Reprocessing in the United States is legal under the Federal Food, Drug  and Cosmetic Act (FDCA).  For detailed information on FDA regulation of third-party reprocessing see: FDA Regulation of Reprocessing.

An original device that complies with all of the applicable requirements of the FDCA is not misbranded or adulterated, and may be marketed legally. Therefore, a reprocessed device that complies with all of the applicable requirements of the FDCA is lawful and may be marketed legally in the United States.[1]

The “single-use” label can be confusing.  In fact, whether a device is designated as reusable, “reposable”, reprocessable or “single-use” is a decision made by the device manufacturer, not FDA.  

In a January, 2008 report, 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[2]

AMDR supports transparency around the practice of regulated third-party reprocessing.  One common misconception is that transparency on the subject of reprocessing is somehow connected to the legal documentation commonly referred to as patient informed consent.

While there are legal requirements for what should be included in these documents regarding the risks associated with a specific diagnosis or procedure, there is no legal, regulatory or licensing requirement for inclusion of FDA cleared devices. Including information on medical devices within an informed consent authorization is necessary only when those devices are experimental, or investigational.   FDA-cleared reprocessed devices are neither. 

For information on FDA requirements for informed consent see:  FDA Informed Consent.  For information on informed consent from JCAHO, see:  http://www.jointcommission.org/


[1] See 21 U.S.C. §§ 351, 352, 360, and 360c-360e.

[2] U.S. Government Accountability Office, GAO-08-147, Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk (January 2008), at 1 (emphasis added).