Realizing Reusability Through Reprocessing
Many single-use devices (SUDs) can in fact be safely reused. The label is not a regulatory requirement, and some devices labeled “single-use only” in one country are labeled “reusable” in others. The label has often been applied to devices previously labeled “reusable” without structural adjustments to the device.
Some device manufacturers have even included “cleaning instructions” with so-called SUDs. Some medical devices can clearly not be reprocessed, but many can. In the case of such devices, why is the “single-use only” label used at all?
Click to see a list of SUDs that have been cleared for reprocessing by the FDA and are CE marked as well.
The decision to label a medical device as “single-use only” rests with manufacturers who choose not to conduct the studies necessary to demonstrate that their products can be labeled as reusable. The “single-use-only” label is not a regulatory label, but a manufacturer-designated one. Just because a device is labeled for “single-use” does not mean it is not capable of being reprocessed.