Eastern Maine Medical Center Clinical Engineering

To: From: Subject: All Clinical Engineering Staff Robyn Frick, CCE Clinical Engineering Manager Equipment Risk Assessment Superse+es DD: ,Risk ClassesDate+: .!"/!1##" Purpose: Procedure: 23 223 Eac1 +e4ice type 5or category6 is initially e4aluate+ for risk by Clinical Engineering Management an+ is +ocumente+ in t1e Equipment Management Database 5%'S7S063 'nce a risk le4el is +etermine+, a plan for inspection an+ maintenance can be ma+e by Senior 8ME0 or Clinical Engineering Management an+ +ocumente+ in t1e Equipment Management Database 5%'S7S063 Risk Criteria is as follo9s: A3 High Risk : A +e4ice is consi+ere+ ;ig1 Risk 5Co+e 16 base+ on t1e follo9ing criteria, an+ is inspecte+ at least yearly: 13 0ypically a life support or critical +e4ice "3 2ntensi4e sc1e+ule+ maintenance require+ $3 &otentially 1ig1er failure rates <3 Maintenance 1istory s1o9s 1ig1er failure rates .3 =reater risk to t1e patient if +e4ice fails or is not maintaine+ >3 'ne!of!a!kin+, mission critical +e4ice ?3 &otentially 1ig1 monetary loss +ue to income loss or 1ig1 repair costs Medium Risk : A +e4ice is consi+ere+ Me+ium Risk 5Co+e "6 base+ on t1e follo9ing criteria, an+ is inspecte+ at least e4ery t9o years: 13 0ypically a monitoring or +iagnostic +e4ice "3 )ess intensi4e sc1e+ule+ maintenance require+ $3 )ess frequent failures <3 Maintenance 1istory s1o9s less frequent failures .3 )esser risk to t1e patient if +e4ice fails or is not maintaine+ >3 8ack!up +e4ice a4ailable ?3 )esser monetary loss +ue to income loss or repair costs Low Risk : A +e4ice is consi+ere+ )o9 Risk 5Co+e $6 base+ on t1e follo9ing criteria, an+ inspecte+ at least e4ery t1ree years: 13 0ypically a general care or t1erapeutic +e4ice "3 )o9 sc1e+ule+ maintenance require+ $3 )o9 failure rates <3 Maintenance 1istory s1o9s lo9 failure rates .3 )o9 risk to t1e patient if +e4ice fails or is not maintaine+ >3 8ack!up +e4ice rea+ily a4ailable ?3 )o9 monetary loss +ue to income loss or repair costs 0o establis1 criteria for risk base+ assessment of me+ical equipment Current Date: 1 !"#!" $ %!1

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2223

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C3

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No Scheduled Maintenance : A +e4ice is t1is risk category 5Co+e <6 is base+ on t1e follo9ing criteria, an+ is inspecte+ at least before initial use: 13 0ypically a general care or non!patient +e4ice "3 @o sc1e+ule+ maintenance require+ $3 Minimal failure rates <3 Maintenance 1istory s1o9s minimal failure rates .3 Minimal risk to t1e patient if +e4ice fails or is not maintaine+ >3 8ack!up +e4ice rea+ily a4ailable ?3 Minimal monetary loss +ue to income loss or repair costs