Technology
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Technologies touting prevention of many of the hospital-acquired conditions that are no longer reimbursed by CMS are becoming more prevalent than ever. The difficulty for materials managers is assessing which ones are are based on unbiased scientific research. Hayes Inc., a company that provides third-party assessment of medical technology, has done extensive research on the efficacy of silver-lined catheters in reducing urinary tract infections. Read about the results and recommendations, including the use of best practices. |
The Centers for Medicare & Medicaid Services (CMS) have recently become less tolerant of hospitals’ errors. On Oct. 1, 2008, it stopped reimbursing hospitals for some hospital-acquired conditions, including incompatible blood transfusions, air embolism and objects left in the body from surgery. Pressure ulcers and falls and trauma also were excluded from reimbursement. Infections after coronary artery bypass grafts and vascular infections or urinary tract infections associated with catheter use are excluded as well. These are incidences that, according to the Leapfrog Group, Washington, D.C., “should have never happened and could have been prevented.”
Another wave of hospital-acquired conditions excluded from reimbursement surfaced on Dec. 1, 2008. These include surgical-site infections following certain elective procedures such as some orthopedic surgeries and bariatric surgery. Specific manifestations of poor control of blood sugar levels, as well as deep vein thrombosis or pulmonary embolism following total knee replacement and hip replacement procedures, also will be excluded.
Device manufacturers have responded with a surge of technologies promising to reduce and prevent hospital-acquired conditions. A barrage of IV smart pumps, computerized physician order entry systems, spectroscopy devices, coated catheters and more are being marketed to supply chain and value analysis professionals.
Many of these devices are packaged as the perfect remedies for hospitals striving to reduce errors. But when it comes to the efficacy, safety and cost-effectiveness of these devices, supply chain decision-makers often are left in the dark. That’s because there’s little evidence-based research to support most of these proposed solutions.
Medicare’s ruling has urged hospitals to clean up their acts and stock up on error-proof technologies. However, the prescription for careful practice requires more than meets the eye. A closer look at one popular technology promising to reduce the most common hospital-acquired condition reveals that the device may not be a silver bullet after all.
Medicare’s ruling
With Medicare buckling down on the $110 billion it spends annually on beneficiary care, health care analysts predict this new regulation will save Medicare about $21 million per year.
But that means hundreds of thousands of the 12.5 million hospital stays that Medicare pays for each year will cut into hospitals’ bottom line. Medicare is the largest insurer in the United States, and its move has prompted four state Medicaid groups to exclude up to 28 hospital-acquired conditions from reimbursement. According to CMS, Medicaid directors in nearly 20 states have or are considering methods to eliminate payment for some hospital-acquired conditions.
Health care analysts say more insurers—public and private—are predicted to follow. In addition to cutting costs, regulations have been implemented to improve the quality of care in hospitals, reduce the number of preventable events and reduce unnecessary treatments.
Technologies answer
The flood of new medical technologies aiming to reduce or prevent hospital-acquired conditions makes it difficult to determine which products are based on unbiased scientific research. With so many marketing claims being made, this is no simple task.
Sales reps usually have several studies to demonstrate effectiveness in hand. However, manufacturers have a significant financial interest in showing only the studies that support their products.
Direct access to the medical literature can provide a more balanced view, but with hundreds of thousands of journal articles added each year, who has time to find all the relevant articles, let alone make sense of the conflicting claims?
Supply chain and value analysis professionals can turn to evidence-based health technology assessments (HTAs) as an efficient and reliable way to determine the efficacy of products being offered to prevent hospital-acquired conditions. Evidence-based HTAs are based on objective data from clinical trials, rather than customer surveys or expert opinion. The data are collected through a systematic search of the scientific literature and then critically analyzed to ensure that the study design and outcomes are accurate and trustworthy. Assessments also consider ancillary costs, so that supply chain and value analysis professionals can strategically find the most cost-efficient solutions.
As an example, catheter-associated urinary tract infections (CAUTIs) are the most common hospital-acquired condition to occur during hospital stays. According to the Centers for Disease Control and Prevention (CDC), urinary tract infections (UTIs) accounted for 32 percent of all 1.7 million hospital-acquired infections in 2007.
About 80 percent of hospital-acquired UTIs are attributed to the use of indwelling urinary catheters, which compromise normal host defenses and provide bacteria with a conduit from the skin to the bladder. An estimated 12 percent to 16 percent of hospital patients will have a urinary catheter at some time during their stay. Indwelling catheters are primarily used to allow drainage of urine from the bladder where there is concern for blockage or retention, and to allow the accurate measurement of urine production in critically ill patients. Catheters also are used to stop bleeding after surgeries involving the urethra, such as transurethral resection of the prostate.
Urinary catheters also are inserted to prevent infection of sacral wounds, to reduce the risk of skin breakdown and to reduce the time demands of nursing staff.
The majority of CAUTIs are asymptomatic. But the frequency of catheter use in hospitalized patients is so high that even a low rate of UTI complications causes significant morbidity and mortality, particularly from blood stream infection. According to an analysis of the most recent data from the National Nosocomial Infections Surveillance system, the National Hospital Discharge Survey, and the American Hospital Association Survey, CAUTIs were responsible for more than 13,000 deaths in U.S. hospitals in 2002.
A solution afoot
Silver hydrogel-coated catheters (SHCs), which have been around since the 1980s, are making a comeback because they have been proposed to prevent or reduce the number of CAUTIs in patients.
Hayes Inc., Philadelphia, a third-party company that provides evidence-based assessments of health care technology, recently conducted an assessment from peer-reviewed published studies to evaluate SHC urinary catheters for prevention of CAUTIs in short-term catheterizations of less than 30 days.
SHCs have a thin monolayer of colloidal silver (silver alloy) applied to both the inner and outer surfaces of either latex or silicon catheters, which are then coated with a permanent layer of hydrogel. The use of silver to prevent infection can be traced back 2,000 years to Greek and Roman texts that tout silver remedies. Since then, silver has been used as an antiseptic, to slow the spoilage of food and water, and to prevent infections in burns. Silver ions destroy infectious microbes, such as viruses, bacteria and fungi (yeast).
Although high levels of silver exposure can be toxic, silver coatings have a safe track record. Silver has been demonstrated in vitro to inhibit the ability of bacteria to attach, multiply and migrate along a silver-coated catheter, suggesting that it should be very effective for preventing CAUTIs.
However, our assessment determined that silver isn’t entirely as effective as many reviews have implied. When evaluating published reports on SHCs from 1950 to September 2007, we found an interesting pattern. Of the nine randomized controlled trials of SHCs that have been reported, five demonstrate large reductions in CAUTIs ranging from 24 percent to 80 percent, while one other showed no difference. However on closer examination, the endpoint for those six studies was bacteriuria, or bacteria in the urine, not an actual symptomatic infection.
This is an important distinction, because while bacteriuria is usually the first step leading to a CAUTI, many patients with catheters have bacteria in their urine and never become sick. Of the three remaining studies, one was presented as an abstract that lacked sufficient information for meaningful interpretation.
Only two studies published in full looked at the clinically relevant endpoint of clinical infection. One study conducted by Thibon et al., published in the February 2000 issue of Journal of Hospital Infections (JHI), found no reduction in CAUTIs from SHCs, while a much larger study conducted by Karchmer et al., published in the Archives of Internal Medicine in 2000 found a statistically significant reduction in infection rates—but a reduction of 20 percent. Furthermore, the study was not blinded and was funded by the manufacturer of SHCs, two factors which may have biased the result.
This suggests that while SHCs may reduce the incidence of CAUTIs associated with indwelling catheters that are in place for an extended period of time—four or more days—the impact may be marginal, depending on what other measures have been put into place.
Hospitals are probably better off making sure they have the basic interventions in place, such as washing hands, using catheters only when absolutely necessary, adhering to hygienic practices for catheter care and implementing systems to remove catheters as soon as they are no longer necessary before using SHCs.
According to a recent survey of health care quality professionals by the American Society for Quality (ASQ), training staff on proper hand-washing procedures ranked in the top four of error-proof medical procedures that hospitals should implement for prevention of any never event.
The Infectious Diseases Society of America also has recognized the importance of quality control for the prevention of CAUTIs and states that SHCs should not be a first-line intervention.
Cost analysis
The cost-effectiveness of SHCs is dependent on a number of factors. The first is the difference in cost between regular catheters and SHCs. A Hayes analysis of medical equipment costs found a price range of $13 to $19 for silver hydrogel-coated catheters, although some types run as high as $39.
For latex or silicone-coated latex catheters, there was a price range of $1.69 to $15. Therefore, the incremental cost associated with silver-coated catheters ranges from $4 to $11.31 on the low end of the price spectrum.
The cost-effectiveness of SHCs also is dependent on a number of hospital-specific factors, such as the background prevalence of catheter-associated urinary tract infections at an institution, the likelihood of complications, the cost of treating complications, and the anticipated reduction in CAUTIs after the introduction of silver hydrogel-coated catheters.
While a number of cost-benefit models have been published demonstrating that SHCs are cost effective, the values assigned to the different factors varies widely from model to model, sometimes by as much as a factor of 10.
Most models base the expected reduction in CAUTI on studies that measured only bacteriuria, which, as previously discussed, is not the same as infection. Therefore, hospitals would be best served to make their own calculations, using data from their own hospital and using realistic rates for the expected reduction in infection.
What it means
A survey posted on the Agency for Healthcare Research and Quality Web site in July 2001 found that hospitals are adopting antimicrobial urinary catheters much more quickly than the basic quality measures such as hand washing, which have better evidence and a larger impact.
This has probably been driven in part by the confusion between bacteriuria and infection, with the result that the studies showing impressive reductions in bacteriuria have drowned out the much more modest results from studies that measured the clinically meaningful endpoint of infection. There may be a role for SHCs if CAUTI rates remain high despite full implementation of basic quality improvement measures, or for vulnerable populations such as elderly or diabetic patients in the intensive care unit, but not as the first response.
Health technology assessments based on a systematic and critical analysis of all clinical trials provides a firmer basis for decision-making around new technologies than do individual trials, opinion pieces or vendor literature.
Materials management professionals, consequently, should be prepared to use an evidence-based approach when sifting through the flood of technologies being offered to prevent hospital-acquired conditions. With Medicare and additional insurers cutting back on reimbursement, it’s more important than ever to be strategic, mindful and cost-effective when adopting new devices.
| Hospitals struggle to prevent catheter-related UTIs |
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The survey was sent to all 119 VA hospitals in the United States, and to a random sample of 600 nonfederal hospitals that have an intensive care unit and 50 or more hospital beds. The surveys were completed by infection control specialists or hospital epidemiologists; the response rate was 70 percent for non-VA facilities and 80 percent for VA hospitals.—Bob Kehoe, associate publisher |
A University of Michigan Health System and VA Ann Arbor Healthcare System study published in January 2008 underscores just how difficult a time U.S. hospitals are having in preventing catheter-associated urinary tract infections (CAUTIs). The national study, published in the journal of Clinical Infectious Diseases, found hospitals seem to lack a consistent strategy for preventing CAUTIs. Among the study’s findings:| Nonreimbursement edict |
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Medicare no longer reimburses hospitals for certain hospital-acquired conditions that were not present at the time of admission. These reimbursement denials were implemented in two phases during the fourth quarter of 2008: As of Oct. 1
As of Dec. 1
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This article first appeared in the January 2009 issue of Materials Management in Health Care.
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