UNIVERSITY OF TOLEDO PROFESSOR PETITIONS FDA FOR REPROCESSING BAN (Orthopedics This Week)
University of Toledo professor has petitioned the FDA to ban the reprocessing of pedicle screws and other implantable orthopedic devices.
OTW recently covered the results of multicenter research studies that proposed a superior standard of care and method of delivery that completely eliminated contamination in pedicle screws: Are Your Sterile Implants Really Sterile?
Following the studies, lead researcher Aakash Agarwal, Ph.D., filed a petition with the Food and Drug Administration requesting that the Commissioner of Food and Drugs cease clearing 510(k)s and approving premarket approvals (PMA) for reprocessing of pedicle screws and other implantable orthopedic devices and cease clearing 510(k)s for reusable implantable orthopedic devices.
In the petition, Agarwal highlighted that pedicle screws are being contaminated in two different ways:
First, they undergo repeated bulk-cleaning with dirty instruments from the OR, leading to residue build up at the interfaces and possibly on the surfaces. Due to its concealed nature, this remains unnoticed by the Sterile Processing Department or o...
