Improving health care with medical devices
AJANTHY ARASARATNAM, JENNIFER BARRAGAN, OLUMUREJIWA FATUNDE, HEIKE HUFNAGEL, MLADEN POLUTA, ADRIANA VELAZQUEZ BERUMEN
Medical devices range from simple bandages that heal scrapes, to prostheses for amputated limbs, to Magnetic Resonance Imaging (MRI) systems that reveal inner organs without a single cut to the human body. Together, they help diagnose, monitor, treat, or mitigate virtually every disease and injury known to science. However, while more than 1.5 million types of devices are commercially available, many patients do not have access to them.
Picture the following: an under-equipped clinic receives a state-of-the-art baby incubator as a goodwill donation. Two weeks later, however, the incubator lies unplugged due to frequent power outages and power fluctuations that have made it unusable while a premature newborn sleeps inside, hugging a plastic bottle that has been wrapped in a blanket and filled with hot water.
Such make-do solutions are rarely adequate. Devices that were designed and intended for wealthier markets, or cheaper, stripped down substitutes are imported to developing countries, and thus often fail in extreme conditions of heat, dust, and unreliable power.
Low-resource settings face unique challenges including limited funding, weak procurement systems, shortage of patient safety measures, and inadequate maintenance and user training. Addressing these challenges will require context-specific devices and significant improvements in resource generation, procurement practice, medical device regulation and training.
To that end, Member States have given WHO a special mandate. In 2007, the World Health Assembly1 adopted the first-ever resolution on health technologies, which authorized the Medical Devices Unit to pull together the many jigsaw pieces necessary to enhance universal access to appropriate, quality, and safe medical devices.
This task began with a global survey, published in 2011, on the state of medical devices and related policies. It not only identified a severe shortage of appropriate medical devices for low-resource settings, but the resulting insight also allowed the Unit to identify key areas of need.
The Medical Device Technical Series, which was partially released in 2011 in English, French, and Spanish, covers topics such as sourcing appropriate donations, procurement, maintenance, and policy development. Those documents already published have been put to use in many countries with overwhelmingly positive feedback.
In Uganda, for example, the guides have been distributed to two universities offering diploma and graduate level courses in biomedical engineering, to the National Advisory Committee on Medical Equipment, and to the Infrastructure Division of the Ministry of Health. In Tanzania, the series “has boosted understanding and good practice on health technology management at large” said Valentino Mvanga, Head of Health Care Technical Services at the Ministry of Health, and has helped healthcare technology managers simplify the development of Tanzania’s device-related protocols by customizing the information to suit their environment.
The Unit is developing a Priority Medical Device Clearinghouse that will include information frequently requested by countries, such as lists of medical devices by intervention and technical specifications. The project is already making a difference. In India, technical specification templates have led to the development of specifications for a broad range of medical devices.
1 60th World Health Assembly