According to MassDevice.com, “The US Food and Drug Administration has released final guidance on how manufacturers of reusable medical devices should validate instructions for these products.” Four categories fall into the new guidance’s outline:
- Reusable devices supplied sterile to users, who then must reprocess – clean or sterilize – those devices after initial use but before use on patients
- Reusable devices supplied non-sterilized to users who must then reprocess those devices before both initial use and subsequent uses
- Reusable devices intended for reuse by a single patient, but that must be reprocessed before each use
- Single-use devices supplied non-sterilized to users who must process those devices before use
