Reprocessing of single use devices (SUDs) is regulated by the FDA. Stryker’s Sustainability Solutions must obtain 510(k) clearance and comply with the same medical device regulations as Original Equipment Manufacturers (OEMs), as well as comply with additional requirements:

  • Reverse-engineer OEM devices
  • Validate cleanliness and sterility
  • Validate functional performance
  • Validate replacement components as equivalent to new

The U.S. FDA and substantial equivalence

The U.S. FDA sets stringent quality and safety standards for the reprocessing industry that assure devices are substantially equivalent to the original device. We satisfy all FDA regulatory requirements to reprocess medical devices and ensure that Stryker’s reprocessed devices are substantially equivalent to original equipment devices.

  • In addition, we warrant our reprocessed and remanufactured devices and carry a liability policy similar to that of other original equipment manufacturers.

How we ensure safety and quality

designverificationReprocessed devices are tested to ensure the devices perform according to the established functional requirements
designvalidationDesign validation is performed in order to ensure the product meets the needs of our customers
reverseengineeringRigorous engineering studies are conducted on the materials, coatings and components of SUDs to determine which devices can be effectively reprocessed and are equivalent to the OEM device
sterilizationDevice-specific cleaning and sterilization processes are established and performed in accordance with strict industry standards recognized by the FDA (AAMI TIR 30 and ISO 11135-2007)

performancetestingEach device is tested for proper functionality and inspected to ensure performance is equivalent to that of the OEM

At Stryker, quality is first in everything that we do. We are driven to make healthcare better for our customers by providing innovative products and services that meet regulatory requirements through our effective quality system.

At a glance

FDA QSR
compliant

105+ cleared 510(k)s

ISO 13485
certified