MARCH 2010
`VOLUME 18, ISSUE 3
`
`Fighting
`Infection
`Packag
`
`PHARMACEUTICAL&MEnDICAL®
`PackaI
`THEPACKAGINGMAGAZINEFORTHEHEALTHCAREINDUSTRY
`NEnws
`
`www.pmpnews.com
`
`C A Canon Communications LLc Publication
`
`Medline Industries, Inc.; |PR2015-00511
`Exhibit 2104
`
`Page 1 of4
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2104
`Page 1 of 4
`
`

`

`Rigid Packaging
`
`Novel Tray Design Aims to
`Tackle Infection
`'
`
`1
`
`Medline Industries’ unique catheter management system abides by industry
`guidelines with the aim of reducing catheter-associated urinary tract infections.
`
`
`By Gina-Louise Monari
`Senior Editor
`
`
`
`edline Industries
`Inc’s (Mundelein,
`
`IL) novel Foley
`
`catheter man-
`
`agement system
`
`is a revolutionary approach to
`
`managing catheters and reduc-
`
`ing catheter-associated urinary
`
`tract infections (CAUTI). The
`
`shift from a two-layer tray
`
`to a one-layered tray to sup—
`
`port the sequence of events dur-
`
`ing catheterization represents a
`
`major change for clinicians within
`
`the hospital setting. The produ
`Above: Medline Industries‘ new GM"
`
`launched alongside a compr
`one-layer Foley tray is shown open
`here
`
`professional awareness
`
`ERASE CAUTI, using
`
`RightNew packaging for Med-
`includes patient and family
`line's one-layer Foley catheter
`components.
`tray features directions on the
`outside so the nurse can read
`Developed by Deborah Adler and
`Medline’s urological product divi-
`the instructions before going
`into the patients room.
`sion and marketing division,
`the
`one-layer tray design encourages
`aseptic technique. According to Sue
`MacInnes, chief marketing officer
`for Medline, the marketer conducted
`intense research on catheter-associ-
`ated urinary tract infections, which
`is reportedly the number-one hos-
`pital infection. The project, how-
`ever, brought about a unique set
`of challenges: evaluating a proce—
`dure that had not been looked at for
`a long time, working with clinicians
`who have developed their own indi-
`
`
`
`techniques,
`vidual
`and dealing with
`the day-to—day challenges of
`in a
`job requirements.
`,
`
`busy ECC
`
`“The tray is a no brainer,” says
`Melinda Hill, ER staff educator at
`setting faster and
`more eflicient.”
`Trinity Mother Frances Hospital and
`Medline’s research coincided with the
`Clinics (Tyler, TX). “It’s laid out in
`timing of studies and guidelines released
`perfect order for the staff member to
`by industry experts on ways to prevent
`go from A—Z without fumbling around
`CAUTI, including limiting the duration
`and creating opportunity for cross con-
`of the catheter, identifying alternatives
`tamination. It has made placing a Foley
`
`Medline Industries, Inc.; |PR2015-00511
`Exhibit 2104
`
`Page 2 of4
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2104
`Page 2 of 4
`
`

`

`
`
`
`
`[MIL INK "It'll
`
`Duo—“m.-
`\i ‘-’m--—--.
`
`
`
`to catheterization or not catheterizing
`at all if possible, compliance with regu-
`latory bodies, and patient satisfaction.
`According to the Centers for Disease
`Control and Prevention (CDC) Health-
`care Infection Control Practices Advi-
`sory Committee, clinicians are advised
`to insert catheters only for appropri-
`ate indications, to leave them in place
`only as long as needed, and to consider
`using alternatives to indwelling urethral
`catheterization in selected patients when
`appropriate. Examples of appropriate
`indications for indwelling urethral cath-
`eter use include acute urinary retention
`or bladder outlet obstruction; the need
`6%?
`to accurately measure urinary output in
`
`mummwwwmr'um
`
`.L"IrE01 INI
`wont-glean. :m-antmmottw:
`critically ill patients; perioperative use
`\Mcml
`drummpummmrmnwtompm
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`7
`for selected surgical procedures; assisting
`
` and 1mm u: mm mow-um an (an elm-mum and
`h. mwm-mm nun mum
`the healing of open sacral or perineal
`" Y
`
`wounds in incontinent patients; pro-
`
`Patient education (right) is a co m‘
`94‘: the ERASE own brochure (cover left), which details
`longed immobilization; and improving
`.
`~ should know about their catheter how to reduce infection
`comfort for end-of-life care if needed.
`what a urinary catheter is, w “‘18,
`
`5 of a urinary tract infection.
`“When we examined the current state
`what CAUTIIs. and tell-12$
`
`outer sticker that includes reasons for
`2>aer or not there
`tools to identify
`of the industry, we realized that the cur-
`was a clinic
`catheterization, a catheter placement
`
`rent trays did not support the recom-
`6% eptable reason to
`checklist, and an area for clinician to
`catheteriz A
`mended guidelines,” MacInnes say.s
`
`MWhifiE>was alarming for the
`sign and date. A removeable sticker
`“We expanded our research to the bed-
`
`can then be placed in the patient’s
`side nurse, visiting hospitals to observe
`@es force, ultimately the right
`to support the correct clinical
`chart. There is also a tag to put on
`nurses and interview them on the pro-
`the catheter to alert staff as to when it
`cedure. After digesting our learnings,
`$7W
`differentdesignconcepts.”
`was placed. The tray’s product label
`Deborah approached us with 56%ng
`includes a schematic of the tray compo—
`nents to ease viewing of tray contents,
`At first, Medline’s goal was
`and instructions are attached to the
`variance in practice by sequo’filE he
`components to mirror the
`2>opriate
`steps in catheterization. The
`the goal
`was to bring to the clinicians’ atten-
`tion to proper indications for using sil-
`ver versus non-silver catheters, which
`would reduce cost and support appro-
`priate use of silver. Many facilities
`were using silver catheters and ques-
`tioning whether the added expense
`had any effect on the number of infec-
`tions they were experiencing in their
`facilities, while industry guidelines
`actually supported the concept of not
`catheterizing.
`the recommend-
`“We looked at
`ed processes and incorporated each
`step of the CDC guidelines into the
`tray constructions,” MacInnes says.
`“We now had a tray that used trigger
`
`“We expanded
`our research... When
`
`we examined the state
`
`of the industry, we
`realized that the current
`
`trays did not support
`the recommended
`
`guidelines. ’3
`
`“Medline is winning ten-fold, and so
`are our customers,” MacInnes says.
`The new tray design follows intui-
`tive flow of the procedure to reduce
`variance in care process and promotes
`efficiency. Trigger tools promote rec-
`ommended CDC guidelines with an
`
`label with step-by-step illustrations.
`“This is a clear departure from the
`industry norm where instructions are
`obscure, in small typeface and hidden,”
`MacInnes says.
`A product booklet is included in every
`tray. The brochure shows a pictorial image
`of the kit components on the outside cover.
`Inside the booklet is a clear, step-by-step
`guide to catheter insertion.
`Patient and family education is provided
`as a perforated addition to the instruction
`sheet to ensure the clinician is prompted to
`give support and education to the patient
`on signs and symptomsof a urinary tract
`infection. This can potentially reduce hos-
`pital readmissions and emergency room
`visits and improve patient satisfaction
`scores for patients and families that want
`
`Medline Industries, Inc.;
`
`|PR2015-00511
`Exhibit 2104
`
`Page 3 of4
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2104
`Page 3 of 4
`
`

`

`
`
`information and answers on how to care
`for themselves once they leave the hospital.
`“As educators at our facility, we were
`really impressed with the new Medline
`catheter tray design to help prevent CAU-
`TI,” says Becky Schlabach RN, CNOR,
`Perioperative Educator, Goshen Gen-
`eral Hospital (Goshen, IN) “Medline has
`really done their homework on what nurs-
`es need and how to render great patient
`care. The tray is very intuitive, and our
`colleagues were pleased with and sold on
`the product from the first use. Medline
`has also developed a competency-based
`learning model that is available free of
`charge that helps drive home the impor—
`tant learning aspects of catheter care and
`CAUTI prevention. This is a great prod-
`uct from a great company.”
`The kit’s components include PVP
`swabsticks to cleanse the peritoneal area
`prior to catheterization; a securement
`device in every tray; and a packet of hand
`sanitizer. The swabsticks reduce the num-
`ber of steps to cleanse the patient, which
`is important because the nurse and the
`patient are anxious about the procedure.
`Anything that can be done to combine
`steps to make the process more efficient is
`appreciated by both participants.
`The securement device keeps the cathe-
`ter from moving, which is a recommen
`guideline. The hand sanitizer explicitl
`lows recommended guidelines and '
`that many times is overlooked. A
`Although clinicians on l\
`
`e’s staff
`
`worked on the education components,
`the company needed to simplify it to
`ensure that it was simple enough for a
`patient or family member to understand.
`All education materials were reviewed
`
`extensively by Medline’s board and sub-
`sequently tested for reading grade level
`and consumer acceptability.
`
`Highlighted at Medline’s ERASE
`CAUTI Web site is the introduction
`of new and innovative packaging for
`three of its existing catheters. The new
`tray design and arrangement, instruc-
`tions, and labeling components are
`designed to help the healthcare worker
`be more efficacious.
`Medline’s Silvertouch 100% Sili-
`
`cone Foley Catheter Management Sys-
`tem Tray comprises latex-free catheters,
`which incorporate the power of silver
`through
`atented process that binds sil-
`ver ion
`e catheter’s lubricious coat-
`
`in
`
`Qtydrophilic coating is covalently
`to the catheter surface, hydrating
`u1c y and maintaining its lubricity for
`Wag seven days, helping to reduce fric-
`tion and irritation.
`
`“This is a clear
`
`departure from
`
`the industry norm
`where instructions are
`
`obscure, in
`
`small typeface, 43
`and hidden "5
`
`1
`
`Mac/nnest‘?
`
`
`65
`') e Web link for
`Medline.com/e
`y and was designed
`the ERASE
`n {Jignesh Thakkar,
`under the
`eting/ebusiness at Med—
`directoréb
`eb site consolidates all of the
`hne
`
`in one location, such as product
`
`ation, industry expert commentary,
`edacational offerings on CAUTI, preven-
`on techniques, instructions on proper use
`of the tray, news, and an awareness cam-
`paign that encourages nurses to join the
`“Race to ERASE CAUTI.”
`
`The company’s Silicone-Elastomer
`Coated Latex Foley Catheter Man-
`agement System Tray incorporates
`an innovative manufacturing process
`to provide the maximum amount of
`silicone coating available. Silicone-
`elastomer coating resists encrustation.
`With the 100% Silicone Foley Cath-
`eter Management System Tray, 100%
`Silicone Foley Catheters are completely
`inert to minimize tissue irritation dur-
`ing extended periods of indwelling use.
`A pliable catheter with a firm tip eases
`insertion. This catheter features large
`smooth eyes for maximum comfort and
`drainage and a symmetrical balloon for
`added reliability. I
`
`Reprinted with permission from PHARMACEUTICAL & MEDICAL PACKAGING NEWS, March 2010. On the web at mumnnmmm
`©A Canon Communications LLC Publication. All rights reserved. Foster Printing Service: 866-879-9144, mammarkelingtenflmsmm
`
`MKT210134 LIT608R 7.5M
`
`Medline Industries, Inc.; |PR2015-00511
`Exhibit 2104
`
`Page 4 of4
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2104
`Page 4 of 4
`
`