FAQ

Which hospitals are currently using Stryker Sustainability Solutions to reprocess medical devices?

Most major hospitals in the USA and Canada use remanufacturing and reprocessing, and the majority of these use Stryker Sustainability Solutions for their reprocessing and remanufacturing activities. Stryker’s 3,000+ hospital partners include most of the U.S. News & World Report “Honor Roll” hospitals, and many smaller hospitals rely on the supply cost benefits of remanufacturing and reprocessing to sustain operations and to improve overall quality of care by freeing supply costs to cover investments in technology and staff. Stryker has agreements with all leading American group purchasing organizations as well as numerous nationally recognized hospital integrated delivery networks.
 

How are the reprocessed devices labeled?

Reprocessed devices are required to follow the same regulatory requirements applicable to new devices, including the Code of Federal Regulations, Title 21, Part 801 Labeling, as well as additional requirements that the FDA has enacted for reprocessed single-use medical devices, including the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and Medical Device User Fee Stabilization Act of 2005 (MDUFSA). Following these regulations, Stryker Sustainability Solutions labels reprocessed devices with all or some of the following information depending on the device: (1) "Reprocessed by Stryker Sustainability Solutions," (2) Original Manufacturer’s Name, (3) Original Manufacturer’s Part Number, (4) Description, including size, length, etc., (5) Lot number, and (6) Symbols indicating: "Single Use Only," and "Sterile: Sterilized with ethylene oxide gas," (if applicable).
 

Why should we consider reprocessing?

As the need for medical care grows and Budgets remain constant or even shrink, hospitals must evaluate all opportunities that allow them to continue the superior level of care they deliver. New FDA regulations to assure the safety of reprocessed and remanufactured SUDs, coupled with the fact that reprocessing and remanufacturing has become a community standard, means you are not exposing patients to additional risks.

Does Stryker operate under a license from the Original Equipment Manufacturer (OEM)?

Stryker Sustainability Solutions does not operate under license from the OEM. FDA considers the reprocessor of a medical device as the “manufacturer.” All medical devices reprocessed by Stryker Sustainability Solutions are under warranty. FDA inspection routines are as stringent, if not more stringent, than those of other manufacturers and assure that our process as well as the devices we market are equivalent to OEM devices.

How does the performance of a reprocessed device compare to that of an OEM?

As required by the FDA, Stryker Sustainability Solutions must demonstrate that a reprocessed medical device is substantially equivalent to the OEM device prior to marketing the device. FDA determines that the device is substantially equivalent from the evidence submitted by Stryker in a 510(k) application. Additionally, Stryker devices go through a careful inspection process in which every single device is tested for functionality and visually inspected to ensure process performance. To illustrate, the 2008 GAO report noted that participants in FDA’s Medical Product Safety Network (MedSun) were aware “that reprocessing establishments are more stringently regulated by FDA than are the manufacturers of the original devices, and this provided them a sense of confidence in the reprocessing process.” In fact, the GAO report noted that some MedSun participants stated “that there were actually fewer performance problems with reprocessed SUDs than with new SUDs.”