How Reprocessing Works
The difference between hospital-based and third-party reprocessing
Hospital-based reprocessing is limited to reusable devices and includes only cleaning and sterilization. Reprocessing single-use devices is a highly regulated, complex process, requiring the expertise of a third-party reprocessor to meet requirements established by the FDA.
Third-party reprocessing includes:
- Reusable and single-use devices
- Proven methods for decontamination and cleaning, sterilization, refurbishment and functional testing that meet FDA guidelines
How we reprocess single-use devices
To reprocess and sell single-use devices, we must prove, to the FDAs satisfaction, that we meet or exceed functional requirements. Highly-trained technicians inspect each device multiple times throughout the process and only those passing all inspections and functional tests progress to the next step. Our team of engineers, scientists and technicians work together to develop and validate processes that enable us to decontaminate and clean, functionally test and sterilize devices for at least one additional use.