- FDA issued draft guidance Monday on 510(k) submission recommendations for arthroscopy pump tubing sets intended for multiple patient use. The Class II devices are used to deliver irrigation fluid to sites of minimally invasive joint surgery, like knee, shoulder, hip, elbow, ankle, and wrist joint cavities, the agency said.
- Per the guidance document, FDA is aware of cases when backflow of patient fluids in the irrigation tubing presents risk for disease transmission when used on multiple patients, leading regulators to lay out design, testing and risk mitigation considerations for the products. Regulators detailed key considerations in developing and assessing a good backflow prevention valve.
- FDA is accepting comments on the draft guidance through March 30.
Steris and Arthrex are among the medical equipment manufacturers that produce the tubing sets used in common arthroscopic procedures. The FDA wants to ensure that manufacturers have sufficiently tested parts of the reusable products meant to reduce risk of cross-patient fluid contamination.
"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," FDA wrote. "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."
In addition to addressing standard risk management, biocompatibility, sterility, reprocessing, pyrogenicity, shelf life and packaging, labeling, FDA wants detailed testing of the backflow prevention valve.
The piece is meant to ensure that the prevention valve effectively keeps contaminated fluid at the surgical site from entering the irrigation system. "We recommend that the testing be performed with both a microbiological and chemical marker to investigate the potential for backflow in the system," FDA wrote, with investigation into device properties that best reduce risk of backflow reaching a prevention valve, such as length of tubing.
The only way to fully eliminate cross-contamination risk is to implement single-use arthroscopy pump tubing sets, FDA said.
A strong 510(k) submission will have a detailed description of each piece of a tubing set, including the backflow-prevention or one-way valve, connector pieces, tubing, and pump. "We recommend that you also provide illustrative schematics and/or engineering drawings of each device component, identify important design features, compare the similarities/differences of those features to legally marketed devices, and identify any applicable FDA-recognized consensus standards," the guidance states.
Last October, FDA said its guidance priorities for fiscal year 2020 include finalizing documents on the 510(k) Third Party Review Program, Safer Technologies Program for Medical Devices, and Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies.
The agency's list of topics on which it intends to release drafts includes Distinguishing between Medical Device Servicing and Remanufacturing, Unique Device Identification: Policy on Enforcement of GUDID Submission Requirements for Certain Class I Devices, and Pragmatic Generation of Validity Evidence for Patient-Reported Outcome Measures Used in Medical Device Submissions.