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.

Also known as a “commercial” reprocessor, is a regulated businesses that, at the request of a hospital or surgical suite customer, collects, inspects, function tests, cleans, packages, and sterilizes (when required) 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 oversight agency’s regulations.

Legal and regulatory liability for the device shifts from the OEM to the reprocessor when the device is commercially reprocessed.

Substances and especially pollutants discharged into the air (as by a smokestack or an automobile). Research consistently shows reductions in polluting emissions through the use of reprocessed medical devices.

The environmental or ecological measure of human demand on nature or the quantity of nature it takes to support a population or an economy.

Greenhouse gas emissions (GHG) refer to the release of gases into the Earth’s atmosphere that trap heat, leading to the greenhouse effect and contributing to global warming and climate change. Research consistently shows 40 to 60% reductions in GHGs through the use of reprocessed devices.

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.

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.

A systematic analysis of the environmental impacts associated with all the stages of a product’s life from cradle to grave. LCAs comparing original to reprocessed devices show a 40 to 60% reduction in greenhouse gas emissions for the reprocessed device.

A linear economy is an economic model based on the ‘take, make, dispose’ principle, where resources are extracted, transformed into products, used, and then discarded as waste. This model emphasizes short-term consumption and does not account for resource regeneration or the long-term sustainability of resource use. In healthcare, the linear economy model is exemplified in the overreliance on disposable, “single-use” medical devices, which drives up costs, waste and greenhouse gas emissions in the healthcare sector.

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 safe, effective, and ready for patient use. The steps may include cleaning, functional testing, repackaging, relabeling, disinfection or sterilization.  

In the United States, Canada, Europe, Japan and other places, “reprocessing” is a term used to describe both what hospitals and regulated commercial reprocessors do.  However, please note, in these jurisdictions, the reprocessing of SUDs is strictly subject to full medical device manufacturer requirements and so hospital “reprocessing” and commercial “reprocessing” are not in practice or standards, the same.   

Therefore, it is important to distinguish unregulated, hospital reprocessing of SUDs from regulated, commercial SUD reprocessing and not intermingle conclusions of one for the other.   

The repeated use or multiple use of any medical device by reprocessing (cleaning, disinfection or sterilization) between uses. In the U.S., to market a device as “reusable,” a manufacturer must provide increased data requirements and invest the resources necessary to demonstrate to FDA that the product can be safely reprocessed by a hospital. Manufacturers of reusable medical devices are responsible for having labeling that bears adequate directions for use, including instructions on preparing a device for use.

Scope 3 emissions are indirect greenhouse gas emissions that are not produced by the company itself but are associated with the company’s activities, including both upstream and downstream emissions. This encompasses emissions from sources such as the extraction and production of purchased materials, and use of sold products and services. Scope 3 emissions make up the vast majority of emissions in the healthcare sector, making supply chains a key area for environmental improvements – and reprocessing an easy, “low-hanging fruit” solution to healthcare emissions.

SUDs are medical devices that have been labelled for intended use on one patient during a single procedure. However, the single-use label does not mean that a device cannot be safely reprocessed.1

SUDs should only be used once, but in some cases, FDA or other regulatory authorities have authorized commercial reprocessors to collect and, when subject to manufacturer regulatory requirements, reprocess these devices to meet the same safety and efficacy standards as new.

A supply chain is a system of organizations, people, activities, information, and resources involved in moving a product or service from supplier to customer. It encompasses the steps it takes to get a good or service from the original manufacturer to the final consumer, including production, handling, storage, and distribution. By making supply chains more efficient and local, reprocessing makes supply chains stronger and more resilient.

Supply chain resilience refers to the ability of a supply chain to prepare for, respond to, and recover from unexpected disruptions or challenges, ensuring continuity of supply, flexibility, and rapid adaptation while minimizing negative impacts. By making supply chains more efficient and local, reprocessing makes supply chains stronger and more resilient.

Sustainability refers to the ability to meet the needs of the present without compromising the ability of future generations to meet their own needs, focusing on environmental, social, and economic balance to ensure a healthy planet and well-being for all. Medical device reprocessing enhances sustainability by allowing healthcare providers to safely reuse medical devices, reducing waste and conserving resources, cutting costs, and minimizing the environmental impact associated with manufacturing and disposing of medical products.

The linear concept that items should, by definition, be used once and thrown out.