AMDR Position on the European Council’s Partial General Approach to a Proposed Medical Device Regulation

OR Today Features AMDR’s Dan Vukelich

SUD Reprocessing was featured during yesterday’s OR Today Webinar Series for continuing education credits. “SUD Reprocessing: Financial & Environmental Impacts for the OR” is archived on the OR Today Website, and was presented by Dan Vukelich, President of the Association of Medical Device Reprocessors (AMDR).  Topics covered included reprocessing as a proven strategy to help hospitals reduce supply chain costs and reduce medical waste; the origins of the industry and its history as an FDA-regulated industry;  proven safety track record; and corresponding case studies and peer-reviewed literature. Of special interest:  AMDR’s tip sheet for how to combat vendor push-back and contracting pitfalls that can limit savings. And those savings from reprocessing? Significant: AMDR estimates that U.S. hospitals save nearly half a billion dollars a year through reprocessing programs.

European Union Adopts final Medical Device Regulation: AMDR urges European Member States to “opt in” to CE marking paradigm for SUD reprocessing

Last week marks a milestone for medical device makers, including commercial SUD reprocessors in Europe. After nearly five years of negotiations, the European Union finally passed a comprehensive new EU wide Medical Device Regulation (MDR).  For SUD reprocessors, this is a major development as Europe now has in place a “manufacturer” regulatory path for reprocessed SUDs – meaning commercial reprocessors can legitimize their products by demonstrating their products are as safe and meet the same requirements as original equipment.  Best of all, with the introduction of CE marked, remanufactured SUDs, hospitals will have access to lower-priced devices which provides competitive downward pricing pressure on manufacturers for new devices.  This is good news for healthcare consumers in Europe. In order to access these savings for hospitals and consumers alike, AMDR urges European Member States to “opt in” to this CE marking paradigm for SUD reprocessing to help their hospitals safely save money and reduce waste.

AMDR has actively participated in the negotiations with the European Commission, Council and Parliament.  While the final version of the MDR does not include the single, harmonized standard for SUD reprocessing AMDR had hoped for, this Regulation does create a path for commercial firms to demonstrate, scientifically, that their products are safe and effective. 

European hospitals can gain dramatic financial savings with reprocessed medical devices – which can cost 30 to 40 percent LESS than new devices.  Reprocessed and remanufactured SUDs help hospitals reduce regulated medical waste and waste disposal costs.  The stringent requirements for SUD reprocessors will, in AMDR’s view, deter hospitals from reusing SUDs in house, and instead usher in growth for regulated firms that meet the new EU MDR standards. Learn more about the AMDR Position on Final MDR, Article 17 Provisions.

 

ReMaTec News Turns Spotlight on Reprocessing

ReMaTec News taps into the world of “single-use” device (SUD) reprocessing and in doing so brings news from the FDA-regulated industry of third-party medical device reprocessing to its global readership. The Magazine, which focuses on remanufacturing, begins with a Q&A with Dan Vukelich, AMDR’s President, then continues coverage of the Reprocessing industry in a second article, noting that AMDR members perform the majority of the commercial reprocessing in the US and serve over 1,000 European hospitals – including 95% of German university medical centres. The US Food and Drug Administration (FDA) has regulated the industry since 2000, and the sector has quantified its value: today many of the US hospitals with whom AMDR members work save more than $1 million annually through programmes that depend upon reprocessed medical devices.  Remanufacturing is the focus of ReMaTec 2017 in Amsterdam this June, where AMDR will be part of a panel that offers a cross-sectoral approach to reman, looking at issues such as regulatory obstacles, intellectual property, reverse logistics and core management from a variety of points of view. Read more of ReMaTec’s profile of AMDR, reprocessing and remanufacturing here.

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Reprocessing: From FDA Regulation to Best Practice

AMDR is honored to be included in the April issue of DOTmed’s HealthCare Business news. AMDR is celebrating its 20th year and the article, written by Dan Vukelich (AMDR’s President and CEO), explores the path of single-use device (SUD) reprocessing, from FDA regulation to best practice.  Safety, savings and sustainability are cornerstones of the FDA-regulated reprocessing industry.  AMDR members are committed to assisting health systems to maximize economic and environmental benefits of reprocessing. The article also provides an overview of the reprocessing procedure, which medical devices are commonly reprocessed and provides an overview of the proven safety record of the industry. To maximize the savings and sustainability potential of reprocessing, hospitals can partner with multiple vendors (OEM and reprocessor) to maintain more clinical autonomy and control over their device mix. A fact sheet created by AMDR also explores how to best maximize SUD reprocessing savings. The full article from DOTmed’s Healthcare Business news can be found here.

Hospitals Save Millions With Sustainability Programs

Healthcare Finance has come out with a new article that profiles hospitals and how they can save millions of dollars with sustainability programs. Citing advocacy group Practice Greenhealth, the article points out that hospitals are the second greatest commercial energy user behind commercial food service, emitting roughly 8 percent of the country’s greenhouse gas emissions. Hospitals also produce more than 4.67 million tons of waste every year and use 7 percent of the country’s commercial water supply. With a formidable environmental footprint, more hospital systems are focusing on how to reduce their imprints and save money.

SUD medical device reprocessing is one option that has saved $2.5 million in one year for the OR at the Cleveland Clinic for ‘the same clinical outcomes and it makes care more affordable’. Other solutions that health systems are targeting include operating room waste, energy efficiency, recycling and even zero waste printers. Read More.

AMDR Files Amicus Brief With Supreme Court, Supports ‘First Sale’ Doctrine

AMDR 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. In its brief, AMDR supports the first sale or patent exhaustion doctrine. Through the action taken by filing an amicus brief, AMDR continues its commitment to promote the safety, savings, and sustainability benefits brought to healthcare by the medical device reprocessing industry. Oral arguments for the case are scheduled for March 21, 2017. Read more.

 

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ProPublica shines light on staggering scale of wasted medical supplies

The high cost of medical supplies that hospitals throw away is the focus of a new ProPublica article. The article examines evidence of vast waste in the healthcare system and the ways this waste can ultimately drive up healthcare costs for all. According to the article, “experts say the United States might be squandering a quarter of the money spent on health care. That’s an estimated $765 billion a year.” Combatting the waste, one shipping container at a time, are organizations like Partners for World Health, a nonprofit that partners with hospitals and medical clinics to collect medical equipment and supplies that would otherwise go to the landfill, and donate them overseas. The article goes on to cite other reports of waste (the $2.9 million in wasted neurosurgery supplies at the UC, San Francisco Medical Center) and points out how rural hospitals in the U.S. could benefit from receiving similar cast-offs from their wealthier counterparts. Read more.

 

MedTech Summit Preview: AMDR’s Dan Vukelich Talks Reprocessing, Europe & MDRs

MedTech Summit Preview: AMDR’s Dan Vukelich Talks Reprocessing, Europe & MDRs

Dan Vukelich, President at the Association of Medical Device Reprocessors (AMDR), USA, who will be presenting at the MedTech Summit in June, explains that for single use devices: “Everything is set to change in Europe with regard to the reuse of “single-use” devices (SUDs).  Practices vary by country.  Some hospitals, such as in Germany, reuse SUDs under regulations.  Others, such as France, have banned it altogether.  The bulk of SUD reprocessing, overtly or covertly, lawful or unlawful, has been happening within hospitals.  With the adoption of the MDR, a more harmonized approach is going to take shape which will, in AMDR’s view, steer hospitals to reprocess SUDs through regulated, commercial remanufacturers which demonstrate conformance to all medical device manufacturer requirements.” Access the complete MedTech Insight interview with Dan in the December 7, 2016 edition here (subscription required).

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Becker’s Spine Review Profiles Stryker Sustainability Solutions

Single-use device reprocessing takes center stage this week as Becker’s Spine Review profiles the reprocessing industry with some help from Bill Scott of Stryker Sustainability Solutions. As one of the first original equipment manufacturers to enter the reprocessing market, Stryker serves over 3,000 hospitals and health systems helping them realize both financial and environmental sustainability. In 2016, Stryker’s reprocessing program helped health systems save $299 million and eliminate 12.9 million pounds of medical waste from landfills. SUD reprocessing is widely embraced by U.S. hospitals because it is a key strategy for achieving financial and environmental sustainability without sacrificing quality patient care. Stryker’s Bill Scott goes on to note that the SUD reprocessing industry wouldn’t be where it is today if not for FDA regulation. Regulation provided a strong foundation for dramatic industry growth, and helped the industry achieve an outstanding track record of patient safety. Even with the financial, patient safety and environmental benefits, there are roadblocks. To overcome these obstacles and maximize benefits, health systems should look for a third-party reprocessor that is committed to growing their savings year-over-year, does not limit the purchase of reprocessed devices, provides ample training and onsite support and will guarantee mutually agreed upon savings targets. Read More.

10 Reasons Healthcare Needs Sustainability

10 Reasons Healthcare Needs Sustainability

In a recent GreenBiz article, Practice Greenhealth’s Janet Howard explores how healthcare can sometimes get in the way – paradoxically – of health and wellness. Pointing out that “there’s a global climate-change crisis, yet hospitals are the second-highest energy consumer of any sector and generate more than 30 pounds of waste per bed per day”, Howard outlines a call to action for hospitals to “walk the walk” of sustainability practices with 10 reasons to practice a better approach. From human health and the environment to employee engagement to cost savings, mission and ethics, Howard puts forward compelling and common sense approaches that can make a big impact. Read More.