Devices are shipped to the hospital in clearly marked boxes. These are placed in the supply room next to original devices. When getting devices for cases, most of our partners use reprocessed devices before selecting the original ones – to realize critical savings.
Once collection containers have arrived at our plants, contents are sorted to isolate reprocessable devices from devices that cannot be reprocessed. Reprocessable devices are tallied and recorded in our computers. Devices that cannot be reprocessed are broken down into component parts and recycled to the extent possible
An array of automated cleaning equipment is augmented by manual processes. All cleaning protocols are proprietary and device specific.
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.
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.
Verifying that devices perform as intended is an integral component of the Stryker system. This can involve electrical profiling, examining high-speed rotation, measuring curvature, evaluating pressure decay, or other device-specific functional indicators.
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.
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.
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.
After undergoing a final inspection, all devices are quarantined for a minimum of 72 hours before they are released. Devices are shipped to the hospital in clearly marked boxes. These are placed in the supply room next to original devices. When getting devices for cases, most of our partners use reprocessed devices before selecting the original ones – to realize critical savings.
