Asuntos regulatorios farmacéuticos: acceso abierto

La Asociación Estadounidense de Gastroenterología publicó recientemente un artículo titulado Probióticos y el microbioma : ¿Cómo podemos ayudar a los pacientes a entender los probióticos?, en el que se detallan sus planes de ofrecer un servicio de sello para las empresas que buscan fundamentar las evidencias que respaldan las afirmaciones sobre sus productos probióticos. El documento analizaba cómo, en virtud de la Ley Federal de Alimentos, Medicamentos y Cosméticos (la Ley), los suplementos dietéticos y los productos alimenticios pueden afirmar que afectan la “estructura o función” del cuerpo sin pasar por el proceso de aprobación de la FDA que se requiere para que los productos farmacéuticos hagan tal afirmación. La decisión del Congreso de tratar los suplementos y los alimentos de manera diferente a los productos farmacéuticos se basó sin duda en la seguridad relativa de los alimentos y los suplementos, porque las afirmaciones sobre la estructura/función no afirman que el producto pueda tratar, curar. o prevenir una enfermedad, y porque hay otras disposiciones en la Ley y en otras leyes que exigen que dichas afirmaciones sean veraces, no engañosas y fundamentadas. Si bien el artículo se refiere cínicamente a este marco regulatorio bien establecido como un “sistema de honor” y lo utiliza como base para defender un nuevo programa de “sello”, el hecho es que ha dado a los consumidores acceso a innumerables productos seguros, eficaces y enormes que no habrían estado disponibles si los fabricantes hubieran tenido que pasar por el proceso de aprobación requerido para los productos farmacéuticos.

The world has become obsessed with technology these days to the point that virtually everyone tends to be unaware of how the same technology could cause harm, except for a select few. In the realm of healthcare delivery, risk and compliance management are key to not only ensuring the safe application of technology in healthcare delivery, but also to providing strategies to successfully manage negative outcomes. Cardio-Pad™, a medical technology solution designed and assembled in Cameroon for ECG reading and monitoring in rural areas of sub-Saharan Africa, is examined through the lens of risk and compliance management. A good description of the components and recent updates to the operation of this device, which has received several awards for its contribution to improving the quality of healthcare delivered to citizens in rural areas of sub-Saharan Africa, is reviewed. A qualitative comparison is made of the design and operation of this device manufactured in Cameroon, a country that throughout this paper has shown little respect or desire to implement international standards regulating device production, with constant reference to international standards. The results obtained detail the various institutions in Cameroon that are typically required to support the continued development of the Cardio-Pad™. In addition, we reveal details from a risk and compliance management perspective. These small but technical details that for a layman benefiting from the application of this device cannot be seen, until one experiences the unpleasant nature of not paying attention to these details. The risk and compliance tools used in risk management are used in this paper to shed more light on what happens to this medical technology. The rhythm method is equally used to show how possible examples of compliance risk, hazard risk, control risk and opportunity risk could be effectively managed within the Cardio-Pad design team led by Arthur Zang. A main suggestion is to create a risk management and compliance department within this company. Certain activities resulting from the analysis of this device using the Rhythm Tool are also proposed to assist with the continuous improvement of this device. The suggestions in this document on what should be done by both the Cardio-Pad™ team and the Government of Cameroon through its Ministry of Public Health are used to condition the approval or recommendation of this device for international use.