Risk management in POCT blood glucose monitoring: FMEA approach aligned with ISO 15189:2022.

ABSTRACT:

Objective

Point-of-care testing (POCT) blood glucose meters provide rapid and convenient monitoring for clinical care and chronic disease management. However, their accuracy is often compromised by risks associated with personnel, equipment, and procedural inconsistencies. This study systematically assesses these risks using the Failure Mode and Effects Analysis (FMEA) method and proposes control measures aligned with ISO 15189:2022 standards.

Methods

This study evaluated the risks associated with POCT blood glucose meters in clinical laboratory settings, encompassing the pre-analytical, analytical, and post-analytical phases. A multidisciplinary team employed FMEA to identify potential failure modes and their impacts. A risk matrix classified risks based on probability and

SUBMITTER: Luan X 

PROVIDER: S-EPMC11892846 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature