Hospitals Save Money, But Safety Is Questioned

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.