FDA released draft guidance that outlines device design considerations, risk mitigation strategies and testing recommendations for 510(k) submissions of arthroscopy pump tubing sets that are intended for multiple patient use. The guidance comes after FDA received reports of backflow of patient fluids, raising questions of potential disease transmission.
The scope of the guidance covers Class II arthroscopy pump tubing sets, defined under 21 CFR 888.1110 as arthroscope as an electrically powered endoscope intended to make visible the interior of a joint.
In announcing the guidance, FDA noted that arthroscopic procedures often use one source of irrigation fluid for multiple patients without replacing the source of irrigation fluid, or replacing/reprocessing the irrigation tubing system between patients. Such a practice may increase the risk of cross-contamination between patients and subsequently lead to infections due to patient fluids traveling back through the irrigation tubing.
With the backflow context in mind, one can assume that sports medicine companies should pay close attention to the draft guidance’s section on mitigation of cross-contamination risk. FDA’s focus here centers on four aspects of device design.
- Prevention of Backflow to the Proximal Irrigation System: FDA recommends that arthroscope designs include at least one backflow-prevention valve or other features that prevent fluid backflow into the irrigation system.
- Components of the Distal Irrigation System: Some designs include separation of the tubing sets into a distal single-use component, with a backflow-prevention valve and a proximal “Day Use” component without a backflow-prevention valve. FDA recommends that all components in the distal irrigation system, including the backflow prevention valve, be discarded after every patient use.
- Components of the Proximal Irrigation System: If arthroscopy companies indicate that the device can be used in multiple patients over a certain time period and then be discarded, performance data should be provided to demonstrate that the backflow-prevention valve or other features adequately prevent backflow and that risk mitigation steps were taken to prevent cross contamination between patients.
- Reusable Devices with the Irrigation System: When irrigation systems are used with reusable devices or accessories, those devices should be designed to withstand multiple cleaning and sterilization cycles. Manufacturers should provide reprocessing validation data for reusable device components in their 510(k) submissions, as well as comprehensive instructions for reprocessing these components after every patient use.
FDA’s 20-page draft guidance outlines all considerations for a 510(k) submission of multi-patient-use arthroscopy pumps, and repeatedly calls out that cross-contamination may always be a factor in these products.
“While FDA believes the recommendations listed below serve as rigorous risk mitigation strategies for reducing the risk of cross-contamination between patients,” the agency said, “it should be noted that the only way to eliminate the risk of cross-contamination from multiple patient use is to utilize single patient use arthroscopy pump tubing sets.”
Carolyn LaWellis ORTHOWORLD’s Chief Content Officer.