Surgical errors have been a problem for so long that it sometimes seems as if nothing changes. Doctors and nurses keep leaving surgical sponges or other operating room tools inside of patients' bodies or operating on the wrong body part. These chronically repetitive incidents are not some urban legend. They are devastating injuries from which serious medical complications can result, as the foreign objects can act as a magnet for infection.
There have been sophisticated solutions proposed to address the problem of surgical errors. For example, bar-coded surgical sponges could aid in double-checking that the correct number of sponges have been retrieved from the patient's body. One of the most effective solutions is much simpler, according to Dr. Atul Gawande, a surgeon and writer.
Gawande is a proponent of something very simple: checklists. He says that the problem with modern medicine isn't that we don't know enough, it's that we know too much, and as a result, little things inevitably are forgotten. His advocacy of checklists, stemming from his experience as a surgeon and professor at Harvard Medical School, has attracted wide media attention.
When Gawande implemented a checklist system for his own operating room, he surprised himself with just how many small medical errors were found each week. In one case, the checklist saved a patient's life. During what should have been a routine surgery, a major artery was cut. The patient quickly went into cardiac arrest due to lack of blood - prompting a need for an immediate blood transfusion. Fortunately, before the operation, a nurse using a pre-operation checklist had discovered that the hospital did not have enough of the patient's type of blood on reserve, and ordered more. Without the checklist to ensure the blood was on hand, Gawande says, the patient would have died.
HHS Red Tape
With Dr. Gawande leading the charge for greater use of checklists in the medical field, doctors who use them are experiencing fewer errors, leading to better outcomes. So far, however, much of the evidence is anecdotal - largely due to bureaucratic problems involving the Department of Health and Human Services and its research partners.
One of the first studies of the effectiveness of checklists was conducted by Johns Hopkins University. The Johns Hopkins researchers used data from Michigan hospitals which had recently introduced a five-step checklist for preventing infections in the intensive care unit. The checklist called for simple, but easily-overlooked steps, such as ensuring that doctors wash their hands and put on sterile gowns and gloves before inserting an IV into a patient.
The study found that by adopting the checklist, the Michigan hospitals were able to dramatically reduce bloodstream infections, and the average unit cut its infection rate from four percent to zero. But the fact that the information was gathered in the first place put Johns Hopkins under fire from the Office for Human Research Protections (OHRP), a division of HHS.
Informed Consent Issue
The OHRP's mission is to guard against abuses of patients in medical studies. It was formed in reaction to unethical medical experiments conducted both in the U.S. and abroad, such as the Tuskegee syphilis experiment, in which patients with syphilis were left untreated, to allow doctors to study the progression of the disease. Today all patients involved in medical studies must grant informed consent to participate. Studies are overseen by Institutional Review Boards (IRBs) - committees at hospitals and other medical centers that review and monitor studies of human subjects.
The OHRP ruled that while the implementation of the checklist program was fine, the collection of data regarding outcomes made it a formal medical study. And because it was a formal medical study, all hospitals involved were required to put the matter before their IRB to ensure that patients' rights were protected. This also meant that all patients were supposed to be given consent forms to sign, in the event that any patients chose not to participate in the study.
Many of the Michigan hospitals were small - so small that they did not conduct formal medical tests and as such had no internal IRB to even approve the study. As a result, the Michigan data on the effectiveness of checklists in hospitals has not become fully available.
To promote proper data collection, the OHRP should change its policy on the gathering of patient data. For his part, Dr. Gawande continues to advocate for checklists. There must be a way through the bureaucratic red tape to allow for the research studies that will help reduce errors and save lives.
One of the valuable checklist items that Gawande points to is one of the simplest. He found that in some countries, it is routine before surgery that all medical staff involved in the operation be introduced by name. This makes it more likely that the team actually functions like a team. For instance, with this simple step, junior members, such as nursing staff, feel they have a real voice and can more easily call a halt if something seems awry.
