Aakash Agarwal (Department of Bioengineering and Orthopaedic Surgery, Engineering Center for Orthopaedic Research Excellence, University of Toledo, Toledo, USA) has filed an official citizen petition to the US Food and Drug Administration (FDA) calling for a ban on the reprocessing of pedicle screws in the USA. The letter and the accompanied evidence have now been formally accepted by the FDA for review, though an FDA spokesperson said that the process could take over a year, depending on how the agency assess the urgency of the petition.
Agarwal requests “the Commissioner of Food and Drugs to cease clearing 510(k)s and approving PMAs [pre-market approvals] for reprocessing of pedicle screws and other implantable orthopaedic devices and cease clearing 510(k)s for re-usable implantable orthopaedic device[s].”
In addition to asking for the cessation of approvals for reprocessed pedicle screws and interbody cages, the petition requests that every implantable orthopaedic device should be provided “such that it is not touched or exposed before implantation, by the operating room staff, in the sterile field.”
Summarising his reasons for filing this citizen petition, Agarwal enthuses: “Practicing and improving asepsis is at the core of surgical philosophy!”
This petition follows the news that implants are getting contaminated in two separate steps, as reported in the September 2018 cover story of Spinal News International. Contamination occurs outside the operating room, due to the reprocessing of pedicle screws, and also inside the operating room, when the devices left exposed within the “sterile field” are infected with several common bacterial strains.
Speaking to Spinal News International, Agarwal explains how evidence from the literature underpins his rationale for worrying about reprocessed pedicle screws: “Research has identified that orthopaedic implants undergo repeated bulk-cleaning with dirty instruments from the operating room, leading to microbial and non-microbial residue build up at the small interfaces and possibly on the surfaces. This remains unnoticed by the Sterile Processing Department or other hospital staff, as there is no way to inspect each of the hundreds of implants at microscopic levels individually, and at interfaces not directly visible.
“Furthermore, the implants are also being contaminated intraoperatively. Sterile implants are directly touched by the scrub technician with soiled gloves for loading onto an insertion device. They are then kept exposed on the working table. A multicentre trial has shown that by the time it is implanted in the patient, it can harbour up to 10e7 bacterial colony forming units. Additionally, one study group used a functional, impermeable sterile guard around the implant to intraoperatively shield the device until insertion into the patient; they reported zero contamination. Thus, [the use of a sterile guard represents] an effective precautionary measure against possible surgical site infection (SSI), or subclinical and chronic sepsis leading to screw loosening and pain.”
The likelihood of post-operative infection depends on three factors: (i) the bacterial concentration left from surgery; (ii) the virulence of said bacteria; and (iii) the patient’s immune (natural or boosted by antibiotics) response at the surgical site. Not all patients will have infections, but some will. Agarwal points to a recent randomised trial from Mount Sinai Beth Israel hospital in New York, USA, that found a 12.7% infection rate. He explains: “It is in the patient’s best interest to be exposed to the lowest bacterial dose during surgery; many of these patients are also immunocompromised and have at least one associated high-risk factor that predisposes them to infection, such as old age, obesity, smoking, diabetes mellitus, ischemia secondary to vascular disease, or irradiation.”
Citing the 12.7% infection rate, Agarwal postulates: “That could represent up to 100,000 patients suffering from surgical site infection in the USA alone. Now multiply that over the entire globe—isn’t this is a serious cause for concern?”
There is a precedent for this action, as the Scottish government has already banned the reprocessing of spinal implants used in surgery. The Scottish Health Department said in a statement that repeatedly reprocessing implants in the hospital “is a suboptimal procedure”, following a letter in 2006 from the then chief medical officer for Scotland, Harry Burns.
Asked if he thinks the FDA would approve this petition, Agarwal comments, “I hope so. Previously, only industrial and clinical teams were liable for surgical complications (such as infection or hardware loosening). Now, as it is an official investigation, the particular department of our government is also liable for public safety from the contaminated implants—as this has been brought to their attention.”
He continues: “I think it [the high post-operative infection rate caused at least in part by reprocessing pedicle screws] simply slipped through the cracks in the US system. The system is very disjointed, and one half does not know what the other half is doing. Surgeons themselves do not clean the implants, and the decontamination and cleaning departments have no say on how the industry works; it is their job to clean it as per the standard operating procedure of the hospital. For industry, large companies are risk averse, and whoever makes this decision will be held responsible. So, for them sometimes it is safer to not make a decision. At other times, they cannot foresee the value [of taking a certain action, such as banning reprocessing orthopaedic implants].
“However, industry is now realising that this major upgrade would avoid risky and uncertain repeated reprocessing, the need for backup inventory, and logistical challenges such as storage and identification. Way more than six billion pedicle screws (imagine the number if we also account for all other orthopedic devices) are stored in US hospitals. Half of the stored inventory capital from that could be freed up by packaging them in individual sterile tubes (because it is always surgery ready: lean system flow), and that monetary resource can be used for other developmental work and/or growth.”
Furthermore, Agarwal states in the petition that there is no negative environmental impact of the banning of reprocessed pedicle screws, but notes that there would be some environmental advantages, specifically in the reduction of water and electricity use that would arise from no longer repeatedly cleaning or sterilising the devices at the hospital or in other facilities.
Agarwal is director of Research and Development for Spinal Balance, a company providing sterile and proprietary no touch orthopaedic implants. He is also an editorial board member for Clinical Spine Surgery & Spine, as well as an advisory board member for the Center for Musculoskeletal Disruption and Innovation as part of National Science Foundation. He claims royalties from Joimax and Paradigm Spine.