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

Area of Science:

• Medical Devices and Diagnostics
• Global Health
• Regulatory Science

Background:

• Poor-quality medicines are documented in resource-limited settings, with similar issues observed for medical devices (MDs) and in vitro diagnostics (IVDs).
• Scientific literature lacks comprehensive reports on the quality problems of MDs and IVDs in these regions.
• Discrepancies are attributed to weak regulatory oversight, limited awareness among stakeholders, and inadequate quality assurance in diagnostic laboratories.

Purpose of the Study:

• To highlight the underreported issue of substandard and counterfeit MDs and IVDs in resource-limited settings.
• To identify key challenges hindering the assessment and reporting of MD and IVD quality issues.
• To propose strategies for improving the quality and safety of MDs and IVDs in underserved regions.

Main Methods:

• Literature review and analysis of existing reports on medical product quality.
• Identification of factors contributing to the scarcity of data on MD and IVD quality.
• Synthesis of expert observations and potential solutions.

Main Results:

• A significant gap exists between observed quality issues with MDs/IVDs and documented evidence in scientific literature.
• Weak regulatory frameworks and lack of awareness are primary reasons for underreporting.
• Diagnostic inaccuracies can be misattributed due to poor laboratory quality assurance.

Conclusions:

• Addressing poor-quality MDs and IVDs requires clear definitions, field surveys, and strengthened national regulatory oversight.
• Enhanced information exchange between regulatory authorities globally is crucial.
• International collaboration, including expanded quality labeling by industrialized nations, can improve patient safety in resource-limited settings.