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by Robert Garment and
Amanda Doreson

This article is from in the April 2007 issue of DOTmed Business News. A list of registered users that provide sales & service can be found at the end.


Mobile C-arms -- the name comes from the characteristic "C"-shape all this equipment shares in common -- are radiographic and fluoroscopicsystems with an X-ray tube at one end of the "C" and an image intensifier and charge-coupled device (CCD) camera at the other. They are highly maneuverable and multi-positional, allowing for different angulations of the imaging system around the patient, enabling physicians to see real-time images from virtually any angle.

Invented by Phillips in 1953, the vast majority of C-arms are mobile. Fixed C-arms are sometimes found in special procedure suites. Mini C-arms, originally design for use with the extremities, offer lower cost, a more compact size, and comparable performance of full-size Cs, resulting in the growth of their popularity. C-arms are used for a multitude of normal and emergency room diagnostic procedures. They've also become indispensable tools in non-invasive therapeutic procedures such as arthroscopic surgery to assist in the positioning of plates and screws, and in pain management therapy to guide the placement of needles.

Mobile C-arm market leaders

The majority of the U.S. mobile C-arm market is controlled by a handful of manufacturers, with the leader being GE/OEC. The three other top C-arm companies are Philips Medical, Siemens Medical, and Ziehm Imaging, based in Germany. Ziehm -- currently the leading manufacturer of mobile C-arms in Europe -- is looking to increase its market share in the U.S. with its new Vision FD flat panel detector (FPD) mobile C-arm -- the first digital and mobile with a flat-screen panel. The leading manufacturers of mini C-arms are Hologic (Bedford, MA), OEC and Orthoscan (Sherborn, MA).

The 800 pound gorilla has left the room

It is impossible to discuss C-arms today with industry insiders for more than two minutes without mention of the GE/OEC shutdown. In case you haven't been paying attention, inspections conducted by the FDA during July and August, 2006, revealed CGMP (current good manufacturing practices) deficiencies, including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions at OEC's facilities in Utah and Massachusetts. Manufacturing cannot resume until the problems have been corrected. The consent decree signed by GE/OEC in January 2007 as a result of investigations by the FDA has effectively shut down shipment of OEC products, include the 9900 Elite C-Arm System, 9900 Elite NAV C-Arm System, 9800 C-Arm System, 2800 UroView System, 6800 MiniView System, Insta-Trak 3500 NAV System, and ENTrak 2500 NAV System, as well as their components and accessories.

According to Dave Denholz, CEO of Integrity Medical Systems, Ft. Meyers, FL, and just about every other C-arm dealer we talked to, "OEC held about 60 to 65 percent of the U.S. market prior to being shutdown. The vacuum OEC has created has sent shockwaves across both the new and used C-arm markets," Denholtz observed. Siemens and Philips were not prepared for the increased demand for their products as a result of the sudden disappearance of OEC from the equation, and are not likely to make the capital investment to increase production, as OEC could be re-certified at any time.


OEC 9400s and 9000s reconditioned, calibrated,
and waiting for Quality Assurance testing

A temporary price spike

Historically, C-arms have been among the least expensive imaging devices. But the OEC situation has changed all that -- if only temporarily. Ted Hoover, Director of Sales & Marketing for Bighorn Biomedical, Pine Haven, Wyoming, reported that OEC's absence has caused a run on the used mobile C-arm market. "Prices have gone up across the board for equipment and parts since the OEC news hit the street," Hoover noted, "but we've been able to meet our customers' needs because we have a large inventory of meticulously refurbished equipment. And we sell to customers worldwide." Bighorn specializes in and carries a full line of refurbished OECproducts.

Reports as to when OEC will reopen its doors vary, but most people believe it will be sometime near the beginning of 2007. Leon Gugel, President of Metropolis International, Queens, NY, believes that prices will "plummet" when OEC C-arms hit the market again. "Shutting down an OEM is nothing new. The market will bounce back quickly," he stated.

Another industry veteran in the C-arm business, Bill Adkins, President of National X-ray, Sarasota, FL, said "I don't have any inside knowledge, but would bet that before the end of this year, GE/OEC will have a C-arm on the market coming out of another facility. Now that's just me speculating, but it's too big a market for GE to let is slide for long."

"C" stands for Versatility

"Every year they find a new use for a C-arm," Leon Gugel noted. Mobile C-arms are used for minimally invasive, spinal, general, and orthopedic surgeries; pain management; and cardiac, urology, vascular, and neurovascular applications. Fixed C-arms are used more for diagnostic angiography as well as interventional treatments. C-arms are used alongside MRI scans to ensure the contrast agent is placed correctly. Mini C-arms are turning up in more and more doctors' offices. Thomas Ray Becker, MD, an orthopedic surgeon in private practice in Gurnee, Ill, has had a mini C-arm in his office for 4 years. "It has allowed me to do procedures in the office that otherwise would have ended up in the operating room," he says.

Mini c-arms are also valuable in sports medicine: the Baltimore Ravens purchased a mini C-arm because it can be easily transported between the team's training camp and their playing field and can be used for quick diagnosis views of foot, ankle, knee and hand injuries.

OEM vs. ISO issues

The "turf wars" between OEMs and third-party service providers will never go away, but the good news is that competition gives every healthcare provider a choice. Many ISOs see the OEMs as not easy to work with, but those who have good relationships tend to say GE/OEC is usually the most third-party friendly in the C-arm arena. Many ISOs like to do business with Toshiba, even though it is still a small player in the C-arm field, because they don't have a second-hand program. Ted Huss, President of Medical Imaging Resources, Queen Creek, AZ, believes there will always be a role for ISOs because, "The OEMs will always be too expensive to cover the needs of the entire marketplace. Not every healthcare facility can afford the latest and greatest equipment," he asserted. "I view my role as that of an architect or orchestra leader who gets the best result through management of individual talents. I work at the grass-roots level and know who to trust, who is competent, and who is responsive to the client's needs. Look at used and refurbished systems as 'bridges' to the time when you can afford, and truly need, the most expensive stuff," he added.

Kenneth Saltrick, President of Engineering Services, KCS, Twinsburg, OH, said "As long as companies like mine can produce parts for the ISOs, the ISOs will remain and prosper. Remanufacturing cables or the fresh manufacture of cables will keep them alive. Repairs only last a finite amount of time."

As of August 30, 2006, Engineering Services became an FDA registered remanufacturer of high-end new and refurbished medical cables. One of the opportunities Saltrick sees now is to provide 9800 interconnect cables to the ISOs. "OEC, I believe, cannot manufacture right now," he observed, and that seems to true. "Our builds are less expensive, not cheaper," says Saltrick. "They are of the highest quality."

Remanufactured, refurbished, reconditioned

Darrel Kile, Account Manager Classic Diagnostic Imaging, Solon, OH, says his company prides itself on "taking a machine apart and replacing every critical component that needs replacement. When we're done, the system is virtually as good as new." He has these words of advice when purchasing a refurbished mobile C-arm. "Do more than just kick the tires. Take the covers off, look for signs of dust, hot spots on circuit boards, anything that looks like it was overlooked - and take phantoms shots," Kile advises. "You can't judge a C-arm by its cover; it takes more than fresh paint to refurbish a system," he added.

Companies are careful to use the term "reconditioned" or "refurbished" as opposed to "remanufactured" because the latter has more FDA guidelines attached to it. Since a remanufactured device is basically a remade device devoid of its OEM warranties, the facility doing the remanufacturing must be registered with the FDA and have a 510 clearance on file. To be a refurbisher, a company does not have to abide by such regulations.

ISOs who sell and service Some C-arms dealers only focus on refurbishing and reselling equipment, but most provide service as well. Those who do recommend regular PM (preventive maintenance) schedule is the best way to avoid big repair bills. The number of times a years PMs are required depends on the frequency of use. Some C-arms just need an annual check-up, some should be seen more often.


Philips BV Pulsera is one of the newest
generation of C-arms designed for hospital use.

Don't buy more C-arm than you need

ISOs report that many doctors are simply uneducated about medical equipment, or buy more bang with more bucks than they need to. Doctors often ask for a specific make and model without taking into account their anticipated usage. Knowing your surgical needs is paramount in selecting the right C-arm. "Ask questions. Inquire about how many lines-per-inch the manufacturer guarantees," advises Dave Denholz. Orthopaedic and podiatric centers, for example, may be well served by a mini-C. Those who use the relatively inexpensive, small devices say technology has advanced to the point where the mini-Cs can provide excellent image quality and ease of use -- all without the need for a costly radiology technologist.

It is also important for doctors to weigh the pros and cons of mobile and fixed c-arms: mobile are more likely to break-down, but there are more FDA guidelines for fixed equipment than mobile ones.

Turning around the tables

Most people are aware that C-arms work in conjunction with specially designed C-arm tables. But many of the ISOs we spoke to said too many end users don't pay enough attention to the table, and sometimes buy the wrong type.

One key feature is design: the table should allow maximum freedom of movement and positioning of the C-arm around the patient. Some tables have a cantilever design -- they look something like a diving board -- which facilitates the C-arm's movement.

Another key feature: the table should be as translucent to X-rays as possible. Carbon fiber tables have this characteristic, and are also lightweight and strong. Carbon fiber is used in many applications where high strength-to-weight ratios are advantageous, such as in jet fighter components. And think about weight capacity -- 500 lbs. should be the minimum, unless it's a purely pediatric application.

Tom Hoover of Bighorn Biomedical -- which is an authorized dealer for the full line of Medstone tables - also says to look for the U.L. seal of approval. Motorized tables, like any electrical product, should be tested and proven safe to operate - particularly when they often have a lot to lift.

Covering your costs

As a helping hand for purchasing decision-makers, GE Healthcare offers a feature on its website (http://www.gehealthcare.com) that calculates payback on a purchased system in terms of patient volume required to recoup the cost of a C-arm, as well as a breakeven calculator for leasing options.

C-ARM Sales and Service Providers

Domestic

Michael Bushior, Advanced Medical X-ray, CT
Joe Zaremba, Advanco Medical Systems, MO
DOTmed100
Gus Antus, Ampro International, Ltd, AZ
John Kollegger, Ltd, Bay Shore Medical , LLC, NY
Russ Surrantt, Bighorn Biomedical Services, Inc., WY
DOTmed Certified
Darrel Kile, Classic Diagnostic Imaging, OH
DOTmed Certified/100
Charles Moore, CMoore Medical Sales & Service, GA
Mike Jackson, Combined Imaging Associates, TN
Russell Froelich, Computron Medical Corporation, IL
Randy LaValley, C-Thru Imaging LLC, CT
Sal Aidone, Deccaid Services Inc., NY
DOTmed Certified
Don Bogutski, Diagnostix Plus Inc., NY
DOTmed Certified/100
Samir Dahdah, Doral Medical Equipment, FL
Kenneth Saltrick, Engineering Services, KCS Inc., OH
DOTmed Certified
Michael Parnell, EquipStat Medical Equipment, FL
Tony Asbille, Global Star, AR
Jonathan Shapiro, Greenwich Instrument Co Inc, CT
Richard Fosco, HealthWare Inc., IL
DOTmed Certified/100
Courtney Lane, Innovative Xray Services LLC, TX
David Denholtz, Integrity Medical Systems, Inc., FL
DOTmed Certified/100
Jasbir Chahal, JcBiomedical International LTD., Alberta
Tedd Huss, MEDICAL IMAGING RESOURCES, AZ
Leon Gugel, Metropolis International, NY
DOTmed 100
Jim Miller, Miller Medical Imaging, OH
Ken Wieselman, Mini C Sales, IL
Bill Adkins, National X-Ray Corporation, FL
DOTmed Certified, DOTmed 100
Mitchell Guier, North American Medical, MO
German Filgueira, PODER, Inc., MO
DOTmed 100
Evelyn Narvaez, Pro Battery Specialist, FL
Richard Stock, Radiological Imaging Services, PA
DOTmed Certified
Michael Baumgartner, Remesta Medical Corp, TN
William Brooks, Salem Medical Electronics, Inc., NC
Edward Olson, Service 2000, Inc., IL
Dustin Holt, Surgical Connections Inc., GA
Majid Shambayati, TSC, TX
Ricardo Rosas, Universal Medical Engineering Services, FL

International Users

R.S. Kanwar, Allengers Medical Systems Ltd., India
Felix Donoghue, FX Rays & Imaging, India
DOTmed 100
Carlos Duran, Ingeniera Clinica, Colombia
Hossam Eldin Zidan, Zahran, Saudi Arabia