FDA issues final guidance for multiple use arthroscopy pump tubing sets
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The FDA issued final guidance for 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use.
According to the FDA guidance document, 510(k) submissions should include a description of all device components integral to multiple patient use tubing sets. Illustrative schematics and/or engineering drawings of each device component are also recommended, as well as identification of important design features, the similarities and differences of those features to legally marketed devices and the identification of any applicable FDA-recognized consensus standards.
The FDA also recommends the submission of risk management information that identifies hazardous situations, estimates the risks and describes risk control measures and overall residual risk specific to the device. Biocompatibility of all patient-contacting materials present in the device should be determined, according to the FDA. The FDA noted references to previous testing experience or the literature may be used for devices that have identical composition and processing methods to arthroscopy pump tubing sets with a history of successful use. However, the FDA added additional biocompatibility testing may be warranted in devices with differences in formulation, processing, sterilization or device surface properties that could affect biocompatibility of the final product.
To ensure that a device is appropriately prepared for initial and subsequent uses, the FDA requires validated instructions on how to reprocess a reusable device or single-use device that is provided non-sterile to the user.
“While the FDA believes the recommendations 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 patients is to utilize single patient use arthroscopy pump tubing sets,” according to the FDA.
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