From the May 2019 issue of HealthCare Business News magazine
While reprocessing is an established and regulated practice in the U.S. and a few other countries in the world, Europe and Japan are now adopting a manufacturer model of regulation for SUD reprocessing. And again, peer-reviewed literature is emerging to demonstrate the safety and cost savings associated with SUD reprocessing.
Sometimes dubbed “SUD remanufacturing” in markets outside of the U.S., a December 2018 Journal of Interventional Cardiac Electrophysiology (U.K.) article looked at remanufactured circular mapping catheters and noted that a “carefully regulated system” of SUD remanufacturing “could provide significant economic benefits without compromising patient safety.”
Similarly, the Portuguese Journal of Public Health article from February 2019 about the reprocessing of single-use laparoscopic devices “confirms the economic advantages of reprocessing.” The article reported a study including two different devices and noted that, “these results are in line with the published literature, proving the validity of using [single use medical devices] after professionally certified reprocessing.”
AMDR has been active in the European Union’s new Medical Device Regulation. Article 17 of the giant new regulatory framework allows for regulated SUD reprocessing/remanufacturing. Thus, AMDR is busy promoting its “regulation is legitimization” message to European hospitals desperate to stop unsafe and inappropriate hospital reuse of SUDs and promote safe, regulated and financially and environmentally sustainable SUD remanufacturing.
Adding to the legitimization of SUD reprocessing in healthcare is the fact that that many of the third-party reprocessors from the early days of reprocessing were acquired by big, respected medical device companies. In 2009, Ascent Healthcare Solutions was acquired by Stryker, becoming Stryker’s Sustainability Solutions division. In 2011, SterilMed was acquired by Johnson & Johnson; in 2012, MediSiss was acquired by Medline, becoming Medline ReNewal; and in 2018, Arjo Inc. acquired ReNu Medical Inc. AMDR believes the future of sustainable healthcare means a refocus on value – not volume. These companies no doubt recognized that FDA’s clearances of hundreds of SUDs for reprocessing dispelled any questions as to the safety of reprocessing, and recognized the alignment reprocessing has with hospitals in their quest to maximize the value of their medical device assets.
Secondly, I have learned that competition is good. Reprocessed SUDs cost much less than buying a device new. This is great, but the savings potential is more significant than that. Reprocessing means hospitals can reduce the amount of new devices purchased – a fact not lost on the manufacturers of some of these devices who have become crafty in their effort to ensure hospitals buy as many disposable products as possible. Further, hospitals reduce waste disposal costs through reprocessing, and studies have shown that hospitals and surgical centers that reprocess pay less for new devices than hospitals that do not.
