Sep 9 2010
More than 350 leading health experts from over 100 countries meet today at a World Health Organization (WHO) forum in Bangkok, Thailand to review new evidence and agree ways to improve developing country access to life-saving medical devices.
"The medical device industry holds great promise for public health, sometimes spectacular promise, sometimes seductive promise," said Dr Margaret Chan, WHO Director-General. "Health officials and hospital managers in all countries, at all levels of development, need guidance. We are also holding this forum because the unquestionable benefits of medical devices are so unevenly and unfairly distributed."
What are medical devices?
Today there are some 10 500 different types of medical devices on the market. They range from high-cost, high-tech diagnostic and therapeutic equipment such as linear accelerators to treat cancer to stethoscopes and other basic technologies that help doctors and nurses provide health care on a daily basis. They also include devices that improve millions of people's lives such as wheelchairs, hearing aids, eyeglasses, pacemakers and prostheses. A new WHO study, Medical devices: managing the mismatch; and an ongoing survey that has so far mapped medical device use in 140 countries, reveal that too many people are currently excluded from their benefits.
Why is access to medical devices variable?
Revenue from sales of medical devices worldwide was estimated at around US$ 210 billion for 2008. Four fifths of that revenue comes from sales in the Americas and Europe. The ongoing WHO survey reveals that the average availability of computed tomography (CT) scanners is one per 64 900 people in average in high-income countries, but one per 3.5 million people in low-income countries. Ten countries have so far reported to WHO that they have no radiotherapy unit at all, depriving almost 100 million people of access to cancer treatment.
Affordability is one problem. Worldwide, annual government expenditure on health ranges from well over US$ 7 000 per person to less than US$ 10. Low levels of expenditure on health in general lead to low levels of expenditure on medical devices. This, in turn, leads to inadequate investment in all forms of medical devices: in some countries, shortages of needles, syringes, and sterilizing equipment mean that up to 40% of injections are unsafe.
A second problem is that most medical equipment used in low-resource settings is imported or donated from industrialized countries. Many of these devices do not function properly.
A third problem is lack of capacity. In many areas, devices are not used to full effect because of erratic power supplies, uncertain water quality, a shortage of health personnel, limited training capacity, difficulties in getting spare parts, and poor or inadequate maintenance.
A fourth challenge is the absence of a single naming system, harmonized regulatory processes and universally standardized medical devices. This is often exacerbated by the lack of effective management of medical devices at government level and within health-care facilities.
The fifth issue is the need to focus more on ensuring that medical devices fulfil their potential to improve public health. This means increasing access to the medical devices that are required to deliver basic services: blood transfusion equipment to prevent women experiencing complications in labour, anaesthesia machines, oxygen supplies and basic surgical equipment. It also means addressing new challenges in public health, notably the ongoing rise of chronic diseases such as cardiovascular disease, stroke, cancers and diabetes, and providing medical devices enabling patients to self-monitor their health.
How can the impact of medical devices be improved?
To have public health impact, devices need to be safe, affordable, accessible and appropriate. The new study highlights the advantages of technologies that use alternative power supplies, resist heat, humidity, and dust, relieve the workload, require little maintenance, and can be operated, with no risk to patient safety, by personnel with little specialized training. These include devices like simple glucose meters and test strips for diabetes patients that perform well even in hot and humid homes.
The meeting will focus firmly on improving needs assessment and increasing access to priority devices, especially in low-resource settings. It will aim to agree a set of recommended actions to improve availability, accessibility, appropriateness and safety, and produce a compilation of best practices, available resources, tools and guidelines for integrating medical devices into national health plans, as well as regulation and enforcement.
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