at: https://data.worldbank.org/indicator/SH.XPD.CHEX.PC.CD.
OECD. Health at a Glance 2017. OECD Indicators. Available at: https://www.oecd-ilibrary.org/docserver/health_glance-2017-5-en.pdf?expires=1695829119&id=id&accname=guest&checksum=EEF8CB0C0EAD898F03D1BB9BD984B28A.
Ortiz-Ospina E, Roser M. Healthcare Spending. 2017. Available at: https://ourworldindata.org/financing-healthcare.
WHO. World Health Statistics. 2023. Available at: https://www.who.int/data/gho/publications/world-health-statistics.
Malkin R. Barriers for medical devices for the developing world. Expert Rev Med Devices. 2007. Available at: https://pubmed.ncbi.nlm.nih.gov/18035940/.
PAHO. PAHO and National Regulatory Authorities of Regional Reference Seek To Strengthen Regulation of Medical Products In The Americas. July 11, 2023. Available at: https://www.paho.org/en/news/11-7-2023-paho-and-national-regulatory-authorities-regional-reference-seek-strengthen.
WHO. WHO-Listed Authority (WLA). A Framework for Evaluating And Publicly Designating Regulatory Authorities as WHO Listed Authorities (WLA). Available at: https://www.who.int/initiatives/who-listed-authority-reg-authorities.
WHO. WHO Global Benchmarking Tool (GBT) for Evaluation Of National Regulatory Systems. Available at: https://www.who.int/tools/global-benchmarking-tools.
WHO. Procurement Process Resource Guide WHO Medical device technical series Available at: https://www.who.int/publications/i/item/9789241501378.
UNDP. Procurement for Sustainable Development Strategy 2022-2025. Available at: https://www.undp.org/procurement/strategy#:~:text=UNDP%20Procurement%20for%20Sustainable%20Development,one%20behind%2C%20and%20building%20resilience.
UNICEF. Sustainable Procurement Information Note. Available at: https://www.unicef.org/supply/reports/sustainable-procurement-information-note.
United Nations Office for Project Services Procurement Group. Sustainable Procurement Framework - Annex 1 to the Procurement Manual. UNOPS. 2021, July 1. Available at: https://content.unops.org/service-Line-Documents/Procurement/UNOPS-Procurement-Manual-Annex-1-2021_EN.pdf.
Dyro J, Cheng M. Good Management Practice for Medical Equipment. In: Dyro J. The Clinical Engineering Handbook. Setauket, NY: The Biomedical Engineering Series, Elsevier Academic Press. 31;108-113.
Kaufman R, Guerra-López I. Needs Assessment for Organizational Success. Alexandria(VA): ASTD Press; Feb 2013.
OECD. Health Policy In Your Country. Available at: https://www.oecd.org/health/health-systems/health-policy-in-your-country.htm
V. Di Virgilio, G. Ambroise; “Clinical engineering development in the Uruguayan public health system”; Proc. IEEE Engineering in Medicine and Biology Society, Buenos Aires, Argentina 31/08-4/09 2010.