Medical Devices and Equipment Procurement

Medical devices and equipment (MDEs) are broadly defined as products used in healthcare provision, whether for assistive, diagnostic, treatment or monitoring purposes. Examples include implants, in-vitro diagnostics, delivery beds, malaria nets, surgical instrumentation as well as more complex clinical equipment such as linear accelerators. The World Health Organisation (WHO) recognises the importance of MDEs in ensuring universal health coverage and urges its member states to carefully select, procure, manage and distribute technologies.

A typical MDE procurement process, which follows the device throughout its life cycle, is shown below:

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A study of low and middle income countries (LMICs), including 16 in Africa, suggests that MDEs frequently fall into disuse in resource-poor settings: 40-70% of products are estimated to be broken or remain unused in health facilities.[1] Such issues arise due to mismatches in MDE demand and supply and undiscerning procurement systems. LMIC demand focuses on the procurement of technically simple, low-cost, easy to use and maintain devices able to function in settings with limited infrastructure and user training. In contrast, MDE manufacturers are primarily active in, and attuned to, the needs of high-income settings, providing high-tech, expensive equipment which requires skilled resources and maintenance.

 MDE deployment challenges in LMICs may also arise due to a lack of technical experts able to advise on the selection of appropriate devices. Regulatory bodies able to oversee and advise on tendering are also routinely absent. These challenges result in the procurement of products unfit for use in LMICs and directly translate to lost healthcare resources and poor population health outcomes.

MDE procurement is a complex multi-level process involving multiple stakeholders, as shown below:

Macro-level stakeholders may set the overall direction or scope for MDE related resource allocation; meso-level agents (e.g. regional planners) may be responsible for the tendering and distribution of products. End-users (clinicians and patients) are mainly consulted on issues of clinical need and product experience. The involvement of multiple stakeholders and meso-level tendering by planning decision-makers, rather than clinicians, creates a user-buyer divide. There are often problems relating to culture, power and prestige as well.

Stakeholders at meso or macro levels are responsible for procuring technologies but are not direct technology users and cannot call on MDE-use experience during product selection stages. In contrast, MDE users are likely to be heavily influenced by their own clinical or procurement experience and may neglect to objectively consider all potentially appropriate technologies that would meet health service needs and be financially sustainable. A way needs to be found to integrate these activities together.

The primary factors used for selecting MDE products are: equipment cost, specialist recommendation, and technology regulatory approval. The equipment cost is often just based on the purchase price rather than whole life costs (including acquisition, installation, operating, maintenance, servicing, training, and disposal) and does not therefore truly reflect the cost of the procurement.  Furthermore, a fuller analysis is required which takes into account limited budgets and the specific concerns of LMICs.

A fully integrated decision-making system is required which integrates the three stakeholder levels and is adapted to the needs of LMICs. This is shown below:

Equipment should be prioritised: (i) according to health priorities and health service structures; (ii) according to cost effectiveness and financial sustainability; and (iii) according to relevant specifications and deployment settings. Robust communication and coordination is required to make this work. This model enables the selection of MDE products to be focused on national priorities, incorporates expertise where needed, ensures effective use of limited budgets, takes account of life-cycle costs, and enables the equipment to be fully utilised at the facility level due to its focus on LMIC requirements.

[1] https://pubmed.ncbi.nlm.nih.gov/28821280/