January 2016 - Infection Prevention

INSIDE THE CURRENT ISSUE

January 2016

Infection Prevention

IP Update

FDA offers guidance for blood establishments during Ebola outbreaks

The US Food and Drug Administration (FDA) has released new recommendations for blood establishments to implement additional screening measures during Ebola virus outbreaks.

While WHO has spearheaded the international response to the outbreak, several US agencies including FDA, the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) have also played a role in the response to the epidemic.

For its part, FDA has issued 10 emergency use authorizations (EUAs) for products to treat or diagnose Ebola.

The FDA says its new draft guidance, Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus, is intended to be used when there is an ongoing Ebola outbreak with "widespread transmission in at least one country."

While Ebola symptoms typically present within 21 days of infection, recent analyses have demonstrated that some patients may not become symptomatic till much later. Additionally, scientists have discovered that infectious Ebola virus and viral RNA can remain present in certain parts of the body and bodily fluids for months after symptoms have resolved. Other reports have signaled the possibility of asymptomatic infection, which could in theory lead to infection of others.

For these reasons, FDA is recommending blood establishments implement additional screening measures when the CDC declares there is widespread Ebola transmission in one or more countries.

Facilities that collect blood or blood components are instructed to ask potential donors about any history of Ebola infection, travel or residence in any country effected by an outbreak or contact with infected persons in the previous eight weeks.

FDA says that blood establishments should indefinitely defer donors who have had Ebola virus. The agency also recommends deferring donation by eight weeks for any donors who traveled to or lived in an effected country, or were in close contact with an infected individual.

WHO has identified convalescent plasma, or plasma gathered from recovered Ebola patients, as a potential treatment for the disease. While some uncontrolled studies have been conducted to investigate the use of convalescent plasma to treat Ebola, such uses are still considered investigational by FDA and WHO.

Visit FDA for the guidance at www.fda.gov/downloads/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/
Guidances/Blood/
UCM475072.pdf

CAUTI Precautions

Evidence-based infection-prevention protocol and products are best tools for control

by Susan Cantrell, ELS

Catheter-associated urinary tract infection (CAUTI) numbers are astronomical: 560,000-plus patients develop CAUTI each year,¹ resulting in more than 13,000 deaths.² According to the National Healthcare Safety Network, UTIs are the most common type of healthcare-associated infection³ (HAI), accounting for thirty percent of infections reported by acute-care hospitals.⁴

The Centers for Medicare and Medicaid Services’ Partnership for Patients (PfP) and the Centers for Disease Control and Prevention (CDC) report that CAUTI rates are rising.¹ The problem is not that catheters carry excessive risk of infection; it is the sheer volume of catheters used across the nation on a daily basis that pumps up the numbers. Approximately fifteen to twenty-five percent of patients are catheterized during their hospital stay.³ Approximately seventy-five percent of UTIs acquired in the hospital are associated with a urinary catheter.^1,3

It is estimated that seventy percent of UTIs—380,000 cases and 9,000 deaths—could be prevented through consistent application of infection-control best practices.^1,5 The greatest risk factor for acquiring a UTI is prolonged use.³ The longer the catheter dwells in the body, the more likely bacteria and yeast will travel up the catheter and result in a CAUTI. The risk, on a daily basis, of acquiring a CAUTI is three to seven percent.⁶ Clearly, urinary catheters’ use should be limited only to when absolutely necessary, should be subjected to exquisite care, and should be removed as soon as possible.

Oddly enough, there is no universally accepted evidence-based tool to reduce CAUTI. Recognizing this tool gap, the American Nurses Association, a partner of PfP, developed an evidence-based, user-friendly tool to help prevent CAUTI in hospitals.¹ The one-page tool, "Streamlined Evidence-Based RN Tool: Catheter Associated Urinary Tract Infection (CAUTI) Prevention,"⁷ is based on the CDC’s 2009 "Guideline for Prevention of Catheter-Associated Urinary Tract Infections.⁴ This evidence-based tool incorporates an algorithm used to determine whether it is appropriate to employ a urinary catheter, when alternative means of resolving retention and incontinence issues may be appropriate, and timely removal. A checklist on catheter insertion is included, with cues for essential maintenance and post-removal care.⁷

The CDC provides the "Catheter-associated Urinary Tract Infection (CAUTI) Toolkit."⁸ The toolkit outlines costs related to CAUTI: two to four extra days’ stay at the hospital, unnecessary antimicrobial use, and increased costs to the tune of up to 0.5 billion per year nationally.⁸

Nathan McHugh, Product Manager, Skin Care, Sage Products, addressed the costs of CAUTI. "CAUTI is a costly and common condition resulting in patient discomfort and hospital-discharge delays. It is gaining attention now because the Centers for Medicare & Medicaid Services (CMS) no longer reimburse hospitals for the extra cost of caring for patients who develop CAUTI."

"As the only class of HAIs not declining over the last few years, CAUTIs are the greatest HAI challenge to healthcare providers today," stated Steve Woody, CEO, Avadim Technologies. "With new CMS reimbursement penalties focusing on central-line–associated bloodstream infection and CAUTI, the potential for lost reimbursement and increased costs continues to rise. Not only is CAUTI a ‘never event,’ resulting in the lost cost of unreimbursed care but CAUTI is an increasing factor in the hospital-acquired conditions penalty and the value-based purchasing withhold, and it can have an impact on the readmissions penalty. Poor CAUTI scores can potentially lose hospitals more than three percent of total CMS reimbursement. Unreimbursed costs of care can exceed $10,000 per infection."⁹

"CAUTI has been associated with increased morbidity, mortality, hospital cost, and length of stay," added Timothy O’Halla, President and CEO, Eloquest Healthcare Inc. "Although there has been modest improvement in CAUTI rates, progress has been much slower than other device-associated infections."⁵

Products that help reduce risk of CAUTI

Clearly, it is important to use every tool in the bag to prevent CAUTI. In addition to evidence-based infection-prevention measures, other tools to thwart CAUTI are to be found in related products. In its CAUTI toolkit, the CDC mentions that use of alternative and supplemental means can help.

The ReliaFit Male Urinary Device from Eloquest Healthcare Inc.

O’Halla described the benefits of using Eloquest Healthcare’s alternative to indwelling urinary catheters (IUCs) for males. "Among the multiple evidence-based recommendations for CAUTI prevention, eliminating the risk associated with unnecessary IUC days is emphasized. The preventive role of the ReliaFit Male Urinary Device is its use as an alternative to IUCs in appropriate male patients. As a direct result of its non-invasive design, ReliaFit can reduce the risk of CAUTIs. Additionally, ReliaFit is one-size-fits-all and can reduce device leakage and healthcare-acquired skin injuries seen with other external devices.

"The cost avoidance associated with ReliaFit extends from the prevention of CAUTI and improved patient satisfaction, which may positively impact the value-based purchasing model and total performance score. ReliaFit’s one-size-fits-all feature eliminates the need to stock several different sizes and, by doing so, can reduce SKU counts."

O’Halla related the experience of one long-term acute-care hospital, located in the Southwest, that used ReliaFit with success. "It was part of a quality-improvement initiative. During its implementation, the CAUTI rate fell to zero, and a significant decrease in IUC device-days was achieved. No complications or adverse events were reported as a result of the device intervention."

Dale Medical Products offers a urinary-catheter–securement product, the Hold-N-Place Foley Catheter Holder. Josh Brezack, Urology Product Manager, explains how it works to prevent CAUTIs. "Our Hold-N-Place Foley Catheter Holders come in both a leg-band and a short-term adhesive version that, together, offers a wide range of applications and options. Our holders do not allow ‘pistoning’ of the catheter, keeping it in place to reduce urethral traumas such as dislodgement and erosion of the bladder neck or urethra. These conditions are two of the leading causes of CAUTI. Our adhesive holder is gentle on the skin, breathable, and highly versatile. Our leg band is soft and supple, great for long-term catheterized patients or for skin-sensitive or diaphoretic patients. Dale also offers a large leg-band holder, ideal for bariatric patients or for placement around the waist to secure suprapubic catheters."

The Dale Hold-n-Place Foley Catheter Holder from Dale Medical

Brezack referred to a published scientific study that supports the efficacy of the Hold-N-Place Foley Catheter Holder. "In 2007, a study was conducted that found the average CAUTI cost the hospital a minimum of $758 to treat.¹⁰ This amount is a nonreimbursable cost to the hospital system. With proper protocols and use of a Dale Foley holder, a hospital can save substantially over the risk of having to treat CAUTIs regularly.

"Organizations such as the Society of Urologic Nurses and Associates, CDC, and the Wound Ostomy and Continence Nurses Society all recommend use of a Foley securement device to lessen the potential for CAUTIs," Brezack pointed out.

Skin care and CAUTI

Healthy skin is the first line of defense in preventing infections. McHugh, Sage Products, highlighted the importance of good hygiene in preventing CAUTIs. "The Association for Professionals in Infection Control and Epidemiology (APIC) and the Society for Healthcare Epidemiology of America (SHEA) are leading the fight to reduce CAUTI. They both have produced guidelines and recommendations that include meatal care as part of CAUTI reduction. APIC’s Guide to Preventing Catheter-Associated Urinary Tract Infections, 2014,¹¹ states, ‘Provide routine hygiene for meatal care,’ whereas the SHEA Practice Recommendation: Strategies to Prevent Catheter-Associated Urinary Tract Infections in Acute Care Hospitals: 2014 Update¹² states, "Employ routine hygiene; cleaning the meatal area with antiseptic solutions is unnecessary."

New M-Care Meatal Cleansing Cloths for
the Foley-catheterized patient from Sage Products

McHugh explained that standards for proper meatal cleansing are, unfortunately, not well-defined, leading to significant process variation. "Sage Products’ new M-Care Meatal Cleansing Cloths for the Foley Catheterized Patient can be used as part of the patient cleansing protocol, to improve hygiene and adherence to infection-control policy. M-Care Meatal Cleansing Cloths provide a rinse-free, hygienic alternative to soap, basins, and hospital tap water."

Basins have been proven to increase the risk of HAIs; so, removing basins and standardizing a cleaning procedure is important, stated McHugh. "In a study analyzing the basins from 88 hospitals across the U.S., 62 percent were contaminated with at least one pathogen commonly associated with HAIs."¹³

McHugh related the experience of a hospital located in the Northeast that illustrated eliminating basins reduces CAUTI risk factors. "When basins were completely eliminated from two medical-surgical units of a 370-bed facility located in the Northeast, CAUTI rates dropped to zero within one month and remained at zero for five months."¹⁴ Mc Hugh concluded, "By eliminating basins, and following APIC and SHEA guidelines, the impact of CAUTI can be reduced at your facility."

Another product designed to help maintain skin integrity is Theraworx from Avadim Technologies. Woody described how Theraworx helps to promote healthy perineal skin. "Theraworx technology is a patented, broad-spectrum hygiene formulation with patent-pending protocols for topical skin application. It is nontoxic and mucous-membrane safe. We are seeing tremendous interest in the reductions in CAUTI rates being realized by hospitals implementing use of Theraworx for insertions and perineal care of catheterized patients.

Theraworx Specialty Care Pack, used prior to Foley insertions, from Avadim Technologies.

"The key to Theraworx helping reduce CAUTI," explained Woody, "is its ability to help optimize the acidic mantle of the outer layer of the skin, the stratum corneum." Woody referred to a study by Elias that described how the normal acidic pH of stratum corneum, around 5.0, allows normal healthy flora to flourish but is deadly to pathogens.¹⁵ "If pH rises, infection-causing pathogens can survive and grow," said Woody.

Woody explained how Theraworx differs from soap and water. "Almost all hospitals clean the perineum of catheterized patients with soap and water, typically at a pH of 9 or higher. In so doing, the antimicrobial acidic mantle of the skin likely is degraded, opening the door for pathogenic growth and infection. Theraworx provides a broad-spectrum hygiene, mucous-membrane safe perineal alternative, optimizing the acidic mantle rather than degrading it.

"We can cite numerous positive outcomes," noted Woody, "but one of the best is the experience of Little Company of Mary Hospital and Health Care Centers in Chicago." They had thirty-seven CAUTIs in 2013 and twenty-nine in 2014. In late 2014, they implemented Theraworx protocols and have seen only five CAUTI so far this year.

References

1. American Nursing Association. ANA CAUTI Prevention Tool. http://nursingworld.org/ANA-CAUTI-Prevention-Tool. Last accessed December 1, 2015.

2. Allen-Bridson K. NHSN catheter-associated urinary tract infection surveillance in 2015. http://www.cdc.gov/nhsn/pdfs/training/2015/cauti-2015-w-answers.pdf. Last accessed December 1, 2015.

3. Centers for Disease Control and Prevention. Catheter-associated urinary tract infections (CAUTI). http://www.cdc.gov/HAI/ca_uti/uti.html. Last accessed December 1, 2015.

4. Gould CV, Umscheid CA, Agarwal RK, et al. Guideline for prevention of catheter-associated urinary tract infections 2009. http://www.cdc.gov/hicpac/pdf/CAUTI/CAUTIguideline2009final.pdf. Last accessed December 1, 2015.

5. Association for Professionals in Infection Control and Epidemiology, Inc. APIC implementation guide: guide to preventing catheter-associated urinary tract infections. http://apic.org/Resource_/EliminationGuideForm/0ff6ae59-0a3a-4640-97b5-eee38b8bed5b/File/CAUTI_06.pdf. Last accessed December 1, 2015.

6. Lo E, Nicolle L, Classen D, et al. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29(Suppl 1):S41-S50.

7. American Nurses Association. Streamlined evidence-based RN tool: catheter associated urinary tract infection (CAUTI) prevention. http://nursingworld.org/MainMenuCategories/ThePracticeofProfessionalNursing/Improving-Your-Practice/ANA-CAUTI-Prevention-Tool. Last accessed December 1, 2015.

8. Gould C. Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention. Catheter-associated urinary tract infection (CAUTI) toolkit. Activity C: ELC prevention collaboratives. http://www.cdc.gov/HAI/pdfs/toolkits/CAUTItoolkit_3_10.pdf. Last accessed December 1, 2015.

9. Hoffman C. Trial without error: calculating the actual cost and benefits of a CAUTI therapy. Healthcare Purchasing News. 2015 July:39(5):44-45.

10. Anderson DJ, Kirkland KB, Kaye KS, et al. Underresourced hospital infection control and prevention programs: penny wise, pound foolish? Infect Control Hosp Epidemiol. 2007 Jul;28(7):767-773.

11. Association for Professionals in Infection Control and Epidemiology, Inc. APIC releases updated guide to preventing catheter-associated urinary tract infections. Am J Infect Control. 2014 Aug;42(8):819.

12. Lo E, Nicolle LE, Coffin SE, et al. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35(Suppl 2):S32-S47.

13. Marchaim D, Taylor AR, Hayakawa K, et al. Hospital bath basins are frequently contaminated with multi-drug resistant human pathogens. Am J Infect Control. 2012;40:562-564.

14. Stone S, Chaffee D, Rowin K, et al. Removal of basins to reduce catheter-associated urinary tract infections. Poster presented at Association for Professionals in Infection Control and Epidemiology, Inc; New Orleans, LA; July 2010.

15. Elias PM. The skin barrier as an innate immune element. Semin Immunopathol. 2007 Apr;29(1):3-14.