Single-use Medical Devices Re-processing: Regulatory Status Quo.
10.3969/j.issn.1671-7104.2018.03.015
- Author:
Huihui WEI
1
;
Yumei WANG
1
;
Xiaojie DUAN
1
;
Wanhui LIU
2
;
Zhaopeng YANG
1
;
Liming XU
1
Author Information
1. National Institutes for Food and Drug Control, Beijing, 100050. ##Email#.
2. School of Pharmacy, Yantai University, Yantai, 264005. ##Email#.
- Publication Type:Journal Article
- Keywords:
regulatory status quo;
reprocessing;
risk assessment;
risk control;
single-use device(SUD)
- MeSH:
China;
Equipment Reuse;
Equipment Safety;
Equipment and Supplies;
Risk Assessment;
United States
- From:
Chinese Journal of Medical Instrumentation
2018;42(3):210-214
- CountryChina
- Language:Chinese
-
Abstract:
Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the regulatory status quo of single-use medical devices is reviewed. The regulatory development, important regulatory documents and regulatory approaches of single-use medical device reprocessing in the United States, Germany and the UK are introduced. And how to perform scientific risk assessment and effective risk control is discussed. The information is useful to establish China-specific regulations, and to develop relevant standards, guidelines or specifications and the risk control strategies.
