Study of Adverse Events of Endotracheal Intubation.
10.3969/j.issn.1671-7104.2021.06.021
- Author:
Jianbing YIN
1
;
Weihong LI
2
;
Hua YU
1
;
Lan ZHANG
1
;
Chao ZHENG
1
;
Ye ZENG
1
;
Wei WANG
1
Author Information
1. Center for Medical Device Adverse Events Monitoring of Zhejiang, Hangzhou, 310009.
2. Center for ADR of Taizhou, Taizhou, 318000.
- Publication Type:Journal Article
- Keywords:
adverse events;
balloon leak;
endotracheal intubation;
medical device;
silastic
- MeSH:
China;
Critical Care;
Critical Illness;
Humans;
Intensive Care Units;
Intubation, Intratracheal/adverse effects*
- From:
Chinese Journal of Medical Instrumentation
2021;45(6):692-697
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:In order to further decrease and reduce the serious adverse events of silicone rubber endotracheal intubation in clinical use, especially in anesthesia and intensive care.
METHODS:Through the first stage analysis on the registration and certification of endotracheal intubation products in China, adverse events of products in recent five years in Zhejiang province, domestic and foreign literature of adverse events of products, retrieval of product citation standards, content integrity of product instructions, and expert seminar on serious adverse events, combined with the air leakage of endotracheal intubation products in recent two years, product material and clinical application with normative aspects.
RESULTS:Silicone rubber endotracheal intubation products in clinical intensive care have certain clinical safety risks, especially for long-term use of critically ill patients.
CONCLUSIONS:According to the four cases of serious adverse events of silicone rubber endotracheal intubation in the clinical intensive care unit, we put forward some suggestions for the manufacturers, clinical users and regulatory agencies to further decrease and reduce the serious adverse events of silicone rubber endotracheal intubation.
