The management and application of cold-chain for in vitro diagnostic reagent / 中国医学装备

ABSTRACT

Objective: To carry out effective management for the cold-chain temperature of in vitro diagnostic reagent so as to provide safe and credible inspection basis for clinical diagnosis and treatment. Methods: The remote control and alarm platform of cold storage and refrigerator were applied to achieve acceptance for temperature control of in vitro diagnostic reagent, and achieve acceptance for temperature and achieve differentiation management for unqualified product. These methods could ensure controllability of temperature for the reagent with requirements of cold-chain. Results: Through the management of cold-chain of in vitro diagnostic reagents, hospital has achieved effective supervising for them, and hospital has concrete record for these reagents in the entire medical process, and all of them were traceability. Therefore, it provide effective guarantee for clinical safety. Conclusion: The support of informatization technique and implementation of management system of hospital can ensure the cold-chain management of entire process is not out of control, and enhance the stability and accuracy of clinical test results and effective guarantee the safety of diagnosis and treatment for hospital.