Overview of Standards for External Defibrillators
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Transcript of Overview of Standards for External Defibrillators
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Overview of Standards for
External Defibrillators:
Role of FDA
Charles Ho, Ph.D.
FDACDRHODECharles.ho!fda.hhs."ov
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O$tline
1.1. %h& $se standards'%h& $se standards'
#.#. FDA(s role in standardsFDA(s role in standards
).). *ist of +aor standards*ist of +aor standards
-.-. *i+itations of standards*i+itations of standards
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1. %h& $se standards'
Standards failitate o++$niations inStandards failitate o++$niations in
/re0+aret reviews./re0+aret reviews.Standards /rovide test /rotools withStandards /rovide test /rotools with
/assfail riteria, whih for+ a o++on/assfail riteria, whih for+ a o++on
lan"$a"e between +an$fat$rers andlan"$a"e between +an$fat$rers and
FDA for s$bstantiatin" lai+s.FDA for s$bstantiatin" lai+s.2o need2o needto re0invent the wheel eah ti+e.to re0invent the wheel eah ti+e.
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Exa+/le:3o lai+ ade4$ate batter& a/ait& to
/ower a defibrillatorReferene: A2S5AA65 DF78, la$seReferene: A2S5AA65 DF78, la$se
18#.#18#.#Protool: At O9C, the batter& sho$ldProtool: At O9C, the batter& sho$ldenable the defibrillator to deliver at least #8enable the defibrillator to deliver at least #8shos at the +axi+$+ sho ener"&.shos at the +axi+$+ sho ener"&.
O9C test is +ore de+andin" than roo+O9C test is +ore de+andin" than roo+te+/erat$re test.;te+/erat$re test.;
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$t need to be in s$ffiient detail to allow>$t need to be in s$ffiient detail to allow
inter/retation b& both desi"n en"ineers and FDA.inter/retation b& both desi"n en"ineers and FDA.
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Re+e+ber, +ost standardsRe+e+ber, +ost standards
onernin" external defibrillators areonernin" external defibrillators are
vol$ntar&.vol$ntar&.
3he onl& +andator& standard for an3he onl& +andator& standard for an
external defibrillator is the Perfor+aneexternal defibrillator is the Perfor+ane
Standard for Eletrode *ead %ires andStandard for Eletrode *ead %ires and
Patient Cables, #1 CFR [email protected] Cables, #1 CFR 7@7.
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#. FDA(s Role in Standards
Altho$"h FDA had been involved in theAltho$"h FDA had been involved in thedevelo/+ent and $se of +edialdevelo/+ent and $se of +edialdevie standards for deades, thedevie standards for deades, theFood and Dr$" Ad+inistrationFood and Dr$" Ad+inistration6oderni=ation At BFDA6A of 1@@6oderni=ation At BFDA6A of 1@@
for+ali=ed the /roess.for+ali=ed the /roess.
Above state+ent ada/ted fro+ FDA website.
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FDA liaisons attend standardFDA liaisons attend standardo++ittee +eetin"s, /artii/ate ino++ittee +eetin"s, /artii/ate in
dis$ssions and vote on /ro/oseddis$ssions and vote on /ro/osed
standards, in order that thestandards, in order that theres$ltant standards +a& be +oreres$ltant standards +a& be +ore
ae/table to both the ind$str&ae/table to both the ind$str&
and the FDAand the FDA..
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Dr. Osar 3ovar is o$r Pri+ar&Dr. Osar 3ovar is o$r Pri+ar&*iaison for standards on external*iaison for standards on externaldefibrillators at the AA65 DFdefibrillators at the AA65 DF
Co++ittee and the 5ECCo++ittee and the 5EC 3C ?#SC3C ?#SC?#D63 1@?#D63 1@ Co++ittee.Co++ittee.
Dr. Rihard ra& is the AlternateDr. Rihard ra& is the Alternate
*iaison*iaison.
.
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3he FDA has onl& one vote in3he FDA has onl& one vote in
eah standards o++ittee, $steah standards o++ittee, $st
lie an& other entit&. 3h$s, so+elie an& other entit&. 3h$s, so+estandards +a& not be 188standards +a& not be 188
ae/table to FDA.ae/table to FDA.
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5n that ase, FDA reo"ni=es onl&5n that ase, FDA reo"ni=es onl&
the /arts of a standard that FDAthe /arts of a standard that FDA
a"rees with, and delines toa"rees with, and delines toreo"ni=e the /arts that FDA doesreo"ni=e the /arts that FDA does
not a"ree withnot a"ree with..
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Reo"nition of a standard>& reo"ni=in" a standard, or>& reo"ni=in" a standard, or
/arts of a standard, FDA indiates/arts of a standard, FDA indiates
that we have reviewed thethat we have reviewed thestandard and fo$nd it +ostl&standard and fo$nd it +ostl&
ae/table for s$bstantiatin"ae/table for s$bstantiatin"
lai+s +ade in a /re+aretlai+s +ade in a /re+arets$b+ittal.s$b+ittal.
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1)
Exa+/le: A
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5f a +an$fat$rer hooses not to o+/l&5f a +an$fat$rer hooses not to o+/l&
with an FDA reo"ni=ed standard, orwith an FDA reo"ni=ed standard, or
tests a defibrillator $sin" la$ses in thetests a defibrillator $sin" la$ses in thestandard that FDA delines to reo"ni=e,standard that FDA delines to reo"ni=e,
FDA will still review the /re+aretFDA will still review the /re+aret
s$b+ittal on a ase b& ase basis.s$b+ittal on a ase b& ase basis.
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1ioo+/atibilit&>ioo+/atibilit&
for defibrillator eletrodes B/ads orfor defibrillator eletrodes B/ads or
/addles:;/addles:;
5SO 18@@) G iolo"ial eval$ation5SO 18@@) G iolo"ial eval$ationof +edial devies 00 Part
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Environ+ental testin":Environ+ental testin": 5EC ?88?70#0#: Environ+ental testin" 05EC ?88?70#0#: Environ+ental testin" 0
Part #0#: 3ests 0 3est Ea and "$idane:Part #0#: 3ests 0 3est Ea and "$idane:ShoSho
5EC ?88?70#0?: Environ+ental testin" 05EC ?88?70#0?: Environ+ental testin" 0Part #: 3ests 0 3est F: IibrationPart #: 3ests 0 3est F: IibrationBsin$soidalBsin$soidal
5EC ?8
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-. *i+itations of standards
Standards do not over ever& as/et ofStandards do not over ever& as/et of
the external defibrillator. For exa+/le,the external defibrillator. For exa+/le,there is no linial or ani+al st$d&there is no linial or ani+al st$d&
/rotool in the AA65 DF78 standard./rotool in the AA65 DF78 standard.
BHowever, an infor+ative annex DD inDF78 has so+e historial notes on
linial st$dies.
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F$rther, it is widel& ae/ted thatF$rther, it is widel& ae/ted thatbi/hasi wavefor+s are s$/erior tobi/hasi wavefor+s are s$/erior to+ono/hasi wavefor+s and res$lt in+ono/hasi wavefor+s and res$lt ini+/roved /atient s$rvival. >$t thei+/roved /atient s$rvival. >$t the
standard that overs basi safet& andstandard that overs basi safet& andeffetiveness re4$ire+ents, AA65effetiveness re4$ire+ents, AA65DF78, does not /rohibit +ono/hasiDF78, does not /rohibit +ono/hasiwavefor+s.wavefor+s.
A new defibrillator with this oldtehnolo"& an still lai+ o+/lianewith DF78.
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*astl&, so+e standards /er+it a lar"e*astl&, so+e standards /er+it a lar"e
leewa& in desi"nin" the defibrillator,leewa& in desi"nin" the defibrillator,
so that /erfor+ane o$ld var&so that /erfor+ane o$ld var&onsiderabl& fro+ +an$fat$rer toonsiderabl& fro+ +an$fat$rer to
+an$fat$rer.+an$fat$rer.
An exa+/le is the differene between
delivered ener"& and seleted ener"&
in a defibrillator.
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Fro+ DF78, la$se #.1#.181;Fro+ DF78, la$se #.1#.181;
Delivered ener"&Delivered ener"&
J sho ener"& at$all& delivered to a /atientJ sho ener"& at$all& delivered to a /atient
Fro+ la$se #.1#.18?;Fro+ la$se #.1#.18?;Seleted ener"&Seleted ener"&
J ener"& intended to be delivered, asJ ener"& intended to be delivered, as
deter+ined b& the settin" of a ontroldeter+ined b& the settin" of a ontrolKs$all&, this is the ener"& shown in the ener"&Ks$all&, this is the ener"& shown in the ener"&dial of the defibrillator front /anel.dial of the defibrillator front /anel.
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