Good as New? | The Reuse of Medical Devices
Hospitals Save Money, But Safety Is Questioned
Sunday, December 11, 2005
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.