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.
Patients in the middle
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.
'Nobody's track record is perfect'
"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.
"Nobody's track record is perfect," he said.
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.
Reprocessing gaining popularity
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.