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Hospitals ignoring 1-time-use warnings

Report documents patient injuries tied to reused medical devices

Dec 11, 2005 | Washington Post A growing number of U.S. hospitals 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, and 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 promotes healthy competition with device makers and 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.

The Washington Post examined thousands of pages of documents, including FDA records, court filings and internal company reports, and documented dozens of cases over the past decade of patient injuries and device malfunctions after single-use devices were reused.

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.

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