Regulation of medical diagnostics and medical devices in the East African community partner states.

BACKGROUND: Medical devices and in vitro diagnostic tests (IVD) are vital components of health delivery systems but access to these important tools is often limited in Africa. The regulation of health commodities by National Regulatory Authorities is intended to ensure their safety and quality whilst ensuring timely access to beneficial new products. Streamlining and harmonizing regulatory processes may reduce delays and unnecessary expense and improve access to new products. Whereas pharmaceutical products are widely regulated less attention has been placed on the regulation of other health products. A study was undertaken to assess regulation of medical diagnostics and medical devices across Partner States of the East African Community (EAC). METHODS: Data was collected during October 2012 through desk based review of documents and field research, including face to face interviews with the assistance of a structured questionnaire with closed and open ended questions. Key areas addressed were (i) existence and role of National Regulatory Authorities; (ii) policy and legal framework for regulation; (iii) premarket control; (iv) marketing controls; (v) post-marketing control and vigilance; (vi) country capacity for regulation; (vii) country capacity for evaluation studies for IVD and (viii) priorities and capacity building for harmonization in EAC Partner States. RESULTS: Control of medical devices and IVDs in EAC Partner States is largely confined to national disease programmes such as tuberculosis, HIV and malaria. National Regulatory Authorities for pharmaceutical products do not have the capacity to regulate medical devices and in some countries laboratory based organisations are mandated to ensure quality of products used. Some activities to evaluate IVDs are performed in research laboratories but post market surveillance is rare. Training in key areas is considered essential to strengthening regulatory capacity for IVDs and other medical devices. CONCLUSIONS: Regulation of medical devices and in vitro diagnostics has been neglected in EAC Partner States. Regulation is weak across the region, and although the majority of States have a legal mandate to regulate medical devices there is limited capacity to do so. Streamlining regulation in the EAC is seen as a positive aspiration with diagnostic tests considered a priority area for harmonisation.

[Cross-sectional study of iron level during pregnancy at the Mohamed V Military Training Hospital, Rabat]. / Etude transversale du statut martial au cours de la grossesse à l'Hôpital Militaire d'Instruction Mohamed V, Rabat.

Iron deficiency is the most widespread nutritional disorder. Anaemia during pregnancy is common in developing countries. The purpose of this study was to check iron levels during pregnancy by evaluating laboratory indicators of iron deficiency. Our study was conducted in the Department of Obstetrics and Gynaecology of the Mohamed V Military Training Hospital (MVMTH) and included 66 patients monitored during three trimesters of pregnancy. Biochemical tests including ferritin, serum iron, CRP and blood counts were performed. The average age of patients was 28.3 years, with a standard deviation of 5.2. The prevalence of iron deficiency was 15.2% (n = 10), 25.8% (n = 17) and 42.2% (n = 28) in the first, second and third trimester, respectively. Anemia progressed from 10% (n = 7), 24% (n = 16) to 42% (n = 28). ANOVA test was used to compare the means for the parameters serum ferritin and iron, hemoglobin and hematocrit within the three trimesters. This showed a significant difference with p = 0.001. This study highlights a high prevalence of iron deficiency during pregnancy, especially in the third trimester, that would justify a systematic iron supplementation.