The FDA has issued draft guidance on arthroscopy pump tubing sets intended for multiple-patient use.
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. These devices are designed to deliver irrigation to the surgical site, these devices may become contaminated with “backflow” of patient fluids that travel back through the irrigation tubing and cause infections in subsequent patients, according to the agency. They are used in arthroscopic procedures on knees, shoulders, hips, elbows, ankles, and wrist joint cavities.
The FDA said it has received reports of such backflow of patient fluids. The draft guidance outlines the device design considerations, risk mitigation strategies, and testing recommendations for these multi-patient pump tubing sets. The draft guidance document also clarifies the terminology used to describe arthroscopy pump tubing sets intended for multiple patient use.
The only way to eliminate the risk of cross-contamination from multiple-patient use is to use
single-patient-use arthroscopy pump tubing sets, the agency added.
You can read the draft guidance here. Comments are due within 60 days from the January 28, 2020, publication in the Federal Register.
