FDA releases draft guidance on arthroscopy pump tubing sets for multiple patient use
Click Here to Manage Email Alerts
The FDA published a draft guidance document with recommendations on premarket notification 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use.
According to the draft guidance, arthroscopy pump tubing sets were developed to deliver irrigation fluid to the surgical site during arthroscopic procedures in the knee, shoulder, elbow, hip, ankle and wrist. Class II arthroscopy pump tubing sets that are classified under 21 CFR 888.1100 arthroscope fall within the scope of the document. The document noted devices that provide arthroscopic irrigation and are under product code HRX require premarket notification 510(k). The guidance noted that to remove the risk of cross-contamination for multiple patient use, single-patient use arthroscopy pump tubing sets should be used.
The draft guidance highlighted device design considerations, strategies for risk mitigation and testing recommendations for the arthroscopy pump tubing sets that should be included with 510(k) submissions. The draft guidance noted submissions should have a description of device components pertinent to multiple-patient use tubing sets and design features that may decrease backflow to allow for multiple patient use. It also recommends a description of function and specification of the backflow prevention valve be included.
“The risk of cross-contamination from multiple patient use of arthroscopy pump tubing sets can be mitigated by a combination of device design, labeling, proper device handling and performance testing ... ” the document noted. “While FDA believes the recommendations listed below serve as rigorous risk mitigation strategies, it should be noted that the only way to eliminate the risk of cross-contamination from multi-patient use is to utilize single-patient use arthroscopy pump tubing sets.”
Reference: