Study on Risk Assessment Model of in Diagnostic Reagent Adverse Events Based on BP Neural Network.
10.3969/j.issn.1671-7104.2019.02.017
- Author:
Qing ZHU
1
;
Jing DING
1
;
Wenxia REN
1
;
Yangdui MAO
1
;
Wen WANG
2
Author Information
1. Zhejiang Pharmaceutical College, Ningbo, 15100.
2. Center for Medical Device Evaluation in Zhejiang Province, Hangzhou, 311100.
- Publication Type:Journal Article
- Keywords:
BP neural network;
adverse events;
in vitro diagnostic reagents;
pre-filtering;
risk assessment
- MeSH:
Indicators and Reagents;
adverse effects;
Neural Networks (Computer);
Risk Assessment
- From:
Chinese Journal of Medical Instrumentation
2019;43(2):136-139
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To modify the monitoring process and means of adverse events diagnostic reagents,improve the quantity and quality of adverse events reported ,and reduce the workload of regulatory authorities,eventually ensure the safety and effectiveness of diagnostic reagents.
METHODS:The pre-filtering risk assessment system based on BP neural network was used to evaluate the adverse events of diagnostic reagents.According to the evaluation results,the administrative supervision departments took corresponding countermeasures.
RESULTS:The BP neural network learned the historical data,and the risk evaluation results of the adverse events were basically consistent with the expert group.
CONCLUSIONS:BP neural network can be used to evaluate the risk of adverse events and achieve risk signal aggregation of adverse events.
