When it comes to treating patients, safety is everyone’s first concern. Medical professionals realize that reprocessing is safe, cost-effective, and environmentally responsible.
The reprocessing of devices labeled by the original manufacturer for “single-use” has been a common clinical practice for over two decades. In fact, the “single-use” label is chosen at the manufacturer’s discretion, often for economic reasons, not patient safety reasons. The “single-use” label is NOT an FDA designation.
Manufacturers appear to use the term “for single-use” as part of their labeling without justifying whether, in fact, the device can be safely reprocessed for subsequent use… the “for-single-use” label is a misnomer.
— Dr. John Clough of the Cleveland Clinic, providing testimony on behalf of the American Hospital Association before the Senate Health, Education, Labor and Pensions (HELP) Committee (June 27, 2000).
In a document made public on March 3, 2008, the U.S. Government Accountability Office (“GAO”) wrote:
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 to FDA’s satisfaction 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.
Stringent FDA regulation of third-party reprocessing provides the clinician and the patient an assurance of high quality device manufacturing standards, resulting in safe, and effective reprocessed devices. Regulated third-party reprocessing is an effective tool in helping healthcare providers control spiraling healthcare device costs, while also decreasing regulated medical waste.