A Review of Medical Device Procurement at National Level: Integrating Support Systems for Clinical Engineers Towards Efficient, Transparent and Standardized Procurement Processes

Abstract

This study explores the role and the key support system required by clinical engineers in enhancing national-level medical device procurement to ensure efficiency, safety and standardization. Using WHO's 2022 data from 11 South-East Asian countries as a foundation, the review identifies critical gaps in the national-level procurement infrastructure, particularly in the availability of regulatory support, standardized procurement processes and technical specifications to support the national level procurement practice. These deficiencies highlight the need for a robust framework that supports clinical engineers in making informed, evidence-based procurement decisions. The study also emphasizes the importance of Health Technology Assessment (HTA) and Clinical Evidence Databases (CED) as essential tools for evaluating the safety, effectiveness and long-term performance of medical devices. In addition to technical evaluation, the research highlights the necessity of standardized procurement guidelines and detailed technical specifications to reduce variability in device quality and ensure compliance with national and international standards. The role of continuous education and training is also examined, stressing that clinical engineers must stay updated on advancements in medical technology, regulatory requirements and sustainability practices to effectively support procurement processes. By continuously upgrading their knowledge and skills, clinical engineers can ensure that procurement decisions are aligned with the current best practices and healthcare priorities. Collaboration among key stakeholders including governments, regulatory authorities, manufacturers and clinical engineers is identified as crucial for establishing transparent, efficient, and equitable procurement systems. Regulatory bodies must ensure that all devices meet stringent safety and performance standards, while manufacturers need to provide accurate technical data and engage in sustainable production practices. Governments, in turn, play a critical role in centralizing procurement processes, standardizing guidelines and facilitating partnerships across the public and private sectors. This research concludes that by effectively putting clinical engineering support systems in place, national procurement strategies can be significantly enhanced. It is hoped that this integration will not only streamline procurement processes but also improve healthcare delivery and patient outcomes in ensuring that devices procured at the national level meet the highest standards of safety, quality, and sustainability.