Arthroscopy pump tubing sets intended for multiple patient use - Premarket Notification (510(k)) submissions: guidance for industry and Food and Drug Administration staff

Arthroscopy pump tubing sets intended for multiple patient use - Premarket Notification (510(k)) submissions: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 23, 2021
Language(s):
English
Format:
Text
Subject(s):
Arthroscopy -- instrumentation
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance document provides recommendations for 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use. These devices are designed to deliver irrigation fluid to the surgical site, such as knee, shoulder, hip, elbow, ankle, and wrist joint cavities, during arthroscopic procedures. In arthroscopic procedures, clinicians often use a single source of irrigation fluid for multiple patients without replacing the source of irrigation fluid or replacing or reprocessing the irrigation tubing system between patients. This practice may increase the risk of cross-contamination between patients and subsequent iatrogenic infection, because the irrigation system can become contaminated with patient fluids that travel back through the irrigation tubing (a phenomenon hereafter referred to as “backflow”). FDA has received reports of backflow of patient fluids which raises the question of potential for disease transmission when using irrigation and tubing systems in such a manner on multiple patients. This guidance outlines the device design considerations, risk mitigation strategies, and testing recommendations for arthroscopy pump tubing sets intended for multiple patient use. This guidance document also clarifies the terminology used to describe arthroscopy pump tubing sets intended for multiple patient use.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (20 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918351274706676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918351274706676