Standardization of the Donation Process to Low to Middle-Income Countries Based on Good Automated Manufacturing Practices Principle

The World Health Organization (WHO) estimates that 70% of medical devices in the LMIC context become decrepit before the end of their anticipated useful lives. This is mainly because the needs and associated variables of LMIC are not considered in the initial design of the medical devices, which particularly considers the needs of the initial purchaser. However, medical devices find their way to LMIC through donations. Unfortunately, it is common for the recipients to lack the necessary tools to use the donated medical devices because the donated equipment did not consider the realities of the end user.

By introducing the collaboration of the Biomedical Engineering discipline, advanced public health solutions could be materialized to optimize donated medical devices. These solutions could range from the logistical hurdles during transit to the infrastructure needs of the donation institution. Given the idealistic nature of the donation of medical devices, Biomedical Engineers could turn the efforts into a logical, practical, and realistic goal.

Due to the large complexity of the issue, this paper will focus on providing solutions to the initial donation process by utilizing aspects of Good Automated Manufacturing Practices (GAMP5). The purpose of utilizing the GAMP5 principles to the initial donation process is to reduce the number of requirements that a Biomedical Engineer must implement before the device makes it into the donation institution's workflow. By integrating GAMP5 into a standardized form within the donation process, donated medical devices would be more likely to contribute to the long-term success within the donated institution.