The Association of Medical Device Reprocessors (AMDR), the global trade association representing the interests of commercial medical device reprocessing companies, joined advocacy groups, non-profits and many leading technology companies and filed an amicus curiae brief in support of Impression Products in the case before the U.S. Supreme Court, Impression Products vs. Lexmark. Oral arguments for the case are scheduled for tomorrow, March 21, 2017.
“AMDR has a duty and obligation to promote the safety, savings and sustainability benefits brought to healthcare by the medical device reprocessing industry. As such, we cannot overlook any prospective threat to our industry or our healthcare partners. AMDR filed an amicus curiae (friend of the court) brief in support of Impression Products to underscore the importance of the long-standing ‘first sale’ doctrine at issue in this case. In it, we highlight that, for over 150 years, the law has encouraged the right of consumers to reprocess, repair, recycle or resell their property as they see fit,” said Daniel Vukelich, CEO and President of AMDR.
The positive impact of reprocessed devices extends to financial and environmental costs, while maintaining strict safety standards. The U.S. Food and Drug Administration regulates the reprocessing of “single-use” devices, holding reprocessors to the agency’s medical device manufacturer standards. Today many of the hospitals with whom AMDR members work – including a majority of America’s Honor Roll hospitals, as listed by U.S. News & World Report - save more than $1 million annually through programs that depend upon FDA-cleared reprocessed medical devices. Hospitals and healthcare providers can use those savings toward hiring more medical professionals or improving patient care. Additional savings of reprocessed single-use devices include a reduction in medical waste, allowing hospitals to divert millions of pounds from local landfills each year.
In its brief, AMDR supports the first sale or patent exhaustion doctrine. If an original manufacturer can avoid the patent exhaustion/first sale doctrine simply by including a “single-use” restriction with the sale of a patented product, reprocessors of such devices would risk liability for patent infringement. A manufacturer could force consumers, including hospitals served by AMDR members, to purchase new replacement devices from the manufacturer. This drives up the cost of healthcare for consumers, increases medical waste and serves only to drive up profits for medical device companies.
The Court’s decision could have a direct impact on consumer rights. Public Citizen, the Intellectual Property Professors and American Antitrust Institute, Intel, and Dell are among the organizations that have also filed amicus briefs in support of Impression Products.
The Association of Medical Device Reprocessors (AMDR) is the global trade association representing the legal, regulatory and other trade interests of the commercial medical device reprocessing industry. Our members perform a majority of the commercial reprocessing in the United States.