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Hospitals
Save Money, But Safety Is Questioned
By Alec
Klein
Washington
Post Staff Writer
Sunday, December 11, 2005; Page A01
http://www.washingtonpost.com/wp-dyn/content/article/2005/12/10/AR2005121001213.html
A growing number of U.S. hospitals,
including at least eight in the Washington area, are saving
money by reusing medical devices designated for one-time use,
ignoring the warnings of manufacturers, which will not vouch for
the safety of their reconditioned products.
Hospitals are not required to tell
patients that reconditioned devices will be used in surgery --
surgeons themselves often do not know. The Food and Drug
Administration regulates the practice, and many hospital
administrators say reusing single-use devices is not only cost
effective but also poses no threat to patients because the
instruments are cleaned with such care that they are as good as
new.
But single-use devices have
malfunctioned during reuse, federal records and interviews show.
In one instance, an electrode from a catheter broke off in a
patient's heart. In another, a patient's eyeball was impaled.
And an infant who for months gagged and retched on a
resterilized tracheal tube now can take food only from a tube
attached to his stomach.
Based on available data, it is
impossible to compare how often single-use devices malfunction
in their first operation versus subsequent uses. That is because
the FDA, which devotes few resources to overseeing what is now a
fast-growing industry, began requiring only last year that
hospitals report whether a malfunctioning device had been
reprocessed.
The Washington Post examined
thousands of pages of documents, including FDA records, court
filings and internal company reports, and was able to document
dozens of cases of patient injuries and device malfunctions
after single-use devices were reused over the past decade.
In one case in March 1998,
cardiologist Peter Karpawich removed from a child's body a
single-use catheter, which was handed to a nurse. The device tip
appeared to be twisted, and the shaft at one end of the catheter
had separated from its bonding. After investigating,
manufacturer Boston Scientific Corp. told the FDA that the
problems were "likely due to aggressive disinfecting and
cleaning between uses."
Although the patient was fine,
Karpawich said, Children's Hospital of Michigan in Detroit
immediately stopped all reprocessing of single-use devices. "If
there is the remotest possibility that a catheter might be used
twice, that you could potentially harm a patient, you should not
use it," he said. "It's common sense."
Nonetheless, single-use devices are
being manufactured and reused with increasing frequency. New
plastics and other materials make it possible for companies to
build intricate -- and sometimes delicate -- specialized devices
that many doctors say are particularly effective in treating
patients. The FDA allows manufacturers to choose between getting
approval for a device to be used once or multiple times.
Companies are frequently choosing one-time use, which means
their products do not have to be as sturdy, their liability is
diminished after the first use and they are ensured a steady
stream of replacement orders. The manufacturers often ship the
devices sealed individually in sterile packaging, marked with
warnings that they are not to be reused.
At the same time, hospitals are
increasingly disregarding the one-time-only designation as a
manufacturer's ploy to force them to buy more devices than they
need. Many hospitals are comfortable with reprocessing
single-use devices, in part because they have a long tradition
of resterilizing the metal and rubber devices that have been
used in surgery for generations.
Hospitals in all 50 states and the
District, including many of the nation's leading hospitals, are
believed to reprocess at least some single-use devices. In the
Washington region, the National Naval Medical Center in
Bethesda, where the president gets his checkup, at first said it
did not use reprocessed devices. But after The Post
independently confirmed that it does, the medical center said it
does use them on a limited basis. So do Suburban Hospital
Healthcare System in Bethesda, four Northern Virginia hospitals
in the Inova Health System, and George Washington University
Hospital and Greater Southeast Community Hospital in the
District. "Because of the rising cost of health care and medical
supplies, reprocessing is a cost effective way to provide a high
quality product to our patients," GWU said in a statement. The
other hospitals echoed the sentiment.
Several local medical institutions,
including Georgetown University Hospital and the Children's
National Medical Center in the District, said they do not reuse
single-use devices. Sibley Memorial Hospital, also in the
District, will not reuse such a device either, because it wants
"to know that it's absolutely safe and sterile," hospital
spokeswoman Sheliah Roy said.
While hospitals reprocess in-house,
they are increasingly sending their used devices to outside
companies to clean and resterilize. The three biggest U.S.
reprocessors, which dominate the industry, declined to disclose
the hospitals they serve but said they have 3,370 accounts.
There are about 4,800 U.S. hospitals, according to the American
Hospital Association. Last year, the big three reprocessors said
they refurbished about 4.6 million single-use devices, which
were used in medical procedures involving almost every part of
the body.
That is a big change from the late
1980s, when the reprocessing business started as health care
costs spiraled. Then, only a handful of small operators, some
working out of their garages, refurbished single-use medical
devices, at first limiting their work to the resterilization of
sutures that had been opened but unused. The industry is
expected to surpass $100 million in revenue this year.
Although their reconditioning
methods have become much more sophisticated, reprocessors often
need to take apart the medical instruments -- many involving
small openings and delicate attachments -- to figure out how
they are made and how they can be cleaned. While device makers
raise questions about such practices, the American Hospital
Association has supported reprocessing as far back as 2000,
noting the FDA's oversight and the cost savings for hospitals.
Reprocessors say their reconditioned devices can cost hospitals
about half as much as a new single-use device. New biopsy
forceps can cost $60; reused, as little as $15. Hospitals that
reuse such devices said that the practice may not directly lead
to a discount in a patient's bill but that it allows them to buy
additional medical equipment or hire more personnel.
Device makers say the single-use
tag is not just a label. "Single-use devices typically contain
difficult-to-access areas that create barriers to cleaning and
permit blood, tissue or other bodily fluids to contaminate the
reprocessed device, allowing potential transmission of viral and
bacterial infections," said Stephen J. Ubl, president and chief
executive of the Advanced Medical Technology Association, which
represents device makers worldwide.
An association that represents
reprocessors said there is "no credible evidence" that
refurbished single-use devices are riskier than new ones.
Caught in the middle of the debate
are patients like Brian D. Reid. The 34-year-old firefighter
recently entered Christ Hospital in Cincinnati for a procedure
to treat an irregular heartbeat. Reid did not know that a
single-use cardiac catheter employed in his procedure had been
previously threaded into some else's heart.
"I didn't really have a problem
with" it, Reid said after the procedure, when he learned about
the reuse.
But, he added, "I don't think there
would be any harm with the hospital disclosing that" on the
"informed consent" form patients must sign. Reid's form
explained that the catheter procedure is "generally considered
to be safe," but it noted several risks, from bleeding to a
heart attack to death. It did not say that the doctor may place
a refurbished single-use medical device in the patient's body.
Reprocessors have changed their
position on patient consent in recent months. At first they said
they saw no need to inform patients when single-use devices are
reused, because they are safe. Now they say they would support
such informed consent as long as hospitals also disclose the
risks of new devices.
Fed Through a Tube
Susan and Tony Van Duyn think
patients should know when single-use devices are reused.
Their 5-year-old son, Sean, lives
in his own world. For hours each day, he sits on his knees
inches from a television, his sandy blond head tilted to the
left, hazel eyes blank, mouth agape, bouncing up and down,
clapping to a children's video, "Blue's Clues." It is the only
thing he will watch on television. He cannot eat or drink from
his mouth, which his family's lawyer says is the result of a
failed reprocessed medical device. The hospital and doctors
involved in Sean's treatment settled a lawsuit with the family,
so no court determined the facts of their case.
Days after his birth in 2000, Sean
was rushed to Arnold Palmer Hospital for Children & Women in
Orlando because of a brain inflammation. He had neurological
damage. During surgery, doctors inserted a tube in Sean's throat
to help him breathe. But the tube turned out to be too big and
caused an injury to the lining of his airway, the family said in
its lawsuit. That required a tracheotomy -- cutting a hole in
Sean's throat below his Adam's apple -- in January 2001. A
plastic tube was inserted in his throat so he could breathe.
Through its in-house sterilization department, hospital records
show, the medical facility reprocessed the tracheal tube despite
an explicit warning on the packaging from the manufacturer that
the device was not to be resterilized.
The hospital does not dispute that
it resterilized the device, said its attorney, Richards H. Ford.
Two reprocessed tubes were used in Sean's throat for nine
months, while he vomited and retched several times a day. The
Van Duyns said they repeatedly asked their doctors whether Sean
was having a bad reaction to the tubes and whether they should
use a new one. They said the doctors told them that Sean was
vomiting and retching because of his neurological problems.
Sean's dry heaving got so bad at one point that he suffered a
hernia, where a portion of his stomach became lodged in his
chest cavity.
Finally, in September 2001, Sean's
mother decided on her own to give him a new tracheal tube. She
said his retching stopped immediately. When she compared the old
and new tubes, she noticed the reprocessed tubes had been bent
out of shape, which the family believes was caused by the
hospital's heat sterilization process. But by then, Sean had
permanent damage. The family contends that Sean lost the ability
to eat and drink from his mouth because of the faulty
reprocessed tubes. "There is a window of time during which we
learn to swallow properly and take things by the mouth, and he
passed that time, so now he can't eat or drink," said James F.
Bleeke, the Van Duyn attorney.
Ford, the hospital's attorney,
defended his client by saying it "makes absolutely no sense"
that any hospital personnel would place a plastic medical device
in a high-heat sterilizer, adding that the hospital used
appropriate methods to resterilize the instrument. In any event,
Ford said, the child's eating problem was more likely caused by
his neurological damage and not by the tube.
The cost of a new tracheal tube
then: about $42.
For Sean's mother, the question
remains: Why did the hospital reuse the device? "I just don't
think these one-time-use devices should be reused in any shape
or form," she said.
Broken Devices and Complaints
Hospitals, concerned about such
questions, over the past several years have turned to
reprocessing companies that ostensibly have more expertise to
clean, sterilize and refurbish single-use medical devices. That,
however, has not always protected patients from injury or
prevented devices from failing, according to complaints filed
with the FDA by doctors, hospitals and other health care
professionals.
The FDA records, while limited in
their disclosures, document these separate incidents, for
example:
In January 1999, an
electrophysiology catheter was threaded into the heart of a
32-year-old patient at a Wichita hospital. But the doctor had
difficulty removing the device. A "small piece of metal
electrode broke off while still in heart and lodged in right
atrium," the records say. The device had been reprocessed by
Paragon Healthcare Corp., acquired two years later by
Phoenix-based Alliance Medical Corp., one of the big three
reprocessors. Alliance said it does not use Paragon's
reprocessing methods.
In March 1999, a manufacturer told
the FDA that it fetched six of its gastrointestinal biopsy
forceps from a Florida hospital, which had them reconditioned by
Lakeland, Fla.-based Vanguard Medical Concepts Inc., another
major reprocessor. The manufacturer tested the single-use
devices -- about eight feet long -- by cutting them into
segments to access the tubing. It found that they were not
sterile. The FDA concluded then that new testing was needed.
Mark A. Salomon, Vanguard's senior vice president of corporate
development, said his firm paid a lab to test the devices and
found them sterile. He said sterility is a "confidence level,
not an absolute" because when batches of devices go through
sterilizers, the results are statistical probabilities of
cleanliness. He said there was "less than a 1 in 1 million
chance that a device will be rendered unsterile."
In about January 2001, "During a
gall bladder operation, the [patient] was burned slightly by the
shaft of a laparoscopic scissor and required two stitches,"
records say. The reprocessor, Alliance, which is merging with
Vanguard, studied the problem and said it could have been caused
by a reprocessing error. It said it may have replaced the
insulation sheathing on the scissor incorrectly.
In about May 2003, a physician was
making an initial groove into a patient's cataract with a sharp
instrument when the "tip snapped in half and impaled itself in
the central nucleus of the lens." The device had been
reprocessed by Alliance, which said the patient had no permanent
damage. In its own testing, the reprocessor said, there was no
evidence that the reconditioning contributed to the device's
failure. In addition, Alliance said such a device failure is
found among new single-use instruments.
Around June this year, a trocar, a
pointed shaft designed to be inserted into a vein or body
cavity, "shattered into multiple glass-like sharp fragments
while in the [patient's] abdomen" during surgery. The
reprocessor, SterilMed Inc., based outside of Minneapolis, said
the trocar had been removed from its packaging but not used when
it resterilized it.
"In every case we've investigated,"
SterilMed found that the device problems were not its fault,
said its president and chief executive, Brian F. Sullivan. He
also said such device problems are commonly found in complaints
against device makers. And he said highlighting some
reprocessing problems distorts the industry's good work.
Some Single-Use Devices That Are Reprocessed
On average, medical device reprocessors say they save hospitals
about 50 percent off the price of a new single-use medical
device.
Nobody's track record is perfect,"
he said.
At the Hospitals
The big three reprocessors say they
perform a great service for hospitals, noting that they reduced
hospital waste by 935 tons in 2004, the first year such numbers
were tabulated.
Kenneth Hanover, president and
chief executive of the Health Alliance of Greater Cincinnati, a
chain of six hospitals, said that device makers threatened to
charge his facilities more if they reprocessed devices but that
he ignored them. His hospital chain has been reusing single-use
devices, including catheters and biopsy forceps, for several
years, reprocessed principally through Alliance. Asked whether
the hospital chain has encountered any problems with reprocessed
devices, Hanover said none had been brought to his attention.
This year alone, he said, the chain will save about $1 million
through reprocessing, which he said means it can buy more
surgical devices and other medical equipment.
Aside from saving hospitals money,
reprocessors stress that they follow strict cleaning and
sterilization procedures and say they test every device they
recondition. They also note that Congress's investigative arm,
the Government Accountability Office, "found little available
evidence of harm from reuse" when it looked into the matter in
2000. The GAO also said that "reprocessing is not invariably
safe." In addition, the FDA requires reprocessors to register
with it and submit paperwork validating the safety and
effectiveness of their work and periodically inspects
reprocessors' facilities.
The big three said they are paid
per device reprocessed. If they are not able to recondition a
single-use device, they say, they will absorb the cost. They
said the system does not create an incentive to return to a
hospital a reprocessed device that is not fully sterile or
functional. Their business, they say, depends on their
reputation for safe reprocessing.
"We're only as good as the last
device we deliver to that customer, so it has to function
appropriately," Vanguard's Salomon said.
Several hospitals vouch for the
reprocessors' work. That includes the Mayo Foundation. In a
recent letter, an official from its Jacksonville, Fla., clinic
informed manufacturers' sales representatives that it was about
to begin reusing single-use devices by hiring Alliance, citing
the practice's safety and "the dramatic reduction in our supply
costs that will occur." The clinic asked the sales reps to "not
speak negatively to any surgeon, nurse or other employee about
[single-use device] reprocessing while on hospital property."
Erik Kaldor, a spokesman for the
Jacksonville Mayo Clinic, explained the letter was written to
remind "sales reps from these companies who may not welcome our
policies" to not speak poorly about reprocessing because they
are trying to sell new devices. He said the Mayo Clinic in
Rochester, Minn., also reprocesses single-use devices.
The Johns Hopkins Hospital in
Baltimore said it also has just begun reprocessing single-use
devices through Vanguard. John D. Hundt, Hopkins's administrator
of surgery, said its operating rooms intend to refurbish about
30,000 single-use devices, including drill bits, burs and
blades, in the first year.
But Shannon J. Tillman, president
and chief executive of Millstone Medical Outsourcing LLC, one of
the few reprocessing firms that works with device makers,
questions how the others do their job. Tillman's firm has access
to the device makers' original product design requirements. Most
other reprocessors do not have those documents, but they say
they have sophisticated research and development departments to
assess how a device was made.
Still, Tillman said, "I think it
would be very difficult" for another reprocessor to recondition
a single-use device without the original manufacturer's help,
given the complexity of the product's material and design.
Working in concert with a device maker is "much less risky," he
said.
"How do you know for sure," Tillman
asked, "what you put back in the hands" of a doctor?
Staff researcher Richard Drezen
contributed to this report.
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