Well, as one would say, healthcare devices play a very important role in the provision of healthcare and improving health at all levels: the individual and the population. WHO recognizes this. The organization states, “One of WHO’s strategic objectives is to ensure improved access, quality and use of medical devices.” Routine medical procedures from bandaging a sprained ankle to diagnosing HIV/AIDS or implanting an artificial hip would not be possible without medical devices. Meanwhile, technological innovation is so productive that such a huge amount of medical devices are manufactured at such a rate that yesterday’s newest device is obsolete before the ink dries on the instruction manual for today’s newest device. Some of the serious issues that affect the trajectory are-they are too diverse, too diverse in terms of types of devices, degree of complexity, applications, uses, users, categories, etc. And then there is the issue of medical device context dependency, research in medical devices is often not based on public health needs.
But as part of healthcare, medical devices will be best used within the more general context of a comprehensive healthcare package, which is deemed sufficient to meet public needs: prevention, clinical care (screening, diagnosis, treatment and management, follow-up and rehabilitation) and access to appropriate healthcare.
Rather than taking a stance on the fact that medical devices exist, and then simply waiting for the fruits of their technological readiness, what is really needed is a redefinition of what is still required for medical devices within an agenda that will make full universal access more of a fact. This agenda includes the crucial “4 A’s”: availability, accessibility, suitability and affordability. There are four dimensions in which the medical devices agenda extends from upstream innovation activities to rational choices about which medical devices to purchase, based on need, and then how to apply them in an efficient manner that leads to optimal improvement in health. A medical device that is fully appropriate for the specific context or setting for which it is intended is a medical device that is fully appropriate for that given context or setting.
The context here refers to the correct use of appropriate medical devices with a health need, designed to solve it in the best possible way, meeting the stated need. In practice, almost every second device developed in the developing world was designed for use in the developed world. Three quarters of these do not work in the new environment and simply remain collecting dust. Factors include the absence of needs assessment, proper design, well-built infrastructure, spare parts available in case of equipment breakdown, consumables and lack of knowledge in the procurement and maintenance of devices, among healthcare workers. Most of these problems are part of a larger problem in most countries: the absence of a medical device management system.
Even more worrying is that the latest, innovations and practices related to medical devices, with regard to their choice and application are not generally aligned with public health needs. For a scheme aimed at making relevant medical devices accessible worldwide, WHO conducted the Priority Medical Devices Project, thus establishing a health-based approach to medical devices. This starts with the identification of the most serious health problems; on a global scale, this therefore means the use of global burden of disease and/or disease risk factor estimates1. Proper reference to appropriate relevant clinical guidelines is included here in the second step, which presents the highlights of how best to manage the health problems.
Then after all those two earlier steps, it was necessary to relate the results in the third and final step to produce a list of key medical tools that would be needed to manage the identified high-burden diseases at any level of health care provision and in any context. This step-by-step approach enabled the PMD project to identify and highlight all relevant key medical tools for the treatment and management of global high-burden diseases within relevant clinical guidelines. Indeed, the lack of mention of any of the ancillary products needed to help improve the functionality of people with such diseases was a particular cause for concern.
Another challenge is that proper equipment management is never established neither at the government level nor within health care facilities. Lack of standardization can also greatly hinder the usability and integration of devices. Some of these possible answers would include the design of medical devices to make them more appropriate for the given context and increased focus on better staff training in the specific use of particular medical devices. This report describes how an agenda on access to appropriate medical devices could be structured through the application of critical 4 components: availability, accessibility, suitability and affordability for 15 global high-burden diseases, as well as some cross-cutting issues. Some of the findings from this research point to several areas that should be researched to facilitate the availability, accessibility, suitability and affordability of medical devices. Development of portable affordable spirometry equipment for appropriate diagnosis and prognosis of chronic obstructive pulmonary disease (COPD) or asthma in low-resource settings; and the development of more suitable hearing aids, which can help people with hearing impairment, regardless of their age or condition.
One of the cross-cutting issues that will be considered as an excellent example is the development of simple, affordable and reliable susceptibility tests for bacterial and viral antigens.
These tests will effectively and efficiently replace culture systems for detecting pathogens and can potentially aid in the diagnosis of many high-burden infections and neglected tropical diseases. The "4 A" questions - Is the medical device: Available? Accessible? Appropriate? Affordable? - have been applied to some examples of key medical devices identified in an effort to further investigate downstream issues associated with poor access to appropriate medical devices. The PMD project hopes that all players in the medical device sector can use the findings of this report to help make public health a core focus of their activities, as well as build on the policies, tools and innovations of the WHO Global Initiative for Health Technologies.
