A wide-ranging study of the nation's hospitals has found that, while surgical "never events" are rare, they still pose a threat to patient safety and a considerable financial burden to hospitals. Foreign objects such as towels and sponges are left inside patients' bodies about 39 times a week, wrong procedures are performed on patients 20 times a week, and wrong body site operations are performed about 20 times a week, estimates a study from the Johns Hopkins University School of Medicine. In all, the study counted 80,000 "never event" episodes that resulted in hospital payouts of about $1.3 billion between 1990 and 2010.
Study leader Marty Makary, MD, an associate professor of surgery at the Johns Hopkins University School of Medicine, says he's not surprised by the findings. "Many surgeons know how easy it is to leave a sponge behind. Sponges will often change colors. They are packed in tightly. We may put in 20 sponges during a case and have to take all of them out. So it is actually not inconceivable that we could leave a sponge behind," says Makary, who is also the author of Unaccountable: What Hospitals Won't Tell You and How Transparency Can Revolutionize Health Care.
"In the majority of cases nothing happens," he told HealthLeaders Media. "The sponges are undetected, so they aren't even captured in the study we did. There are many more undetected sponges than the ones we measured. We put artificial things in patients all the time, like mesh and prosthetics. The body just incorporates it. It's sterile when it goes in. Sometimes these sponges can get infected or even cause pain, and in those situations it will prompt a scan or an X-ray and it will be discovered and surgically removed."
Using the National Practitioner Data Bank, Makary's researchers found malpractice judgments and settlements for surgeries associated with retained foreign bodies, wrong sites, wrong procedures, or wrong patients. They identified 9,744 paid malpractice judgments and claims over 20 years, with payments totaling $1.3 billion. Death occurred in 6.6% of patients, permanent injury in 33%, and temporary injury in 59%. Using published rates of surgical adverse events resulting in a malpractice claim, the researchers estimate that 4,044 surgical never events occur nationally every year. More serious events involved costlier settlements.
"We've never really had a way to measure this on a national level," Makary says. "Until now we have relied on estimates from voluntary reports from hospitals, and we know that is haphazard." The NPDB is a good source for malpractice claims data for never events because it filters out frivolous lawsuits, he says.
While the study's findings may appear to be alarming, Makary believes they are low-balled. "Although we believe the cases we identified are real, we don't know what the upper end of the range is. We are simply describing the lower end of the range. We believe these are accurate and true cases because hospitals don't pay money for frivolous lawsuits."
"The problem could be three to four times larger than the cases we identified in our study," he adds. "If 60% to 75% of retained objects are never detected and those that are may not necessarily result in a hospital payment, we know that the one-in-seven, one-in-eight, or one-in-nine that we are seeing in the data represent only a fraction of the true scope of the problem."
The study found that surgeons between the ages of 40 and 49 were responsible for one-third of the never events, compared with 14.4% of surgeons over age 60. "That was an interesting finding. I don't have the real explanation for that finding. It may be that once you are a high-volume surgeon you are at the most risk," Makary says. "But it disproves or at least lends less credence to the idea that younger surgeons and very old surgeons are the ones who have the most events associated with them."
In addition, 62% of surgeons were cited in more than one malpractice report and 12.4% were named in separate surgical never events. "All doctors have a 62% chance of being sued. Most of them are frivolous lawsuits, so I can't draw much from that," Makary says. "But the 12.4% having previously been involved in a paid settlement for a retained foreign body tells us that we have a high-risk group, and perhaps education efforts or other prevention efforts can be directed toward this high-risk group."
Makary points to protocols such as post-operative checklists and technology that already exists to flag retained sponges. "We have sponges with radio frequency ID tags sewn into the sponge, where a sensor can detect during or after an operation if one of these things is still in the abdomen," he says. "It's technology that makes sense. I've tried it and it works. Hospitals should adopt this technology if they want to get serious about reducing the human factor in this problem."
As troubling as never events are, Makary says they are probably impossible to eliminate because surgeons and other clinicians practice medicine in complex, labor-intensive, high-pressure environments. "For example, the wrong-patient, wrong-procedure confusion will continue to be something that will be a longstanding challenge, even though these events are rare," he says.
Makary believes that increasing transparency in the reporting of never events will motivate hospitals into action. "Some states now have public reporting of never events, like Pennsylvania. It affects hospitals' consumer ratings," he says. "The transparency increases the accountability and the amount of resources a hospital devotes to the problem."