STERILE PROCESSING TECHNICAL MANUAL - CHAPTER 6:
REGULATIONS AND STANDARDS *NEED TO REVIEW
AND/OR UPDATE TO HSPA 9TH EDITION.
In mwhat mways mdo mregulations mand mstandards minfluence mhealthcare mprofessionals? m- mRegulations
mand mstandards mimpact mevery mhealthcare mprofessional, mincluding mthose mworking min mthe mSterile
mProcessing mdepartment m(SPD).
What mare mthe mpotential mconsequences mwhen mregulations mand mstandards mare mnot madhered mto? m-
mWhen mregulations mand mstandards mare mnot mfollowed, mthe mresults mcan mvary mfrom mlegal
mconsequences mto mpoor mpatient moutcomes.
What mis mthe mdefinition mof m"regulation"? m- mRules missued mby madministrative magencies mthat mhave
mthe mforce mof mlaw.
What mis mthe mdefinition mof m"standard"? m- mA muniform mmethod mof mdefining mbasic mparameters mfor
mprocesses, mproducts, mservices, mand mmeasurements.
Who mare mthe mentities minvolved min mthe mdevelopment mof mstandards? m- mIndustry, mnonprofit
morganizations, mtrade massociations, mand mothers mdevelop mstandards.
Are mstandards mtypically mconsidered mlegally mbinding, mor mcan mthey mbe mincorporated minto mlaw mby
mgovernmental mbodies? m- mGenerally, mstandards mare mnot mlaw; mhowever, mthey mmay mbe mincorporated
minto mlaw mby mgovernmental mbodies.
For mwhat mreasons mmust mSterile mProcessing m(SP) mtechnicians mbe mfamiliar mwith mapplicable
mregulations mand mstandards? m- m• mRegulations mmust mbe mfollowed mand mfailure mto mcomply mwith
mthem mmay mresult min mlegal mconsequences mto mthe mhealthcare mfacility.
• mRegulations mand mstandards mmay minclude mworkplace msafety missues, mwhich mmay mhelp mto mprotect
mSP mtechnicians mfrom mexposure mto minfectious magents mand mtoxic msubstances.
• mRegulations mand mstandards mmay minclude mdisinfection mand msterilization mpractices.
• mWith mcareful mcompliance mwith mregulations mand mstandards, mpatient msafety mis mat mits mhighest mlevel
mof mquality mcare.
Who missues mregulations mand mstandards mthat mgovern mvarious msectors? m- mRegulations mand mstandards
mare missued mby mfederal, mstate, mand mlocal mgoverning magencies.
How mdo mprofessional morganizations mcontribute mto mthe mhealthcare msector min mterms mof mstandards
mdevelopment? m- mStandards mare malso missued mby mprofessional morganizations mand mprovide msignificant
massistance mto mhealthcare mpersonnel mbecause mthey mare mdeveloped maccording mto mbest mpractice.
What mis mthe mdefinition mof m"best mpractice"? m- mA mmethod mor mtechnique mthat mhas mconsistently
mshown mresults msuperior mto mthose machieved mby mother mmeans.
, What mrole mdoes mthe mU.S. mFood mand mDrug mAdministration m(FDA) mplay min mrelation mto mmedical
mdevices mand mpatient mcare? m- mThe mU.S. mFood mand mDrug mAdministration m(FDA) mis mresponsible mfor
mensuring mthat mmedical mdevices mare msafe mand meffective mfor mpatient mcare.
mdisinfectants, mpackaging mmaterials, msterilizers, mand mquality mmonitors msuch mas mbiological mindicators
m(BIs).
What mfactor mdetermines mthe mlevel mof mregulation mimposed mon ma mmedical mdevice? m- mThe mlevel mof
mregulation mplaced mon many mdevice mdepends mupon mhow mthe mFDA mclassifies mthat mdevice.
What mlevel mof mrisk mis massociated mwith mClass mI mdevices mand mwhat mare msome mexamples mof mClass mI
mmedical mdevices? m- mLow-risk mdevices, msuch mas mmost mhandheld msurgical minstruments, mhospital
mbeds, mand multrasonic mcleaners.
What mspecific mregulatory mcontrols mare mapplied mto mClass mI mdevices mby mthe mFDA? m- mThese mitems
mare msubject mto m"general mcontrols", mwhich minclude mregistration mand mdevice mlisting, mmedical mdevice
mreporting, mand mquality msystem mregulation mand mlabeling.
What mlevel mof mrisk mis massociated mwith mClass mII mdevices mand mwhat mare msome mexamples mof mClass mII
mmedical mdevices? m- mDevices mconsidered mto mpose mpotential mrisks mgreat menough mto mwarrant ma
What madditional mregulatory mmeasures mare mtypically mimposed mon mClass mII mdevices? m- mClass mII
mdevices mare musually msubjected mto mperformance mstandards, mpostmarket msurveillance mstudies, mand
mspecific mguidelines mor mspecial mlabeling.
What mis mthe mclassification mof mdevices mthat mundergo mthe mhighest mlevel mof mregulation mand mwhat
mare msome mexamples mof msuch mdevices? m- mThe mmost mstringently mregulated mdevices minclude mheart
mvalves, mpacemakers, mand mother mlife-sustaining mdevices.
What mis mthe mrequirement mfor mmanufacturers mof mnew mClass mIII mdevices? m- mManufacturers mof mnew
mClass mIII mdevices mmust mobtain ma mpremarket mapproval m(PMA) mfrom mthe mFDA mto mdemonstrate
mproduct msafety mand mefficacy.
What mis mthe mdefinition mof mthe mterm m"premarket mapproval m(PMA)"? m- mThe mFDA mprocess mof
mscientific mand mregulatory mreview mto mevaluate mthe msafety mand meffectiveness mof mClass mIII mmedical
mdevices.
How mdo mFDA mregulations mserve mto mprotect mthe msafety mof mpatients mand mhealthcare mworkers,
mparticularly mSterile mProcessing m(SP) mtechnicians, mand mwhat mspecific mrequirement mdoes mthe magency
mmanufacturer mto mprovide minstructions mfor muse m(IFU) mwith mthe mproduct.
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