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`
`Medline Industries, Inc.; |PR2015-00511
`Exhibit 2103
`
`Page 1 of4
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2103
`Page 1 of 4
`
`

`

`HEALTHCARE-ASSOCIATED INFECTIONS AND THE CONTRACTING EXECUTIVE: PART 2
`
`Catheter-associated
`urinary tract infections
`
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`
`infections affect the bladder, and may
`also affect the kidneys. Urinary cathe-
`ters are used in almost all hospital pa-
`tients receiving major surgery and in
`many other situations. In recent years,
`up to 560,000 healthcare-associated
`urinary tract infections have occurred
`annually, 40 percent of which are pre-
`ventable, according to Partnership
`for Patients.
`
`“Patient safety concern alone is a
`good enough reason to establish pro-
`tocols to reduce the incidence of CAU-
`
`Tls, but now there is definitely a finan-
`cial
`incentive as well,” says Michelle
`Christiansen, MS, PA, clinical resource
`team, urology, Medline Industries Inc.
`“CAUTI can have a significant impact
`on a health system’s bottom line and,
`given the frequency of these infections,
`costs add up quickly.
`“Research shows that CAUTI in~
`
`creases hospital costs and length of
`stay,” continues Christiansen, whose
`company offers the ERASE CAUTI
`
`
`
`Medline Industries, Inc.; |PR2015-00511
`Exhibit 2103
`
`Page 2 of4
`
`Striving for a 50 percent reduc-
`
`tract infections is not an unrealistic
`
`tion in catheter—associated urinary
`goal, says Rich Lyon, BA, MA,jD, ;
`
`RN, CIC, infection control coordina—
`tor for Mercy Medical Center in Can-
`ton, Ohio. But for Lyon and the team
`at Mercy, it’s only the beginning.
`“We’ve nearly reached that goal [of
`50 percent reduction], and have set our
`targets on ‘zero tolerance,” says Lyon.
`In the meantime, he and the Mercy
`team are watching with pride the steady I
`downward curve of the incidence of
`
`EE
`
`CAUTIS in their facility
`A catheter-associated urinary tract
`infection is caused by germs that enter
`the urinary system through a catheter .
`that has been inserted into the blad—
`
`der to drain urine, according to Part-
`nership for Patients, :1 publicvpt‘ivflte
`entity created in April 2011 by the
`Department of Health and Human I
`Services in an attempt to make 1105—
`
`pitalcaresaferandlesscostly.These 1
`
`II
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2103
`Page 2 of 4
`
`

`

`
`
`
`HEALTHCARE-ASSOCIATEDINFECTIONS
`
`And we wanted silver~coated catheters because of their
`
`antimicrobial action.” Medline offered both, and Mercy
`proceeded to trial the kit in three patient care units.
`After a successful trial, the new product (and manda-
`tory training program) was rolled out to the test of the
`hospital. A baseline of CAUTI occurrence data had a1-
`rcady been collected prior to the changes, so patient care
`managers and directors could see their performance on a
`unit-by-unit basis.
`
`Training
`Lyon was especially attracted to the ERASE CAUTI on-
`line training program. All staff involved in inserting Foley
`catheters or in Foley catheter care were instructed to view
`the online training modules and take tests on the material
`
`program, which encompasses education, a new tray design,
`and implementation process. “Research also shows that
`these infections can, in some cases, be deadly.”
`CAUTIs are patient—safety indicators and are publicly
`reported, says Christiansen. What’s more, as of 2008, these
`preventable infections are no longer reimbursable by the
`Centers for Medicare 8: Medicaid Services, as a result of
`the Medicare Modernization Act of 2003 and the Deficit
`
`Reduction Act of 2005. “Hospitals and patient care provid-
`ers are under more pressure than ever to prevent CAUTIS,
`and their rates need to be trending towards zero," she says.
`
`CAUTI reduction program
`Mercy’s efforts to eradicate catheter-associated urinary
`tract infections began in late fall 2011, explains Lyon. “We
`were dissatisfied with our own per»
`formance compared with the [Na-
`tional Healthcare Safety Network]
`measures,” he says.
`(The NHSN
`is a Centers for Disease Control
`
`"Hospitals and patient care
`providers are under more
`pressure than ever to prevent
`CAUTIs, and their rates need
`to be trending towards zero."
`
`and Prevention reporting program,
`which
`allows
`liealthcare
`facilities
`
`to electronically share information
`regarding the safety of patient and
`heaithcare personnel.)
`The hospital established a CAUTI
`reduction team, which included in—
`fection control, nursing and urology.
`Step 1 was to review where Mercy
`Stood with UTI events during the
`previous 12-month period, says Lyon. Step 2 was to talk
`with Marcy’s prime vendor, Medline Industries, about po—
`tential solutions, including the company’s one-layer Foley
`catheter kit.
`
`______......,,,L
`
`Older kits stack their components, so that the nurse
`must take them out, stack them somewhere on the sterile
`field, and retrieve them as needed, explains Lyon. ”That’s ‘
`inconvenient for the nurse, and nurses have so much
`
`more to do now than they did in the past.” In contrast,
`Medline’s kit is in one layer, so nurses don’t have to stack
`or unstack anything.
`Choosing a catheter wasn’t difficult, he says. “we
`wanted to go latex—free, which we had prior to this.
`
`— Michelle Christiansen, MS, PA, clinical resource team,
`urology, Medline Industries Inc.
`
`, presented. They were able to access the modules via termi-
`nals at the hospital (including those in the medical library)
`and on their home computers.
`After three or four days, each additional day that a Foley
`catheter is in, the risk of infection increases by 5 to 8 per—
`cent, says Lyon, citing studies. So Mercy stressed educa-
`tion on insertion technique, particularly in the emergency
`department and the OR. in the ICU, where many catheter-
`associated urinary tract infections occur, the emphasis was
`on post—insertion catheter care. That means cleaning of the
`insertion site at least daily, and more if the patient's con-
`dition necessitates it; and discontinuing catheterization as
`soon as possible.
`
`
`
`Medline Industries, Inc.; |PR2015-00511
`Exhibit 2103
`
`Page 3 of4
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2103
`Page 3 of 4
`
`

`

`
`
`_EALTHCARE-ASSOCIATEDINFECTIONS IIIIIIIIIIIIIIIIIIIIII_IIIII_
`
`""""""""""
`
`7
`
`“\Vith any major change in
`products, you will often encoun-
`ter misgivings or resistance by
`the end—user staf ,” says Lyon.
`“It is crucial that they be pro-
`vided adequate product change
`rationale and support
`training
`to help ease the transition.” In
`fact, when asked to identify the
`single most
`important
`factor
`in Mercy’s success in reducing
`CAUTIS, he answers, “Educa-
`tion, education, education, rein—
`forcement and continual perfor-
`mance feedback to the nursing
`staff and physicians."
`
`
`
`
`
`used, how it must be cared for,
`and that it needs to be removed
`as soon as circumstances will
`
`allow,” he says. The ERASE
`CAUTI
`kits include a patient
`education card which explains,
`in English and Spanish, why the
`Foley has been used and if it’s
`still needed.
`“This education card en-
`
`courages a patient to become
`an advocate in their Oer care,”
`
`card
`says Christianscn. The
`reviews
`information such as,
`“\Vhat
`is a urinary catheter?”
`and “What you should know
`
`
`”Studies have shown that often
`physicians don’t know a Foley has been
`placed in a patient, or that its use has
`been continued beyond necessity.”
`
`— Rich Lyon. BA, MA, JD, RN, CIC, infection control coordinator for Mercy Medical Center
`
`I | |.. |
`
`i
`
`which reminds the doctor that a cathetet’s additional usage !
`
`i
`
`—_____!____—
`Physicians and patients
`about your catheter.” It also reviews ways the patient can
`Nurses and OR techs aren’t the only ones involved in Mer-
`reduce the risk of acquiring a catheter—associated urinary
`tract infection, including washing their hands and asking
`cy’s CAUTI reduction program. Physicians and patients are
`their doctor daily if the catheter is still clinically needed.
`part of the program as well.
`“If the catheter can be removed from the patient when
`“Studies have shown that often physicians don’t know a
`Foley has been placed in a patient, or that its use has been
`it is no longer needed, their risk of getting an infection is
`continued beyond necessity,” says Lyon. That’s why, after
`dramatically decreased.
`48 hours of catheterization, Mercy places a reorder sheet,
`“One of the biggest misconceptions regarding cath-
`eterization is that nothing can be done to prevent CAUTI,
`because the coionization of bacteria is inevitable,” she says.
`“Going up against that mindset is quite the obstacle.”
`But with training, teamwork and the right products,
`hospitals and patients can overcome it. JHC
`
`time must be ordered.
`Patients themselves can play a role in reducing catheter-
`
`associated urinary tract infections, he continues. “It is im— '
`
`
`portant that the patient understand why the Foley is being
`
`Medline Industries, Inc.; |PR2015-00511
`Exhibit 2103
`
`Page 4 of4
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2103
`Page 4 of 4
`
`