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 How we reprocess single-use devices

As an FDA-registered medical device manufacturer, we are held to the same standards for cleanliness, sterilization and functionality as the original equipment manufacturer. After a device is used at a facility, it goes through these steps to become a reprocessed device.

Reprocessing
Start
Device collection and shipping
Decontamination and cleaning
Refurbishing
Quality and functionality testing
Packaging and labeling
Sterilization

SUD Reprocessing Cycle

(click on each icon to learn more)

Recycling Tear Drop

Recycling

In addition to cost savings through reprocessing, we divert medical devices from landfills. We collect and ship devices at no cost to the facility, reducing operating room waste disposal costs by up to 70 percent.

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.

Refurbishing

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.

Sterilization

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.