How Does It Work?
Commercial reprocessing is essentially remanufacturing. Commercial reprocessing, or remanufacturing of single use devices, offers a solution to hospitals and healthcare systems to provide safe and effective patient care, while eliminating medical waste and reducing the cost of waste removal.
Working with hospitals, surgical centers and healthcare systems, AMDR members collect devices. The devices are then disassembled, cleaned, function-tested, repackaged and sterilized. The reprocessed devices meet or exceed the requirements of the original manufacturer and are 100% traceable, enabling quality controls and accountability.
COLLECTION OF USED MEDICAL DEVICES
AMDR members collect tens of thousands of devices every day for reprocessing. All invasive devices require FDA’s 510(k) clearance or, in Europe, CE marks to be reprocessed. This assures they are safe and effective.
In addition to meeting the same regulatory requirements as required for any medical device, reprocessors must also produce scientifically validated cleaning, functional performance and high-level disinfection and/or sterilization data demonstrating their products are just as safe and effective as original equipment. The standards reprocessors adhere to come from AAMI, ANSI, ISO, IEC and ASTM, among others. Canada, the European Union and Japan are among the growing list of countries that also have strict regulations to assure patient safety.
SORTING AND LABELING
Devices are sorted and identified. Each device is marked, labelled or etched with a unique identifier used to trace the device for the life of the product.
Traceability allows reprocessors to know exactly which devices were used at which hospital, and how many times it’s been reprocessed.
CLEANING AND DISINFECTION
Extensive proprietary processes are used to decontaminate, disinfect, and clean medical devices.
TESTING AND INSPECTION
Reprocessors function test and/or inspect 100% of their devices.
Perhaps this is why researchers have found that reprocessed devices may actually fail less than original equipment.
HIGH-LEVEL DISINFECTION / STERILIZATION
Devices are high-level disinfected and/or sterilized. AMDR members adhere to the same disinfection and sterilization standards as applied to original equipment.
High-level disinfection and sterilization standards meet FDA, ISO, AAMI, ANSI and other international standards.
REPROCESSED DEVICES ARE RETURNED TO HOSPITALS
Reprocessed devices cost up to half that of new devices. In 2018, hospitals saved over $471M by reprocessing devices. Hospitals partner with reprocessors to control procedure and supply costs, using the savings to hire or retain nursing staff, invest in new medical equipment, or address indigent care, for example.
Hospitals that partner with professional reprocessors realize an immediate cost savings of up to 50%. The competitive effect has been known to drive manufacturers to lower prices for new devices. Hospitals buy fewer new devices, reducing their medical devices expenditures and waste disposal costs are reduced as hospitals generate less medical device waste, which saves additional disposal costs.