Cross Contamination, Infection Risk From Arthroscopy Pump Tubing Sets Results in FDA Guidance
The FDA has issued new draft guidance intended to address the risk of cross contamination from arthroscopy pump tubing sets, which may lead to backflow that transfers infections to multiple patients.
In a Draft Guidance Premarket Notification for Arthroscopy Pump Tubing Sets issued on January 28, federal regulators outline a number of recommendations for 510(k) submissions for approval of new devices, which are intended for use on multiple patients. The guidance comes following reports of backflow problems that may have already led to disease transmission with the devices.
An arthroscope is an electrically powered endoscope used to perform joint surgery, and to make the interior of a joint more visible. These are often paired with pump tubing to deliver irrigation fluid to a surgical site, like a knee, shoulder, hip, elbow, ankle and wrist joint cavities during arthroscopic procedures. However, during arthroscopic surgical procedures, doctors often use a single source of irrigation fluid for multiple patients. They often do so without replacing the source of irrigation fluid or replacing or cleaning the irrigation tubing system between patients.
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By not replacing the irrigation source or tubing, this can increase the risk of cross contamination between patients and increase the risk of the irrigation system becoming contaminated with patient fluids during backflow, when it travels back through the irrigation tubing. This can lead to subsequent infection from the patient fluids contaminating the irrigation system.
The draft guidance focuses on device design considerations and risk mitigation strategies. It includes testing recommendations for arthroscopy pump tubing sets intended for multiple patients.
“While 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 patient use is to utilize single patient use arthroscopy pump tubing sets,” FDA officials wrote in a press release.
The draft guidance also clarifies the terminology used to describe arthroscopy pump tubing sets intended for multiple patient use.
The public comment period for the draft guidance will be open until March 30, 2020. Comments intended for the FDA’s consideration to develop the final version must be submitted by that date. Information on how to submit public comments is detailed in the draft guidance.
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