Federally regulated businesses that, at the request of a hospital or surgical suite customer, inspects, refurbishes, function tests, cleans, packages, and sterilizes medical devices labeled by the original manufacturer as “single-use” in such a manner that:
- The quality, physical characteristics, and functionality of the devices are not adversely affected, or such characteristics are improved;
- The devices remain safe and effective for an additional single-use; and
- The devices are reprocessed in full compliance with U.S. Food and Drug Administration (FDA) or similar federal agency’s regulations.
An industrial system that is regenerative by intention and design. It replaces the end-of-life concept with restoration, shifts toward the use of renewable energy, eliminates the use of toxic chemicals, and aims for the elimination of waste through the superior design of materials, products, systems, and business models.
The environmental or ecological measure of human demand on nature or the quantity of nature it takes to support a population or an economy.
Group Purchasing Organization (GPO)
An entity that helps health care providers – such as hospitals, nursing homes, and home health agencies – realize savings and efficiencies by aggregating purchasing volume and using that leverage to negotiate discounts with manufacturers, distributors and other vendors.
- Life cycle analysis (LCA): A comprehensive evaluation of the impact of an asset incurred over its lifespan
- Green House Gas (GHG) emissions:
- Linear economy
- Scope 3 Emissions
- Supply chain
- Supply chain resilience
A broad term that includes the label and other written, printed, or graphic matter accompanying a device. For example, labeling would include device inserts, leaflets used to promote the device, text written on the box, and the immediate container for the device.
These requirements relate to submissions that contain safety and effectiveness information that FDA reviews prior to marketing a device. The two types of premarket submissions that may be required before you reprocess a SUD are: (1) an application for premarket approval (PMA); and (2) a premarket notification submission (510(k).
Reprocessing includes all the steps performed to make a contaminated reusable or single-use device ready for patient use. The steps may include cleaning, functional testing, repackaging, relabeling, disinfection or sterilization.
The repeated use or multiple use of any medical device including devices intended for reuse or single-use, with reprocessing (cleaning, disinfection or sterilization) between uses.
A single-use device, also referred to as a disposable device, intended for use on one patient during a single procedure. It is not intended to be reprocessed (cleaned, disinfected/sterilized) and used on another patient. The labeling may or may not identify the device as single use or disposable and does not include instructions for reprocessing.
The linear concept that items should, by definition, be used once and thrown out.