More Issues With Reprocessing Implants
Previous studies have also concluded that reprocessing in health facilities is impractical given the workload and the intricacies of the devices.
Earlier studies have shown that reprocessing led to an increase in endotoxin levels on implants and instruments. The study by Alfa et al. concluded that the final deionized (DI) water rinse was the source of the contamination, noting that there was biofilm formation in the DI tank.
Scotland has completely banned reprocessing of implants that are used in spine surgery. In Scotland, the deadline for conversion of orthopedic units to prepackaged, sterile, single-use implants was December 31, 2007. We are approaching 2019, and United States still has not mandated such changes, while other countries like the Netherlands and Japan are actively enrolling or approaching uniformity in this new practice.
The researchers concluded that repeatedly reprocessing pedicle screws could be a cause of surgical site infection and inflammatory responses post-surgery and suggested that the use of prepackaged, sterile, single-use implants as the only alternative.
Intraoperative Contamination
Reprocessing is not the only source of contamination for pedicle screws. Screws that are initially sterile are also contaminated during surgery.
In a separate study published by Agarwal and team in the Global Spine Journal, “Implant Prophylaxis: The Next Best Practice Toward Asepsis in Spine Surgery,” the researchers analyzed articles published between 2000 and 2017 that evaluated the contaminants present on spine implants and the associated processing and handling methodology suggested to avoid them.
In conducting their study, the researchers asked: “What are the sources of contaminants on an implant used for surgery?” and “What are the known practices and/or suggested implant handling techniques, both preoperative and intraoperative?” Eleven articles were found that were relevant for the analysis.
Five of the 11 articles showed that surgical gloves were a vehicle for contamination. One study showed that changing gloves just prior to handling a pedicle screw could reduce infection rate from 3.35% to 0.48%. This study concluded that avoiding the transfer of patient’s skin flora to the implant (and subsequently deep in the bone) via surgical gloves reduced infection.
Exposure was shown to cause implant contamination in 3 out of the 11 articles. In one of these studies, researchers covered implants immediately after opening and compared them to a sample of uncovered implants. Only 2.0% of the covered implants demonstrated contamination compared to a 16.7% rate of contamination for the uncovered implants. Another group of researchers who compared the differences in contamination between covered and uncovered implants found that the after 120 minutes of exposure, the covered group of implants were 18.2% contaminated, while the uncovered implants were 55% contaminated.
Based on these studies, Agarwal and colleagues concluded that the current techniques for handling and processing implants were in need of scrutiny and called for new policies and procedures for handling sterile implants.
Thank you to the spine surgeons, researchers and scientists for this very important evaluation. As former spine surgeon I try to transfer my new knowledge with regard to the origin of surgical site infections (SSI), resulting from my work for Operating Room (OR) Airflow Standards since several years.
Unfortunately, in the report is nothing written about airborne bacteria respectively microorganisms as origin of SSI. Several well conducted studies show the high importance of the contaminated air of OR for the SSI genesis (e.g. Charnley 1972, Whyte et al. 1982, Lidwell et al. 1987). Charnley (1972) demonstrated the dependence of the SSI rate from the number of air changes in the OR. Lidwell et al. (1987) found a direct relationship between the air contamination and the SSI rate – with a high advantage of laminar airflow (LAF) technology compared to turbulent/dilution airflow technology. Whyte et al. (1982) stated to the origin of bacteria in the surgical wound with regard to the air or patient’s skin: “… the most important and consistent route of contamination was airborne”. Those study results were never corrected by other/later studies. Comparing evaluations of cfu directly in the OR show considerably better results for LAF technology (e.g. Andersson et al. 2014). However, the comparing results in ORs for the different OR airflow technologies didn’t get the required attention. In contrast, primarily register based SSI results influenced even the WHO Global Guidelines for the prevention of SSI (2016). It should be known that register data is not enough sufficient for basic assessments and conclusions (Windeler et al. 2017). Furthermore, several publications from German authors (Brandt et al. 2008, Breier et al. 2011, Gastmeier et al. 2012, Bischoff et al. 2107) comparing the SSI rates of LAF technology and turbulent/dilution airflow technology base upon data for only individual hospital uses (published in an official German document) because of significant bias. Generally, it isn’t clear in most studies comparing different airflow technologies if all sterile instruments, trials, implants are in the protected zone of LAF technology during the complete surgery. Otherwise, there is more danger for SSI.
IN CONCLUSION, the focus to avoid SSI/biofilm should also lie on not contaminated air in the OR and on the right air technology with always LAF for high sensitive surgeries. Furthermore, all influences on air contamination with microorganisms should be known – to undertake everything for the avoidance of air contamination.
PROF. DR. KARIN BÜTTNER-JANZ, MBA
Delegate of Germany for European Standard CEN TC 156 WG 18 (air technology of operating rooms)
Member of DIN Committee 1946-4, Germany (air technology of operating rooms)
Past President of ISASS
buettner-janz@spinefoundation.info
Thank you PROF. DR. KARIN BÜTTNER-JANZ for sharing that.
We were excited to see a comment from you. I still remember reading about you in SNI, especially how you went from Olympics to spine surgery to research, innovation and advocacy in 2009: https://spinalnewsinternational.com/karin-buettner-janz/
This is the question many have asked:
“Interesting results.
I guess the most pressing question is where is the contamination coming from?” for example Dr. Bob Hirschl
I usually comment:
“The current study was only designed to assess the level of contamination using standard-sterile-technique vs two-step-asepsis-technique.
1. However based on everything I have read, researchers cite patient’s own flora as the original source, which then transfers to gloves and then to implants.
2. The quality of air may also not be pristine, as other studies has proven bacterial growth with increase in exposure time (inside the sterile field).
”
So we agree with you 100%. I look forward for the day when the air in the OR (for all countries) is pristine.
Below is my email if you like me involved in any way.
Thank you!
Sincerely
Aakash Agarwal
aakash.agarwal@utoledo.edu
This is common sense, how did we miss it (blatant failure) for so long!
I wonder how many patients have suffered till date due to this negligence, and were consoled saying “it is just bad luck, infection happens, we are just doing our best”.