ProgressReportFebruary2010

LNE/GMED:SharingaPassionforProgress

RiskManagementAppliedtoMedicalDevices: ComplyingwithENISO14971:2009
byMarcHenriWinter,TechnicalDirector,LNE/GMEDNorthAmerica

WithrevisedstandardstakingeffectonMarch1,2010,nowistheperfecttimetoreviewthe riskmanagementprocessandchangesunderENISO14971:2009(EuropeanversionofISO 14971:2007). Whetheramedicaldeviceaimsatdiagnosingadisease,treatingthecauseoralleviatinga handicap,theexpectationisthatitachievesthisgoalwithoutharmingthepatient/usernor presentinganunacceptablerisk.Thewordriskandvariationsofsafearecitedacombined 105timesintheEuropeanMedicalDeviceDirective.Clearly,thedemonstrationofamedical devicessafetyiscentraltocompliancewithinternationalmedicaldeviceregulations. EditorsNote:Boostyourknowledgeof Reminder of Key Changes ENISO14971atRiskManagementasAppliedto Under EN ISO 14971:2009 MedicalDevicesa1daytrainingpresentedby LNE/GMED.Thiseventtakesplaceinthe ISO 14971:2007 (and EN ISO 14971) made WashingtonDCareaonJune25,2010andis fundamental changes from the original 2000 limitedtoaverysmallclasssize.Reserveyour directive in considering potential risk: spottodaybyemailingcalling3014950477or Phase of the Life Cycle: Requirements 7.1 emailingbruce.seidel@lnegmed.com. and 7.3.2 addressed the need to examine different stages of the product, including http://www.LNEAmerica.com/14971Training manufacture, product release, in-use errors and disposal. TheRiskManagementApproach(ISO14971)was developedin2000tosupportsafetybydefining Type of Hazard: This version of the standard distinguishes between hazard thedetailedobjectives,requirementsand (potential source of harm) and hazardous methodsrelativetothisapproach.ByMarch1, situation (circumstance in which people, manufacturersshouldhavetransitionedtothe property, or the environment are exposed to newEuropeanversionofENISO14971,which one or more hazards). The risks must be wasreissuedinNovember2009with estimated for both. modificationsaffectingtheEuropean Confirmation of Standard Applicability to appendices).Notethattherequirementsofthe all medical devices, including in vitro Europeanstandardareidenticaltotheonesfor diagnostic devices (IVDs), for which a ISO14971:2007. specific annex (H) was added about the identification of hazards.
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RiskManagementObjectives RiskManagementisdefinedasthesystematicapplicationofmanagementpolicies, proceduresandpracticestothetasksofanalysis,evaluation,supervisionandriskcontrol.Its goalistoenablemedicaldevicemanufacturerstoidentifyallforeseeablehazardsand hazardoussituationsrelevanttoaparticulardeviceanddemonstratethatrelatedriskhas beenreducedtoanacceptablelevel. ImplementingRiskManagement 6 Stages of Risk Management Process Anevolutionofthestandard,Risk Managementnowinteractswithnearly allofamanufacturersactivities, includingdesign,engineering,production, purchasing,sales,qualityassuranceand regulatoryaffairs.Itsalsoaperpetual process,beginningwithproductdesign anddevelopmentandcontinuinginthe field,whereuserfeedbackcanreveal actualperformance.Thechartonthe followingpageoutlinesthesesteps, whicharefurtherexplainedbelow: 1. RiskAnalysisaimsatidentifying allforeseeablehazardous situations,consideringthe characteristicsofthedevice,the wayitisusedandhowitis disposed. Willpeopleusethedevice correctly? Whereintheproduction processmightvariations impacttheconformityof thedevicetoitsintended productspecifications? Eachoftheserisksisthen weighted,oftenbya multidisciplinaryteam,to consideritsprobabilityof occurrenceandthe seriousnessofitspotential effects.

Source: EN ISO 14971:2009

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2. RiskEvaluationconsistsofthejudgmentoftheacceptabilityoftherisk,basedon preestablishedcriteria.

3. RiskControlaimsatreducingriskthroughavailablecontrolmeasures.Whilethe completeeliminationofallrisksmaynotberealistic,itsreductionmustbeconsistent withthestateoftheart,ameasurethatnaturallyshiftsasscienceprogresses.Inthis evaluation,expectedpatientbenefitsarecomparedtothelevelofresidualrisk, includingriskfactorsarisingfromintendedriskcontrolmeasures.

4. OverallResidualRiskiseventuallyreviewedforacceptance,lookingatthebig picture.Thisincludestheverificationofconsistency,therelevanceoftherisk reductionsolutionsandthatthesequenceofdysfunctiondoesnotgenerate additionalrisks.

5. RiskManagementReport:Thissetofrecordsgeneratedalongtheriskmanagement process,arereviewedandsignedbythequalifiedpersonorteamtoconfirmthat: Theriskmanagementplanhasbeenappropriatelyimplemented; Theoverallresidualriskisacceptable; Appropriatemethodsareinplacetoobtainrelevantproductionandpost productioninformation. 6. ProductionandPostProduction:Duringthisstage,dataiscollectedandanalyzed proactivelytoverifyiftheevolutionofscientificandmedicalknowledgemaysuggest newarisingrisksorthatarisk/benefitbalanceisbecominglessfavorable. ThisstepislinkedwiththenewEuropeanrequirementforactivelyupdatingthe clinicalevaluationofthedevice.Itmayincludethereviewofcustomercomplaints (individuallyandtheirtrends),publishedliteratureandpublicdatabasesonadverse eventsexperiencedonsimilarmedicaldevicesandpostmarketclinicalfollowup.The reviewoftheactualvariabilityofthemanufacturingprocessandthedeviationsor nonconformitiesmayalsobeanappropriatewaytoconfirmthecorrespondingrisks. RiskManagementvs.FMEA ToincorporateRiskManagementintotheirQualityManagementSystem,most manufacturersapplymethodsbasedonFailureModeandtheirEffectAnalysis(FMEA), whichmaybesplitintoDesign(DFMEA),Process(PFMEA)andUse(UFMEA).WhileFMEAis ariskmanagementtechniquementionedbythestandard,itdoesnotaloneaddressallthe requirementsofENISO14971. Foraparticulardevice,ariskmanagementfileregroupsthefollowing:

Theriskmanagementplanandtheconfirmationofitsimplementation

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 Theresultsoftheidentificationofthehazardoussituationandtheevaluationofthe correspondingrisks Theevidenceofthemitigationofeachindividualrisk Theacceptationoftheserisks,individuallyandglobally Therecordsofthereviewsoftheriskcontrols,priortothecommercialreleaseofthe deviceandduringthepostproductionphase,asnewinformationarises. Byexaminingvariousstagesoftheproductandtakingintoaccountbothhazardsand hazardoussituations,ENISO14971:2009seekstobetteridentifyareasofincreasedrisk, allowingmanufacturestheopportunitytoimplementeffectivecontrols.

Formoreinformationonthistopic: EditorsNote:BoostyourknowledgeofENISO14971atRiskManagementas AppliedtoMedicalDevicesa1daytrainingpresentedbyLNE/GMED.Thisevent takesplaceintheWashingtonDCareaonJune25,2010andislimitedtoaverysmall classsize.Reserveyourspottodaybyemailingbruce.seidel@lnegmed.comorcalling 3014950477.Programdetails:http://www.LNEAmerica.com/14971Training SeeGHTFdocument:ImplementationofRiskManagementPrinciplesandActivities withinaQualityManagementSystem:

http://www.ghtf.org/documents/sg3/sg3n15r82005.pdf

LNEisarecognizedNotifiedBodyofferingmanufacturersproducttesting,independent certificationandrelatedtrainingtoensurecompliancewiththeEU,FDAandother governmentalauthorities.LNEssubsidiaryGMEDNorthAmericaprovidesmanufacturers withalocal,onestopsolutionforenteringworldmarkets,whileconfirmingthequalityofits products.

FormoreinformationonCEmarking,certificationofqualitymanagementsystemsor answerstoanyquestionsrelatingtocertification,pleasecontact: BruceSeidel(301)4950477bruce.seidel@lnegmed.comwww.lnegmed.com

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