Assessment of the Regulatory Approval Process of Medical Devices in Ethiopia: A Mixed Sequential Explanatory Study.

BACKGROUND: Cognizant of indispensable role as important health intervention tools, the global medical devices industry continues to bring new medical devices with varying degrees of technologies and complexities. Ensuring the safety, good performance and timely access of them have become challenging for regulatory authorities, particularly for developing countries including Ethiopia. In Ethiopia, the role of the regulatory authority is complicated further because of the lack of specific policies. Medical devices regulation is still being dealt under drug policy. OBJECTIVES: This study was aimed to assess the regulatory approval processes of medical devices in Ethiopia. METHODS: A mixed sequential explanatory study design was employed. Quantitative data were collected using a structured self-administered questionnaire and standard checklist; qualitative data were collected through in-depth interviews using a semi-structured guide. RESULTS: Retrospective trend analysis (2015 to 2018) indicated that 3,804 medical devices were registered in Ethiopia. Findings from the quantitative study indicated that 73.3% of regulatory experts had commendable knowledge on the medical devices regulatory system. However, gaps were identified in inspection and auditing (63.8%), practically understanding the system and procedures (24.3%), and having competencies in executing the critical core functions (6.9%). The top five challenges reported include (i) lack of capacity to assess dossiers (80.8%); (ii) lack of effective legislation (64.1%); (iii) provision of ambiguous feedback on deficiencies after dossier evaluations and delay in their communication (63.9%); (iv) long waiting time for approval (61.1%); and (v) lack of experienced and qualified staff (55.7%). In addition, the absence of a specific policy for medical device regulation presents a great hurdle. CONCLUSION: Basic functional systems and procedures for the regulation of medical devices in Ethiopia are present. However, there are still gaps that are impeding effective regulation of medical devices especially for those with advanced features and complex-monitoring modalities.

High Mortality from Blood Stream Infection in Addis Ababa, Ethiopia, Is Due to Antimicrobial Resistance.

BACKGROUND: Managing blood stream infection in Africa is hampered by lack of bacteriological support needed for antimicrobial stewardship, and background data needed for empirical treatment. A combined pro- and retrospective approach was used to overcome thresholds in clinical research in Africa. METHODS: Outcome and characteristics including age, HIV infection, pancytopenia and bacteriological results were studied in 292 adult patients with two or more SIRS criteria using univariate and confirming multivariate logistic regression models. Expected randomly distributed resistance covariation was compared with observed co-resistance among gram-negative enteric bacteria in 92 paediatric blood culture isolates that had been harvested in the same hospital during the same period of time. RESULTS: Mortality was fivefold increased among patients with positive blood culture results [50.0% vs. 9.8%; OR 11.24 (4.38-25.88), p < 0.0001], and for this group of patients mortality was significantly associated with antimicrobial resistance [OR 23.28 (3.3-164.4), p = 0.002]. All 11 patients with Enterobacteriaceae resistant to 3rd. generation cephalosporins died. Eighty-nine patients had pancytopenia grade 3-4. Among patients with negative blood culture results, mortality was significantly associated with pancytopenia [OR 3.12 (1.32-7.39), p = 0.01]. HIV positivity was not associated with increased mortality. Antimicrobial resistance that concerned gram-negative enteric bacteria, regardless of species, was characterized by co-resistance between third generation cephalosporins, gentamicin, chloramphenicol, and co-trimoxazole. CONCLUSION: Mortality was strongly associated with growth of bacteria resistant to empirical treatment, and these patients were dead or dying when bacteriological reports arrived. Because of co-resistance, alternative efficient antibiotics would not have been available in Ethiopia for 8/11 Enterobacteriaceae-infected patients with isolates resistant to third generation cephalosporins. Strong and significant resistance covariation between 3rd. generation cephalosporins, chloramphenicol, gentamicin, and co-trimoxazole was identified. Pronounced pancytopenia was common and associated with increased mortality. HIV positive patients had no excess mortality.