FDAnews.com
January 19, 2009
Higher-priced, antimicrobial devices are expected to see double-digit growth through 2012 as government initiatives to reduce the spread of hospital acquired infections (HAIs) seek to tackle the issue at the source, analysts say.
Medicare reimbursement changes coupled with a new HHS five-year prevention initiative are expected to accelerate the shift to these coated products and encourage devicemakers to explore alternative technologies to lower infection risks, Aaron Dickson, co-president of Millennium Research Group (MRG), said at a web conference last week.
“Manufacturers that are able to demonstrate the effectiveness of their antimicrobial products at preventing infections will benefit from increasing product demand and sales,” Dickson said. “Manufacturers without antimicrobial-coated catheters will experience limited revenues as the markets for noncoated devices contracts.”
The Centers for Disease Control and Prevention reported that 1.7 million people in the U.S. contract an HAI each year, resulting in more than 100,000 deaths and adding as much as $20 billion to healthcare costs.
As a result, Medicare cut reimbursement for treatment of HAIs last October. Under the new guidelines, some of the most preventable conditions no longer covered include surgical site infections, central line-associated bloodstream infections, pneumonia caused by ventilators and urinary tract infections from catheter insertions.
HHS unveiled a plan earlier this month to establish a set of five-year national prevention targets to reduce and possibly eliminate HAIs. The plan lists a number of areas in which HAIs can be prevented and outlines cross-agency efforts to reduce healthcare costs.
“Given the diversity of medical products on the list causing HAIs, it is clear that some device segments are being affected,” Dickson said.
MRG predicts that two of the most affected segments will be the markets for urinary and vascular-access catheters — which, combined, were valued at more than $600 million in the U.S. last year. Smaller segments, such as sterile drapes for use during catheter insertion, also will be affected.
Studies Needed
Another MRG analyst told D&DL no conclusive studies have been conducted to show which antimicrobial coating is the most effective at preventing HAIs, and each manufacturer has its own proprietary coating that uses different compounds, such as silver and chlorhexidine.
While devices with antimicrobial coatings have been shown to reduce infection risks over the short term, the issue of superior infection protection remains controversial, MRG said.
As a result, MRG expects studies in this area — for instance, a push to produce evidence highlighting the effectiveness or superiority of specific catheters that offer increased infection protection.
MRG also expects sustainable preventable infection methods will lead to the use of alternative devices to lower infection risk, such as peripheral-inserted catheters instead of central venous catheters and intermittent catheters in lieu of foley catheters. Currently, approximately $200 million in acute central venous catheters and more than $180 million in foley catheters are sold in the U.S. every year.
“This is a particular important development to device manufacturers, given the shear size of these markets,” Dickson said.
Infection control in MRI practices has been another growing area of concern for hospitals, clinics and manufacturers. Experts say the spread of methicillin-resistant Staphylococcus aureus is in part a consequence of outdated imaging pads and nonexistent cleaning procedures. They warn that manufacturers and imaging centers could be held jointly responsible.
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