overview of standards for external defibrillators

7/23/2019 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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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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overview of standards for external defibrillators

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