An antibiotic-resistant “superbug” known as CRE (Carbapenem-resistant enterobacteriaceae) has killed several patients in U.S. hospitals over the last few years. In 2015, CRE killed two people and infected five others at UCLA’s Ronald Reagan Medical Center, while an estimated 179 more patients may have been exposed.
Although CRE was to blame, it was not the cause of the problem. Authorities suspected the deadly germs were transmitted by inadequately sterilized medical scopes known as duodenoscopes, which are difficult to clean because of their complex design. Duodenscopes are not the only surgical instruments prone to contamination, though. Early investigations by the Center for Public Integrity (conducted in 2012) revealed that the issue of dirty instruments is national in scope and is not limited to one particular type of surgical instrument.
Since the UCLA case in 2015, there have been ongoing reports regarding the use of dirty surgical equipment in U.S. hospitals. One of the most significant recent cases involves Detroit Medical Center (DMC) where, earlier this year, an unannounced inspection was carried out following reports of dirty equipment. Although much of the recent conversation is regarding DMC and their efforts to fix the problem, most reports have failed to cover what this all means for the surgical implants market.
To shed light on this important matter, Jason Haider, CEO, Xenco Medical, a MedTech company revolutionizing the surgical implants market, sat down with me to debunk the superbug sterilization myth - that the blame of superbug transmission in hospital environments lays solely with the hospital sterilization process. Haider highlights the extent to which the medical device industry itself has been culpable and how Xenco’s SETx technology is addressing this problem.
What is Xenco Medical doing to address this important issue?
Haider: Well, to begin to truly address the hospital-related spread of superbugs, or, for that matter, any kind of pathogens, it’s important to address the historical failure of medical device design in anticipating the insidiousness of pathogens. While instruments have become increasingly complex, their new geometries have not sufficiently reflected a drive to prevent the transmission of pathogens from one patient to another. To properly address this, we’ve leveraged materials science to change both the performance and manufacturing process of implant systems. Replacing traditional metal systems, which are used in hundreds of patients because of their cost-prohibitive manufacturing process, the Xenco Medical implant systems are the first entirely disposable, composite polymer systems of their kind. What this has done is eliminated the risk for pathogen transfer from patient to patient through improperly sterilized instruments. As antibiotic-resistant superbugs have become a critical public health issue, the mitigation of patient-to-patient transmission requires change at a step even before the internal logistics of hospitals. That’s what we’ve done with each product launch.
Aren’t sterilized surgical tools safe? That’s what the medical community would have you think, right?
Haider: Whether it is through pathogen transfer through the hidden crevices of instruments with complex geometry, or bioburden that accumulates on open metal instruments during surgical procedures, traditional, reused surgical devices have played a role in surgical site infections. As antibiotic-resistant superbugs have become a public health issue, the vulnerability of these systems to patient-to-patient transmission prevents them from truly being safe. What’s worrying is that as antibiotic resistance grows, treatment of a hospital acquired infection becomes more difficult.
Why do hospitals still use traditional tools and systems?
Haider: Until very recently, hospitals have had no other choice than to use these kinds of systems. They’ve largely been affected by the inertia of a surgical device industry that has not changed its instrument manufacturing process for several decades. Because the surgical device industry has almost uniformly invested millions of dollars into metal inventory that worsens with every use, hospitals have, until now, been dependent on devices more vulnerable to pathogen transmission.
With healthcare in the national conversation, do you see a push to move away from reused tools?
Haider: Absolutely. As part of the Affordable Care Act, CMS will penalize hospitals with poor outcomes and high costs and will reward those with superior outcomes and low costs. This mandate to demonstrate value is having a significant impact on how hospitals choose which medical devices are approved. It has empowered value-based selection committees at hospitals to move away from reused tools and choose single-use systems that reduce the risk of pathogen transmission while eliminating sterilization and processing costs.
What can patients do, what should they be asking their doctors before surgery?
Haider: It’s important to be as informed as possible about any kind of surgical procedure one will undergo. In light of surgical site infection rates and the even more serious, albeit less common, instances of superbug transmission, asking a surgeon if a single-use system is available for their procedure is the least one can do.
According to the Centers for Disease Control and Prevention (CDC), each year in the United States, there are at least 2 million people who become infected with bacteria that are resistant to antibiotics and at least 23,000 people die every year as a direct result of these infections. It has long been established that the unchecked culture of antibiotic prescription fueled the rise of superbugs. The CDC has noted that prescribing antibiotics when they are not necessary or wrongly prescribing antibiotics in outpatient settings is common. Though this overconsumption of antibiotics has given rise to a wave of superbugs, it’s clear that the healthcare industry has also failed in containing these bacteria from patient-to-patient.
It’s clear after speaking with Jason Haider that, if more companies innovate around the threat of pathogen transmission, we would be in a much better position to curb the spread of these deadly organisms. The hospital sterilization process is not nearly enough, since the complicated devices used in invasive procedures are not capable of undergoing true sterilization before every procedure. It may be a long road, but the time for change is now.