Having played a key role in the establishment of the commercial reprocessing industry in America, the Association of Medical Device Reprocessors (AMDR) has sought, both domestically and internationally, to promote a healthier, more transparent medical device paradigm that helps our members’ hospital and healthcare delivery partners better control and optimize the value of the medical technology they already own.

Japan is the most recent country to take steps to give hospitals access to remanufactured (commercially reprocessed) single-use medical devices.  The Japanese Ministry of Health, Labor and Welfare department released its official standards last summer, and as a result of these newly released standards, the healthcare industry has taken notice.

In February, companies and prospective companies involved in medical device cleaning and sterilization formed a council to focus on single-use device remanufacturing in Japan. The Asahi Shimbun reports that the council is made up of nine companies, including Japanese arms of U.S. remanufacturers of medical devices.

AMDR sees this as a major development for the global remanufacturing medical device industry.  Japan joins the growing number of countries adopting a clear regulatory path for remanufactured single-use devices.  The new standards enable commercial remanufacturers to legitimize their products by demonstrating their devices are as safe as and meet the same requirements as original equipment.

Best of all, hospitals will soon have access to lower-priced devices, providing competitive downward pricing pressure on manufacturers for new devices. This is good news for healthcare consumers in Japan.  Allowing hospitals to purchase remanufactured devices enables hospitals and healthcare providers to achieve the triple aim of increasing quality, reducing costs and improving patient care.

Remanufactured single-use devices help hospitals reduce regulated medical waste and waste disposal costs. The stringent requirements for single-use device remanufacturers will, in AMDR’s view, deter hospitals from reusing single-use devices in-house, and instead usher in growth for regulated firms that meet the new standards. Japanese hospitals can expect dramatic financial savings with remanufactured medical devices – which can cost 30 to 40 percent less than new devices.