Used Medical Equipment

Press Release

SOURCE:
IAMERS (International Association of Medical Equipment Remarketers and Servicers)
85 Edgemont Place
Teaneck, NJ 07666

CONTACT:
Diana Upton
201-357-5400

For Immediate Release

IAMERS PRESIDENT CALLS FOR RELAXATION OF AFRICAN TRADE BARRIERS TO PERMIT INCREASED U.S. EXPORTS OF PRE-OWNED MEDICAL IMAGING EQUIPMENT

(Washington, D.C.) IAMERS President and Executive Director Diana Upton applauded the recent efforts of President Obama to encourage U.S. companies to trade with Africa. Speaking about President Obama’s “Doing Business in Africa Campaign” and his recent meeting with fifty African leaders, Ms. Upton commented: “IAMERS stands ready to provide much needed medical equipment to Africa. There is a pressing demand for the pre-owned MRIs, CTs and other imaging equipment which IAMERS members sell and service. All of the major U.S. Hospitals have recognized that pre-owned medical equipment has been a win-win for patient care. We know that IAMERS members can also help African hospitals. IAMERS members can provide the crucial spare parts and assemble the technicians to help support this effort. One of our IAMERS members is working successfully in Cameroon and we hope to spread the word”.

Ms. Upton further commented that “Unfortunately, despite the pressing need in Africa and the U.S. companies who stand ready to export excellent medical equipment, several African countries, including some who attended the President’s meeting last week, maintain procurement policies which restrict or discourage the purchase of pre-owned medical equipment.” The U.S. International Trade Administration in its extensive review of the global import market for pre-owned medical devices, lists Ghana, Guinea, Senegal, Tanzania, and other African  countries as imposing licensing and ‘safety reviews’ which restrict rights for importation in some manner.[1]

Ms. Upton expressed her hope that the U.S. Government would tie the announced initiatives in new U.S. financing to a reduction in the trade barriers of African countries for the sale of pre-owned U.S. medical equipment. “We hope that the billions committed by the U.S. come with an understanding that the countries receiving these initiatives will not tie the hands of IAMERS members who wish to provide desperately needed medical equipment. There must be a comprehensive effort so that the pre-owned equipment makes a difference in patient care and is supported. For that, we need the cooperation of African government partners. Opening markets for pre-owned equipment, will help patient care and encourage servicing support.”

[1] For further information, see “Global Import Regulations for Pre-Owned Medical Devices”, U.S. Department of Commerce, International Trade Administration. http://www.ita.doc.gov/media/publications/pdf/medical2008.pdf.

IAMERS was formed in 1993. Our membership is worldwide and represents the best companies ranging from the largest OEMs to smaller highly specialized ones that sell, service and finance pre-owned medical imaging devices.

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Press Release

SOURCE:
IAMERS (International Association of Medical Equipment Remarketers and Servicers)   85 Edgemont Place
Teaneck, NJ 07666

CONTACT:
Diana Upton
+1.201.357.5400

For Immediate Release

10th Annual IAMERS European Meeting to Discuss Opening New Markets for Pre-Owned Imaging Devices

(Berlin, Germany)  International Association of Medical Equipment Remarketers and Servicers (IAMERS) will open its’ 10th Annual Meeting in Berlin on September 10th with not-to-be missed presentations from industry movers and shakers. “This year we have brought together industry leaders to engage in frank and dynamic discussions about where the industry is heading,” said Diana Upton, IAMERS President. Ms. Upton continued, “Regulations restricting some market initiatives and the impact of the Affordable Healthcare Act in the United States are having a rippling effect upon our industry.  We are pleased to have the who’s who of the industry joining our discussions. That is why IAMERS continues to be the leading voice on pre-owned and remanufactured imaging equipment.” Networking remains a major draw of the IAMERS meetings. .Mads Vittrup, Agito Imaging Sales Manager adds, “We are coming to Berlin because we also see all of our friends and business associates in one place. We always walk away with business opportunities from these IAMERS meetings.”

One of this years’ crucial challenges and the conference theme is the opening of new markets in an era where some countries are reportedly imposing more requirements to do business. IAMERS is fortunate to be hearing from long time IAMERS contributor and newly named president of GE Global Services, Joseph Shrawder, current CEO of GE Healthcare of Latin America. IAMERS founder,  and Oxford Instruments CEO, David Band commented: “I regard Joe Shrawder as one of the smartest guys in the industry. It’s worth the trip just to get his take on where things are going.”

A special program on FDA inspections by former FDA Associate Director Cap Uldriks will lead the first day activities. The European Union directorate on medical devices has signaled that it will have a representative present a special program on the latest directives pertaining to hazardous waste and electronic equipment.

“We expect to be discussing key issues and trends during this two day conference” said Rick Stockton President of Kosmic Medical. “We must ask ourselves why is it that half of the world limits the sale of used equipment and how we can formulate an effective strategy to change that calculus for everyone’s benefit?”

IAMERS was formed in 1993. Our membership is worldwide and represents the best companies ranging from the largest OEMs to smaller highly specialized ones that sell, service and finance pre-owned medical imaging devices.

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Press Release

SOURCE:
IAMERS (International Association of Medical Equipment Remarketers and Servicers)
85 Edgemont Place
Teaneck, NJ 07666

CONTACT:
Diana Upton
201-357-5400

For Immediate Release

Senator Tammy Baldwin Opens the 21st Annual IAMERS Meeting

(Washington, D.C.)  IAMERS, (International Association of Medical Equipment Remarketers and Servicers) opened its’ 21st Annual Meeting in Washington D.C. with the presence of Senator Tammy Baldwin from the State of Wisconsin. Senator Baldwin serves on the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP), the Senate Budget Committee, the U.S. Committee on Homeland Security and Governmental Affairs, and the U.S. Senate Energy and Natural Resources Committee.

Ms. Baldwin expressed her conviction for Quality Healthcare in the United States, and the role that IAMERS and their members play in the delivery of quality, state-of-the-art product’s, and services. IAMERS members are at the lead of the Green Initiative in addition to the cost containment of the healthcare spending debate.

Ms. Baldwin closed her remarks with the promise to continue the pursuit of quality and affordable Healthcare for all the people of this United States.

IAMERS was formed in 1993. Our membership is worldwide and represents the best companies ranging from the largest OEMs to smaller highly specialized ones that sell, service and finance pre-owned medical imaging devices.

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Featured IAMERS Member | NFS Leasing, INC.

How can we support your sales objectives? Why do we consider ourselves to be a different kind of leasing company? What is NFS Leasing’s unique niche? How can we best meet your needs and help you market refurbished and remanufactured systems and services to your clients? How can we partner with you to create a win-win?

In summary, NFS Leasing is a private, self-funded lessor providing leasing solutions for Medical Imaging and Information Technology systems. Our core competency is to provide financing for challenged credit customers. We can work with organizations and healthcare providers of all sizes, from early stage to established, throughout the US and Canada. NFS provides efficient, simple procedures and processes without bureaucracy, and we have the resources to work with IAMERS members and respond quickly to your customers. We have the ability to fund 20k to multi-million dollar transactions.

NFS’s dedication and knowledge of the healthcare industry, and our expertise in the financial arena is combined with our commitment and unique ability to engage healthcare institutions and providers with all credit qualities.

In the face of unprecedented industry changes and the transition from fee-for-service to a value based population health reimbursement model, many healthcare institutions are being challenged. Although leasing can be a potential solution for meeting Diagnostic Imaging technology and equipment financing needs, an increased number of providers are not credit approved by increasingly conservative captive or traditional lenders, and therefore require access to alternative funding sources. As your market for refurbished and remanufactured imaging equipment continues to grow, NFS can support your clients with creative leasing programs that will meet their imaging technology acquisition needs.

What makes NFS Different?

  • Responsive, aggressive, creative
  • Solid understanding of imaging technology and healthcare economics
  • We use our capital to fund deals
  • Full service lessor (not a lease broker)
  • Finance all credits profiles, all customer sizes, physician entrepreneurs to medical centers
  • Unique ability to finance “Story Credits”
    • Privately held, less than stellar financials, prior bankruptcy

Our goal is to develop a mutually beneficial, long term, strategic working relationship with each IAMERS member. We welcome the opportunity to work with you in partnership to close new business. Let’s create a win-win for our organizations and most importantly for your customers.

Rich Vassallo
Medical Business Development Manager
richardv@nfsleasing.com
978-564-3682
nfsleasing.com

Vitame Vas Do Praha!

This year is IAMERS’ 20 year anniversary. In Prague we’ll be continuing the celebration of our anniversary welcoming our next 20 years. Today we are the only trade association in the world representing vendors of pre-owned medical imaging equipment and services. These past 20 years were filled with marketplace changes and challenges for our members and the organization. The years ahead look to be even more challenging. What started out 20 years ago as an effort to respond to potential regulation of vendors of used medical devices by the FDA in the United States, has expanded to meet similar challenges around the world. We began and continue to function as a unique self- policing organization dedicated to the expansion of our marketplace by continuous education of our members, relationship building with government regulatory agencies through lobbying, education of the marketplace and outreach, and teaming with other associations when our combined strength is more able to accomplish the objectives IAMERS’ members require to support the expansion of their business base and to limit regulation.

I look forward to meeting with you in Prague for a spirited exchange of ideas and to raise a glass to toast our 20th anniversary. An anniversary is not the culmination and end of the work. As we toast and cheer our 20 year anniversary and our many accomplishments, we will also be opening the door and welcoming the next 20 years for IAMERS as it continues its objective to support its members through education, engagement and the interaction with governments worldwide in an effort to keep the path clear for the very important business of marketing high value medical devices and associated services to our ever changing medical imaging marketplace.

Welcome to Prague!

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Global Market Regulatory and Competitive Climate Overview for Refurbished/Remanufactured Medical Devices

At least one respected commentator has predicted that the global market for refurbished medical equipment will be worth $8.45 Billion by 2017. This market will include diagnostic imaging equipment, surgical devices, ra diation oncology equipment and biotechnical equipment. While the definitions of ‘refurbishing’ and ‘remanufacturing’ are very much the subject of debate, industry players typically concede that these terms involve the restoration of used equipment to conditions which are consistent with original equipment manufacturers’ specifications. The sale of ‘refurbished’ or ‘remanufactured’ equipment is often accompanied by a parts or a service warranty undertaken by trained and experienced personnel.

Small hospitals and group medical practices reportedly make up the largest end-user segment for refurbished or remanufactured devices. While the United States is the largest market for refurbished medical devices, Europe, Latin American, South America and the Middle East represent growth areas. Some of this growth has been limited by blanket bans instituted by certain countries for the importation of used medical equipment. IAMERS is working on behalf of its members to limit or remove these trade obstacles.

IAMERS is composed of both original equipment manufacturers and independent refurbishes/remanufacturers and brokers. All IAMERS members undertake a pledge to support the ethical sale of medical equipment and have strongly supported educational programs and when possible, ISO certification. Established and respected U.S. based IAMERS members (particularly small businesses) have faced competitive challenges by the practices of some original equipment manufacturers.

These practices include the withholding of ‘assembly’ information in contravention to the specific requirements of 21 C.F.R. Section 1020.30(g) which requires upon the request of a third party the disclosure of information concerning the assembly, installation and testing (AIAT) for each certified component in a diagnostic x-ray system. Notwithstanding this obligation and corollary obligations for disclosure (see 21 C.F.R. Section 820.170[b]) IAMERS members continue to experience the withholding of passwords, equipment manuals and training. To date, the FDA has not sought to enforce these regulations on a consistent basis. The net result has been that some IAMERS independent servicers, are unable to service equipment at a competitive rate and smaller hospitals and group practices are forced to engage the servicing departments of more expensive OEMs. This results not only in a diminished competitive environment but also in higher health care costs.

Recently, some OEMs have engaged in a practice of limiting software access and limiting passwords through the use of ‘locational licenses’. The OEM takes the position that while the equipment has been sold to the hospital or group practice, the software is leased.  This ‘locational license’ practice limits or prohibits the ability of an owner of medical equipment from transporting the device to another location absent the written consent of the OEM from whom the device is purchased.

Implementation of the locational licenses is but yet another competitive concern as the independent servicers are unable to service the equipment in the new location absent the hospital/group practice obtaining the consent and agreement of the OEM.  IAMERS senior management has yet to learn this year of an OEM consenting to the servicing of the medical equipment in a new location by an independent servicer. Some independent servicers are reluctant to document their concerns about anticompetitive behavior because of additional concerns about retaliation. Servicers are in many instances dependent upon OEM cooperation to obtain spare parts and access to higher diagnostic levels.

The net effect of the OEM practices of withholding passwords, equipment manuals and training and the implementation of locational licenses is to limit the cost effective choices available to smaller hospitals and group practices. IAMERS is pleased that the National Rural Hospital Association has engaged in dialog with IAMERS to encourage choice. IAMERS is also pleased that group practice associations have also reached out to IAMERS to encourage choice and to encourage competitive alternatives.

When challenged concerning this anticompetitive conduct, some OEMs point to quality assurance regulations promulgated by the FDA as reasons to withhold access. Ironically these same OEMs will contract for the use of independent servicers when a location of a service call is geographically inconvenient or when an emergency prevents their immediate availability to a customer.

In 2006, IAMERS president Diana Upton received a FOIA response from the FDA which noted that there is no greater incidence of adverse events in the operation of used equipment than that which might occur with new equipment. IAMERS believes that the election to withhold information to experienced servicers (many of whom were formerly employed by the OEMs) on quality assurance grounds is inappropriate.

The overall effect of the withholding of access and the spotty and inconsistent enforcement by the FDA of its own safety regulations is to negatively affect small businesses ability to bring about safe and competitive options. The FDA has openly conceded that anticompetitive concerns are not within its regulatory ambit. Some representatives have said that in the absence of IAMERS being able to identify an ‘adverse’ event which is caused by the withholding of passwords or access/assembly information; they are not willing to act.  IAMERS hopes to develop strategic relationships with policymakers both domestically and abroad to open markets, lower costs and encourage safe device operation. IAMERS does not wish to have the catalyst for regulatory involvement to be an adverse event. IAMERS will continue to reach for strategic partnerships.

Medical Device Excise Tax Key Facts

Here are some key facts about the medical device excise tax from our general counsel Robert Kerwin.

 

Celebrate the 20th Anniversary as the Only Trade Association for Pre-owned Medical Equipment

Come help us celebrate IAMERS 20th Anniversary as the Only Trade Association for Pre-owned Medical Equipment. May 1-3 in New York City.

Check out the details and find the registration form here.

What You Need to Know When Buying or Selling Pre-owned Medical Equipment

We know buying and selling pre-owned medical equipment can be confusing. Below is our list of need to knows. Continue Reading…

Medical Device Excise Tax Update

We believe this letter between our general counsel and the IRS to be good news for people who sell used equipment, and good news for most sales of refurbished equipment.

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