Research Strategies for Quality Evaluation of Medical Wound Dressings.
10.12455/j.issn.1671-7104.250058
- Author:
Yanhui XU
1
;
Xiang LI
1
;
Jinsheng XIE
1
;
Fang LIN
1
;
Jingfeng ZHENG
1
Author Information
1. Fujian Institute for Food and Drug Quality Control, Fuzhou,
- Publication Type:Journal Article
- Keywords:
key performance indicators;
medical wound dressings;
quality evaluation system;
research strategy
- MeSH:
Bandages/standards*;
Quality Control;
Humans;
Wounds and Injuries/therapy*
- From:
Chinese Journal of Medical Instrumentation
2025;49(4):453-459
- CountryChina
- Language:Chinese
-
Abstract:
Due to the wide variety and varying quality of medical wound dressings, as well as the current lack of unified national or industry standards for regulation, this paper proposes a research strategy for establishing a quality evaluation system for medical wound dressings. By developing a technical roadmap, this strategy clarifies the process flow and key points in the quality evaluation process, establishes evaluation methods for various types of medical wound dressings, and addresses important issues such as how to determine key performance indicators based on product characteristics and how to research and validate test methods for key items. This provides a detailed and feasible research strategy and evaluation method for medical wound dressing manufacturers, testing institutions, and regulatory authorities. It reduces the difficulty and cost of quality evaluation for medical wound dressings and has certain significance in standardizing and improving their quality level, ensuring their safety and effectiveness, and serving the quality and safety regulation of medical devices..
