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Xiagang Luan

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Articles

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

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By Lingling Ke, Minxuan Feng, Weiqun Peng, Xiagang Luan
| PLOS ONE
Discussion This study systematically employed Failure Mode and Effects Analysis (FMEA) to assess the clinical use of point-of-care testing (POCT) blood glucose meters at two hospitals, aligning with ISO 15189:2022. The analysis identified critical risks, including inadequate performance verification prior to hospital entry, insufficient personnel training, data management deficiencies, insufficient calibration and inadequate quality control (QC) [10,11].
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