Single-use devices are intended for, of course, one time. But the U.S. Government Accountability Office (GAO) says using such a device a second time may be OK under certain conditions. It came to that conclusion after reviewing FDA data on reprocessed SUDs, and device-related adverse events, as well as FDA documents and inspection reports, studies published in peer-reviewed journals, and relevant statutes and regulations. GAO interviewed FDA officials and officials from associations of manufacturers, reprocessors, and providers. Despite the limitations of available data, FDA's analysis of reported device-related adverse events does not show that reprocessed SUDs present an elevated health risk.

Reprocessing a single-use device (SUD) calls for cleaning, sterilizing, and performance-testing it before reuse. And then it's relabeled for what it is. Reprocessed SUDs can range from relatively simple items for external use, such as inflatable sleeves to improve blood circulation, to complex items placed inside the body, such as catheters inserted into the heart to monitor cardiac function.

“FDA has reviewed available adverse event reports associated with reprocessed SUDs and has not identified a causative link between the adverse event and the fact that the devices involved were reprocessed,” says the report. In September 2006, the Director of FDA's Center for Devices and Radiological Health testified that based on available adverse event data, FDA had identified 434 reports submitted from October 2003 to July 2006 in which reprocessed SUDs were identified on the reporting form. Most of the reports, including 15 involving deaths, did not involve a reprocessed SUD. For example, FDA determined that many of the reported events involved reusable devices such as magnetic resonance imaging machines or SUDs on their initial use. Of the 434 reports, FDA further reviewed the 65 events that it found actually involved or were suspected to involve a reprocessed SUD and that the reprocessed SUD was one of several possible causal factors in the adverse event. In reviewing these 65 reports, FDA found that the types of adverse events reported to be associated with the use of reprocessed SUDs were the same types of events that are reported for new, nonreprocessed devices.

The decision to label a device as single-use or reusable rests with the manufacturer. If a manufacturer intends to label a device as reusable, it must provide data demonstrating that the device can be cleaned and sterilized without impairing its function. Thus, a device may be labeled as single-use because the manufacturer believes that it cannot be safely and reliably used more than once, or because the manufacturer chooses not to conduct the studies needed to demonstrate that the device can be labeled as reusable.

Read the entire report at www.gao.gov/highlights/d08147high.pdf.