The mistakes largely result not from surgeon fatigue, but from the
stress arising from emergencies or complications discovered on the
operating table, the researchers reported.
It also happens more often to fat patients, simply because there is
more room inside them to lose equipment, according to the study.
Both the researchers and several other experts agreed that the number
of such mistakes is small compared with the roughly 28 million
operations a year in the United States. "But no one in any role would
say it's acceptable," said Dr. Donald Berwick, president of the
Boston-based nonprofit Institute for Healthcare Improvement.
The study was done by researchers at Brigham and Women's Hospital and
Harvard School of Public Health, both in Boston. It was published in
Thursday's New England Journal of Medicine (news
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web sites).
The researchers checked insurance records from about 800,000
operations in Massachusetts for 16 years ending in 2001. They counted 61
forgotten pieces of surgical equipment in 54 patients. From that, they
calculated a national estimate of 1,500 cases yearly. A total of $3
million was paid out in the Massachusetts cases, mostly in settlements.
Two-thirds of the mistakes happened even though the equipment was
counted before and after the procedure, in keeping with the standard
practice.
Most lost objects were sponges, but also included were metal clamps
and electrodes. In two cases, 11-inch retractors — metal strips used to
hold back tissue — were forgotten inside patients. In another operation,
four sponges were left inside someone.
The lost objects were usually lodged around the abdomen or hips but
sometimes in the chest, vagina or other cavities. They often caused
tears, obstructions or infections. One patient died of complications,
but the researchers withheld details for reasons of privacy.
Most patients needed additional surgery to remove the object, but
sometimes it came out by itself or in a doctor's office. In other cases,
patients were not even aware of the object, and it turned up in later
surgery for other problems.
The study found that emergency operations are nine times more likely
to lead to such mistakes, and operating-room complications requiring a
change in procedure are four times more likely. A rise of one point in
body-mass index, a measure of weight relative to height, raises the
chances of such a mistake by 10 percent.
The length of the operation or the hour of day does not appear to
make a difference, suggesting that fatigue does not cause such mistakes.
"It tends to be in unpredictable situations," said lead author Dr.
Atul Gawande of Brigham and Women's Hospital.
Some other researchers said fatigue could promote such mistakes in a
way undetected by this study.
The Boston research team suggested that more X-ray checks be done
right after those operations where such errors are most likely. Metal
instruments and radiologically tagged sponges show up in such checks.
Eventually, wands similar to supermarket bar-code readers might be
developed to detect missing equipment, researchers said.
Dr. Sidney Wolfe, health research director of the public-interest
lobby group Public Citizen, said the real number of lost instruments may
be even higher, because hospitals are not required to report such
mistakes to public agencies. He said they should be.
However, some others said such mistakes are so rare — occurring about
50 times in 1 million operations — that figuring out how to prevent them
could be difficult.
"Something has to be done about this. It's just a very tough balance
to decide. Do we really want to add this hoop for every patient to jump
through?" said Dr. Kaveh Shojania, author of a 2001 federal study on
medical mistakes.
Lori Bartholomew, research director at the Physician Insurers
Association of America, said: "I find it's going to be difficult to make
much more improvement, because some of the risk factors are things that
are hard to control." The Rockville, Md., group represents medical
malpractice insurers.