Development of Medical Equipment Quality Control Indicators Using the Delphi Method
- VernacularTitle:基于德尔菲法的医疗器械质量控制指标构建研究
- Author:
Xinxin HUANG
1
;
Bingzhen ZHANG
;
Liping MA
Author Information
1. 浙江大学医学院附属邵逸夫医院 浙江 杭州 310016
- Publication Type:Journal Article
- Keywords:
Delphi method;
medical equipment;
quality control;
indicators
- From:
Chinese Hospital Management
2025;45(12):11-13,26
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish quality control indicators for medical equipment,with the aim of promoting and popularizing quality control for medical equipment,and improving the overall level of quality control for medical equipment.Methods A preliminary framework and content for medical equipment quality control indicators were developed through field research,and expert inquiries were conducted using the Delphi method to ultimately construct medical equipment quality control indicators.Results Two rounds of expert questionnaires were conducted with 41 experts,both achieving 100%response rates.The expert authority coefficients were 0.91 and 0.93,respectively,with all index variation coefficients less than 0.15.Kendall's Wcoefficients of concordance were 0.185 and 0.134(P＜0.05).The reliability coefficient of the second-round questionnaire was 0.840,with all l-CVl exceeding 0.8.The universal agreement S-CVl was 0.833,and the average S-CVl was 0.972.Thus,this questionnaire demonstrates good reliability and validity.A set of 12 quality control indicators for medical devices was finally developed.Conclusion The quality control indicators for medical equipment constructed are relatively scientific,objective,reasonable,and operable.The results are highly credible and provide effective references for improving the quality control level of hospital medical equipment.
