The FDA has issued draft guidance on arthroscopy pump tubing sets intended for multiple-patient use.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.
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