The U.S. Food and Drug Administration (FDA) has announced draft guidance that provides recommendations for 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use.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/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This draft guidance outlines the device design considerations, risk mitigation strategies, and testing recommendations for arthroscopy pump tubing sets intended for multiple patient use. This draft guidance also clarifies the terminology used to describe arthroscopy pump tubing sets intended for multiple patient use.
The scope of this document is limited to Class II, arthroscopy pump tubing sets classified under the following regulation:
· 21 CFR 888.1100 Arthroscope.
· An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also are intended to perform surgery within a joint.
· Devices that supply arthroscopic irrigation are found under product code HRX and require premarket notification (510(k)). These irrigation devices may be part of an arthroscopy pump system or marketed separately as accessories to arthroscopy pump systems.
While the FDA believes the recommendations listed below serve as rigorous risk mitigation strategies for reducing the risk of cross-contamination between patients, it should be noted that the only way to eliminate the risk of cross-contamination from multiple patient use is to utilize single patient use arthroscopy pump tubing sets.
Comments may be submitted by March 30, 2020.
