Advancements in healthcare technology can be exciting, but also troubling. During an OR case we were involved with, we listened to two surgeons discuss an article published by the American College of Surgeons entitled AI is Poised to “Revolutionize” Surgery. We were impressed (or distressed?) by their enthusiastic embrace of the article’s message.
We read the paper and were troubled by the authors’ assertion that they were “genuinely concerned about the rapid adaptation of AI into our daily lives, but that AI in surgery was not moving fast enough.” Considering all we see and hear about AI’s risks, this seems contradictory. While AI is a highly influential technology, ensuring its nonhazardous and beneficial incorporation into our lives seems to be a good goal for safeguarding its long-term future—and all of us.
We see obvious benefits when considering the many new technologies that have penetrated our daily lives, like smartphones, automotive safety devices, airline travel, and military weapon development. Respectively, these might facilitate rapid communication, decrease motor vehicle accidents, optimize flight safety, and protect our country from attack from a rogue nation. However, there are dark sides to these technologies, such as cybersecurity risks, eroded driving vigilance, complex designs that impair quick fixes, and the threat of nuclear war.
But what about the industry we are professionally and inextricably wedded to, the delivery of healthcare services? Are there concerns that in our desire—and haste—to embrace new technologies, we may fail to critique certain interventions that benefit patients properly? Might some technologies brought to the patient’s bedside have sidestepped regulatory channels? Might our noble sense to do more and better for our patients be jeopardized by the new and sexy? Perhaps we may be guilty of worshiping at the altar of healthcare technology advancements.
Table of Contents
- The farming of human tissues: The challenge of bioprinting
- Treating cancer with a supercomputer: Maybe not?
- Spinal fusion and bone growth stimulators
- Endoscopic submucosal implantation
- The promise of a drop of blood
- Pelvic mesh can mess things up
- Too much metal?
- Essure™ ensures? Likely not!
- A billion dollars a year of cement
- Fractured cardiac rhythm management (CRM) devices
- Gene therapy goes very badly
- Robotic surgery may not be all that it’s cracked up to be
- Where do all of these healthcare technology advancements leave us?
Let’s look at some healthcare-related initiatives where an overly enthusiastic adoption might have led to either overt failure or certain unforeseen and negative consequences. We also want to note that a Luddite approach (anti-technology) is not our intent. Rather, a slow and highly critical analysis might be the best course, like with AI. We will start with a couple of corporate efforts that overshot reality and then look at a few specific examples where patients may have suffered.
The farming of human tissues: The challenge of bioprinting
Dreaming big is not to be discouraged, but dreaming too big may not be such a good thing. Consider the start-up Organovo, a California-based company with high expectations of developing lines of human tissues in the field known as bioprinting. They “printed” liver and renal tubular tissues using 3D bioprinting technology.
There was great fanfare as the bioprinted tissues were successfully transplanted into mice, with hopes for FDA clearance on the horizon. The sheer difficulty of the endeavor stymied this effort and their zeal for technological achievement surpassed realism. That said Organovo is still pursuing efforts in the domain, and in vitro experiments of bioprinted intestinal tissue have been published. This is one of those cases where the enthusiasm for the technology initially outstripped what was reasonable but later reigned in. Let’s hope they are successful in what is a domain where science is just hard to do.
Treating cancer with a supercomputer: Maybe not?
IBM teamed up with expert clinicians at Memorial Sloan Kettering Cancer Center to train the supercomputer IBM Watson to diagnose and treat patients with cancer. The platform frequently gave bad advice, such as the time it recommended the administration of a drug known to worsen bleeding in a patient who was already hemorrhaging. No patients were injured, but it was labeled by many oncologists as faulty and potentially dangerous for its intended purpose of synthesizing enormous amounts of data to reveal novel diagnostic and treatment insights.
Spinal fusion and bone growth stimulators
Due to inadequate validation and controls, the FDA ordered a massive recall of bone growth stimulators. These devices are inserted during the spinal fusion procedure to speed the healing of broken bones and ensure the fused units heal into single, solid bones.
Many serious concerns were raised, especially concerning the systemic dispersion of chemical contamination from the device, resulting in tissue death, additional surgery, impaired bone healing, paralysis, and death. A Class 1 recall was ordered, the most severe and immediate type of recall that the FDA can order.
Endoscopic submucosal implantation
Endoscopic treatment of gastroesophageal reflux disease (GERD) has gained popularity over the last several years as an alternative to long-term medications for patients with confirmed GERD.
Endoscopic submucosal implantation or injection of a bulking agent (e.g., polymethylmethacrylate beads, zirconium oxide spheres) was trademarked as the Enteryx procedure.
While long-term studies were underway, some serious complications, including 2 deaths, were reported with its use, and the product was quickly withdrawn from the market by Boston Scientific, the proprietary maker of Enteryx. Post-procedural surgical attempts found that the injections resulted in significant fibrosis and the presence of material so stuck to the esophageal wall that an obstructing mass effect resulted. While removing the extramural polymer completely is highly desirable, this is often impossible due to the dense adherence to the esophageal wall and adjoining structures, including the vagus nerve. Inadvertent direct injection of the polymer led to the death of a patient.
The promise of a drop of blood
Imagine a revolution in blood testing that might ultimately result in home labs offering health screening at a fraction of the current cost and virtually eliminate the logistics of getting to and enduring blood draws. Enter Elizabeth Holmes and the company Theranos. Professing the ability to do virtually any blood test with a single drop of blood, she raised over 700 million dollars to fuel her dream. Just a few years back, Theranos was valued at 9 billion dollars. She’s now in prison, and the entire thesis was determined to be a fraudulent enterprise.
Pelvic mesh can mess things up
The FDA ordered two companies distributing pelvic mesh for pelvic organ prolapse to cease all sales. The decision came after both companies failed to demonstrate that their products provide long-term quality outcomes comparable to transvaginal surgical tissue repair. As a result, the safety and effectiveness of these pelvic mesh products could not be assured.
The FDA’s actions were prompted by thousands of lawsuits claiming various harms, including bleeding, persistent severe pain, incontinence, and loss of sexual function. These injuries were largely attributed to the poor design, marketing, sales practices, and improper implantation of the pelvic mesh technology, as noted by both the courts and the FDA.
Too much metal?
Certain joint arthroplasty procedures have been associated with high failure rates, affecting up to 43% of patients. These failures are linked to exposure to toxic compounds from the implanted technology, which was originally intended to relieve pain and improve a patient’s quality of life. The compounds released by the implants are associated with serious health issues, including cardiomyopathy, muscle and bone loss, DNA mutations, and an increased risk of cancer. Research has shown that ions released from cobalt-chromium-molybdenum implants can enter the bone marrow, hindering bone growth.
Essure™ ensures? Likely not!
The Essure™ device, a Bayer product, was designed, marketed, and inserted as a permanent birth control device. It was removed from the market because of unexpected pregnancies and sometimes severe patient injury. The need for follow-up surgery in those with the newly implanted device was demonstrated to be well over 10 times that of those who underwent laparoscopic tube interruption surgery.
A billion dollars a year of cement
The cementing compound used in the early 2000s generated sales of almost one billion annual dollars for Medtronic, until it was revealed that its use was associated with abnormal bone growth, cancers, and reproductive issues. Many thousands of patient injuries generated lawsuits, which some judged as being the “tip of the iceberg.” Concerns were raised that the manufacturer downplayed the technology’s risks while also being marketed for off-label use.
Fractured cardiac rhythm management (CRM) devices
Okay, we get it; advancing healthcare technology can be difficult. Even the leads of technologically complex CRMs have proven to be an enormous challenge, often resulting in them being too hastily marketed and sometimes causing patient injuries from fracturing. With hundreds of thousands implanted and some suffering from dysfunction (often fracture related), Medtronic at one point removed from marketing the Sprint Fidelis Implantable Defibrillator leads worldwide. Unnecessary shocks or absent shocks when needed were occurring, leading to well over 100 reported deaths. Medtronic settled lawsuits totaling $268 million from the Sprint Fidelis issue alone.
Gene therapy goes very badly
You may recall the saga of Jesse Gelsinger, a teen enrolled in an early gene therapy (GT) trial. Jesse suffered from a genetic disorder termed OTC deficiency, resulting in toxic levels of ammonia accumulating systems-wide. His disease was managed reasonably well with lifestyle and dietary restrictions, although there were episodes of critical concern.
Enrolled in a GT trial, an adenovirus engineered to deliver a functional version of the mutant OTC gene was administered. The GT triggered an all-out inflammatory assault, and he died quite rapidly. Several other children in GT trials for immune disorders developed cancer in just a few years.
Robotic surgery may not be all that it’s cracked up to be
It’s interesting, and perhaps not surprising, that the U.S. is the international outlier in embracing robotic surgery (RS) for many procedures that many CRNAs see in their daily caseloads. Its initial marketing was based on overcoming technical challenges for specific surgeries. However, it has evolved largely through aggressive marketing and now penetrates many surgical domains where its application exceeds the evidence supporting its use.
We came across studies demonstrating inferior outcomes from RS compared to traditional surgery for breast and cervical cancer, which has led to the FDA formally releasing a safety warning. But for our purposes here, let’s examine a 2024 study in JAMA Surgery that looked at the dramatic uptick in RS for cholecystectomy and its associated outcomes, including the rate of bile duct injury necessitating surgical reconstruction and a variety of other serious 30-day complications, compared to a traditional laparoscopic approach.
In well over a million cases of cholecystectomy, RS procedures were associated with a three-fold increase in bile duct trauma that required reoperation during the first postoperative year, compared to laparoscopic procedures. There was also a higher rate of additional, unplanned biliary interventions and serious complications in those undergoing RS.
The study authors did not mince words, advising that “the utility of RS for cholecystectomy should be reconsidered given the availability of an already minimally invasive, predictably safe laparoscopic approach.” Surgeons are optimistic that RS applications will increase access to minimally invasive surgical procedures. While perhaps so, consider that there is significant evidence, and even our clinical observation that RS is more expensive, involves longer in-room times, and necessitates special staff training.
Where do all of these healthcare technology advancements leave us?
Our intent is not to thwart, diminish the value of, or otherwise urge restraint in the research and development of novel technologies or improve upon current ones. We can all think of enormous patient care strides from technological advancements. Nuclear and ultrasound imaging, transplantation, stem cell therapy, physiologic and safety monitors, pharmacological therapies, and the Nobel-prize-winning gene editing process, CRISPR-Cas9, are but a few.
That said, we may overcomplicate our objectives or move too hastily to adopt new approaches that may not be ready for primetime. We selected just a handful, among hundreds, of technologically concerning advancements. Care provided at the “sharp end,” at the interface of the clinician and patient, must consider short-term outcomes and economics and stringently and objectively account for its downstream consequences. Ultimately, ethics should be at the core of human progress initiatives. Uncritical worship of technology may be a recipe for a flawed action.
As CRNAs ourselves, we understand the challenge of fitting CRNA continuing education credits into your busy schedule. When you’re ready, we’re here to help.
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