After analysing national malpractice claims, Johns Hopkins patient safety researchers estimate that a surgeon in the United States leaves a foreign object, such as a sponge or a towel, inside a patient’s body after an operation 39 times a week.
The researchers also found that surgeons perform the wrong procedure on a patient 20 times a week and operate on the wrong body site 20 times a week.
Reporting online in the journal Surgery, the researchers said they estimate that 80,000 of these so-called “never events” occurred in American hospitals between 1990 and 2010 – and believe their estimates are likely on the low side.
The findings – the first of their kind, it is believed – quantify the national rate of “never events,” occurrences for which there is universal professional agreement that they should never happen during surgery. Documenting the magnitude of the problem, the researchers said, is an important step in developing better systems to ensure never events live up to their name.
“There are mistakes in healthcare that are not preventable. Infection rates will likely never get down to zero even if everyone does everything right, for example,” said study leader Dr. Marty Makary, an associate professor of surgery at the Johns Hopkins University School of Medicine. “But the events we’ve estimated are totally preventable. This study highlights that we are nowhere near where we should be and there’s a lot of work to be done.”
For the study, Dr. Makary and his colleagues used the National Practitioner Data Bank, a federal repository of medical malpractice claims, to identify malpractice judgments and out-of-court settlements related to retained-foreign-body (leaving a sponge or other object inside a patient), wrong-site, wrong-procedure and wrong-patient surgeries. They identified 9,744 paid malpractice judgments and claims over those 20 years, with payments totalling US$1.3 billion. Death occurred in 6.6 per cent of patients, permanent injury in 32.9 per cent and temporary injury in 59.2 per cent.
Using published rates of surgical adverse events resulting in a malpractice claim, the researchers estimate that 4,044 surgical never events occur in the United States each year. The more serious the outcome, the more the patient (or his family) was paid.
Dr. Makary said the National Practitioner Data Bank is the best source of information about malpractice claims for never events because these are not the sort of claims for which frivolous lawsuits are filed or settlements made to avoid jury trials. “There’s good reason to believe these were all legitimate claims,” he said. “A claim of a sponge left behind, for example, can be proven by taking an X-ray.”
By law, hospitals are required to report never events that result in a settlement or judgment to the National Practitioner Data Bank. If anything, he said, his team’s estimates of never events are low because not all items left behind after surgery are discovered. Typically, they are found only when a patient experiences a complication after surgery and efforts are made to find out why, Dr. Makary said.
In their study, never events occurred most often among patients between the ages of 40 and 49, and surgeons in this same age group were responsible for more than one third of the events, compared to 14.4 per cent of surgeons over the age of 60. Sixty-two per cent of the surgeons were cited in more than one separate malpractice report, and 12.4 per cent were named in separate surgical never events.
Dr. Makary noted that at many medical centres, patient safety procedures have long been in place to prevent never events, including mandatory “time outs” in the operating room before operations begin to make sure medical records and surgical plans match the patient on the table. Other steps include using indelible ink to mark the site of the surgery before the patient goes under anaesthesia. Procedures have long been in place to count sponges, towels and other surgical items before and after surgery, but these efforts are not foolproof, Dr. Makary noted.
Many hospitals are moving toward electronic bar codes on instruments and materials to enable precise counts and prevent human error. Surgical checklists, pioneered at Johns Hopkins, are also often in place.
Along with better procedures to prevent never events, better reporting systems are needed to speed up safety efforts, said Dr. Makary.
He advocated public reporting of never events, an action that would give consumers the information to make more informed choices about where to undergo surgery, as well as “put hospitals under the gun to make things safer”.
At the moment, he noted, hospitals are supposed to voluntarily share never event information with the joint commission that assesses hospital safety and practice standards, but that does not always happen.