As the Covid-19 pandemic continues to unfold, it is clear that the virus has fundamentally impacted every aspect of life in the United States. The healthcare sector has had to completely reimagine much of what was once standard operating procedure. This has driven adoption of new tools in many areas of the life sciences industry.
For instance, the surge in demand for pre-sterilized surgical technologies at healthcare facilities. These systems are being implemented as a way to both curb risk factors associated with Covid-19 at hospitals and also reduce the possibility of bacterial co-infections. With increased attention being paid to pathogens and the deadliness of surgical site infections that occur as co-infections with Covid-19, innovative single-use technologies for complex surgical procedures are becoming more widely used at many centers. This trend has been most apparent in the number of major medical device companies rapidly adopting the single-use model during the pandemic. In September, both Boston Scientific and Ambu A/S executives revealed their commitment to growing the sterile, single-use medical device market through single-use scopes.
This increase in demand for sterile, disposable surgical technologies can be explained by recent research, including a recent article published in the medical journal ?Patient Safety in Surgery entitled ?COVID-19 in the Operating Room: A Review of Evolving Safety Protocols. In the article, researchers noted that in light of Covid-19, “?disposable medical equipment should be used [because] recent data has shown that Covid-19 might survive and be transmitted indirectly from virus contamination of common surfaces and objects after virus aerosolization in a confined space with infected individuals.” The researchers call attention to the increased risk of Covid-19 infection to hospital staff handling reusable surgical systems by advising that reused “instruments sent to the sterilization unit must be labeled and the staff in the unit must be made aware of the COVID status of the case, and must handle the instruments while wearing a full PPE.?”
Beyond the risk of a direct infection to hospital staff, the stakes for lowering surgical site infections have never been higher. Though it has been established by scientific articles such as Surgical Site Infections linked to Contaminated Surgical Instruments, published in the Journal of Hospital Infection,? that reused instruments pose a higher risk for surgical site infection due to improper sterilization of metal instruments, the higher risk for mortality with a Covid-19 co-infection has accelerated the demand by centers for sterile, disposable surgical systems to avoid severe complications. The existing risk of surgical site infections due to pathogens on reused instruments has been compounded by the spread of Covid-19, creating an increased demand for infection-curbing surgical technologies. As researchers in the article Co-infections among patients with COVID-19: The need for combination therapy with non-anti-SARS-CoV-2 agents? put it, “clinicians must have a high index of suspicion for coinfection among COVID-19 patients.”
In the context of this new normal, sterile-packaged technologies for complex, invasive surgeries have found a significant increase in demand. This is especially true for spine surgery, which accounts for some of the longest and highest risk procedures for surgical site infections.
When asked about the viability of microorganisms on today’s medical devices, Xenco Medical Founder and CEO Jason Haider noted, “in order to appreciate the impact a single-use implant system can make versus a reused system in curbing pathogen transmission, it’s important to understand the insidiousness of bioburden in surgical systems. Whether it’s the cannulated geometry of certain instruments that protects residual tissue or fluids from proper cleaning or it’s biofilm accumulating on implants and instruments exposed to the operating room air for extended periods of time, reused systems pose a set of sterility challenges that can only truly be overcome by a paradigm shift to disposable instruments.”
Haider’s San Diego-based company is a developer of composite polymer spinal systems that come with implants pre-attached. Xenco Medical’s sterile surgical products are even delivered through surgical vending machines, helping to further curb the chance of surgical site infections.
Haider stresses the importance of incorporating both materials science and packaging engineering to create entirely disposable implant systems.
“In order to deliver a truly sterile, single-use surgical system without compromising on the durability and functionality of the instruments and implants, it is necessary to start at the level of material composition and build upward from there,” he said.
The company adopts a multipronged approach in manufacturing each sterile system.
“From taking into account the interfacial bond strength and glass fiber orientation of our composite material, to designing a durable sterile barrier of primary and secondary layers, we tackled the problem of pathogen transmission using an interdisciplinary approach,” Haider noted.
Materials science and packaging engineering go hand in hand in the development of Xenco’s polymer-based devices. According to Haider, “the materials science enables us to make the disposability of the instruments cost-effective, ensures it performs like metal in strength, and outperforms existing reusable systems in implant delivery.”
As sterile surgical platforms see an increase in demand, it is worth examining the extent to which these packaged implants and instruments are validated.
“Validations against environmental conditions range from bubble emission tests, in which ?packages are immersed in water to check for any damages that would lead to the compromising of the sterile barrier to burst testing, where air is inserted into a package to identify the point at which an aged package bursts.” he said.
But the bottom line for the adoption of pre-sterilized single use surgical systems is safety.
?”It boils down to eliminating unnecessary risk. By using surgical instruments and implants that are not only ultrasonically cleaned, gamma sterilized, and hermetically sealed but used only once, patients who undergo surgery and hospital staff who handle these devices eliminate any chance that traces of a previous patient’s tissue or fluids can be transmitted in cases of improper sterilization as well as biofilm accumulated from the air,” he said. “It only makes sense to control as many variables as possible, especially with the increased need for safety today.”
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