Association of Medical Device Reprocessors

GlobeNewswire Press Release

Posted on February 1, 2012

Vascular Solutions, Inc. announced that it is marketing a reprocessing service for the ClosureFAST radiofrequency ablation catheter in the United States. The ClosureFAST catheter, which is manufactured and marketed by VNUS Medical Technologies, Inc. division of Covidien, is widely used for performing endovenous therapy for the treatment of varicose veins. Vascular Solutions’ reprocessing service is designed to help physicians reduce medical waste and lower their costs.

…”Reprocessing has proven to be a safe and effective way for hospitals and clinics to cut down on medical waste and reduce operating costs. As a result, the vast majority of U.S. hospitals are now contracting with third-party reprocessors for a wide variety of medical devices,” said Howard Root, Chief Executive Officer of Vascular Solutions. “Reprocessing has become one of the fastest-growing segments of the medical device industry, and we are very pleased to be entering this market in collaboration with NES for the ClosureFAST catheter, which we estimate to be generating in excess of $70 million in annual sales in the U.S.”

…Hospitals and clinics that subscribe to the service send their used ClosureFAST catheters directly to NES for reprocessing. Upon completion of reprocessing, customers receive those same catheters back, ready for a second use. NES’s validated reprocessing system for the ClosureFAST catheters involves multiple stages, including decontamination, cleaning, drying, packaging, labeling, sterilization, and biological quarantine testing. As part of the process, each catheter is subjected to function testing and undergoes multiple inspections to ensure that quality standards are met…

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For more information about third party reprocessing, be sure to follow AMDR on the Web, Twitter and Facebook!

The following article appeared November 10, 2011 on the HealthLeaders Media website.

Published by Jon Cantlupe

Talk to enough physicians and hospital execs, and you will hear a term they use to refer to colleagues deviating from their peers, whether they aren’t doing enough to improve patient care, are falling behind in their work, or are spending too much: outliers.

“No one wants to be an outlier,” Kevin McGuire, MD, MS, chief of the orthopedic spine service at Beth Israel Deaconess Medical Center in Boston and assistant professor of orthopedic surgery at Harvard Medical School, told HealthLeaders Media.

In spine care, McGuire found a lot of outliers, surgeons wasting money by wasting medical implant devices. McGuire admits he was once an outlier too…

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The following article appeared in The Jerusalem Post on December 12, 2011:

Published By: Judy Siegel-Itzkovich

The Health Ministry has failed for the last 15 years to determine its policy for reusing certain medical equipment, which could save as much as NIS 70 million a year, the State Comptroller’s Report revealed.

The issue has been debated for many years, but it has not been resolved.

Some Israeli hospitals have, been criticized for reusing “disposable” equipment after sterilization, while the state comptroller has now criticized the ministry for not establishing a policy that would lead to more and safer reuses…

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For more information on international reprocessing, be sure to check out the AMDR Summary: International Reprocessing of “Single-Use” Medical Devices.

The Journal of Healthcare Contracting recently interviewed Steven Weinberger, M.D., executive vice president and CEO of the American College of Physicians, regarding the unsustainable cost of care.  For the full article, download the digital issue of JHC here:

The need to improve quality of care and to ensure patient safety are key issues facing the medical profession today. But there’s a new elephant in the room, which may be just as critical to acknowledge: the unsustainable cost of care.

Writing in the Annals of Internal Medicine (Sept. 20, 2011), Steven Weinberger, M.D., executive vice president and CEO of the American College of Physicians, calls for medical schools to teach residents the need for stewardship of resources and practicing in a cost-conscious fashion. “It is the responsibility of the medical profession to become cost-conscious and decrease unnecessary care that does not benefit patients but represents a substantial percentage of healthcare costs,” he writes.

The following article appeared in the October 2011 issue of Outpatient Surgery Magazine

Published by Dan O’Connor, Editor-in-Chief

Once viewed as risky and rogue, reusing reprocessed single-use devices is now seen as a great way to spare landfills and OR supply budgets. It’s estimated that more than 9 million single-use devices —from opened and unused items to used arthroscopic shavers and trocars — are reprocessed each year and then repurchased by surgical facilities for around half the cost of new. Nearly two-thirds (64.8%) of the 268 surgical facility leaders Outpatient Surgery Magazine surveyed admit to reprocessing, even though their surgeons and their patients might not always approve.

If you can’t beat them, join them

Perhaps the surest sign that reprocessing is here to stay came last month, when Ethicon Endo-Surgery, one of the largest and most respected medical device companies in the world, bought SUD reprocessor SterilMed, a surprising move given Ethicon’s open disdain for medical device reprocessing. Ethicon was widely rumored to engineer “kill switches” in its Harmonic scalpels ($400 new, $150 to $200 reprocessed) to prevent them from working after they’d been reprocessed. In announcing its acquisition of SterilMed (which will retain its name), Ethicon acknowledged “the rapid changes occurring in the U.S. healthcare system” and called reprocessing “a rapidly growing market segment.” It also took a swipe at its new competitors…

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To find out how your facility can achieve savings with a reprocessing program, be sure to follow AMDR on the web, Twitter, and Facebook!

The following article appeared in the January 2012 issue of Outpatient Surgery Magazine

Published by Kirby Harvey, RT, ST

We recently sent out $4,000 worth of single-use devices for reprocessing and received most of them back for $1,600. Not bad, right? FDA-approved third-party vendors safely reprocess many of your most common disposables and sell them back to you for half to one-third the cost of new. It’s a relatively easy way to cut overhead costs without compromising patient safety, and yet many surgical facilities still aren’t taking advantage of it. I’ve found that there are 2 big hurdles to clear when transitioning from single-use-only to reprocessing: getting buy-in from surgeons and staff, and finding the right service to suit your needs.

Overcome the stigma
Healthcare providers tend to have a one-track mind: It’s all about the patient. The idea of reusing a device that says “single-use only” clearly on the label leaves many of us uneasy — and rightfully so. A good way to overcome this unease is to conduct your own QI study of the safety and efficacy of reprocessed single-use devices…

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To find out how your facility can achieve savings with a reprocessing program, be sure to follow AMDR on the web, Twitter, and Facebook!

AMDR President Dan Vukelich has been selected as a speaker for the Sterilisation for Medical Devices conference, scheduled for May 23-24 at the Radisson Blu Royal Hotel in Dublin, Ireland. The following is an overview from the conference’s website:

The Informa Life Sciences’ annual conference on Sterilisation for Medical Devices brings together leading sterilisation and quality assurance experts from some of the leading industries and Notified Bodies. We pride ourselves on bringing you some of the best speakers in the field with the practical information to make your sterilisation processes highly efficient efficient.

This year, we bring to you practical case studies from some of the leading industries in the field. We also have 2 Notified Bodies giving you advice on understanding and complying with NB requirements and how to satisfy the sterilisationISO standards. We also bring you valuable insight from the Saudi FDA on single use devices and the consequences of reuse.

This conference offers expert speakers, key information on which devices should be sterilised in which way and why, as well as how to be compliant, validationof your sterilisation process and advice on outsourcingsterilisation. Methods covered include ethylene oxide sterilisation, hydrogen peroxide/gas plasma sterilisation and radiation sterilisation. Also explore the importance of bioburden controland take a look at the capability ofemerging markets for sterilisation. 

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Millennium Research Group reports that Price Competition and Increased Use of Reprocessed and Refurbished Devices to Limit Growth in Us Arthroscopy Market (December 12, 2011):

While procedure volumes will increase, there will also be a significant downward pressure on selling prices of arthroscopic devices. The mature and commoditized arthroscopy market has seen little technical innovation in recent years. As a result, products are relatively undifferentiated and competition is largely on price. Additionally, increasing rates of reprocessing of single-use devices and refurbishing of reusable devices will exert further downward pressure on selling prices.

About Millennium Research Group

Millennium Research Group (www.MRG.net), a Decision Resources Group company (www.DecisionResourcesGroup.com), is the global authority on medical technology market intelligence and the leading provider of strategic information to the healthcare sector. The company provides specialized industry expertise through multiclient market research, ongoing Marketrack™ projects, customer loyalty tracking, facility-level procedure forecasting, and customized solutions.