Social Practice and
`Clinicians’ Meaning of Urinary
`Catheter Insertions
`
`A Case Study of Context-Based Design
`
`by
`Trent T Haywood, MD, JD
`Keith Kosel PhD, MHA, MBA
`Jessica N. Martin
`Teresa N. Clark, MBA, MPH
`
`VHA Pilot with Medline Industries, Inc.
`April 2010
`
`Publication Pending
`
`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2102
`Page 1 of 8
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`

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`Social Practice and Clinicians’ Meaning
`of Urinary Catheter Insertions
`
`OVERVIEW
`Urinary catheterizations are a common part of the
`clinical landscape in most hospitals across the
`country. Despite their routine nature, urinary
`catheterizations account for a sizable portion of all
`hospital-acquired infections, as well as additional
`costs to an already overburdened healthcare
`system1. Previous medical literature focused on
`the procedural aspects of urinary catheter insertion
`such as the maintenance of sterile technique or the
`avoidance of dependent catheter loops2. This case
`study addresses the previously overlooked area of
`the context in which the urinary catheter insertion
`unfolds. By focusing on context, with a particular
`focus on the social practice that encompasses
`urinary catheter insertion, opportunities for design
`improvements emerge that would not have emerged
`with a limited focus on the clinical practice. Further
`use of inductive observational studies, such as
`the one undertaken by Medline Industries Inc.
`(Medline), provide the potential for better patient
`care and patient outcomes through the revealing
`of insights left unrecognized in deductive methods.
`
`Often, the literature isolates the clinical practice
`from its context, which places us in the position of
`creating idealized models that are not context-
`based. The need exists to understand clinical
`practices in a manner that does not separate the
`practice from the natural setting in which it unfolds.
`
`This case study may serve as an early effort to
`create a broader application of inductive research
`approaches that leads to better design of practice
`improvement and product design. By utilizing
`inductive methods of qualitative research and
`expanding the focus to include the social practice
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`VHA Pilot with Medline Industries, Inc.
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`along with the clinical practice, such research
`efforts may enhance our capacity to create designs
`that work well in actual practice.
`
`If we can improve our knowledge regarding context-
`based design, we can better match the designer’s
`intent with the practitioner’s goals to perform well
`in the natural setting. The highlighted case study
`provides such an opportunity to enhance our
`knowledge as it explores the practice of urinary
`catheter insertions, which may appear simple
`and straightforward until one explores the context
`in which the practice unfolds and the clinician’s
`meaning of urinary catheter insertions.
`
`DESIGNING FOR URINARY
`CATHETER INSERTION
`A leading area of interest is catheter-associated
`urinary tract infections (CAUTI). Urinary tract
`infections constitute 36% of all hospital-associated
`infections (numbering over 560,000 in 2002) and
`over 13,000 deaths3,4. Between 15% and 25%
`of all hospitalized patients receive a short-term
`indwelling urinary catheter5. While reported rates
`of UTI among patients with urinary catheters
`vary substantially, national data from the Centers
`for Disease Control and Prevention’s National
`Healthcare Safety Network ranged from 3.1 to 7.5
`infections per 1,000 catheter days6.
`
`To address this new quality and safety environment,
`clinicians and providers work continuously to
`uncover practices that will improve quality and
`decrease patient safety risk. Clinicians and
`providers often look to government agencies
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`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2102
`Page 2 of 8
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`Social Practice and Clinicians’ Meaning of Urinary Catheter Insertions
`
`that provide guidance such as the recently released
`CDC guidelines for CAUTI7. In addition, they
`seek advice or expertise from quality organizations
`regarding best practices such as the National
`Quality Forum or CMS’s Quality Improvement
`Organizations. And finally, they adhere to safe
`practices or advisory pronouncements by
`organizations such as The Joint Commission.
`
`One group of market participants, healthcare
`manufacturers, are often overlooked in this effort
`to improve the quality and safety of health care
`services. Often, these organizations are thought
`of as suppliers more than safety or quality experts.
`Yet, it is undeniable that the manner by which
`products are designed can significantly impact the
`clinician’s ability to provide high quality health care.
`
`One such manufacturer, Medline Industries, Inc,
`set out to design a urinary catheter management
`system that would aid the clinician’s efforts to
`reduce CAUTI. The catheter management system
`would reduce variations in catheter insertion
`practices; improve maintenance of sterile technique;
`decrease rates of inappropriate catheterizations;
`and increase awareness among clinicians and
`patients regarding the timely removal of urinary
`catheter. Medline, Inc., worked closely with a
`clinical advisory panel of physicians, nurses, and
`infection control professionals and reviewed the
`evidence in the medical literature of causes of
`catheter infections and the unnecessary use of
`catheterizations8. After gathering input from the
`subject matter experts, Medline interviewed hospital
`personnel to better understand their needs related
`to urinary catheterizations and then worked with
`designers to create a catheter management system
`that would be better designed to achieve the
`stated objectives.
`
`However, Medline, Inc., wanted to better
`understand the context in which catheter insertions
`unfold in the natural setting of clinical practice.
`
`Through an understanding of clinicians’ actual
`behaviors and attitudes in the clinical setting,
`Medline could design a catheter management
`system that was based upon the reality of clinical
`practice versus idealized models of practice.
`
`THE RESEARCH STUDY
`Given VHA’s experience in conducting field
`research in hospital settings, Medline Industries, Inc.,
`determined that VHA could help it understand the
`context of urinary catheter insertions in the natural
`setting of the clinical practice. As part of the VHA
`methodology, we expanded the scope to ensure
`that we could capture data related to the context
`from two perspectives, clinical and social practice.
`
`Our primary goal was to understand the actual
`clinical practice of urinary catheter insertion and
`not anticipate idealized models exist in practice.
`We focused our intentions on:
`
`1) understanding the objectives of catheter
`insertions from the clinician’s perspective,
`
`2) clarifying the actual practice that unfolds, and
`
`3) identifying areas where the catheter
`management system aided clinicians or
`failed to aid clinicians based upon the
`clinician’s perspective on the practice.
`
`The case study utilized an inductive method of
`qualitative research that allowed themes and
`patterns to emerge in the natural setting. The
`study utilized narrative inquiry, direct observations,
`and visual ethnography without a predetermined
`framework. The study was bounded by time
`(3 separate visits of 3 days per visit), locations
`within the hospital setting (emergency department,
`medical/surgical floors, operating room), and
`access to patients that would allow direct
`observations by researchers.
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`3
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`VHA Pilot with Medline Industries, Inc.
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`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2102
`Page 3 of 8
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`Social Practice and Clinicians’ Meaning of Urinary Catheter Insertions
`
`The case study unfolded over three different site
`visits to Providence Sacred Heart Medical Center
`& Children's Hospital in Spokane, Washington.
`The first site visit allowed us the opportunity to gain
`understanding of the clinical and social practice of
`urinary catheter insertion at Providence Sacred Heart
`Medical Center & Children's Hospital. Originally, we
`conducted research for three days in the emergency
`department and on several medical/surgical floors
`(4-North, 5-South, 5-North). However, we eventually
`expanded our observational research to include
`patients receiving urinary catheters in the operating
`room. While the data obtained from the operating
`room enhanced the research, we did not include such
`data in our examination of the redesigned urinary
`catheter tray. We returned to Providence Sacred
`Heart Medical Center & Children's Hospital
`12 weeks later, which was 4 weeks after Medline had
`introduced the newly designed catheter management
`system. On the return visit, we conducted the study
`on the same medical/surgical floors and the
`emergency department that had been involved in the
`initial visit. For the three days we were present, six
`urinary catheter insertions occurred in the emergency
`department and no observations of insertions
`occurred on the medical/surgical floors. Finally, we
`returned for a third visit based upon final product
`design modifications that had occurred since our last
`visit a few months earlier. The observations on the
`final visit consisted of eleven observations that
`occurred in the emergency department and one
`observation in cardiac care unit.
`
`Hospital personnel in the various areas observed
`were made aware of the research team’s presence
`and the general purpose of the study. Throughout
`the study, we continually articulated to the clinicians
`and personnel at Providence Sacred Heart Medical
`Center & Children's Hospital that our aim was to
`learn from them in an inductive manner.
`
`Given the inductive structure to the study, VHA
`researchers captured observable data in detail in
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`VHA Pilot with Medline Industries, Inc.
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`the form of articulated words, artifacts used in the
`clinical setting, or visual ethnography that revealed
`aspects of the context of the clinical practice. We
`often verified our data capture with the clinicians
`through narrative inquiry. Based upon these
`research methods, we were able to identify themes
`that emerged out of the data. We divided those
`themes into those aspects that related to the clinical
`practice and those that related to the social practice
`in which the urinary catheter insertions occurred.
`
`THEMES: CLINICAL PRACTICE
`Our research identified three overarching themes
`that clinician’s utilized as they interacted with
`patients and among themselves. Through narrative
`inquiries, we continued to hear the clinician’s
`discuss these themes as the primary focus for the
`clinician’s and how the clinician’s make meaning
`of the urinary catheter insertion practice. The
`combination of simultaneously achieving all three
`themes suggested a successful catheter insertion
`for a clinician where problems in any one of the
`three areas could lead the clinician to viewing
`the practice as problematic or difficult. Such
`categorization was not operator-dependent as
`non-compliant patients or product design problems
`could be the source for placing an attempted
`urinary catheter insertion into the problematic
`or difficult different category.
`
`Sterile Technique
`All observed clinicians took steps to maintain sterile
`technique during urinary catheter insertion. The
`clinicians varied in the manner in which they created
`the location and size of the sterile field. Some clini-
`cians preferred to utilize the space between the pa-
`tient’s legs and others preferred to create sterile field
`close to the foot of the bed and a few incorporated
`areas such as the patient’s chest or the bedside tray.
`Yet, the maintenance of sterile technique continued
`to be a consistent priority and also used to evaluate
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`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2102
`Page 4 of 8
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`Social Practice and Clinicians’ Meaning of Urinary Catheter Insertions
`
`a successful insertion. In one situation, the clinician
`articulated that the procedure had “not gone well”
`in his view when a non-cooperative, mental health
`patient contaminated the sterile field and forced the
`clinician to restart the practice and seek additional
`support to temporarily restrain the patient.
`
`Patient Comfort
`All observed clinicians voiced that one of the
`primary goals during the practice of urinary catheter
`insertion is to keep the patient comfortable or
`decrease the experience of pain. Clinicians expressed
`the following attitudes regarding patient comfort:
`
`“ Making sure I don’t hurt the patient is
`upper-most in my mind.”
`
`“ It’s important to make sure the patient is
`comfortable at all times.”
`
`“ After maintaining the sterile field, patient
`comfort is my next priority.”
`
`Time - Faster is Better
`The clinicians articulated that timeliness of completing
`the practice was important. The clinicians stated
`that the preference is to properly and quickly insert
`the catheter.
`
`“ Time is of the essence.”
`
`“ Patients are nervous, anxious, and the longer
`it takes me to get it (the catheter) in, the more
`anxious they may become.”
`
`When one clinician retold to us that he heard
`the insertion on a non-cooperative patient had
`“not gone well,” he mentioned the time element
`as a signal of a less than optimal experience.
`
`THEMES: SOCIAL PRACTICE
`In reviewing the observational data collected for the
`social practice of urinary catheter insertion, the data
`led us to conclude there are primarily 3 phases of
`the social practice between the clinician and patient
`during the insertion of the urinary catheter. The three
`
`phases are continuous but distinct phases of the
`social relationship that occurs between the clinician
`and the patient as the urinary catheter insertion occurs.
`
`Initiation
`In the first phase, which we called the “initiation”
`phase, the clinician establishes or maintains the
`relationship with the patient through words, touches,
`or gestures, designed to help the patient understand
`the urinary catheterization practice. The patient
`typically signaled understanding through nonverbal
`gestures such as head nodding and occasionally
`through verbal pronouncements, “I’ve had one of
`these before, I’m ready.” Typically, the clinician
`would wait for this patient signal before proceeding
`with the catheterization.
`
`Navigation
`In the second phase, which we called the “navigation”
`phase, the clinician often transitioned to a different
`interaction with the patient. The clinician’s interaction
`with the urinary catheter took on more prominence.
`For the clinician-patient interaction in the navigation
`phase, the clinician established control of the
`patient through the use of more directive language
`or physically position the patient into the desired
`posture. The patient acquiesced and would try to
`accommodate the demands of the clinician. After
`positioning the patient, the clinician would interact
`with the patient throughout the catheterization
`primarily through instructional statements regarding
`the procedure; affirming words to ensure patient of
`the practice; or directive guidance where patient failed
`to maintain position. The clinician would continue to
`remain in control of the relationship throughout the
`navigation phase until the phase often concluded
`with the clinician making statements that affirmed
`successful outcome of the practice such as, “OK it’s
`in, everything looks good. I’m getting urine flow now.”
`
`Completion
`The final phase, which we called the “completion”
`phase, the clinician-patient interaction transitioned
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`5
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`VHA Pilot with Medline Industries, Inc.
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`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2102
`Page 5 of 8
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`Social Practice and Clinicians’ Meaning of Urinary Catheter Insertions
`
`back to where the patient regains control. As part of
`the transition, the clinician might clean the perineum.
`Also, the clinician would reposition the patient close
`to the patient’s original positioning. The clinician might
`use words to signal the transition “Is there anything
`I can get you?” The patient generally acknowledged
`the transition through nonverbal gestures or occa-
`sional verbal gestures, “Good, I’m glad that’s done!”
`
`DISCUSSION: IMPROVEMENT
`DESIGNS BASED ON
`OBSERVATIONAL DATA
`With identification of the themes uncovered during
`the initial phase of the research, VHA provided
`Medline with the results of the observational data.
`As part of the research provided to Medline, VHA
`categorized potential opportunities into three areas:
`
`1) designs for clinical practice,
`
`2) designs for social practice, and
`
`3) designs for learning.
`
`The three opportunities areas were not created in a
`mutually exclusive fashion but created to highlight
`the specific opportunities that may arise from these
`different elements of urinary catheter insertion.
`
`To address the opportunities identified based on
`the initial research findings, Medline conducted
`a series of iterative product redesign meetings.
`These product design meetings evaluated the design
`options for aspects of the clinical practice, social
`practice, and learning. Upon completion of this
`process, Medline’s product redesign focused on
`several elements with three primary areas of interest:
`
`1) streamline tray to reduce steps for the clinician,
`
`2) provide design that better supports clinician’s
`education of catheter tray elements and
`insertion process, and
`
`3) offer design that enhances the likelihood of
`patient education as part of the practice.
`
`Prior to the final site visit by VHA researchers,
`Medline conducted catheter tray training, which was
`voluntary but encouraged by Providence Sacred
`Heart Medical Center & Children's Hospital manage-
`ment. Medline personnel provided the
`training during shift changes for the clinical personnel
`at Providence Sacred Heart Medical Center & Chil-
`dren's Hospital. The training sessions lasted any-
`where from 15 to 20 minutes and consisted of live
`design demonstrations followed with question-and-
`answer session. Providence Sacred Heart Medical
`Center & Children's Hospital management estimated
`that 60-70% of frontline staff participated in the
`training.
`
`Because of the specific focus that Medline had in the
`redesign of the catheter tray, the VHA observations
`in the second phase focused narrowly on the afore-
`mentioned three primary areas. Similar to the initial
`phase, VHA used an inductive method to uncover
`the relationship between the product redesign and
`the clinical practice, social practice, and learning.
`
`Design for Clinical Practice
`Certain patterns previously observed persisted in
`the clinical practice. Observed clinicians continued
`to create sterile fields in a variety of locations. Also,
`clinicians continued to exhibit different personal
`preferences for use of gloves packaged separately
`from the tray versus those contained within the tray.
`In addition, clinicians did not routinely perform patient
`education as a result in the change of tray design.
`
`However, the clinicians did prefer the benefits of
`the streamlined tray that created fewer steps for the
`clinician. As a single layer tray, the clinicians did not
`require steps related to maneuvering and positioning a
`two layer tray. Also, the clinicians preferred the change
`to swab sticks that decreased steps for the clinicians
`in the prepping and cleansing of the perineum.
`
`In addition, the clinician’s recognized the patient
`education card and kept the card for the patient
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`VHA Pilot with Medline Industries, Inc.
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`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2102
`Page 6 of 8
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`Social Practice and Clinicians’ Meaning of Urinary Catheter Insertions
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`or placed it in location where the patient might
`review the card. This behavior is a departure from
`previously observed behavior where the education
`cards were discarded without much attention afforded
`to them. In the new tray, the patient education card
`was a separate enclosure that resembled an actual
`“Get Well” card. It was printed on heavy card stock
`with a picture of a vase of flowers on the front and
`printed instructions (in English and Spanish) for the
`patient on the inside. In all cases, the cards were
`recognized by the clinicians and set aside to give
`to the patient or a family member at a later time.
`Comments from clinicians included:
`“ I like this.”
`“ Oh that is nice.”
`“ That’s cool.”
`
`Design for Social Practice
`For the final visit, the research team was able to
`again validate that the three phases (initiation,
`navigation, and completion) existed. While these
`elements of the social interaction remained
`unchanged, the role of the catheter tray changed,
`particularly in the initiation phase. During the
`previous observations, the clinicians did not use
`the catheter to help mediate much of the social
`interaction beyond the necessity of the second
`phase (navigation). In the latest observations, the
`researchers documented that several clinicians
`actually used the catheter tray as a teaching tool.
`In two cases, the clinicians showed the patient the
`unwrapped catheter tray using the outer packaging
`label, a new visual format of a high quality detailed
`photo of tray contents, to describe what was
`going to occur as part of urinary catheter insertion.
`Both cases involved patients that had not had a
`prior catheter insertion.
`
`Design for Learning
`While clinicians may have recognized the new
`visual format of a high quality detailed photo
`showing the contents and positioning of the tray,
`our observations did not reveal a situation where
`
`a clinician had the opportunity to train another
`clinician on the contents of the tray. As such, we
`did not observe a situation where the clinician
`utilized the peel away design contained on the outer
`package. Without an educational situation, it is
`unclear whether the peel away design would have
`better supported the clinician-clinician interaction.
`As discussed above, the observations did reveal
`a benefit of the new design to support clinician-
`patient interaction as clinicians used the new format
`to better explain the procedure.
`
`CONCLUSION
`This case study suggests the need for more efforts
`to increase our knowledge of context-based design
`through observational studies. Through inductive,
`qualitative research methods involving observations
`in the natural setting, narrative inquiry, and visual
`ethnography, researchers, designers, and clinicians
`can uncover opportunities that might have previously
`gone unnoticed. Such new opportunities would
`address aspects of the current knowledge gap where
`we have not studied the context or social practices
`that are part of the clinical practice environment.
`
`As an example, the case study found that product
`design can reduce or exacerbate disruptions in the
`clinician-patient interaction. The clinicians supported
`the change to a single layer tray as the reduction in
`steps as reduced disruptions in patient interaction.
`For the urinary catheter insertion practice, any
`design features that required the clinician to focus
`more on the catheter than the patient interaction
`created a disruption in the clinician-patient interac-
`tion. These same disruptions were associated with
`increased variations in practice that were not of
`value based upon the clinician’s articulated goals
`for a successful urinary catheter insertion.
`
`In addition, the case study revealed that the goal
`for the clinicians should not be viewed solely through
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`7
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`VHA Pilot with Medline Industries, Inc.
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`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2102
`Page 7 of 8
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`Social Practice and Clinicians’ Meaning of Urinary Catheter Insertions
`
`the focus on sterile technique as clinicians do not
`solely focus on sterile technique when performing
`such procedures. The clinicians are simultaneously
`focusing on maintaining sterile technique, providing
`patient comfort or eliminating pain, and reducing
`patient anxiety by decreasing the time it takes for
`the entire process. Thus, a goal for good design in
`this area should decrease the steps the clinician
`must take to properly insert urinary catheters. Such
`a design would maintain the clinician’s goals for
`clinician-patient interaction and reduce variations
`that increase the possibility for contamination.
`Without such context-based design, we run the
`risk of creating practice improvement efforts and
`product design that ideally create better practices
`but don’t address the overall context in which the
`practice occurs.
`
`This case study does not begin to answer many of
`the questions that would abound regarding a broader
`application of context-based approach to product
`design or practice improvement in health care. Even
`within the research findings for this study, there are
`unanswered questions that remain due to the limited
`scope of the study that would have tested further
`design enhancements for urinary catheter insertion.
`Yet, the case study does start to suggest that clinicians,
`and manufacturers, such as Medline, could contribute
`to a growth in our knowledge through context-based
`design research. We need to support the further
`development of research that uses inductive methods
`to understanding the context of clinical practices.
`
`References
`
`1. Saint S. Prevention of nosocomial urinary tract infections. AHRQ, 2001 http://www.ahrq.gov/clinic/ptsafety/chpt15a.htm
`
`2. Wong ES, Hooton TM. Guideline for prevention of catheter-associated urinary tract infections. CDC, 1981
`http://www.cdc.gov/ncidod/dhqp/gl_catheter_assoc.htm
`
`3. Saint, S, Kowalski CP, Kaufman SR, et al. Preventing hospital-acquired urinary tract infection in the United States:
`a national study. Clinical Infectious Diseases, 2008 46:243-250
`
`4. Klevens RM, Edwards JR, Richards CL et al. Estimating healthcare-associated infections and deaths in US hospitals,
`2002 Public Health Report, 2007 122:290-301
`
`5. Warren JW. Catheter-associated urinary tract infections. Intl J of Antimicrob Agents, 2001 17:299-303
`
`6. Edwards JR, Peterson KD, Andrus ML et al. National healthcare safety network (NHSN) report, data summary for 2006,
`issued June 2007. Am J Infect Control, 2007, 35:290-301
`
`7. Gould CV, Umscheid CA, Rajender KA et al. Guideline for prevention of catheter-associated urinary tract infections 2009.
`Centers for Disease Control and Prevention 2009 1-67
`
`8. Medline industries, Inc. CAUTI Prevention Program, Lincolnshire, Illinois, November 10, 2008
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`VHA Pilot with Medline Industries, Inc.
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`Medline Industries, Inc.; IPR2015-00511
`Exhibit 2102
`Page 8 of 8
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