FDA issues statements on VHP sterilization; hip surgery device safety

Editor's Note

Recent announcements from The US Food and Drug Administration (FDA) validate vaporized hydrogen peroxide (VHP) as an established device sterilization method and warn against the use of the Synovo Total Hip Replacement system.

Issued January 8, the announcement about VHP is part of the agency’s multi-pronged approach to improving supply chain resiliency by reducing the use of ethylene oxide (EtO). Specifically, the agency has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization. Other established Category A sterilization methods and include moist heat, dry heat, EtO and radiation. 

Issued January 3, the warning about Synovo Production’s Total Hip Replacement System (also referred to as Synovo Preserve and Endotec BP) recommends that health care providers not purchase the system and remove all systems from inventory. Patients experiencing symptoms should contact their health care providers.

However, the agency does not recommend removing the systems form patients without worsening pain or other systems. Rather, it notes that three specific components—the femoral resurfacing cup, the acetabular fixation cup, and the acetabular bearing—have been modified significantly from devices the agency cleared initially, and thus have not been established as safe and effective.