The market for reprocessed single-use devices (SUDs)  is expected to grow at an impressive rate over the next decade. Some analysts predict a global market for the industry to reach $1.8b by 2022. The fuel for the growth in demand for reprocessed devices stems from a combination of factors. As a solution for hospitals and healthcare systems, reprocessed devices cost an average of 50% less than new devices and they cut down on waste and waste disposal costs. Other factors that affect demand include access. And regulation is the biggest gateway for access. Internationally, we’re seeing significant changes on the front of regulation. In Europe the Medical Device Regulation (MDR) that was finalized in May creates a pathway for the commercial marketing of reprocessing, or more accurately, “remanufactured” SUDs. Specifically, European Members States must elect to “opt in” to the new regulatory paradigm of the MDR and  treat SUD reuse as a manufacturing activity, subject it to all manufacturer requirements.
The UK, Portugal and Germany already allow for the commercial remanufacturing of SUDs.  AMDR has been in communications with Belgian and Dutch Ministries of Health and know both are taking the issue seriously, have begun consultation with stakeholders and intend to make a decision sometime in the near term.  AMDR will focus its attention toward Spain and the Nordic countries in the coming year as the association is confident these countries are looking for financially and environmentally sustainable solutions in healthcare.  AMDR expects most Members States will ultimately opt in as, by doing so, Ministries of Health can legally stop inappropriate SUD reuse in hospitals, but provide hospitals with a legitimate, safe and regulated means to extend the value of the medical devices they already own – reducing healthcare costs and waste.
We are seeing the same trend in non-EU countries where regulatory decisions that address commercial reprocessing are now “on the books” – including Japan and South Africa  – countries that have recently joined the U.S., Canada and Australia in providing a regulatory pathway for safe and effective commercially reprocessing SUDs.
It is no surprise that a global forecast for growth in the industry is correlating with a global uptick in regulatory pathways for safe and effective remanufactured SUDs.