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Background Surgical Instrument Cycle Opera&ng Rooms (ORs) – Dictate surgical instrument needs Central Sterile Processing Department (CSPD) – Reprocesses and manages all instruments flowing to and from the ORs Impact/Results Acknowledgements IOE Collaborators: Mark Grum, Rama Mwenesi UMHS Collaborators: Pat Buchanan, Elvie Casper, Nicole Farquhar, Laura Giuffrida, Julia Jackson, Renee Prince, Amy Redmond, and Jania Torreblanca This research is generously supported by the Center for Healthcare Engineering and PaRent Safety, the Seth Bonder FoundaRon, the Doctors Company FoundaRon, the UM College of Engineering, and the Michigan Quality System Group A Systematic Approach to Improving the Reprocessing of Surgical Instruments Bill Zhang, Leah Raschid, Nina Scheinberg, Amy Cohn PhD, James P. Bagian MD PE, Joseph DeRosier PE CSP, Shawn Murphy MSN RN 2016 Healthcare Systems Process Improvement Conference Problem Statement OR Staff reported frequent problems related to the reprocessing and delivery of surgical instruments 51% of problems reported were due to bioburden/debris 47% of these were caused by the Minor Neuro set Efficiency in surgical instrument reprocessing is a criRcal challenge for hospitals naRonwide MeeRng reprocessing standards requires complex coordinaRon of mulRple hospital func&ons, resources, and stakeholders The University of Michigan Health System (UMHS) conducted 51,583 cases and reprocessed ~15,000 items/day in FY14 Insufficiently cleaned instruments containing “bioburden” or debris negaRvely impact insRtuRonal outcome measures, most notably pa&ent safety Pa&ent Safety Quality Timeliness Financials Staff Sa&sfac&on Goal To have all items required for the proper care of the pa1ent available at the 1me of surgery, properly cleaned, sterilized, and in working condi6on – while ensuring the efficient use of resources. Solution Approach Examined the impacts that i) instrument cleanability and ii) set configura&ons have on reprocessing outcomes Hypothesis 1: Instrument design features impact cleanability Hypothesis 2: SeparaRng high- from low-risk instruments improves reprocessing outcomes Used process-flow mapping techniques to define the current state Created a tool to evaluate how configuraRon impacts reprocessing outcomes and to recommend opRmal set configuraRons Currently developing a Cleanability Indexing system in partnership with clinicians Pilot Separated kerrisons (the highest-risk instruments) from Minor Neuro Set Demonstrated how the cleanability and configuraRon of instruments in a set directly impact outcome measures 1) Purchased 2) Catalogued 3) Grouped into sets 4) Stored in CSPD 5) Used in ORs 6) Decontaminated in CSPD 7) Assembled in CSPD 8) Sterilized in CSPD Instruments Set Scenario 1: No Separa&on Benefits observed associated with this interven&on: 1. No bioburden incidents with the kerrison sets 2. The average number of monthly bioburden incidents in Minor Neuro decreased from 15 to 3 3. The amount of Rme saved in the ORs will result in annual savings of $23,490 to $236,290 (calculated using average bioburden event delays of 5 minutes to 30 minutes) 4. An engineering approach to configuring sets (e.g., high-risk instrument separaRon) can increase quality Scenario 2: Kerrison Separa&on 0 5 10 15 20 25 30 35 40 45 SET, MINOR NEURO UH STRYKER ZIMMER SET, URQUHART LEG HOLDER ORTHO UH POWER, MIDAS REX LEGEND FOOT CONTROL NEURO UH POWER, ANSPACH TRANSPHENOIDAL DRILL NEURO UH ORTHO DRILL SET, WRIGHT EVOLUTION PATELLA ORTHO UH COLONOSCOPE SENTINEL TRIATHLON WRIGHT MEDICAL Number of Incidents Set Name Sets Most Commonly Reported to Contain Bioburden/Debris June 2014 – Feb 2015 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Minor Neuro accounted for ~47% of all events 4 3 4 1 2 7 7 1 4 1 2 2 1 0 1 2 3 4 5 6 7 8 9 January February March April May July August September October November December January 2015 2016 Number of Incidents Month / Year Minor Neuro Bioburden/Debris Incidents Jan 2015 - Jan 2016 Pre-SeparaRon Post-SeparaRon 0 5 10 15 20 25 30 35 40 45 SET, MINOR NEURO UH SET, WRIGHT EVOLUTION… SET, FOOT ORTHO UH POWER, MIDAS REX LEGEND… SET, THOMPSON GENERAL… SET, LAMINECTOMY II NEURO UH SET, ZIMMER PERSONA… SET, TRIATHLON EXTRAS… SET, SCOPE HOGIKYAN… SET, IMPLANT SYNTHES… SET, IMPLANT ZIMMER… SET, BLAHA EVOLUTION… Number of Incidents Set Name Sets Most Commonly Reported to Contain Bioburden/Debris Aug 2015 - Jan 2016 (Post-separa&on) Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Minor Neuro accounts for ~13% of all Events

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    Background Surgical Instrument Cycle •  Opera&ngRooms(ORs)–Dictatesurgicalinstrumentneeds•  CentralSterileProcessingDepartment(CSPD)–Reprocessesand

    managesallinstrumentsflowingtoandfromtheORs

    Impact/Results

    Acknowledgements •  IOECollaborators:MarkGrum,RamaMwenesi•  UMHSCollaborators:PatBuchanan,ElvieCasper,NicoleFarquhar,Laura

    Giuffrida,JuliaJackson,ReneePrince,AmyRedmond,andJaniaTorreblanca•  ThisresearchisgenerouslysupportedbytheCenterforHealthcareEngineering

    andPaRentSafety,theSethBonderFoundaRon,theDoctorsCompanyFoundaRon,theUMCollegeofEngineering,andtheMichiganQualitySystemGroup

    A Systematic Approach to Improving the Reprocessing of Surgical Instruments Bill Zhang, Leah Raschid, Nina Scheinberg, Amy Cohn PhD, James P. Bagian MD PE, Joseph DeRosier PE CSP, Shawn Murphy MSN RN

    2016HealthcareSystemsProcessImprovementConference

    Problem Statement •  ORStaffreportedfrequentproblemsrelatedtothereprocessing

    anddeliveryofsurgicalinstruments•  51%ofproblemsreportedwereduetobioburden/debris

    –  47%ofthesewerecausedbytheMinorNeuroset

    •  EfficiencyinsurgicalinstrumentreprocessingisacriRcalchallengeforhospitalsnaRonwide

    •  MeeRngreprocessingstandardsrequirescomplexcoordinaRonofmulRplehospitalfunc&ons,resources,andstakeholders

    •  TheUniversityofMichiganHealthSystem(UMHS)conducted51,583casesandreprocessed~15,000items/dayinFY14

    •  Insufficientlycleanedinstrumentscontaining“bioburden”ordebrisnegaRvelyimpactinsRtuRonaloutcomemeasures,mostnotablypa&entsafety

    Pa&entSafety Quality Timeliness Financials

    StaffSa&sfac&on

    Goal

    Tohaveallitemsrequiredforthepropercareofthepa1entavailableatthe1meofsurgery,properlycleaned,sterilized,andinworkingcondi6on–whileensuringtheefficientuseofresources.

    Solution Approach •  Examinedtheimpactsthati)instrumentcleanabilityandii)set

    configura&onshaveonreprocessingoutcomes•  Hypothesis1:Instrumentdesignfeaturesimpactcleanability•  Hypothesis2:SeparaRnghigh-fromlow-riskinstruments

    improvesreprocessingoutcomes•  Usedprocess-flowmappingtechniquestodefinethecurrentstate•  CreatedatooltoevaluatehowconfiguraRonimpactsreprocessing

    outcomesandtorecommendopRmalsetconfiguraRons•  CurrentlydevelopingaCleanabilityIndexingsysteminpartnershipwith

    clinicians

    Pilot •  Separatedkerrisons(thehighest-riskinstruments)fromMinorNeuroSet•  DemonstratedhowthecleanabilityandconfiguraRonofinstrumentsina

    setdirectlyimpactoutcomemeasures

    1)Purchased

    2)Catalogued

    3)Groupedintosets

    4)StoredinCSPD

    5)UsedinORs

    6)DecontaminatedinCSPD

    7)AssembledinCSPD

    8)SterilizedinCSPD

    Instruments Set

    Scenario1:NoSepara&on

    Benefitsobservedassociatedwiththisinterven&on:1.  Nobioburdenincidentswiththekerrisonsets2.  TheaveragenumberofmonthlybioburdenincidentsinMinor

    Neurodecreasedfrom15to33.  TheamountofRmesavedintheORswillresultinannualsavingsof

    $23,490to$236,290(calculatedusingaveragebioburdeneventdelaysof5minutesto30minutes)

    4.  Anengineeringapproachtoconfiguringsets(e.g.,high-riskinstrumentseparaRon)canincreasequality

    Scenario2:KerrisonSepara&on

    0 5 10 15 20 25 30 35 40 45

    SET,MINORNEUROUH

    STRYKER

    ZIMMER

    SET,URQUHARTLEGHOLDERORTHOUH

    POWER,MIDASREXLEGENDFOOTCONTROLNEUROUH

    POWER,ANSPACHTRANSPHENOIDALDRILLNEUROUH

    ORTHODRILL

    SET,WRIGHTEVOLUTIONPATELLAORTHOUH

    COLONOSCOPE

    SENTINEL

    TRIATHLON

    WRIGHTMEDICAL

    NumberofIncidents

    SetN

    ame

    SetsMostCommonlyReportedtoContainBioburden/DebrisJune2014–Feb2015

    Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15

    MinorNeuroaccountedfor~47%ofallevents

    43

    4

    12

    7 7

    1

    4

    12 2

    10

    1

    2

    3

    4

    5

    6

    7

    8

    9

    January February March April May July August September October November December January

    2015 2016

    Num

    bero

    fInciden

    ts

    Month/Year

    MinorNeuroBioburden/DebrisIncidentsJan2015-Jan2016

    Pre-SeparaRon Post-SeparaRon

    0 5 10 15 20 25 30 35 40 45

    SET,MINORNEUROUH

    SET,WRIGHTEVOLUTION…

    SET,FOOTORTHOUH

    POWER,MIDASREXLEGEND…

    SET,THOMPSONGENERAL…

    SET,LAMINECTOMYIINEUROUH

    SET,ZIMMERPERSONA…

    SET,TRIATHLONEXTRAS…

    SET,SCOPEHOGIKYAN…

    SET,IMPLANTSYNTHES…

    SET,IMPLANTZIMMER…

    SET,BLAHAEVOLUTION…

    NumberofIncidents

    SetN

    ame

    SetsMostCommonlyReportedtoContainBioburden/DebrisAug2015-Jan2016(Post-separa&on)

    Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16

    MinorNeuroaccountsfor~13%ofallEvents