Calibration of Medical Equipment

7/23/2019 Calibration of Medical Equipment

1/5

AKRAM AL-TAWARAHBiomedical Engineering Manager / Medical Project Manager at Faruk

Medical CityMarch 28, 2012

Tet e!ui"ment #or medical de$ice need to %e cali%ratedyearly&&&ometime #or many reaon 'e cant do that #or one

or t'o tet e!ui"ment &&& need your uggetion

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ee "re$iou comment

Yuri Tan, P.Eng am not ure that it i 'orth the rik o# teting medical de$ice 'ith uncali%rated tete!ui"ment& The "enaltie #rom regulatory agencie may %e $ery e$ere& E$en i# you 'erenot hea$ily "enalied, 'ould the thought that you could %e contri%uting to the harm o#"atient %e enough to caue you to enure that you are deli$ering the highet !uality"roduct "oi%le

March 28, 2012

AKRAM AL-TAWARAH3uri , a""reciate your uggetion and agree 'ith you 1004 #or "roduction line inmanu#acturer com"anie , %ut my !uetion related to any er$ice com"any a clinicalengineer de"artment in ho"ital 'ho ha$ the re"ona%ility to make er$ice #or all medicale!ui"ment ued in ho"ital in thi cae al'ay 'e ha$e ne' e!ui"ment #rom kno'nmedical e!ui"ment manu#acturer com"anie can %e ued to %e aure #or the accuracy o#our tet tool or com"are it 'ith other ne' tet tool&Crito"her again thank #or you inter$ention , kno' their i no limitation #or cali%rated"eriod or time in 5 .001 & 5nly #ocued in making cali%ration or $eri6cation , mention #orone year %ecue many o# cali%ration er$ice in Metrology and Cali%rated Center "eci#ythe #re!uency and e7"iration date %y one year a 3uri aid&

3uri , #rom my kno'ledge and my e7"erince , it a mut to ue cali%rated tet e!ui"ment tomake accurate tet #or your medical e!ui"ment ince you deal 'ith a#ety o# the "atient humanity&

March 28, 2012
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2/5

Dominador, Jr. Garrovillasi 9kram&

Baed on your comment a%o$e, think there i a need #or a re$ie' o# all your e!ui"ment&tarting #rom the %aic o# reading and undertanding e!ui"ment manual& The %et ource o#the #re!uency #or cali%ration i the manu#acturer: recommendationin the manual& 9nd inome o# the e!ui"ment manual, they e$en "ro$ide the cali%ration/ $eri6cation "rocedure to%e a""lied& 9nother i ne' e!ui"ment a "er ac!uired, uually %een "ro$ided %y themanu#acturer 'ith initial cali%ration record/ reult&

n cae that you need to cali%rate old e!ui"ment, $eri6cation uing the ne' e!ui"ment ia""lica%le a long a the latter i "ro$ided 'ith cali%ration record ho'ing that it 'a

tracean%e to kno'n national or international tandard&

etting the #re!uency o# cali%ration in the a%ence o# manu#acturer: recommendation 'ill%e %aed on other #actor like ho' o#ten you ued the e!ui"ment, hitory o# cali%ration o#imilar e!ui"ment, etc&& t i not the e7ternal cali%ration er$ice "ro$ider 'ho 'ill %e theone to et the cali%ration #re!uency& They jut "ro$ide the $alidity o# their er$ice/ 'arrantyin cae you ha$e claim& o'e$er %aed on record, you may et a di;erent cali%ration#re!uency in ome o# your e!ui"ment i# you ha$e not een any change in the reult&

ear >ominador a""reciate all o# your all o# your idea &&& o 'hen you make !uality audit e7ternal audit #or any er$ice or manu#acture com"any you may aked #or cali%ration certi6cate #or theetet e!ui"ment that cali%ration in any cali%rated center &&&'hat a%out thee tet tool notcali%rated , only made $eri6cation %y it o'ner &&& 'hat kind o# #orm you think 'ill ee tocheck it $eri6cation "roce i ok&thank
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3/5

March 2., 2012

Dominador, Jr. Garrovillasi 9kram&

n doing audit, 'e jut #ollo' the auditing "rinci"le and audit tandard& ?e need toundertand 6rt the re!uirement& For intance, 5 .001 re!uirement, 'e do not ak"eci6cally #or a cali%ration certi6cate o# certain e!ui"ment, 'hat 'e ak are record o#cali%ration %eing maintained %y the organiation& n cae an organiation chooe to ue acali%ration er$ice "ro$ider, 'e ak #or the e$idence uually in record "reented %y theer$ice "ro$ider& ?e ha$e to re$ie' the record i# it com"lie 'ith the cali%ration "rinci"le,i&e&, the "roce or method ued in cali%ration i acce"ta%le,the re#erence material ued in

cali%ration i tracea%le to kno'n international or national meaurement tandard, and the$alidity o# the cali%ration reult&


4/5

>ear >ominadorThank #or haring your rich "oint #or thi to"ic&

9"ril ), 2012

Jac !l"#c$"r9long 'ith Chrito"her: caution on long cali%ration inter$al&&&& you can ue the D"recali%rationD data #rom e!ui"ment coming in #or cali%ration to determine acce"ta%le inter$al%aed on your e!ui"ment: ue rik tolerance&

9"ril 12, 2012

AKRAM AL-TAWARAHthank jack &&& ere 'e can ay many #actor e;ect in cali%ration inter$al eithermanu#acturer recommendation , cali%ration hitory or relia%ility o# your tet e!ui"ment &&&&&&or yearly %udget "ro"oal many com"any aume 1year cali%ration i the %et inter$alo, think the %et and im"ortant "oint i to earch #or "oi%le long inter$al that eliminate#ailed o# cali%ration &

9"ril 12, 2012

Gill Pas#"rna R"al#ori 9krahm, The iue o# cali%ration inter$al, de"end motly on the uage o# thee!ui"ment, #or e7am"le a $ernier in daily ue in a machine ho" hould %e cali%rated t'icea year, and ome time e$en in horter inter$al o matter 'hat i the manu#acturer:recommendation # the ame $ernier i ke"t in a cloet and ued to $eri#y ra' material

thickne once in a'hile the cali%ration inter$al can %e totally di;erent&

9 mall clari6cation regarding to 5 .000 and cali%rating re!uirement&1& 9lthough the cali%ration inter$al i determined %y yourel#, mot auditor 'ill not acce"tar%itrary e7tenion o# cali%ration inter$al, their mut %e a "a"er 'ork e7"laining the reaon#or the e7tenion =egarding the e!ui"ment ta%ility not the cot o# cali%ration GG&

1& # any o# your e!ui"ment could not %e cali%rated on cali%ration e7"iry date regardle o#the reaon you mut record the reaon #or e7tending the cali%ration inter$al and the
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5/5

$eri6cation you did& n cae you don:t record it eem that the HM doen:t 'ork&

Iill PaternakHuality er$ice orth 9merica

9"ril 12, 2012

%o" D"l &os'u", M&A,(H)Po' are you all doing 'ith your "rocee 9nd o no' you ha$e determined an in"ectioncycle, %ut no' you dico$ered that one o# your tet e!ui"ment de$ice i out o# cali%ration&?hat i your "roce to going %ack and determining the amount/num%er o# e!ui"ment needto %e rechecked
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Calibration of Medical Equipment