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.
AMDR members work with hospitals and healthcare partners to provide reprocessed medical devices that maintain the highest levels of patient care, reduce medical waste, and lower the cost of medical devices up to 50 percent. Reprocessed devices are as safe as the original product they replace, a finding confirmed by the FDA itself and a 2008 Government Accountability Office (GAO) report.
These participating hospitals – including most the Honor Roll facilities as listed by U.S. News and World Report – rely on commercial medical device reprocessing to bring economic and environmental savings to their healthcare systems, practitioners and the patients they serve.
Many of the hospitals with which AMDR members work report an average of $1 million dollars in savings per year on device costs. In the U.S., reprocessing can divert an average of 50,000 pounds of medical waste from landfills annually per hospital.