Did You Know… Devices intended by the manufacturer to be used on one patient during one procedure are called Single-Use Devices (SUDs). A device labeling may or may not identify the device as single-use or disposable; however, if there are no manufacturer instructions for reprocessing, the device should be considered a SUD.1 The reprocessing SUDs for health care facilities is regulated by the Food and Drug Administration (FDA).
Third party reprocessor, as well as healthcare facilities that reprocess SUDs must meet all applicable premarket requirements listed in the reuse SUD guidance document (pre-market notification and approvals, medical device tracking etc.)2, 3
If a healthcare facility reprocesses a device that was previously marketed as a single-use device, FDA considers the facility to be the manufacturer of that device and therefore they are subject to the same adverse event reporting requirements (Medical Device Reporting or “MDR”) as the original equipment manufacturers or commercial reprocessors. A manufacturer is defined in Title 21 of the Code of Federal Regulations (CFR) at 803.3(o) as “any person who manufactures, prepares, propagates compounds, assembles, or processes a device by chemical, physical, biological, or other procedure.” The manufacturer MDR requirements are in addition to the organizations current user facility adverse event reporting requirements.3
If you reprocess without having validated, Food and Drug Administration-cleared IFUs from the device you can’t assume the items are safe for patient use. That’s because the facility has not validated the change and submitted the data to the FDA in a 510(k) submission. Though your facility may have performed product testing to verify the changes, that is not the same as validation testing by the medical device manufacturer. It’s important to understand the difference.4
Validation: “Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications” (AAMI ST79 Section 2.129). There are three qualification activities covered under validation: installation qualification, operational qualification, and performance qualification.4 AAMI ST79 states that validation is performed by the device manufacturer.2
User verification: “Documented procedures, performed in the user environment, for obtaining, recording, and interpreting the results required to establish that predetermined specifications have been met”2 User verification is product testing to determine if a health care facility can sterilize a medical device based on the predetermined specifications (eg, packaging, cycle parameters) that the medical device manufacturer provides as a result of its validation testing.4
Facilities trying to be cost conscious may think about reprocessing SUDs, however this is a risky situation for the patient and facility. Sometimes facilities may think about reprocessing devices that are unique or not easily found sterile. Again, that is a risky situation and therefore facilities should turn to 3rd party reprocessors that have the ability to do validations that meet the FDA requirements.
- Association of periOperative Registered Nurses. AORN Guidance Statement: Reuse of Single Use Devices in: Perioperative Standards and Recommended Practices 2013, AORN Denver.
- ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- FDA Medical Devices Frequently Asked Questions, at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm121093.htm, accessed on March 29, 2011.
- Young, M. Verification, validation: What’s the difference? OR Manager, Vol.27 No.3, March 2011