Position Paper: The Time Has Come To Change the “Opt-In” Provision of the EU MDR (Article 17)
The “Opt-In” Provision of the EU MDR (Article 17): Undermines EU Law and the Single Market Deprives Hospitals of Sustainable Medical Device Options, and Exacerbates Shortages in the Healthcare Supply Chain The time has come to change it. Summary Health systems are under enormous pressure. Urgently needed amendments to Article 17 of the EU Medical
New AMDR Member Survey Finds Hospitals and Surgical Centers Saved over $465MM (€426MM), Avoided over 98MM Pounds (44.5MM Kg) of Greenhouse Gas Emissions by Using Regulated, Reprocessed Single-Use Medical Devices from AMDR Members in 2023
[Washington, DC / Berlin Germany – 16 October 2024] A record 11,967 hospitals and surgical centers saved nearly half a billion dollars and eliminated greenhouse gas emissions equivalent to 7.5 Olympic swimming pools filled with gasoline by opting for regulated, commercially reprocessed 'single-use' medical devices (SUDs) instead of virgin SUDs in 2023. The data comes
AMDR Statement: Separating the Facts from the Myths about FDA Regulated, Reprocessed LigaSures™
23 September 2024 Statement from AMDR: Separating the Facts from the Myths about FDA Regulated, Reprocessed LigaSures™ In September 2020, a Medtronic-funded study purporting to show soiled reprocessed LigaSure devices was published in the Journal Surgical Endoscopy. After an exhaustive, year-long independent review by the publisher, an important correction was added to the article, indicating
AMDR Action Alert: Your Voice Matters – Hospital Purchasing Representatives Encouraged to Report Anticompetitive SUD Purchasing Contracts and Related Behavior
Last December, the Biden Administration declared war on corporate greed in healthcare. The announcement included a range of fronts in the war, from fighting bloated drug costs to attacking anticompetitive contracts that cause unnecessary waste for hospitals, payors, and the patients they serve. As reported by Healthcare Business News, the White House announcement led the
AMDR Statement: FDA’s Recently Published Guidance Document, “Remanufacturing of Medical Devices,” Addresses Reusable Devices, not Reprocessed Single-Use Devices
On May 10th, 2024, the U.S. Food and Drug Administration issued final guidance titled, “Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff.” AMDR wishes to highlight that the guidance “is not intended to address reprocessed single-use devices” and instead addresses the remanufacturing of reusable
