Module 6: Equipment and Medical Devices

Standardization

During the 7th Annual Unite For Sight Conference in April 2010, Jeffrey Sachs identified the provision of modern technology to underprivileged societies as a crucial action step for the success of the Millennium Development Goals, a set of international development goals that all United Nations countries agreed to achieve by 2015.(1) Medical technology has long been a valuable commodity, and in 2006, the medical device market was valued at over 260 billion dollars. (2) Because of relatively loose regulations in the developing world, developing countries often import substandard equipment. Nevertheless, with the high cost of modern medical equipment, developing countries need to make smart investments of their money, ensuring that their money goes towards high quality instruments. Consequently, international standards and vigilance must be enforced to ensure quality and safety.(3)

For the past 50 years, International Organization for Standardization (ISO) has been active in developing countries to provide technological expertise and regulation. In addition to the importation of medical technologies, the ISO has also been active in regulating the manufacturing of products within developing countries themselves. This practice ensures that developing countries are more likely to be able to export their products. The ISO also seeks to increase awareness in the population about the needs for standardization, while growing IT and local participation. 

Diagnostic Equipment

In health clinics, one’s blood, feces, urine and secretions can be used to diagnose a wide array of diseases and conditions. All of these diagnostic procedures, however, rely on a set of specific diagnostic tests that are often unavailable in the developing world. Without these tests, physicians make their diagnoses based on observing a set of symptoms. This is often an inaccurate science at best, as many symptoms such as fever, chills, or diarrhea can be common to a variety of different diseases.(4)

Diagnosing the inappropriate disease can lead to health complications by prescribing the wrong medication, which can lead to significant side-effects without therapeutic benefits. Worse, prescribing the wrong medication can lead to the development of drug resistance, making it much more difficult for global health workers to effectively medicate the population. For instance, multi-drug resistant tuberculosis (MDR-TB) is an emerging public health concern in the developing world and could become uncontrollable.  

To resolve this difficulty, new, cheap diagnostic tests have emerged. These tests allow diagnoses to occur at smaller, local clinics, rather than larger hospitals, which can be located at some distance from patient homes. Using the technology from home pregnancy tests, an organization called PATH has introduced similar tests for diagnosing hepatitis B and malaria, although these technologies have yet to become as accurate as laboratory tests.(5) PATH is currently working with the University of Washington to develop a project called the Center of Point-of-Care Diagnostics for Global Health, which is working on pursuing and funding research on practical diagnostic technologies and field testing.(6)

One specific technology that has emerged Is called a “lab-on-a-card,” a credit-card shaped piece of plastic that contains a myriad of chemicals and reagents. A stool or a blood sample can be injected into the card, which then gives the spectrum of results within 20 minutes, quickly diagnosing the disease. The card is also designed to be sturdy, contamination-free, simple, and inexpensive.(7) Other rapid tests are being developed by PATH and others to test vitamin A deficiency and screen for cervical cancer.

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Footnotes

(1) Sachs, J. “Breakthroughs in Health Care Delivery in Low Income Settings.” Unite For Sight Global Health and Innovation Conference. 2010. New Haven, CT, Yale University. 

(2) World Health Organization. “Medical Device Regulations: Global Overview and Guiding Principles.” World Health Organization. 2003. Geneva, Switzerland. Accessed on June 9, 2010.

(3) Ibid.

(4) PATH. “The Right Diagnosis, the Right Treatment.” PATH. 2010. Accessed June 22, 2010.

(5) PATH. “Diagnostics Center.” PATH. 2010. Accessed June 23, 2010.

(6) Ibid.

(7) PATH. “New Channels for Rapid Diagnosis: Using Microfluidic Tests to Identify Infection.” PATH. 2010. Accessed June 23, 2010.