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This report originally appeared in the October 2009 issue of DOTmed Business News

Although radiologists may not brag about their contrast injectors the same way they would about a new scanner or upgraded X-ray system, from X-ray to CT to MRI, injectors are a vital component of the medical imaging process.

Contrast injector systems are important as they permit visibility-enhancing substances - such as iron-based or radioactive materials - to be introduced at targeted locations within the human body. In basic terms, they are pumps injecting contrast dyes into veins - usually at 280 psi - to help illuminate target tissues. The presence of this contrast makes it possible to produce imaging studies for radiology, angioplasty and other catheterizations that readily distinguish one set of tissue from another - of critical importance to a surgeon.

Contrast media injectors come in either mobile or stationary configurations. The mobile version is usually mounted to a wheeled pedestal, while stationary injectors are mounted to a rack in either the patient room or the control room.

The contrast injector system is made up of three components: an injector head, a display panel and an electronics box.

While contrast injectors have been around for almost 40 years, the leading OEMs such as MEDRAD Inc., ACIST (a division of Bracco), Swiss Medical Care and Covidien continue to develop new products with better advancements that help the contrast agent flow into the body more safely and efficiently.

State of Business

While the overall injector market is said to be in the neighborhood of $35 to $40 million, industry experts say that number is trending downward because of the economy. However, add-ons and accessories are on the rise.




"Obviously it hasn't been a positive year. There is a huge correlation between scanner placements and injector placements. As people keep confining spending for multi-million dollar projects, we feel the ripple effect," says Michael Farrell, director of operational marketing for MEDRAD Inc. "What we are seeing is that people couldn't afford the multi-million dollar investments and they were buying the refurbished scanners and for that reason they didn't necessarily want to go top end on the injector."

MEDRAD addressed these issues with the release of its Stellant CT injection system, which was designed to meet customer needs.

"We made the unique decision when we came out with Stellant, to come out with a platform. Instead of making you go out and buy a new injector every three or four years, we're going to allow you to add the latest and greatest onto your existing injector," Farrell says.

Bob Williams, vice president of business development for ACIST, believes that things are changing for the better as we enter the end of 2009.

"We had in essence a double-hit with the DRA arriving in 2007 on the capital equipment side and obviously the credit crunch didn't help matters. We followed a similar decline in sales patterns to CT and MRI, however we see things starting to stabilize and people are starting to get back into purchasing mode," he says.

While the OEMs do what they can to improve their businesses, many third-party operators are taking advantage of the fact that people are more price-conscious and looking for different solutions.

"There is little doubt that the state of our economy and, more importantly, the future of health care, are playing a role in the way clients maintain their equipment," says Scott Scofield, CEO of VIVID Imaging, which specializes in the service, distribution, and sale of power injectors, contrast media pharmaceuticals, and injector syringes and related disposables. "We see more cancelled orders as health care providers are looking to extend the life of existing equipment. Clients who typically only consider the OEM for service are looking to quality independent service companies for their support in an effort to reduce cost without reducing customer service and quality."

Two Heads Are Better than One

One of the biggest advancements in injectors has come about in the past five years with the introduction of two-headed contrast injection technology called duel head injectors. One head still injects the contrast medium while a second one injects a saline pre-flush that opens veins so that much less contrast dye is used.




"It was first introduced outside of the U.S. and we saw the advantages and we invested to bring it to the U.S. as quickly as possible. It's now the gold standard for doing cardiac imaging," says MEDRAD's Farrell. "What was interesting about dual flow is that when we introduced it, there was a lot of skepticism. We provided it to leading institutions and they quickly found a much more consistent imaging over time."

Multi-head injectors require less contrast agent and are engineered to allow the same high 9 ml/sec flow rate at only 135 psi instead of 280 psi.

"You need dual-head injectors because it saves contrast and you need it to perform cardiac CT. New CT labs must purchase a dual head injector to optimally use the new CT technology," says Bruno Vandelanotte, owner of the Belgium-based company, Vandelanotte. Vandelanotte provides service on injectors throughout Europe. "With an MRI, you need dual head to reduce the use of the very toxic contrast. It saves time and is much more reliable."

Although it's not a core part of their business, Shared Medical Services does deal in selling injectors and has enjoyed steady business over the years.

"There are always people in the market for them and there's definitely a push towards the dual-heads because they like that they give you the saline flush when they're done, but we still sell a lot of single head, too," says Paul Zahn, director of the Cottage Grove, Wis. company. "Injectors don't break a lot, so they are pretty reliable."

Williams says that ACIST offers its Empower CTA dual-syringe injector with contrast and saline chase, which combined with the right phasing protocol and your scanner, can help maximize the benefits of a cardiac CT study. It offers 10 mL/sec maximum flow rate with "change on-the-fly control" and air embolism protection.

Improvements Continue

Other advancements have been made, and most of the innovation in contrast injector technology has been driven by safety and cost management concerns.

"Most injector systems are very user friendly and the most recent models are very intuitive and some are even voice prompting," says Patrick Miles, sales manager for Med Exchange International Inc. "Good training and documented procedures are vital in limiting user errors."

Another improvement companies are working with is KVO, which stands for "keep veins open." Essentially, if a patient has a needle in their vein or artery and an injection doesn't take place soon enough, an issue of clogging can occur. To prevent that, some MR and CT injectors have a keep vein open function where you can inject a very small quantity of fluid every 70 seconds or create a constant low flow rate of contrast to keep veins open.

In 2007, Swiss Medical Care introduced the CT Expres III, the first syringe-less contrast media injector designed for multi-patient use, eliminating syringes entirely. Last year they released DileJect, which offers interactive program capabilities for the system, which will help improve CT Angio diagnostics while reducing the amount of contrast media injected into the patient.

"This new feature enlarges our injector's programming capabilities to adapt contrast media injection protocols to the latest clinical needs," says Herve Duffour, marketing and sales director for the company. "The programming flexibility opens a new era in contrast injection."

Refurbished Models on the Rise

It's no surprise that people are looking to save money and have looked to the used and refurbished markets when it comes to injector systems. While a new system can run upwards of $50,000-$60,000, a refurbished model can be sold for about 60% to 70% of retail price.

Jeff Mangione, president of Precise Biomedical Inc., describes the refurbishment process as follows: "We dismantle the injectors, clean them inside and out looking for anything questionable. Noisy motors are replaced and all rubber goods and gaskets that seal the injector to keep it contrast free are replaced. All movable parts receive lubrication. Circuit boards are [looked at], but we use the original ones if they give us no reason to replace them."

Miles says that each manufacturer has something unique to offer and the customer usually has a preference as to what refurbished model they are looking for.

"I have a good supply of injectors in stock at most times. There is more demand for the dual heads, so they are a little more difficult to obtain," says Miles. "The servicing issues of proprietary software in some cases limit some of the abilities of the third party."

Proprietary software is less of an issue in some cases. Some of the OEMs are getting into the refurbishment business providing refurbished injectors into the marketplace to meet the demand.

"It's one of the biggest adjustments we have made this year," says MEDRAD's Farrell. "When we trade in pieces of equipment, we bring them back in-house, refurbish them and sell them back to the market place. Initially, this was a response for some of our international locations where they were looking for a more affordable option and maybe a little smaller offering on the technology front. There was a market here for people doing bread and butter work who might not need the latest and greatest so we were able to introduce a value market."

The Place to Train

While problems in contrast injectors aren't that troublesome, being factory trained in contrast media injector servicing can help a biomed department become an indispensable asset to a hospital.

That's why Stephen Maull decided to open Maull Biomedical Training, LLC, a business dedicated to training people on how to service, calibrate and PM injectors.

"All we do is train biomedical service engineers, OEMs or third-party technicians on the different models of contrast injectors," says Maull. "We offer extensive service training."

Instruction begins with a history of contrast injectors, what they are and how they operate. Then the class will split up and spend a day working on one particular model of injector, doing a total operational inspection and a complete PM and calibration. The next day they will switch to a different model.

"All contrast injectors are for the most part the same with the same functions and features," Maull says. "Some will have a few more bells and whistles, but if you know how to operate one, you can mostly operate them all."

Problems Abound

The biggest cause of problems with injectors involves the contrast dripping onto the optical sensors.

"Allowing contrast buildup can lead to a multitude of problems including head replacement," says Scofield. "We counsel our customers on the importance of regular cleaning of their injector. Preventing contrast build up will save $1,000 to $10,000 in annual repairs."

When contrast ends up on the hands of the operators during the course of using the equipment for a clinical procedure, infiltration can occur. Manufacturers recommend replacing circuit boards rather than attempting a cleanup when the contrast media is found to be crusted, caked on and built-up.

"If optical sensors have been doused with contrast, infiltration can create problems. The most important thing that our customers can do on a daily basis is keep them contrast free and keeping them clean because when that contrast dries out, it is the stickiest stuff on Earth and it will bind up anything and everything," says Mangione. "They should take care of their injector because it's an expensive piece of equipment. We have seen what people can do to these machines and it never ceases to amaze me."

He also mentions that a lot of the machines are very static-sensitive. This means touch panels coupled with static discharge can create problems with the units. Other issues include motor problems, such as bearings going bad and interconnect cable problems.

Since the injector head is constantly being moved, cables and connections often get loose or break. Another common problem is found with syringe heaters-these dangle from the injector head, which pull at the connections.

You also see problems dealing with pressure. "During an injection, you don't want to create too much pressure in the syringe or injector in tubing inside the patient," says Maull. "One of the things techs will do is select pressure limits. Sometimes the users will set that pressure limit too low and when it hits, an alarm will go off and it will look like something happened to the flow rate. They are typically dealing with user error."

Leaks can also develop in a syringe and contrast will then find its way into the system internals.

Servicing

The preventive maintenance of contrast media injectors is typically conducted on an annual basis to allow for performance assurance to confirm that the equipment is operating per specifications and to identify and resolve any conditions that might later pose a risk of shock or other safety hazard.

"Our preventive maintenance inspection procedures are extensive and are designed to ensure the contrast injector meets or exceeds manufacturer specifications," says Scofield. "This includes operation and physical inspection, pressure, flow, volume delivery and cables. Unlike most manufacturer service offerings, suspension systems (AKA OCS ARM) are included with our fee."


Final Thoughts

Contrast media is being treated more like a pharmaceutical drug than ever before and documentation is becoming more critical on how much contrast a patient should receive. Companies are creating products with that in mind.

"MEDRAD launched Connect.PACS (part of the Certegra Informatics Platform), which allows you to automatically import into PACS the injection profile," Farrell says. "Previously, the doctor received an image and when they did dictations, they had to rely on the notes from technician. Now, it's automatically imported from the injector, so it offers huge efficiency gains and accuracy."

Lately, we have seen the OEMs move towards software calibration, which requires systems needing an interface when it comes to maintenance. That takes away from the end user performing some service on the systems. Potential problems that could develop include computer-related issues such as power surges or contrast infiltration into the electronic system.

All these efforts continue to inject new life into a market segment that keeps flowing.

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DOTmed Registered Injectors (CT, MR, Special Procedure) Equipment Sales & Service Companies
Names in boldface are Premium Listings.

Domestic
Chuck Marshall III, Florida Service Plus, Inc., FL
Nadia Davis, ND Medica, Inc., GA
DOTmed Certified
Patrick Miles, Med Exchange International, Inc., MA
DOTmed Certified
Jeff Rogers, Medical Imaging Resources, Inc., MI
DOTmed 100
Dan Wheeler, Transtate Equipment Co., NC
Bob Williams, Acist Medical Systems, NY
Stephen Maull, Maull Biomedical Training, LLC, OH
Jeffrey Mangione, Precise Biomedical, Inc., OH
Robert Smith, Inter-Components, TX
Curtis Hagg, Vivid Imaging, VA
Paul Zahn, Shared Medical Equipment Group, LLC, WI
DOTmed Certified/100

International
Bruno Vandelanotte, Vandelanotte, Belgium
Henrique Gomes, Autonomous, Brazil

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