Device collection and shipping
We treat single-use devices like valuable assets, an approach that starts with how we collect and pre-clean devices on-site. This dramatically increases the number of devices we can return, and we are able to do it with minimal effort on the part of hospital personnel. We use customized shipping containers and ship devices as needed, based on collections.
Decontamination and cleaning
Our validated processes ensure the removal of protein, detergent and carbohydrate residues. Residue levels are below those established by AAMI and ANSI standards and by the FDA for safe patient use. Steps include:
- Enzymatic soak, followed by manual cleaning as appropriate.
- Progressive ultrasonic cleaning that’s 3-4 times more powerful than what hospitals and surgery centers use.
- Lower energy ultrasonic cleaning that deeply penetrates all areas of the device.
Devices are tested and undergo minor refurbishment to confirm that original functionality specifications are met. Processes include sharpening and polishing (shavers, blades, etc.), application of lubricant, pad replacement (ultrasonic scalpel) and patient contact materials (pulse oxisensors).
Quality and functionality testing
Inspection is performed on every device to confirm functionality and with most devices durability. Tests are device-specific and include mechanical and electrical tests for sealing pressure, spring actuation, component alignment, energy delivery and diagnostic and imaging functionality.
Packaging and labeling
Reprocessed devices are packaged, sealed and inspected. The packaging is customized depending on the type of device and the sterilization process used. All labeling components are compliant with the FDA standards and include catalogue number, product name and description.
Device sterilization (using ethylene oxide) is handled by the nation’s largest third-party sterilization company. The process includes biological indicators with each load to ensure there is a complete kill of bacteria, viruses and spores.