Weighing the Options
“When evaluating antimicrobials, safety was a major consideration,” recalls Alan Martin, Vygon’s training and education director. “Whenever you use antibiotics in devices, there are always objections from the healthcare community because of fears of resistance. But because silver has such a long history of safety, we could ease the minds of clinicians. Furthermore, it is a very adaptable technology with a proven track record across a variety of industries.”
In 2000, Vygon developed a PICC catheter for the European market that featured a silver-based antimicrobial coating. But the company found that whenever a clinician would clean the PICC with alcohol, the antimicrobial coating would be removed and device’s polyurethane material would break down, causing extensive leakage.
Vygon went back to the drawing board and chose an alternative silver-based antimicrobial technology that could be incorporated into the device’s polyurethane structure during the manufacturing process.
“We wanted something that was totally integrated into the product so that if the product was roughly handled the antimicrobial wouldn’t be rubbed away,” Martin says. “Adding the silver-based antimicrobial to the polyurethane turned out to be a simple and low-cost process.”
Getting to Market
In 2001, Vygon developed the first product in its new line of Multicath Expert antimicrobial CVCs; a three-lumen catheter that featured the new silver-based antimicrobial. Since that time, the company has developed one-lumen, two-lumen, four-lumen and five-lumen CVCs for adult patients, as well as a PICC. They also globally market silicon-cuffed long term catheters featuring an antimicrobial.
Martin notes that the regulatory approval process for antimicrobial products has evolved over the past 10 years. “In the early stages, the process could take a long time since there was some skepticism about the use of antimicrobials in devices,” says Martin. “There was also confusion on whether antimicrobial-protected catheters should be classified as drugs or devices. Today, the process is much simpler because regulatory agencies have a solid view of antimicrobials and already have the answers to their questions.
The Selling Climate and Process
When selling Vygon’s products, Martin notes that it is a multidisciplinary decision making process since healthcare facilities are integrating antimicrobial-protected devices into their overall infection control plans.
"Unlike the U.S., the rest of the world isn’t currently dealing with issues related to lack of reimbursement for HAIs but they are certainly headed in that direction,” Martin explains. “Healthcare facilities across the globe are focused on infection prevention so we’ve had the greatest success when we can sell our products within an infection control bundle.
"It is a very multidisciplinary decision making process these days. We see infection control, clinicians, materials management, risk management and the nurses who will be heavily involved in using these devices – they are all very important parts of the puzzle,' he says. "We do a lot of education these days, getting healthcare facilities to think about disease control guidelines, whether it is guidelines from the CDC, EDCD or other agencies.”
Vygon is now turning its sights to neonatology, where bacterial colonization of indwelling catheters is widespread. The company is starting some early discussions around silver-based antimicrobial catheters for this clinical area.
“It is a very interesting area because no one else has ever done it and we have the capabilities to do it,” says Martin. “I really believe antimicrobials will continue to be an area of development among medical devices because they enable us to offer greater benefits over nontreated devices.”
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