Hospital-acquired infections (HAIs), which can spread easily and cause life-threatening illness and prolonged hospital stays, are arousing considerable concern in the medical community. The "superbug" known as methicillin-resistant Staphylococcus aureus (MRSA) may be the most visible and virulent HAI, but it is only one of many types. MRSA is particularly dangerous because it does not respond to most antibiotic therapies, but other HAIs also cause severe illness and even death, although they are more easily treated. Nevertheless, they too are increasingly resistant to at least one or more common antibiotics.
Medical device and pharmaceutical companies are seizing the opportunity to help hospitals with infection control. While interest in infection control isn't new, hospitals are under greater pressure to control HAIs, as bacteria become more resistant to existing therapies and payers tally the mounting costs of treatment for complications that might have been preventable. Infection control products, while often derived from supply categories sold as commodities, can command premium pricing if they are effective and face little competition.
The Centers for Disease Control (CDC) estimates HAIs affect more than 1.7 million patients a year, causing about 100,000 deaths and generating up to $20 billion or more a year in expenses. In August 2007, Medicare, the federal program that pays for health care for Americans aged 65 or older, announced (in a final rule that has yet to be formally adopted) that as of October 1, 2008, it will not reimburse hospitals for treating preventable medical errors and accidents, including certain HAIs. Medicare cited the following HAIs and said it is considering inclusion of others: catheter-associated urinary tract infections, vascular-catheter associated infections, and mediastinitis after coronary artery bypass graft surgery (inflammation of the mediastinum, which is a group of structures in the chest, including the heart, trachea, and esophagus).
In addition, bills now pending in Congress encourage a coherent national strategy to fight anti-microbial drug resistance. The U.S. Food and Drug Administration in July 2007 proposed guidelines for manufacturers of antimicrobial devices, requiring that clinical data has to support any claims that their product reduces or prevents infections.
Manufacturers of medical devices for surgical and intensive-care units are jumping on the bandwagon. A majority of the most serious bacterial outbreaks occurs in these hospital departments. Manufacturers have been coating invasive, basic hospital supplies like feeding tubes and IV systems with anti-microbial compounds. The concept isn't new, but it is being used on more products and with new kinds of compounds.
C.R. Bard, for example, expects infection control to play an important role in driving its device business forward, particularly its thriving urology unit, which comprises about 30% of the company's total revenues. While traditional urological drainage product sales rose 6% in the first nine months of 2007, Bard's anti-microbial-coated Bardex IC line of Foley catheters saw sales climb 11%.
In November 2007, Bard got U.S. regulatory clearance for a silver-coated breathing tube for ventilator patients. The device, which is called the Agento, is the first endotracheal tube with antimicrobial properties and Bard's first respiratory product. According to the CDC, 15% of patients on ventilators develop a lung infection known as ventilator-associated pneumonia (VAP), and, every year, 26,000 die from it. Based on clinical data submitted by Bard, the FDA is allowing the manufacturer to claim that Agento reduces rates of VAP. The company has said that it is likely to coordinate the product's launch with the pending publication of clinical trial results in a major medical journal.
