Quality of medical devices and in vitro diagnostics in resource-limited settings

Abstract

The phenomenon of poor-quality medicines in resource-limited settings is well documented, and field observations reveal similar problems with medical devices (MDs) and in vitro diagnostics (IVDs). In scientific literature, however, there are only scarce reports and documents providing evidence of quality problems of MDs or IVDs in resource-limited settings. This discrepancy may be ascribed to (i) the poor regulatory oversight of MDs/IVDs in resource-limited settings, (ii) a general lack of awareness of the problem of poor-quality MDs/IVDs amongst the scientific community and decision-makers, and (iii) poor quality assurance in diagnostic laboratories in resource-poor settings, precluding tracing quality problems of IVDs from the other potential causes of diagnostic inaccuracy. The problem of poor-quality MDs/IVDs in resource-limited settings is a complex one to address. Firstly, operational definitions for substandard and counterfeit MDs/IVDs are required, as well as ad hoc field surveys, to ensure proper appraisal of the real extent of the problem. Investments are needed to reinforce the national regulatory oversights on MDs/IVDs in resource-limited settings, and to encourage a proactive and transparent exchange of information between Northern and Southern regulatory authorities. Industrialized countries can play a role by expanding and strengthening their regulatory oversight and quality labels to those MDs/IVDs that are frequently used in resource-poor settings. Hopefully, the combination of these measures will result in better protection of patients in resource-poor countries from the effects of being exposed to poor-quality MDs and IVDs.