Single-use Medical Devices Re-processing: Risk Assessment and Quality Control Technologies.
10.3969/j.issn.1671-7104.2018.05.016
- Author:
Huihui WEI
1
;
Xiaojie DUAN
1
;
Wanhui LIU
2
;
Qingquan HUANG
1
;
Zhaopeng YANG
1
;
Yumei WANG
1
;
Liming XU
1
Author Information
1. National Institutes for Food and Drug Control, Beijing, 102629.
2. School of Pharmacy, Yantai University, Yantai, 264005.
- Publication Type:Journal Article
- Keywords:
re-use;
risk assessment;
ristk control technology;
single-use devices (SUDs)
- From:
Chinese Journal of Medical Instrumentation
2018;42(5):368-371
- CountryChina
- Language:Chinese
-
Abstract:
The reuse of high-cost single-use medical devices (SUD) is permitted in many countries, such as the United States, Germany and the United Kingdom, but strict regulatory requirements must be met. In addition to regulatory policies and regulations, such as market access mode and special requirements on Good Manufacture Practice (GMP), there are strict technical requirements on the potential risk control and quality assurance system. Therefore, effective risk assessment and risk control technology are the keys to ensure effective quality control and safe use of SUDs. In this article, based on analyzing the technological requirements of the national regulatory on SUDs in the United States, Germany and Britain, and combined with the review from latest relevant literature, to discuss the strategies of how to carry out scientific risk assessment. Some risk control technologies on the reuse of SUDs are introduced, which will provide support for the further study on risk control strategies and regulatory decisions for the reuse of SUDs in China.
