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INSIDE THE CURRENT ISSUE |
January 2016 |
Infection Prevention
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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draft guidance, Recommendations for Assessment of Blood Donor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 |
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CAUTI Precautions
Evidence-based infection-prevention protocol and
products are best tools for control
by Susan Cantrell, ELS
C atheter-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.
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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."
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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."
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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.
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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.
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