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

Medical Device Reprocessing Market expected to grow 2-fold over next 5 years

MarketsandMarkets, a market research firm, forecasts that the Medical Device Reprocessing Market is expected to more than double in size over the next 5 years. The recently published research report: “Medical Device Reprocessing Market by Product (Reprocessed Device (Catheter, Endoscope, Laparoscopic Instruments, Biopsy, Pulse Oximeter), Service), Application (Cardiology, Gastroenterology, Arthroscopy, Orthopedic, Anesthesia) – Global Forecast to 2022″, estimates that the Medical Device Reprocessing Market is expected to reach USD 1,754 Million by 2022 from an estimated USD 823.5 Million in 2017, at a CAGR of 16.3%. Read More.

 

Medline Industries Opens New Factory in Redmond, OR

Oregon’s The Bulletin reported on the opening of a new medical device reprocessing factory in its state. Medline Industries recently opened a new $12 million office and manufacturing facility in Redmond’s Desert Rise industrial park. According to the article, the factory “employs about 165 people, most of whom are involved in washing, sharpening and testing more than 1,000 different items, from compression sleeves to electronic surgical tools.” Medline ReNewal, an AMDR member, is the medical device reprocessing division of Medline Industries.

Medical device reprocessing is regulated by the U.S. Food and Drug Administration, which must approve single-use devices for re-use. Medline and other companies that gather the devices from hospitals and surgery centers become the manufacturers of record, according to Medline ReNewal’s vice president of operations, Steve Bettis. Medline ReNewal is part of the $500 million a year medical device reprocessing industry that includes fellow AMDR members Hygia Health Services, Innovative Health, Stryker Sustainability Solutions, and Vanguard AG of Germany. Read More.

AMDR, Reprocessing Take the Global Stage

Dan Vukelich, AMDR’s president, presented at two industry events in The Netherlands this week. During the ReMaTec 2017 trade show, which focused on the global remanufacturing industry, Dan Vukelich was a panelist for the EU roundtable.  The next stop was Informa’s MedTech Summit, where Dan presented alongside Arjan van Drongelen of the Netherlands, on the latest updates on the reprocessing of single-use devices and implications for industry in light of the new European Medical Device Regulation. 

Dan at ReMaTec 2017

AMDR’s Quarterly Newsletter – Summer Edition

AMDR recently launched its newly formatted quarterly newsletter. The Summer edition of the newsletter includes a round up of events, AMDR news, reprocessing industry coverage and sustainability in healthcare. The newsletter, which is free, can be accessed at bit.ly/AMDRSummer17.  New subscribers can sign up to receive the AMDR Quarterly Newsletter at http://www.amdr.org/subscribe/.

 

 

 

 

 

AAMI Weighs in on Supreme Court Ruling and ‘Right To Repair’ Debate

According to AAMI, the recent Supreme Court ruling in favor of Impression Products (Impression Products, Inc. vs. Lexmark International, Inc.) has the potential to reignite the ‘right to repair’ debate. With the Court’s ruling, “Lexmark’s patent rights were exhausted with the first sale of its toner cartridges, despite restrictions it tried to impose, dealing a blow to companies that use patent law as way to defend against other companies refurbishing and reselling their products.”

Medical device service translates into “big business as healthcare delivery organizations look for ways to contain rising costs and original equipment manufacturers (OEMs) look for solutions to revenue and profitability challenges.” Drawing data from a MarketsandMarkets report that forecasts that the global medical equipment maintenance market is expected to grow by 16.7% between 2015 and 2020, topping $2,240 million by 2020.

Backed by consumer advocates, repair professionals, and other interested stakeholders, the goal of the “right to repair” movement is passing legislation that would make it harder for manufacturers to keep repair information proprietary—something healthcare technology management (HTM) professionals have complained about for years despite the NFPA 99 Health Care Facilities Code requiring manufacturers to provide service manuals. Read More.

A win for the reprocessing industry today! U.S. Supreme Court rules in favor of Impression Products, Inc.

AMDR is thrilled to announce that our efforts at the U.S. Supreme Court – where we joined advocacy groups, non-profits and many leading technology companies and filed an amicus curiae brief in support of Impression Products – have been successful. Today the U.S. Supreme Court ruled in favor of Impression Products (Impression Products Inc. vs. Lexmark, Inc.), reinforcing the long standing importance of the first sale/patent exhaustion doctrine, which makes it possible for the reprocessing industry – and many other commercial products –  to remain available to consumers.  Read the full Supreme Court ruling here. Public Knowledge offers analysis of the ruling here. For a look back at the case’s relevance, check out Fortune’s article from March 2017.

AMDR’s Dan Vukelich talks EU MDR in the May issue of the Journal of Medical Device Regulation

The May issue of the Journal of Medical Device Regulation, a peer-reviewed journal from the UK, recently covered the new EU Medical Devices Regulation in an article by AMDR’s Dan Vukelich. “How will the new EU Medical Device Regulation affect the reprocessing of single-use devices (SUDs)? ” explores Article 17 of the new MDR, with a focus on its impact on the reprocessing industry. According to the article, “experience demonstrates that regulation will provide an overt, legal and safe pathway for hospitals to acquire lower-cost and environmentally preferable reprocessed or re-manufactured devices.” AMDR recently published an official position paper on the new regulation, which included AMDR’s recommendation that European Member States “opt in” to the CE marking paradigm for SUD reprocessing to help their hospitals safely save money and reduce waste.

AMDR Participates in AAMI’s Sustainability Efforts

AMDR participated yesterday in AAMI’s Sustainability Committee meeting held in Minneapolis in conjunction with CleanMed 2017. The Committee is re-evaluating the existing Technical Information Report (TIR) on sustainability of medical devices – elements of a responsible product life cycle. AMDR is proud to have SUD reprocessing included in the TIR and looks forward to continued committee work to raise awareness of sustainability concerns for manufacturers of medical devices.

 

 

SUD Reprocessing, AMDR Featured at EORNA 2017

Just recently convened, last week’s 8th Annual gathering of Europe’s operating room nurses  – known as EORNA 2017 –  included in the program a discussion of the new European Medical Devices Regulations as they pertain to reprocessed and remanufactured single-use devices (SUDs).  AMDR’s President, Dan Vukelich, presented to EORNA attendees the latest data on the safety, savings and sustainability that SUD remanufacturing offers. During the convention, the finalized text for the new EU medical device regulations was published in the Official Journal of the European Union, further bringing into focus the future of SUD remanufacturing for Europe’s healthcare consumers.

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Research Nester reports that reprocessed medical device market is expected to reach USD 4.95 Billion by 2021

According to Research Nester, the Reprocessed Medical Devices Market is one of the fast growing markets across the globe. The report notes these contributing factors: the rise in healthcare technology, the affordability of medically reprocessed devices, the continuous increase in medical waste, and the lack of support for waste removal. As both an economic and environmental solution, reprocessing of medical devices helps the healthcare industry to reduce the cost of diagnosis and treatment while meeting sustainability goals. In terms of market analysis, the global reprocessed medical device market is expected to reach USD 4.95 Billion by 2021 from USD 0.76 Billion in 2013 and it is expected to grow at a CAGR of 19.55% over the forecast period i.e. 2015-2021. Read More.