The FDA released draft recommendations for 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use.
The guidance outlines design considerations, risk mitigation strategies and testing for Class II tubing sets intended for multiple patients. The devices are designed to deliver irrigation fluid to the surgical site such as the knee, shoulder, hip, elbow, ankle and wrist cavities during arthroscopic procedures.
During procedures, clinicians often use a single source of irrigation fluid for multiple patients without replacing the source of irrigation fluid or replacing the irrigation tubing system between patients. This practice could increase the risk of cross-contamination between patients, the agency said.