Costs of Catheterization
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Costs of Catheterization Problems Associated with Catheterization Urinary catheterization has been the source of a long list of complications and costs associated with patient treatment. Issues range from the blockage of urine flow and bladder spasms to more severe complications such as cystitis, blood in the urine, catheter-associated urinary tract infection (CAUTI), and in long term catheter users, an increased risk of bladder cancer.1-3 The difficulties associated with urinary catheterization have resulted in both high human and financial costs: • • • • • • Patient discomfort and suffering Patient death (CDC estimated 13,000 deaths attributable to CAUTI annually)4,6 Increased strain on doctors and nurses5 Increased length of hospital stays5,6 Unecessary anti-microbial use21,22 Increased treatment costs ($0.5 billion annually for CAUTI, other costs unknown)4-6, 8 Additional costs from non-CAUTI complications are not easily quantifiable; these issues are often viewed as an inevitable consequence of catheterization and many go unreported. CMS Policy Changes of 2008 In 2008, the Center for Medicare & Medicaid services implemented the “Hospital-Acquired Conditions Initiative” in which CMS stopped reimbursing hospitals for the treatment of Hospital Acquired Infections (HAI’s) such as CAUTI. Additionally, hospitals were not able to pass the additional costs along to patients. These changes in policy have put the spotlight on generating a standard of best practices for urinary catheterization in order to limit the costs associated with CAUTI.7 The industry, in conjunction with the Center for Disease Control’s (CDC’s) “Guideline for Prevention of CatheterAssociated Urinary Tract Infections 2009” , has focused on the following core strategies:7 • • • • • • Insert catheters only for appropriate indications Leave catheters in place only as long as needed Only properly trained persons insert and maintain catheters Insert catheters using aseptic technique and sterile equipment Maintain a closed drainage system Maintain unobstructed urine flow Additionally, research has focused on the prevention of bacteriuria (bacteria in the urine). This has been reflected not only in the emphasis of clean catheter insertion practices, but in the production and use of

The Root of the Problem The Need for Additional Solutions While the industry response to the issues associated with catheter use and CAUTI has been invaluable, many of these high cost complications remain today. The root cause of these problems has not yet been addressed. In a 2005 interview, Rabih Darouiche, MD, professor and director of the Center for Prostheses Infection at Baylor College of Medicine, put it best during a discussion on strategies to prevent CAUTIs.8 On bacteriuria: “Most patients with an indwelling bladder catheter will have bacteriuria. Most cases of bacteriuria will...

Clinical Evidence The Bladder’s Natural Defenses Two Mechanisms of Defense The bladder’s immune system is comprised of two primary functions: • • The process of voiding (urination) The mucin (GAG) coating of the bladder wall, which acts as a barrier to bacterial attachment The process of voiding urine removes 99.9% of bacteria from the bladder. However, the remaining bacterial population is still sufficient to cause infection. The mucosal lining of the bladder acts to prevent infection from this remaining bacteria.13, 14 Bacteria begin to attach to the top mucinous layer of the bladder...

Clinical Evidence The Importance of the Mucosal Lining Below is a sampling of clinical studies that demonstrate the importance of the bladder’s mucosal lining in fighting bacteria. 1977: Reaction of the Vesical Wall to Bacterial Penetration: Resistance to Attachment, Desquamation and Leukocytic Activity. “To determine the contribution of the bladder wall to defense against infection, we designed a series of experiments wherein movement of the introduced bacteria and inflammatory processes (cystitis) were observed by an autoradiographic technique. As a first defense line the bladder mucosal...

Clinical Evidence Foley Catheters Compromise the Bladder The Flaws of the Foley Catheter The 75 year-old design of the Foley catheter is at odds with the goal of preserving the integrity of the bladder’s mucosal lining. Its shortcomings are two-fold: • As the bladder drains, it collapses around the tip of the Foley catheter. Since the tip has a small surface area, most of the pressure created as the bladder pushes against the tip is focused on a small area of the bladder wall. The pressure of the tip pressed against the bladder wall, combined with the friction of motion during a drainage...

Clinical Evidence Cystoscopic Evidence Additional Visual Evidence Roger Feneley was not alone in using cystoscopy to observe the effects of the Foley catheter on the bladder. Dr. Bruce Wiita, Chief Medical Officer of Poiesis Medical, continually noticed damage inside the bladder caused by catheters. He has accumulated his own collection of visual evidence demonstrating this trauma. Bladder Wall Damage Polypoid Cystitis Bladder Wall Trauma Tip and aspiration damage only 24 to 72 hours after catheterization The images above exhibit the tell-tale signs of damage from the catheter tip and...

Clinical Evidence Foley Clinically Tied to Bladder Trauma Not only is the visual evidence compelling, but a large collection of clinical studies also connect bladder trauma in the bladder and associated complications with the Foley catheter. 1983: The Reversibility of Catheter-associated Polypoid Cystitis “Cystoscopic and histologic evidence of polypoid cystitis [inflammation of the urinary bladder] was recorded in 20 hospitalized patients with indwelling urethral catheters followed by cystoscopy, biopsies and repeated urine samples before and after catheter removal. The majority of the...