(USA TODAY) -- Erica Parks knew something wasn't right in her belly when she left
the Alabama hospital that performed her cesarean section in the spring
Over the next month, her stomach grew so swollen that she
looked pregnant again. By the sixth week, her bowels had shut down
entirely. Parks, an Air Force major, staggered in to see her doctor, who
sent her immediately to the emergency room.
X-rays showed that a
surgical sponge the size of a washcloth had been left in Parks' abdomen.
After a six-hour emergency surgery to untangle the infected mass from
her intestine, she needed nearly three weeks of hospitalization.
now 40, had suffered from what is known officially as a "retained
surgical item" - a sponge or instrument left in a patient's body. Such
mistakes are considered so egregious and so preventable that they're
referred to in the medical world as "never events." They simply are not
supposed to happen.
But they do, about a dozen times a day.
of patients a year leave the nation's operating rooms with surgical
items in their bodies. And despite occasional tales of forceps, clamps
and other hardware showing up in post-operative X-rays, those items are
almost never the problem. Most often, it's the gauzy, cotton sponges
that doctors use throughout operations to soak up blood and other
fluids, a USA TODAY examination shows.
Yet thousands of hospitals
and surgical centers have failed to adopt readily available technologies
that all but eliminate the risk of leaving sponges in patients.
consequences are enormous. Many patients carrying surgical sponges
suffer for months or years before anyone determines the cause of the
searing pain, digestive dysfunction and other typical ills. Often, by
the time the error is discovered, infection has set in.
The complications can last a lifetime. Some victims lose parts of their intestines; some don't survive.
thought hospitals had procedures and checks so these problems couldn't
happen in this day and age," Parks says. "I'm still not 100%; I don't
know if I ever will be. I still have to take medicine that keeps your
(digestion) flowing. They told me there might be repercussions if I try
to have another kid. It's been a terrible ordeal."
A USA TODAY
review of government data, academic studies and legal records suggests
that far more people may be victims of lost surgical objects than
federal statistics suggest. And the medical community's inaction comes
at a high price.
Thousands of victims: There's no federal
reporting requirement when hospitals leave sponges or other items in
patients, but research studies and government data suggest it happens
between 4,500 and 6,000 times a year. That's up to twice government
estimates, which run closer to 3,000 cases, and sponges account for more
than two-thirds of all incidents.
Solutions ignored: The nation's
hospitals have balked at using electronic technologies that sharply cut
the risk of sponges being left in patients. Fewer than 15% of U.S.
hospitals use sponges equipped with electronic tracking devices, based
on a USA TODAY survey of the companies that make those products.
consequences: Hospitalizations involving a lost sponge or instrument
average more than $60,000, according to data compiled by Medicare, which
denies payment for costs stemming from such errors. Related malpractice
suits cost hospitals, on average, between $100,000 and $200,000 per
case, several research studies show.
A decade ago, a landmark
report on health care quality ranked lost sponges and instruments in the
most serious category of medical errors. Issued by the National Quality
Forum, a congressionally funded non-profit, the report urged immediate
steps to drive down incidence rates, including mandatory reporting to
Today, there still is no national reporting mandate,
and the available data suggest little or no progress in curbing
incidence rates, particularly for sponges.
"It's a recurrent, persistent and nearly totally avoidable problem,"
says Atul Gawande, a Harvard public health professor and surgeon at
Boston's Brigham and Women's Hospital. "There are technologies that
reduce the risk, that actually reduce the overall cost (to hospitals and
insurers), and yet they are not the standard. That, to me, is the
Sponge-tracking systems typically add $8 to $12
to the cost of an operation - a tiny fraction of the average procedure's
price. But with hospitals doing thousands, even tens of thousands of
surgeries a year, the investment still has not been an easy sell,
despite the promised savings in liability costs.
hospitals, lost sponges and other surgical items aren't considered a
pressing concern. Other errors, such as lapses in infection control, are
more common. And because symptoms often don't occur for months, even
years, many of the cases are never tracked back to the institution where
they originated. So the people who are responsible may not realize they
have a problem.
"In context of all the things we're worrying
about and striving to improve so patients are experiencing better
outcomes, this is a more rare event," says Nancy Foster, the American
Hospital Association's vice president for quality and patient safety.
hospitals grapple with tight budgets, "the question is, 'How do we
invest scarce resources in achieving safer care for our patients?'"
Foster adds. Deciding whether to invest in electronic sponge-tracking
systems "becomes a matter of prioritizing ... and identifying whether this
particular issue rises to being a this-year problem."
A WAKE-UP CALL
years, doctors and nurses in the highly regarded Indiana University
Health system viewed lost sponges as a problem reserved for others.
Like most hospitals, they used sponge counts to keep track of the
gauzy pads during surgery: count the number that go in; count the number
that come out. They had a better-than-average success rate. Of 34,000
surgeries performed each year at IU Health's three-hospital campus in
Indianapolis, they'd typically get one or two cases in which sponges
were left in a patient.
Then, in 2006, the number of lost sponges
jumped, climbing to a rate of about one a month, and clinical staff
could find no explanation.
"It was very upsetting - after each
case, we'd do a review, trying to figure out, my God, how is this
happening," says Lynn Bridgewater, director of operations and
perioperative services at IU Health's Methodist Hospital in
Indianapolis. "We did education, we changed to a different (counting)
system, we tried having another person in the room doing counts. We were
looking everywhere for solutions."
The health system's clinical
leaders began testing sponge-tracking technologies and settled on one
that uses sponges embedded with a tiny radio-frequency tag. Before
patients are closed up after surgery, they get scanned with a sensor
that detects any sponges left inside the body.
IU Health spends
about $275,000 a year to equip its three Indianapolis hospitals with the
tracking technology, including the annual cost of the tagged sponges -
an average of about $8 per surgery.
IU's hospitals have not had a
single lost-sponge case in the five years since they adopted the
tracking technology, Bridgewater says. It has led to several "saves,"
including a case where the scanner turned up a sponge in a patient after
sponge counts showed that everything had been retrieved.
first, we had some skeptics (about the technology), but now people here
would never want to do a surgery without it," Bridgewater adds.
RISKS OF COUNTING ADD UP
It's no secret that sponge counts aren't reliable.
2008 study led by researchers at New York's Mount Sinai found that
sponge and instrument counts were effective 77% of the time in
identifying cases where items were left behind. A separate study
published the same year by doctors at Minnesota's Mayo Clinic found that
counts failed to show anything amiss in 68% of cases where a sponge was
"When you're counting multiple objects over a longer course
of time, such as an operation, and you have significant competing
priorities and tasks that need to be done, as well as multiple people
coming in and out to perform those tasks, you're going to have errors,"
says Robert Cima, the Mayo Clinic surgeon and professor who led the
Some studies have found that lost sponges are more likely in
surgeries performed under hectic conditions, such as emergency trauma or
operations with unexpected complications. Others have suggested that
the risks of leaving a sponge behind are greater in operations on obese
patients with larger abdominal cavities - the most common surgical site
for lost sponges.
When doctors suspect a sponge has been lost,
they often look for it on X-rays, but that typically doesn't happen
unless a sponge count shows a discrepancy. Even then, a lost sponge can
be difficult to spot, the Mayo study and others have found.
is a problem with detecting these cases once they occur," Cima says.
"There are numerous case reports where patients don't present (symptoms)
for months, years, sometimes decades."
Years ago, the Mayo Clinic
began requiring post-operative X-rays in every patient, regardless of
what sponge and instrument counts showed. But those scans weren't done
until patients were closed up, so another surgery would be needed to
retrieve any items that were spotted, Cima says. To avoid such
surgeries, the hospital adopted one of the new sponge-tracking
technologies, a system where each sponge has a unique bar code that is
scanned before and after it goes into a patient.
The result? Mayo hasn't had a lost sponge case in almost four years.
A LONG TIME SUFFERING
Lenny LeClair's stomach started acting up in the spring of 2006, he
figured he had a routine bug; his doctor's office in Florida recommended
antacids and laxatives.
Over the next couple of weeks, the pain
in his gut became excruciating, and his non-stop vomiting began to have
what seemed like a fecal odor. When relatives dropped by to visit,
LeClair's 6-foot-1 frame looked so wasted that they hauled him to a
doctor, who ordered an immediate CT scan.
The images showed
several sponges embedded in LeClair's intestines, left behind from a
surgery he'd had the year before to treat a digestive disorder.
never crossed my mind that the problems I was having could have been
related to the surgery," says LeClair, 43. "I'd been fine for months. I
thought that was all over."
Over time, the sponges had fused to
LeClair's intestines, causing infections that ultimately chewed through
his colon. He needed repeated surgeries to remove parts of his intestine
and reroute what was left, then spent weeks in a medically induced coma
during his recovery. He'll spend the rest of his life with a plastic
pouch attached to his abdomen to catch his waste.
"I still get
wicked pains in my stomach from the scar tissue, and the scars on the
outside are so bad, I can't ever go swimming or go to the beach or
anywhere I'd take my shirt off," he says. "I've always been a happy guy,
but every day is a struggle now. Some days, I just can't let go of it."
living in New Hampshire, LeClair received a six-figure settlement, plus
legal and medical expenses, after filing a malpractice suit. But little
of that money remains, he says, because he has lost his insurance and
faces ceaseless medical bills for drugs and follow-up treatment.
"I'm happy to be alive," he says, "but I wouldn't wish this on my worst enemy."
MANY CASES, FEW CHANGES
There's no telling precisely how many victims are out there.
than half of the states require reporting of medical errors, including
lost surgical items, but a 2012 study by the inspector general for the
U.S. Department of Health and Human Services found hospitals reporting
just 1% of the events they were supposed to record in those states.
National estimates of about 3,000 cases a year are based on hospital
billing records analyzed by the Agency for Healthcare Research and
Quality, but experts believe many cases aren't captured in those
"There's a lot of potential for under-reporting," says
Jeffrey Hageman, an epidemiologist at the Centers for Disease Control
and Prevention. Some hospitals may be reluctant to document cases
"because of legal ramifications," he adds. "And there's also the amount
of time between the surgery and the discovery of the problem," which
makes it tough to know when - or where - the mistake happened.
major studies since 2008 have concluded that sponges and other items
are lost in anywhere from one in 5,500 surgeries to one in 7,000
surgeries. With federal data showing 32 million invasive surgeries
nationwide each year, that yields 4,500 to 6,000 cases a year as the
actual incidence rate. Studies suggest that 1%-2% of those cases prove
"One (lost item) in 5,000 operations or so seems like
pretty terrific performance, but when we're doing tens of millions of
operations a year it's not nearly good enough," says Gawande, the Boston
surgeon, who authored a landmark study on lost surgical items in 2003.
are the biggest problem, accounting for about 70% of lost surgical
items (needles account for less than 10%; instruments about 5%). And the
available sponge-tracking technologies - both the bar code and
radio-frequency detection systems - are an obvious solution, says
Gawande, whose hospital uses bar codes.
"Whatever system people use, these technologies cut down the risk that sponges are left in a patient almost to zero," he adds.
But the systems remain rare in U.S. operating rooms.
TODAY surveyed the manufacturers of all three sponge-tracking systems
approved by the Food and Drug Administration. Combined, they have sold
their tracking technologies to fewer than 600 hospitals - a small
fraction of the nearly 4,200 that perform surgery nationwide.
still an emerging trend," says Victoria Steelman, an assistant
professor of nursing at the University of Iowa and author of a recent
study on retained surgical items for the Association of periOperative
Registered Nurses. "Is it happening fast enough? Not in my opinion."
MAKING A CASE OVER COSTS
hospital officials at University of North Carolina Health Care decided
on a radio-frequency detection system for surgical sponges, the big
hurdle was costs - and the way they're calculated.
"We had to find savings to offset the expense," says Susan Phillips, UNC Health's vice president of perioperative services.
who pushed for the tracking system after two lost-sponge cases emerged
at UNC's hospitals, says the strongest justification was improved
patient safety, but the potential to cut liability costs was a major
consideration. The technology "pays for itself (if it stops) just one
error," she adds, noting that UNC has not identified a single
lost-sponge case since adopting the technology in 2011.
Phillips couldn't factor those savings into the equation because legal
fees and other costs tied to medical errors don't typically come out of a
surgical department's operational budget. Phillips had to offset the
new system's expense - about $300,000 a year, averaging just over $10
each for the hospital's 29,000 annual surgeries - by cutting other
medical supply costs.
It's a common refrain: The best argument for
sponge-tracking systems is the one that often can't be used - that they
can save a lot of money in the long run.
There's little research
on the costs hospitals incur for follow-up treatment and surgeries tied
to lost sponges - the $60,000-plus estimate from Medicare was generated
in 2008, when the program decided to stop reimbursing hospitals for
certain expenses tied to such problems. But there's plenty of research
suggesting that liability costs might be the biggest consequence.
A 2009 study in the journal Surgery put
the average malpractice costs for a lost sponge at $150,000, including
both awards and legal defense fees, but noted that the figure could be
much higher in some parts of the country.
considering sponge-tracking technologies "do an incomplete cost analysis
and just look at the raw cost of the supplies," Steelman says. "The
facilities that consider all the costs related to preventing retained
sponges are finding that there is a cost savings."
biggest obstacle to wider use of sponge-tracking systems may be that so
many lost-sponge cases are not detected or tracked to the responsible
doctor or hospital.
"There's an element of human nature where
until someone has a retained-sponge case, that person might not feel
vulnerable - and they should," Steelman says. "If we have to wait for
every surgeon to personally experience this before it's considered a
problem, we will have injured many, many patients."