The world has become obsessed with technology these days to the extent where virtually everyone tends not to know how the same technology could cause harm, but for a few. In the healthcare delivery setting, risk and compliance management are key in not only ensuring the safe application of technology with healthcare delivery, but also provides strategies to effectively manage negative outcomes. Cardio-Pad™, a medical technology solution designed and assembled in Cameroon for reading and monitoring of ECG’s in rural areas of Sub-Saharan Africa, is scrutinised through the lens of risk and compliance management. A good description of the components, and recent upgrades to the functioning of this device, which has received several awards for its contribution in improving the quality of health care delivered to citizens of rural areas in Sub-Saharan Africa is reviewed. A qualitative comparison of the design and functioning of this made-in-Cameroon device, a country, which all through this paper is proven to have little respect or desire to implement international standards regulating the production of devices, is carried out with constant reference to international norms. The results obtained details the various institutions in Cameroon which should normally support the continues development of the Cardio-Pad™. It furthermore reveals details from the view of risk and compliance management perspectives. These small but technical details which to a layman who benefits from the application of this device cannot be seen, until one gets to experience the ugly nature of not paying attention to these details Risk and compliance tools used in managing risks are employed in this paper to shed more light on what befalls this medical technology. The paced 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 lead by Arthur Zang. A chief suggestion of creating a risk and compliance management department within this company is proposed. Certain activities resulting also from the analysis of this device using the paced tool are proposed to help with the continues improvement of this device. The suggestions of this paper about what needs to be done both by 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 to be used internationally.
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Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
