December 2003 Bulletin

Patient safety tip from Dr. Herndon — Surgical errors: Will they increase?

A 1970s study by the American College of Surgeons (ACS) and the American Surgical Association reported that 50 percent of non-fatal complications and one-third of deaths from surgery were preventable. It seems that little has changed in the 30-plus years since that report.

In a recent study by Wilson, et al, “complication of, or failure in, the technical performance of an indicated procedure/operation” was the most frequent cause of adverse events in hospitals (34.6 percent). Of these injuries, 14.2 percent led to a permanent disability. Alarmingly, 49.6 percent of the injuries were “highly preventable.” While other “error categories” had higher rates of disability and death, deaths from errors in the technical performance of an operation was too high at 2.2 percent. Of all the “highly preventable” errors reported, only 0.7 percent were not associated with a human error category.

I highlight this category of errors because of the new focus on minimally invasive surgery, specifically total hip replacement. The developers of this technique are to be congratulated on a procedure that minimizes tissue injury, avoids muscle division or cutting and sets the stage for markedly reducing the patient’s pain, hospital stay and need for rehabilitation. However, the procedure is technically demanding, requires the use of special instruments (under development) and X-ray imaging and, most importantly, requires the surgeon to “feel” rather than see the tissues, femur and acetabulum.

This procedure is increasingly being performed in the United States. Yet there are no published clinical trials establishing the learning curve for this procedure, the indications for the operation, the risks for the patient or the long-term outcomes. Clearly, we need such information before minimally invasive hip replacements become commonplace. Based on what we know about the relationship between quantity and quality in some surgical procedures, it should be apparent who in our profession should and should not be performing this procedure. Surgeons need to be trained and need to do enough surgeries to maintain their training. Because the average orthopaedic surgeon performs few total hip procedures per year, it is unlikely that a single surgeon can perform five to 10 minimally invasive procedures per year with a negligible error rate and excellent outcomes. Until more is known about the long-term outcome of this procedure and until the equipment and imaging are perfected and widely available, this procedure should remain the domain of high-volume surgeons under Institution Review Board (IRB) control, ensuring a proper and fully informed consent/shared-decision process.

Perhaps the greater challenge to our profession is not in determining who should start using this new procedure and when, but rather managing pressure from patients who want the procedure. Patients with hip pain have become more aware of the procedure through direct marketing efforts and are actively pursuing this new technology, increasing demand more rapidly than the supply of adequately trained surgeons. Some surgeons may feel forced to pursue training, invest in new equipment and offer this service without completing the learning curve and without IRB control because they fear the loss of patients and future referrals. This would be regrettable. As Thomas Russell, MD, ACS executive director, recently stated: “It is sad to see the principles of market economics overtake the profession’s long-held emphasis on the precepts of quality, self-regulation, education, training, and patient care.”

Orthopaedic surgeons should address this situation—an example of a disruptive technology that will, in my opinion, develop into a procedure that is of great benefit to our patients. A disruptive technology, as defined by Clayton Christensen, is a product or service that is not as good as currently available products or services. It offers other benefits, such as being simpler, more convenient and less expensive, that “appeal to new ... customers.” Once the disruptive service “gains a foothold ... the improvement cycle begins.” The “not-so-good technology eventually improves enough ... to meet the needs of more demanding customers ... eventually crushing” the previous service.

As more is known about indications and outcomes, as training becomes more available and as the equipment is refined, each of us should ensure that we have the required training and experience to perform the procedure with no less than the expected outcomes of today’s successful standard total hip procedure.

Most surgeons also should have an experienced assistant until they comfortably perform the procedure well. Each new case cannot be an “experiment” in the operating room. I suggest that those who perform only a few total hips each year continue doing what you do well until the equipment and imaging improve, making it easier to perform this new procedure. Resist the market pressures that may push you into an uncomfortable situation. By doing so, you can turn the wrench, improving your patients’ safety.

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