Abstract：Objective To realize the quality control of high frequency electric knife, and control the risk of high frequency electric
knife from every link through establishment of high frequency electric knife quality control system based on Deming cycle. In
addition, the application quality of high frequency electric knife was continuously improved through the reciprocating cycle of the
four steps of deming cycle to improve its safety and effectiveness. Methods Four steps of plan, do, check and action of Deming cycle
were applied to the quality control of high frequency electric knife. In the plan stage, the testing cycle of high frequency electric knife
(including routine inspection and periodic detection) was adopted by the medical equipment scoring system based on risk analysis,
and the testing content and method were determined. During the do phase, the quality test of the high frequency electric knife was
performed according to the planned plan, and the test results were recorded. During the check phase, the test results of the records
including the analysis of the test results of the single electric knife, the measurement uncertainty of the single electric knife, and the
analysis of the overall positive rate were analyzed. During the action stage, the electric knife was repaired, maintained and reported
to the disabled according to the results of the analysis. Results The application quality of high frequency electric knife had been
improved effectively. The safety and effectiveness of the clinical application was improved, and the incidence of adverse events was
reduced. Conclusion The establishment of high frequency electric knife quality control system based on deming cycle makes the
quality control system of high frequency electrotome more comprehensive, scientific, effective and more sustainable. And it makes
the application of electric knife more secure and provides a strong technical guarantee for the safety of clinicians and patients.
芦铭. 基于戴明循环的高频电刀质量控制体系的建立[J]. 中国医疗设备, 2018, 33(3): 60-65.
LU Ming. Establishment of Quality Control System for High Frequency Electrotome Based on Deming Cycle. China Medical Devices, 2018, 33(3): 60-65.
