FDA petitioned to ban reprocessing of orthopedic implantable devices

Spinal Tech

Aakash Agarwal, PhD, petitioned the FDA to stop approving the reprocessing of pedicle screws and other implantable orthopedic devices and clearing reusable implantable orthopedic devices.

Dr. Agarwal is the director of research and development at Spinal Balance and an adjunct professor at the University of Toledo (Ohio), and the lead author of several Global Spine Journal studies on pedicle screw infection control. He recently spoke with Becker's Spine Review about the implications of the research for spine surgery practice.

The petition requests:

  • The FDA cease issuing FDA 510(k) clearances or approvals of the reuse or reprocessing of implantable orthopedic devices, particularly pedicle screws and interbody cages.
  • Every pedicle screw or other implantable orthopedic devices should be provided such that it is not touched or exposed prior to implantation by the operating room staff in the sterile field.

According to the petition, preoperative contamination occurs when the pedicle screws undergo repeated bulk-cleaning with dirty instruments from the OR. This can be avoided by using single-use presterilized screws and banning reprocessing, as nations such as Scotland have done. 

Intraoperative contamination occurs when the sterile pedicle screw shafts are directly touched by the scrub tech with soiled gloves for loading onto an insertion device/screwdriver. It is then kept exposed on the working table. A functional impermeable sterile-guard around the implant can shield the screws from intraoperative contamination until it is implanted in the patient, preventing surgical site infection or chronic sepsis leading to screw loosening and pain.

 

Access the petition here.

 

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