TheImportanceofReconfiguringMedicalSupplyWaste

KerriSchopf

Engl138T

11,Apr.2016

1. Introduction

Hospitalsrequirescountlessamountsofsurgicaltools,gowns,andglovesinorderto
successfullysavelives.Muchofthesematerialsarethrownawayaftertheiruse.Theoperating
1
roomgenerates2030%ofahospitalswastewhichcontributestooverflowinglandfills
.There
arecosteffectivealternativestothedisposable,onetimeuseinstrumentsthatcouldlowerthe
medicalsupplywastecomingfromhospitals.Policiesshouldexistthatrequirehospitalsto
recyclematerialsandtousereusablematerialsintheoperatingroominordertodecreasethe
amountofwastethatwillbeaddedtolandfills.

1.1History
Beforethe1980s,hospitalswidelyusedtoolsthatweredurableandpermanentlyreusable.The
instrumentsweremanufacturedfromglass,metal,orrubberwhichmadethemrelativelysimple
toresterilize.Themethodsusedweresimplywipingdownthetoolsanddippingthemin
2
disinfectant
.Thispracticechangedinthe1980sduetotheoutbreakofHIV.AIDSwasjust
widelyspreadingacrossthecountry,andtheyknewitwasaffectingmostlygaymenbuttheydid
notknowwhy.Itwasaveryconfusingandfrighteningtimeformanypeople,sotheytookmany
precautionstomakesurethisdiseasewouldnotspread.Sincetheywereunsurewhether
sterilizationtechniqueswouldeffectivelykillthedisease,disposableswereusedtoease
3
everyonesminds
.

Thesedisposabletoolsarecalledsingleusedevices(SUDs)andareintendedforaonetimeuse
topreventtransmissionofdiseasesfrompatienttopatient.Sterilizationtechniquesoftodayare
proventokilltheHIVvirus,butSUDsstillremain.Thisisjustanexampleofanoutdated
systemthathasnotbeenreconfiguredtothestandardsupheldtoday.Thesterilizationtechniques
inthepastwereclearlynotrigorousandwouldnotbeuptotodaysregulationsbutthereare
newer,saferwaystoreprocesssurgicalinstruments.SUDsarecomingbacktotheforefrontof
discussiontodayduetotherisingconcernsaboutwasteandtheeffectithasontheenvironment.

1.2ProvenInefficiency
Atthistime,thereisnoorganizationthatistrackingmedicalsupplywaste,butin1990itwas
4
estimatedthattheU.S.produced2milliontonsofmedicalwasteperyear
.Thisnumberisdue
largelytotheuseofdisposabletools,surgicalkitsthathaveunnecessaryitems,andtheuseof
5
disposablegowns.ThismakeshospitalsthesecondlargestwasteproducersintheU.S.
.

Itemsthatarebeingthrownawayincludeplastic,metal,andglassmaterials.Thisrepresents20%
6
ofahospitalswastetheothersbeingpaperandorganicwaste
.Mostofthesetoolsare
recyclableandcouldbesavedforreuse.Manyhospitalsactuallydorecyclepaperandorganic
products,butthemedicaltoolsareslippingthroughthecracks.Onlyaboutaquarterofhospitals
7
intheUnitedStatesusedatleastonetypeofreprocessedmedicaldevicein2002.

2.WasteDisposalIssues

Medicalwasteisdisposedofinoneoftwoways:incineratorsandsteamcleaning.Whenwasteis
incinerateditisplacedintoachamberwithtemperaturesashighas2,000degreesFwhich
causescombustionofthematerials.Inthesecondchamberthewasteisconvertedtocarbon
dioxideandwaterandthensteam.Oncethisprocessiscompletetheashesareconsidered
sanitaryandcanbeplacedinalandfill.
Steamcleaningusesautoclavestoapplyheatandpressuretothewaste.Inthisprocessthesteam
sterilizesthewastebykillingoffanymicrobes.Theinstrumentsthenundergoaprocesscalled
shedding.Thisiswhenthemachinecompactstheinstrumentssotheyarenotrecognizableand
arenotreusedafterbeingtakentothelandfill.Autoclavesareusedformanypurposesbutthat
8
includessterilizingmedicalequipmenttogotolandfills.

Themajorityofmedicalwastemustalreadybetreatedinordertogotoalandfillbecauseithas
thepotentialtoinfectothers.Ifleftuntreated,thetoolscouldleaktheircontentsintolocalwater
suppliesorintotheocean.Sincethetoolsarealreadybeingtreateditislogicaltosimply
resterilizethemandrepackagethemforhospitals.Thisway,theyarestillbeingtreated,butthey
arenotcontributingtoglobalwaste.

Globalwarmingandclimatechangeingeneralisattheforefrontofworldissues,therefore,
wasteisconstantlybeingreevaluated.Mostofthattwomilliontonsofmedicalwastegoes
straighttolandfills.Landfillsreleasegreenhousegasesintotheenvironmentwhichareknownto
bealeadingcauseofglobalwarming.Specifically,landfillsreleasecarbondioxide,methane,
volatileorganiccompounds,andhazardousairpollutants.Methaneisofparticularconcern
9
becauseitisabletotrap25timestheheatofcarbondioxide.
Medicalsupplywasteissucha
2

concernbecausemostofthiswasteiscompletelyunnecessary.AJohnsHopkinsresearchteam
10
estimatedthattherewas$15milliondollarsworthof
unused
materialthatwasthrownaway.

Thisdrawsattentiontothefactthatthereareotherthingsthatcanbedonetomanagethewaste,
includingreconfiguringsurgicalpacksandrecyclingmaterialsthatarebothusedandunused.

3.AlternativeShortTerm

Aportionofthisunusedmaterialcouldgotohospitalsinthirdworldcountrieswhoneverhave
enoughmaterialstogetby.Thatunusedmaterialcouldbedivertedfromlandfillsandsavelives
bygettingsurgeonsmaterialsthattheydonothavetheresourcestoobtain.Therearemultiple
agenciesthatcollectunusedmedicalsuppliesandpackthemuptobeshippedtohospitals.
OnesuchagencyisknownasREMEDYwhichstandsforRecoveredMedicalEquipmentforthe
DevelopingWorld.ThisprogramwasinspiredbyDr.Kanzaria,ascholaroftheRobertWood
JohnsonFoundation.Henoticedalloftheopenedbutunusedmedicalsuppliesbeingthrownin
thetrashandknewthedesperateneedforthatequipmentinothercountries.Thoughallofthese
medicalsuppliesarenotlegallyusableintheUS,theyaregratefullyacceptedinthirdworld
11
countries.
OtherlargerscaleprogramsincludeMedShare,EQUIPandMedicalteams
international.Alloftheseorganizationshavethegoaloftakingtheunwantedmedicalsupplies
fromhospitalsthatarestillfunctionalinothercountries.

Anotherwaytoreducewasteisinrecyclingproductsratherthanonlyusingthemonce.Nowthat
sterilizationtechniqueshavebeenverifiedtheycouldbecomeincreasinglyusefulinlowering
medicalwaste.Therearemanycompaniesthat
recycleproductsandreturnthemtothe
hospitalrepackagedasifbrandnew.These
companieshavestrictregulationbytheFDA
toensurethattheirsterilizationtechniquesare
justassoundasthemethodsusedbythe
12
originaldevices.

3.1FDARegulations
AccordingtotheFDAregulationsupdatedin
2015theFDArequiresthatoriginal
manufacturersveryclearlylabelthedevicesso
hospitalsknowexactlywhattheprocessing
rulesareforthatparticulardevice.Onething
thatistakenintoaccountwhendesigningthe
medicaltoolsisthefactthattheymaybe
reprocessed.Forthisreason,allmanufacturers
mustdesigntheproducttofacilitateeasyand
effectivecleaning,aswellasanynecessary
13
disinfectionorsterilizationbytheusers.

Thisistoensurethattherearenodevicesthat
3

havepiecesthatmaybemissedduringthesterilizationprocess.

BeforereprocessingtheFDAdefinesaseriesofstepsthatmustbetakentoensurethedeviceis
successfullysterilized.Closetothepointofusestepsmustbetakentoremoveanyinitial
contaminantsthatcouldbecomecakedontothetools.Thenextstepistothoroughlycleanthe
devices.Manyhospitalshavefacilitiesoftheirownthatcanperformthisstepandothersuse
thirdpartycleaners.MaterialsoutlinedbytheFDAthatdonotneedtobesterilizedare
consideredreadyforuseafterthisstep.Thematerialsthatdoneedsterilizedmustcontinueonto
thatstepbeforetheyaresuitableforreuse.Thiswouldincludeanymaterialsthathavecomeinto
14
contactwithbloodorotherbodilyfluids.

Originalmanufacturers,hospitals,andreprocessorsallareunderthesameguidelinesaccording
totheFDAwhichensuressafeproductsatalllevels.Therearethreecategoriesofdevicesunder
theseguidelinesandeachcategoryisunderdistinctregulations.Devicesthatfallundereach
classhavedifferentrequirementsonthecleaningprocessthatbecomemoreinvolvedasthe
deviceisconsideredhigherrisk.EachstepoftheprocessisalsovalidatedbytheFDAtoensure
qualitycleaningfromthetimeitisusedtothetimeofreuse.

3.2ConcernwithSafety
DespitetheFDAregulationsmanystillfeltuneasyaboutrepackagingusedtools.Somesurgeons
andotherconcernedpartiesbroughtuptheissueofdurabilityofSUDs.TheyarguethatSUDs
arespecificallymadeforonetimeuseandthatiftheyarereprocesseditcouldcompromisethe
integrityoftheinstrument.ThisisavalidconcernandonethattheFDAspecificallylookedinto.
TheFDAfound464outof300,000reportsofcomplicationsthatcouldhavearisenduetofaulty
reusedinstruments.Afterthoroughinvestigationintothereportstheyfoundnopatternof
15
failureswithreusedSUDsthatdiffersfrompatternsobservedwiththeinitialuseofSUDs.

Thisprovidesprooftowardsthefactthatreuseddevicesarejustassoundastheyareoriginally.
4


16
BelowisalistofsomecommonlyreprocessedmaterialsasdefinedbytheFDA.

SurgicalSawBlades
SurgicalDrills
LaparoscopyScissors
Orthodontic(metal)Braces
ElectrophysiologyCatheters
ElectrosurgicalElectrodesandPencils
RespiratoryTherapyandAnesthesiaBreathingCircuits
EndotrachealTubes
PercutaneousTransluminalCoronaryAngioplastyCatheters
BiopsyForceps

Invariablysomeofthesedevicesnowhavepartsthataremorecomplexandthatmaybemore
17
difficulttoproperlysterilize.
.Manyofthesedevicescontainlonglumens,fragilepieces,or
electronicportionsthatcannotbesubmerged.Thismakesitdifficulttocleanwhichiswhythere
wereconcernsexpressedregardingthesafetyofthosetypesofdevices.

InordertoinvestigatethisconcerntherewasastudydonebyagraduatestudentatHopkins
alongwithtwopostdocs.Specificallylookingintoinfectionscausedbyreuseddevices,they
foundnoevidencethatpatientswereharmedduetotheuseofrecycledtoolsandareportwas
18
releasedbytheGovernmentAccountabilityOfficethatannouncedthosefindings.

3.3ReconfiguringMedicalSupplyPacks
Forthosewhoarestillunconvincedaboutthesafetyofrecycledmaterials,anotherinitiativethat
isbeingstartedisreconfiguringmedicalsupplykits.Manymedicalsupplykitsarelargeand
containmanytoolsthatendupunusedattheendofthesurgery.Accordingtoregulationsthey
mustbethrownoutbecausetheywereopenedandcouldbecontaminated.Therehavebeen
manyGreenORinitiativesthatworktolowerthewasteinthesepacks.Dr.Andradeworked
withanurseattheUniversityofMinnesotaMedicalCentertoreconfigureonehospitalpackthat
originallycontained44items.Theywereabletolowerthatnumbertojust27itemswhichalso
19
savedthehospital$50perprocedure.
Usingthisnewpack,everytimethatsurgeryisperformed
thehospitalsaves17instruments.Thisstrategyisbeingpickedupbyotherhospitalsasthey
noticethesuccessofthatstrategy.

4.LongTerm

ReprocessingSUDsisagreatstrategytodivertwastefromlandfillsbuteventuallythetoolswill
begintobreakdownandmustbedisposedof.Duetothis,Dr.Andrade,athoracicsurgeonat
UniversityofMinnesotaMedicalCenterstressedthatthelongtermgoalofhospitalsshouldbeto
20
convertbacktousingpermanentlyrecyclablematerialsthatwillnotbreakdown.
Thesedevices
wouldbemanufacturedfrommoredurablematerialsthatwillbeabletowithstandtheconstant
cleaningandsterilizationprocesses.
5


Allofthesereprocessingstrategiesareextremelycosteffectiveforhospitals.Whenproductsare
21
repackagedtheyaresoldfor4060%lessthanoriginalproducts.
TheHospitalCorporationof
Americabeganrecyclingin2009andwasabletorecycle94tons.Thissavedthem$82million
22
injustthefirsthalfof2009whichrepresentsa25%increaseinsavings.
Repurchasingrecycled
materialswillactuallysavethehospitalsmoneyaswellaslowerwasteinlandfills.Despitethis,
onlyabouthalfofhospitalsrecycleevensomeoftheirmedicalwaste.

5.RootoftheProblem

Manyhospitalsprobablydonottaketheinitiativetostartaprogrambecausetheydonotwant
theheadacheoffiguringoutlogistics.Gettingtheprogramstartedwillnotbeeasy.Ittakestime
toreconfiguresurgicalpackstoindividualhospitalneeds,anditwilltakecoordinationtohave
collectionbinsformaterialstoberecycled.Itwilltakeefforttofindarecyclingcompanyand
managetherecyclingofoldmaterialswiththepurchasingofnewmaterials.Thisprogramwill
notrunitselfwhichisprobablythereasonsomehospitalshavenotstartedtheinitiative.Thisis
whylegislationisnecessary.ItwillgivehospitalsthepushtheyneedtobeginaGreenOR
program.

23
AbusinessknownasWasteManagementIncorporated.
givessuggestionsonhowtobegina
successfulrecyclingprogram.Thestepsareoutlinedasfollows

Performanaudit.

Thecompanyexplainsthatthehospitalneedstofirstevaluatethecurrentrecycling
situation.Theyshoulddeterminewhatkindofwasteismostcommonandwherethe
properdisposalcontainersshouldbelocated.Itisalsoessentialthattheyareuptodateon
thepoliciesofrecyclingmaterialsandtheguidelinesonhowtoproperlydoso.

Identifylocalresources.

Thehospitalneedstoidentifythirdpartyprocessorsthatdealwithmedicalwasteand
determinethecostofthosecompanies.

Establishgoals.

Aplanmustbeestablishedthatdeterminesthenumberofreceptaclesandwheretheywill
belocatedformaximumefficiency.

Maximizethevalueofmaterials.

Hospitalstaffshouldstrivetoproperlysegregateallmaterialsinordertomaximizethe
returns.

Educatestaff.

Itisimportantthatthewholeteamisawareoftheprotocolonwhattorecycleandwhere
torecycleit.Sendingoutnewslettersandemailsregardingtheprocedurecanbe
importantsothestafffeelconfidentaboutthenewrequirements.

Monitorandmeasure.

Thisfinalstepisanongoingprocessbecausetherecyclingprogrammustadapttothe
needsofthehospitalastheychange.Whentheprogramisfirstimplementedtheneedsof
thehospitalmaybemisinterpretedorthehospitalwasteflowcouldevolveovertime.For
thisreason,hospitalsneedtoperiodicallyreevaluatethesuccessoftheirsystem.
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Manufacturersarealsoalargebarriertothereprocessingprogramsinhospitals.Original
manufacturersdislikethereprocessingcompaniesbecausethatiscostingthembusiness.Every
timeatoolisreprocessedinsteadofthrownaway,amanufacturingcompanyhastomakeone
lesstool.Whilethisispropitioustotheenvironment,themanufacturingcompaniesaresimply
lookingtomaintaintheirprofits.Manufacturingcompanieswillsometimesaddapieceofplastic
tothetoolsoitisunfitforreprocessinginanautoclave.Hospitalscommonlyhaveautoclaveson
sitesoanytoolsthatcannotbesterilizedwiththismethodwillmostlikelybethrownaway.

6.PolicyChanges

Inlightofallofthisinformationitwouldbebeneficialtogivehospitalsthatareinitiating
recyclingandrepurposingprogramsataxdeduction.Thiswouldprovidehospitalstheincentive
tolowertheirwastebecausetheywouldbecompensatedfortheirefforts.Theremaybedifferent
regulationsonhowthistaxdeductionwillaffectpublicfundedhospitalsversusprivatehospitals,
buttheoverallgoalshouldbethesame.Thispolicychangeisnecessarybecausemosthospitals
arenottakingtheinitiativetobegintheseprograms.Hospitalsneedtobeeducatedonthe
importanceofrecyclingthetools,andthebenefitsitwillgivethem.Ifhospitalsaregiventhetax
breakitwilllikelygivethemthenudgetheyneedtoinstitutetheirownrecyclingprogram.

7.Concerns

Hospitalsareconcernedthatthiswilladdaheadachetoregularroutinesandwillresultin
confusionandimproperrecycling.Itcanbedifficulttokeeptrackoftheregulationssurrounding
differenttools.Sometoolsmustbewipeddownimmediatelyafteruseandpromptlycleanedand
sterilized,whileothersneedasimplecleaningandarereadyforreuse.Thehospitalsexpress
reasonableconcernswhichiswhyeachstaffmemberneedstobegivenspecificinstructionson
theproperprotocol.Theinitiationofthesystemwillbedifficult,butoncestaffmembersbeginto
adjusttothenewrules,theywillfindittobeverymanageable.Manyotherhospitalsare
providingagoodexampleofthesuccessofsuchprograms.Thereareevenmanywebsitesthat
providetipstohospitalsthatarejustbeginningtheirprograms.

Thebenefitsoftheprogramfaroutweighthecosts.HospitalsthatbeginrecyclingSUDsanduse
reusablematerialsexperiencedrasticsavings.Onehospitalsimplyreconfiguredasupplypack
24
fortheiroperatingroomandsaved
$104,658.

BannerHealthinPhoenixbeganrecyclingand
saved$1,494,050fromreprocessingoperatingroomdevices,andreconfiguringothermaterials
25
inaperiodof12months.
Thesuccessofotherhospitals,alongwiththetaxbreakshouldgive
theskepticsthemotivationtobegintheirownsystem.

8.Communication

ThenumberonegoalofprogramssuchastheAmericanHospitalAssociationshouldbeto
informhospitalsaboutreprocessing.Alloftheconcernsthathospitalshold,whetheritbewith
safety,implementationofarecyclingprogram,orcostshouldbeaddressedinordertogetas
7

manyhospitalsonboardaspossible.Thebiggestobstacleingettingmorehospitalstogogreenis
simplylackofknowledge.

Itisalsoimportantthatallhospitalsareawareofthetaxbreakthatisofferediftheybegin
recycling.Thepolicywillonlyworkiftheinformationisavailabletohospitalsthattheywillbe
compensatedfortheirefforts.Oncethepolicyisineffecteveryhospitalshouldbesentan
announcementthatoutlinesthemainideasbehindthepolicy,andhowtotakeadvantageofthe
taxbreak.Theannouncementcouldexplaintheimportanceofloweringwaste,andhowitwill
benefitthehospitals.Thenitshouldgivedetaileddescriptionsofhowthehospitalscanreceive
thetaxbreakoncetheybeginrecycling.

9.Summary

Asmorepeoplebecomeawareofthechangingclimateandtheeffectsithasonhumans,and
animalsthereismoreofafocusonchangingbadpractices.Wasteinlandfillsisahugecauseof
globalwarmingbecauseitreleasesgreenhousegasesintotheatmospherewhichinturntrapheat.
Hospitalsgenerateanextremelylargeportionofthatwasteduetotheiruseofsingleusedevices
andthrowawaypaperproductsintheoperatingroomandelsewhere.Usingmedicaldevicesonly
onceisunnecessarybecausetherearemanageablewaysofreprocessingandsterilizingthose
devicesforreuse.Itmaybedifficulttobeginarecyclingprogrambutitisimportantinorderto
preservetheenvironment.Inordertoconvincehospitalstolowersupplywastethereshouldbea
policyenactedthatprovidesataxbreaktohospitalsthathaveareprocessingprogram.

Endnotes
1. "StudyDocumentsMillionsinUnusedMedicalSuppliesinU.S.OperatingRoomsEach
Year."
JohnsHopkinsMedicine
.N.p.,27Oct.2014.Web.7Apr.2016.
<http://www.hopkinsmedicine.org/news/media/releases/study_documents_millions_in_u
nused_medical_supplies_in_us_operating_rooms_each_year>
2. Feigal,DavidW.,M.D."TestimonyonReuseofMedicalDevices."
Departmentof
Health&HumanServices
.AssistantSecretaryforLegislation,27June2000.Web.10
Apr.2016.<http://www.hhs.gov/asl/testify/t000627b.html>
3. Nastu,Paul.HalfofHospitalsRecyclingAtLeastSomeMedicalWaste.
EnvironmentalLeader
.7July2010.Web.10April2016.
<http://www.environmentalleader.com/2010/07/07/halfofhospitalsrecyclingatleastso
memedicalwaste/>
4. Chen,Ingfei."InaWorldofThrowaways,MakingaDentinMedicalWaste."
TheNew
YorkTimes.
N.p.,5July2010.Web.7Apr.2016.
5. Kwakye,GiftyPronovost,PeterM.D.,Ph.D.Goinggreeninthehospital:Recycling
medicalequipmentsavesmoney,reduceswasteandissafe.
ScienceDaily
.26Feb.
2010.Web.10Apr.2016.
<http://journals.lww.com/academicmedicine/Fulltext/2010/03000/Commentary__A_Call
_to_Go_Green_in_Health_Care_by.10.aspx>
6. Lee,LindaDr.,TurpinBill.WasteNot.HealthFacilitiesManagement.1January2011.
Web.10Apr.2016.
<http://www.hfmmagazine.com/display/HFMnewsarticle.dhtml?dcrPath=/templatedata/
HF_Common/NewsArticle/data/HFM/Magazine/2011/Jan/0111HFM_FEA_enviro>
7. Kwakye,GoingGreen.
8. TreatmentofMedicalWaste.
BasuraMedicalWaste
.Web.10Apr.2016
9. "PublicHealth,Safety,andtheEnvironment."
EnvironmentalProtectionAgency
.EPA,
31Mar.2016.Web.10Apr.2016.
10. <http://www.hopkinsmedicine.org/news/media/releases/study_documents_millions_in_u
nused_medical_supplies_in_us_operating_rooms_each_year>
11. ReducingWaste,EnhancingHealth.
RobertWoodJohnsonFoundation
.3July2013.
Web.10April2016.
12. "GuidelineforDisinfectionandSterilizationinHealthcareFacilities,2008."
Centersfor
DiseaseControlandPrevention
.CDC,29Dec.2009.Web.10Apr.2016.
13. FoodandDrugAdministration.ReprocessingMedicalDevicesinHealthCareSettings:
ValidationMethodsandLabeling17March2016.PDFfile.
14. Ibid.
15. Ibid.
16. Ibid.
17. <http://www.hhs.gov/asl/testify/t000627b.html>
18. Chen,InaWorld.
19. Ibid.
20. Ibid.
21. <http://www.environmentalleader.com/2010/07/07/halfofhospitalsrecyclingatleastso
memedicalwaste/>
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22. Ibid.
23. <http://www.hfmmagazine.com/display/HFMnewsarticle.dhtml?dcrPath=/templatedata/
HF_Common/NewsArticle/data/HFM/Magazine/2011/Jan/0111HFM_FEA_enviro>
24. <http://www.environmentalleader.com/2010/07/07/halfofhospitalsrecyclingatleastso
memedicalwaste/>
25. Kwayke,GoingGreen.

Images
1. MeSI.ProcedureSet.Digitalimage.
MeSIItalia
.N.p.,2015.Web.10Apr.2016.
<
http://www.imesi.it/wpcontent/uploads/2015/05/setproceduraleaperto062.png
>
2. FoodandDrugAdministration.ReprocessingMedicalDevicesinHealthCareSettings:
ValidationMethodsandLabeling17March2016.PDFfile.
3. Emergo.MedicalDeviceClassification.Digitalimage.
EmergoGroup
.N.p.,n.d.Web.
10Apr.2016.<http://www.emergogroup.com/resources/usaprocesschart>

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