Quality Assurance and Calibration of Medical Devices Practices: Case Study of Government Regional Referral Hospitals in Uganda

The accuracy of medical devices directly influences clinical decision-making and overall patient outcomes. To ensure that medical devices are accurate and safe all the time, it requires robust calibration and quality assurance practices coupled with maintenance. However, this topic is underexplored in studies regarding medical devices in Uganda. Here, we examine the calibration and quality assurance best practices in regional, national, and specialized public hospitals in Uganda. Moreover, we hypothesized that calibration and QA status directly influence medical device usage. To achieve this, we conducted quantitative and qualitative research in a cross-sectional study design in 17 regional referral hospitals, 3 national referral hospitals, and 5 specialized hospitals. A structured questionnaire was administered to 42 participants, which included biomedical engineers, technicians, and maintenance officers. It covered thematic areas of examining the existence of SOPs & QA protocols, availability of test tools, equipment downtime during calibration, calibration support, and training. The results of the study demonstrated that calibration and acceptance testing of donated equipment were performed on-demand. Nearly 43% of respondents had no SOPs and QA protocol, while 26% were unsure of it. Additionally, 20 of 42 respondents recorded the unavailability of test tools. Furthermore, about 75% of the respondents’ sentiment revealed that calibration status directly affects use. This was consistent with a 71% score for a more than 1 month period on average time a medical device remains grounded as it waits for calibration. Overall, the calibration and QA practices of medical devices in public hospitals in Uganda are still in their infancy. It requires administrative, technical, and financial support. This study will become a precursor to calling for more effort, guidance, and strengthening the calibration and QA practices among biomedical engineers in Uganda.