Global Impact: Discuss how bioengineering and biomedical systems can be geared toward the developing world.
Medical devices save lives, but only if they are appropriate and functional: It's the challenge of ensuring quality care in limited-resource settings.
By Jennifer Barragán
Walk into almost any hospital, medical center, clinic, or doctor’s office in the developed world and you are presented with a staggering array of medical devices. The constant murmur of technology makes it clear exactly where you are, and its absence would, in fact, scare you.
A medical facility is essentially defined by the equipment it contains. Perhaps it is a specialized cancer treatment hospital with complex technology like MRI or radiotherapy units. Or it is an emergency trauma center with life-saving resuscitation equipment. Perhaps it is a doctor’s office with the standard examination bed, scale, and blood pressure monitor.
If you are seeking medical treatment, you rely on these devices for your care. However, they are rarely noticed or considered, unless they fail, that is. Fortunately, for most high-income countries, this is a rare occurrence because there are engineers and technicians working to maintain and repair equipment; their daily work helps to ensure patient safety. While some believe there is a need for improvement in our health care system, we can generally rely on accurate and safe screenings, diagnosis, treatment, and rehabilitation. This is, unfortunately, not the case in most of the world.
According to the World Bank, 67 percent of the world’s nations are classified as low- or middle-income. In these countries quality health care is a luxury many cannot afford and in some of the world’s most impoverished areas it is not even an option. Walk into a public health care facility in some disadvantaged areas and what you immediately notice is the poor conditions in which patients are seeking care: patients lying on the floor because of a lack of beds, broken equipment littered throughout the facility, and seeming lack of organization.
This is a dire picture and it is not always the case; however, common themes prevail in health facilities in low- and middle-income countries including the many issues surrounding access to medical devices. Issues include inappropriate technology and donations; lack of spare parts or consumables; poor access to electricity; little or no preventive maintenance; no adverse event reporting; inadequate training for personnel, both clinical and technical; and lack of human resources. Despite the number of challenges, according to the World Health Organization’s 2010 report, Medical Devices: Managing the Mismatch, there is much that can be done to make medical devices “appropriate, available, accessible, and affordable.”
PUBLIC HEALTH AND MEDICAL DEVICES
Public health projects have, until recently, generally focused on “vertical” solutions—that is, they have tended to focus on specific diseases. While this trend continues, more attention is being paid to “horizontal” solutions, that support health systems in preventing, diagnosing, and treating all illnesses, disorders, and disabilities.
Medical devices are an essential component of health systems, but have gone largely unaddressed by world leaders. The reason for this may be due to a lack of understanding of what is required to ensure that medical devices are available to serve their intended purpose, a lack of technical expertise, or misconceptions surrounding financial costs.
 Sophisticated medical devices are used to monitor a new-born in the maternity ward of a rural hospital in Kyrgystan.
Without appropriate and functional devices a health system cannot deliver quality health care. It is as basic as the availability of stethoscopes and thermometers and as complex as the guaranteed continual operation of a radiotherapy unit for the treatment of cancer.
Furthermore, the benefits of appropriately managing medical devices may be underestimated.
Oxygen, for instance, is critical for the treatment of many illnesses, both chronic and acute. In developed countries, oxygen is typically continuously available in hospitals via piping systems. In some settings, however, such systems are too costly. Oxygen tanks or oxygen concentrators can be used, but procurement of these must be done carefully in order to consider appropriate resupply needs and maintenance costs respectively.
Without the proper tools, even if well trained clinical personnel are in place, medical care will be limited. Worse yet, physicians and nurses tend to leave when they lack the tools to do their jobs effectively. Working in an environment where little can be done to help a patient, with the end result often being the loss of human life, is frustrating, depressing, and discouraging.
Providing access to medical devices and their associated consumables—film for x-ray machines or test strips for glucose analyzers, for example—can be a factor in reversing the flow of clinicians out of developing countries. Despite poor financial compensation, ensuring the availability of medical devices may increase the willingness of staff to continue working in their countries. There is a huge advantage in procuring the appropriate equipment and maintaining it throughout its lifetime. This guarantees it is available and functional when needed, leading to better health outcomes. Additionally, making the proper financial investment avoids excessive costs resulting from preventable corrective maintenance expenses or premature replacement of the unit itself.
There is now an increasing interest in medical devices and work is rapidly advancing to provide guidance to countries from international organizations such as the World Health Organization. Additionally, much attention is being paid to the development of innovative technologies. Companies, non-governmental organizations, and universities are working to design devices that are robust, require little or no electricity, have reusable components, are simple to use, and address the most important diseases affecting the developing world today.
WHO has published Compendium of New and Emerging Health Technologies, which describes many examples of such technologies, some in development and others being commercialized.
A rural health care center in Ethiopia provides a basic form of care, lacking advanced medical hardware.
Fetal monitoring is a critical component of prenatal care in high-income countries. Complex devices are used to monitor the heart rate of the fetus before and during labor, and provide a continuous reading of the heart rate. In developing countries , these devices are generally not available so the Pinard stethoscope, which is placed against the mother’s abdomen, is used instead. It is an inexpensive, simple, and readily accessible device but unfortunately, will not provide the level of clinical information that a monitor can.
The Compendium, meanwhile, describes alternative fetal monitoring devices more appropriate to use in low-resource settings. One, which has been commercialized, uses Doppler ultrasound technology and is run on batteries charged by hand cranking.
While designing devices is certainly one solution to this vast problem and the solution most often accredited to engineers, it is not the only one engineers have the capability to be involved in. There are many challenges to be addressed and engineers can play a critical role in each of them to ensure that change is effective and sustainable.
WHAT ARE THE CHALLENGES?
Certain circumstances in developing countries directly influence how medical devices benefit the general public. Countries with few resources tend to have poor infrastructure, meaning that electrical systems, water supply, and roads are often inadequate to support device functionality or the transport of patients or medical equipment. The financial situation also limits how much money is allocated for health care and within that how much is allocated to supporting medical devices.
Many of these same countries have large rural populations, resulting in smaller facilities located in difficult-to-access locations often without the benefit of any electricity, running water, or mobile cell coverage. Larger district hospitals may be better positioned but are still often a fair distance from the rural population. Primary care at the health post and health center level becomes critical as a result. This is all within a political context that may or may not look to meet people’s needs and expectations for health coverage.
It is the responsibility of the engineer to understand these issues and those specific to the environment in which one will work in order to effectively address challenges such as:
• Limited financial resources that affect the amount invested in procuring, maintaining, and managing equipment;
• Lack of available information required to perform needs assessments, regulate medical devices to ensure patient safety, and procure appropriate equipment;
• Poor supply chain management that can limit the availability of consumable and spare parts;
• Lack of training institutions or programs to train biomedical engineers or technicians in the management and maintenance of medical equipment;
• Receipt of inappropriate donations from well-intentioned donors who are unaware of what is required to make a device an asset and not a burden;
• Insufficient clinician and operator training on medical devices;
• Mismanagement of medical equipment due to lack of inventories, preventive maintenance, and disposal policies;
• Poor awareness of the components of the medical device life cycle on the part of policy and decision makers as well as hospital managers, doctors, nurses, and other health care staff.
THE FUTURE
So what can be done? It is important to continue to innovate but innovation in this context does not consist of just designing new devices. It is also important to find innovative solutions that will increase access to safe and effective medical devices.
It is critical that international organizations, non-governmental organizations, universities, professional societies, medical device companies, and individuals work together. Development work is often criticized for its large expenditures and lack of positive outcomes, and while this is an oversimplified and distorted view, there is room for improvement in partnership. Too often organizations work in parallel rather than together. Too often solutions are reinvented because of lack of awareness of what others are doing. Too often organizations compete for funds and the activities that they will address thus blocking each other’s work and detrimentally impacting the persons they have signed on to assist. In a super-connected world, where social media has the ability to drive policy, this should not continue to happen.
While interventions will vary depending on the country, region, or village to be served, there is much to be learned from each experience that can be applied on a global level. Nonetheless, the emphasis should be placed on community involvement. For change to be sustainable, the community must be driving the solutions and national leaders must understand and be on board with any proposed work. Where corruption exists, innovative thinking is essential.
Both short-term and long-term solutions are necessary to save lives and promote better health. Without short-term interventions, people will fail to get the care they need and will die unnecessarily. Without long-term projects, the situation will remain essentially unchanged and quality health care will continue to be out of reach for most of the world’s disadvantaged.
Short-term solutions include enhancing appropriate donations of medical equipment where donors and solicitors are equal participants, building capacity by training technical staff, and providing maintenance support from sources outside the country.
Long-term solutions include advocacy and promoting the importance of medical devices to policy makers and donors alike making the issue attractive enough to invest in. Success stories, such as the ones presented by the Gambia and Jordan at the First WHO Global Forum on Medical Devices, can help in such promotion.
Long-term solutions involve economic and professional infrastructure: building in-country capacity to procure locally from national equipment suppliers rather than relying on international donations thereby improving the national economy; enhancing the recognition of low-resource settings as genuine markets and encouraging major medical device manufacturers to invest in them; developing national research, development, and manufacturing capabilities; increasing the national technical pool by designing diploma and baccalaureate degrees in biomedical engineering or technology; providing data on medical devices such as generic technical specifications, clinical practice guidelines, and a country’s disease burden to enable informed decision making; and improving health financing models.
Some solutions serve in both the short- and long-term. Innovation, if the device can be designed and quickly tested and approved by regulatory authorities, has the potential to work in the short term and of course will provide a way to address the burden of disease in the long term. Medical Devices: Managing the Mismatch, prepared as part of WHO’s Priority Medical Devices project, lists areas of research yet untapped but critical in addressing the global disease burden.
Telemedicine, and other e-health and mobile health projects, can respond to the issues surrounding rural access to health care. The medical device industry can work in partnership with national governments to provide appropriate medical equipment at an affordable cost through purchase pooling and can serve as an honest arbitrator in peripheral activities such as the provision of service contracts where expertise may not be available locally.
Quality health care will not result from dealing with the issue of medical devices nor health systems alone but from looking at the development picture as a whole. There are political, economic, and environmental factors that must be considered. Innovative devices are a great solution but if designed without input from the community, without political buy-in, or without an idea of how the technology will be supported when the implementing organization is gone, any progress made will be short-lived. When we address management of medical devices at the hospital level but fail to consider national health policies, financial constraints, and political will, success will be limited to the lucky few. When we work without input from experts in other fields, we lose an opportunity to broaden our scope of impact.
While the problem of how to address technology issues in the developing world has been around for decades, new momentum exists to ensure that this generation is the one that makes the changes stick. Engineers are touted as problem solvers and it is their unique thinking that will result in our ability, sometime in the near future, to walk into a health facility anywhere in the world and hear that comforting murmur of technology.
DIFFICULT DECISIONS
What would you do if posed with the decision to purchase a CT machine or laboratory diagnostic equipment for a hospital in a developing country? These decisions are faced routinely by hospital managers but often they are not equipped with the information needed to make the right choices. The impact on the health of the population should be the primary driver, but sometimes managers, with their desire to modernize, may overlook some critical facts. In the developing world in particular, limited budgets require careful purchasing.
As a theoretical example, consider a population where the primary disease burden is malaria, diarrheal diseases, and HIV, but the local hospital decides to purchase a CT scanner. This is an inappropriate use of funds as the public health needs of that population indicate that the laboratory diagnostic equipment (e.g. microscopes, centrifuges, chemistry analyzers, and CD4 machines) will improve the health of the population more than would the purchase of a CT.
Furthermore, those making procurement decisions sometimes see only the cost of the device itself (the tip of the iceberg really) and do not take into account all the costs associated with keeping a unit running. This includes the cost of installation, of training, of maintenance and repair, of consumables and spare parts.
When total costs are considered, a better decision as to what to procure can be made. In another theoretical example, given a certain budget a health care manager can purchase five x-ray machines outright but instead a better choice might be to buy just three to cover the ancillary costs and increase the chances that the purchased units will remain operational. If only the cost of the unit is considered, much more will have to be invested to support and operate them. It is also important to consider that machines that are not properly installed or maintained can lead to patient safety issues, ranging from misdiagnosis to fatalities.
The problems faced are often quite more complex but guidance for countries is being developed that will hopefully address these complexities and lead to an increased number of medical devices available to the population.
TO LEARN MORE
For more information on the WHO’s work in medical devices, you can visit www.who.int/medical_devices/ or contact medicaldevices@who.int
The Power and Potential of Medical Devices video can be found at www.youtube.com/watch?v=92wBe8eTKBY
The WHO report Medical Devices: Managing the Mismatch is online at whqlibdoc.who.int/publications/2010/9789241564045_eng.pdf.
Compendium of New and Emerging Health Technologies can be downloaded at www.who.int/medical_devices/innovation/new_emerg_tech/en/.
A record of the First WHO Global Forum on Medical Devices, including the success stories of Gambia and Jordan, is available at www.who.int/medical_devices/gfmd/en/index.html.
Steps being taken by WHO to address issues affecting the health workforce are outlined at www.who.int/hrh/resources/strengthening_hw/en/index.html.
For a report on the health workforce crisis, particularly in Africa, see www.mckinseyquarterly.com/Addressing_Africas_health_workforce_crisis_2079. Accessing the full article requires registration at the Web site.
Jennifer Barragán is a biomedical engineer in the Medical Devices unit of the World Health Organization. She previously served as the medical equipment program manager for the Clinton Foundation Health Access Initiative in Ethiopia and as a biomedical flight controller in Mission Control at NASA’s Johnson Space Center.
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