AMDR continues its speaking and Conference tour of Europe to encourage Ministries of Health, healthcare professionals and other stakeholders to evaluate the provisions of the new European Medical Device Regulation (MDR) as Article 17 requires that each European Member State affirmatively allow, or “opt in,” to the single use device reprocessing provisions. Until now, there has been no single European standard or regulation of single-use device (SUD) reprocessing. The inconsistency and lack of standards has ultimately proven unacceptable and, with the passage of a comprehensive new MDR in Brussels last May, requirements for the reprocessing and remanufacturing of single-use devices are about to change for all of Europe.
Article 17 of the MDR sets forth the newly developed requirements for single-use device reprocessing. In it, subject to it being permitted by national law, the MDR requires that single-use reprocessing must meet manufacturer requirements. This means that those that reprocess SUDs, including hospitals, manufacturers or commercial reprocessors, will have to meet all the same requirements as applied to any other new medical device — from having a quality system to vigilance reporting to clinical evaluations.
With some exceptions that may allow for in-hospital reprocessing (AMDR will address this more when the European Commission releases their “common specifications”), this new approach will assist European Ministries of Health, healthcare professionals and providers, to stop unvalidated and unregulated reuse taking place in hospitals and instead outsource those activities to professional, regulated commercial firms that meet the MDR’s manufacturing requirements. In addition to providing a safe, regulated alternative, as hospitals in North America and Germany have long known, reprocessing extends the lifespan of the devices hospitals already own – thereby promoting value. This drives down costs and reduces medical waste. Further, with the availability of lower priced reprocessed versions of single-use medical devices, this drives competition and helps to lower the price of new devices as well.
Already the UK has adopted regulations for SUD reuse consistent with the new EU MDR. In the document, the UK agency distinguishes in-hospital reuse of SUDs as “SUD reprocessing” from regulated, commercial activities which it dubs “SUD remanufacturing.” AMDR has been engaged with other European Member States as they evaluate the Regulation and we believe many will take the UK’s SUD remanufacturer approach.
We encourage you to learn more about reprocessing as a supply chain strategy during one of the following events:
AMDR will be presenting at
- 3rd Annual Infection Control, Sterilization & Decontamination in Healthcare Congress February 21 and 22, 2018, in London
- Nordic Conference on Sustainable Healthcare 2018 February 15, 2018 in Stockholm
- MedTech Summit June 11-15, 2018 in Amsterdam
As part of these speeches, AMDR will address the differences between hospital reuse and regulated, commercial reprocessing and remanufacturing operations, outline the new manufacturer standards applicable to SUD reprocessing, and will provide guidance on what European Ministries of Health need to do to opt in to these regulations. AMDR is hopeful that the new requirements will help Ministries of Help to stop the inappropriate reuse of SUDs in hospitals and instead encourage use of safe, regulated and commercially reprocessed and remanufactured SUDs.
AMDR is committed to healthcare and the hospitals and clinicians that strive to provide the best care possible to all patients. To meet this responsibility, AMDR members work with their healthcare partners to better align the medical device industry with the fundamental interests of hospitals by making SUD reprocessing and remanufacturing a key supply chain strategy for all hospitals.