Ascent has developed proprietary processes and/or equipment for each component of our reprocessing system. Listed below is an overview of our process:
Receiving
When received at one of our facilities, all orders are ticketed to assure order content integrity.
Sorting
An initial sort of each order's contents takes place to eliminate obvious rejects, heavily soiled items, or unapproved products.
Cleaning
An array of automated cleaning equipment is augmented by manual processes. All cleaning protocols are proprietary and device specific.
Data Entry & Cycle Marking
Once cleaned, each device is identified and coded with a distinct mark to indicate reprocessing cycles. The mark allows us to store and retrieve information about the device, including the number of times it has been reprocessed.
Restoring
Many devices must be functionally restored. This may include meticulously removing burrs or dull edges on cutting instruments or the replacement of sheathing on laparoscopic instruments. Automation is our preferred method of processing, but it is also augmented by manual processes by trained technicians.
Testing
Verifying that devices perform as intended is an integral component of the Ascent system. This can involve electrical profiling, examining high-speed rotation, measuring curvature, evaluating pressure decay, or other device-specific functional indicators.
Final Clean
The process of restoring and testing can reintroduce debris onto devices. Our heated RO/DI (reverse osmosis/de-ionized) final rinse system removes any remaining residuals.
Packaging
In packaging areas where highly filtered air circulates at more than twice the rate as that of the typical hospital operating room, all devices are packaged, sealed and labeled in Mylar/Tyvek® pouches, using precisely calibrated and validated machinery.
Sterilization
Ethylene Oxide (EO) sterilization processes are validated to the ANSI/AAMI/ISO 11135-1994 standard, recognized by FDA. Our validated process is based on the conventional release of product using a microbiological indicator to ensure a Sterility Assurance Level (SAL) of 10-6.
Final Inspection & Product Release
After undergoing a final inspection, all devices are quarantined for a minimum of 72 hours before they are released.