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 other hospital staff. Agarwal noted that this type of contamination can be avoided by using a single-use pre-sterilized screws.
The second way that pedicle screws are being contaminated is intraoperatively. Sterile pedicle screw shafts are directly touched by the scrub tech with soiled gloves for loading onto an insertion device. They are then kept exposed on the working table.
A multicenter trial has shown that by the time it is implanted in the patient, it can harbor up to 10e7 bacterial colony forming units. Agarwal noted that use of a functional impermeable sterile-guard around the sterile-implant, which shields the pedicle screws intraoperatively until it is implanted into the patient, resulted in zero contamination. This would be an effective precautionary measure against possible surgical site infection (SSI) or subclinical and chronic sepsis leading to screw loosening and pain.
This could become a major safety initiative undertaken by FDA in upcoming years concerning the handling and delivery of orthopedic implants. It may be prudent for orthopedic device manufacturers to start the remediation process now to avoid delay in future, i.e., by addressing this gap in their quality system, before the FDA gets intimately involved in this initiative.
The FDA Office of the Executive Secretariat acknowledged receipt of the letter and assigned it docket number FDA-2018-P-4143 for future reference.