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Safety Instruments/Devices
untuk
Keselamatan Pasien
Dr. A. Samhari Baswedan MPA
Workshop Keselamatan Pasien dan Manajemen Risiko Klinis di Rumah Sakit
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Empiris - Teoritis - Praktis
MENGAPA?HARUS SAFETYDEVICE
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Safety Devices dalam Pelayanan Kesehatan
CONTINUUM of CAREPASIEN
sakit
PASIEN
SEHAT
Medikasi(MedicineDelivery)
Farmasi Nursing Tindakan
(Inter-vention)
Fisik SpecimenData &Images
DIAGNSTIK
TERAPI
Adapted from Safety Framework, RS Persahabatan akarta, No!ember "##$
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Safety Device dan Multi-ausal T!eory
“Swiss Cheese” Diagram (Reason, 1991)
asb#%#&
KTD
KNC
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MENGAPA?HARUS SAFETYDEVICE
HAI!"SI!#R"SI $ Re%&se $ NSI T&NT&TAN Rp
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ALAT KESEHATAN dengan RISIKO TERKECIL "eraki"at KTD (#Adverse Events$%#Unintended Negative
Outcomes$)-
APA?SAFETY DEVICE
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SAFETY DEVICEPRINCIPLES
1
' T!e RIHT DEVICE for
' T!e RIHT PROCEDURE for' T!e RIHT PATIENT
2Safety in
' Pro!"ring# U$ing#
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aonomSafetyDevices Medi'ation
Deli(er)
Dia*nosti'
Medi(a)
S)rin*es
Non
S)rin*es
Spe'imen #apture
Data!Ima*e
#apture
ADS
R&PS
I+
#atheter
Non%I+
#atheter
"lood
Non%"lood
Therap)
Inter(ention Sa,et) Tools
+a'uum
T&"Es-#.SED
S)stem/
ther T&"Es
or De(i'es
#are Related
Non%#are Related
Non*Medi(a)
WasteMn*mnt0
1ood2 .inen2 Gas2 Am3ulan'e et'0
"uildin*
thers
Medi'al!"ioWaste
-Sharps/
Waste
Safety
De!i(es
E#G2 &SG2
MRI2 #T%S'an
I#& Monitor
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ALAT &ang 'ANYAK (i)a*ai DI RS
'lat Suntik
'lco!ol Sa"Sarung TanganI at!eter#Dressing$
*otol Infus % Infusion Set
at!eter % N+T Tempat Tidur Termometer Tensimeter
,+'m"ulansS+ % .ontgen % T-Scan % M.I dll/
SD'01'0 Mereka M,M,N0I 1riteria S'F,T23
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BAGAIMANA?MEMILAH dan MEMILIH
Sa+,& D,i!,.
LAKUKAN Device Va/", 'udit4
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A"(i1
'paka!
1TD Terkait dg 5eralatan3 (.')
5eralatan
SD'0Safety3
Teruskan .'utk mencari
5enye"a"
Mendasar1TD4
SEERALAKUKAN
DVA1
YA1
TIDAK
M6NIT6.
(0'I%*SI%NSI)and.,I,7
YA1
'ELUM
FOKUS PADA Uni:HIH RISKS +or
In+,!ion$#I2ag,# L,ga/
HIH in
U$ag,Con$"2a4/,$#Pro("!ion Pr,$$"r,#Ca)ia/ In,$2,n
LAKUKAN La)oran KTDNSI#RCA# FMEA# Ri$* ra(ing (//
1TD krn'lat3
1TD krnara 5akai3
P,2a*aian Safety Device mencega! 1TD (an mengurangi "iaya total .S(,ngan mencega! risiko pem"orosan "iaya pelayanan%pengo"atan (an
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KRITERIA SAFETY DEVICE
SAFETY 'AHAN TEKNOLOI
PROSES
ntuk 5'SI,N
ntuk 5,T+'S
ntuk F'SI8IT'S
ntuk8IN+1N+'N
ntuk
'N++'.'N
T,1NIS
16NS,5T'8
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KRITERIA KONSEPTUAL
Safety
'M'N
untuk
5asien untuk
5etugasuntuk
Institusi%Fasilitas% 5rogram
untuk
8ingkungan
untuk
1elangsunga
n
*isnis
Beyond Quality…
Safety
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#1 :AMAN untuk PASIEN
RISIKO TERKECIL untuk KTD & KNC
(HAI/BSI, Drug Re!t"n$, %n
IATROENIC DAMAE k'u$u$n
SALAH DIANOSIS )
Beyond Quality
Safety
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ANALISA HASIL SURVEILANS
SECARA UMUM
Infeksi RS tertinggi adalah :
' Infeksi Aliran Darah (IAD) dan kejadian Plebitis .
Berikutnya:
' Infeksi Saluran Kemih (ISK)
' Infeksi Saluran Napas (ISN dan VAP)
' Infeksi Luka perasi (IL).' Kejadian Dekubitus.
Data RS di Cakarta2 Cuni%A*ustus 77
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#2: AMAN untuk
PETUGAS KESEHATAN.
RISIKO TERKECIL
untuk NSI & Blood Spltt!"TI$AK %!%udkn ERROR 't $IPAKAI
Beyond Quality
Safety
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SIAPA . - KAPAN. - DIMANA.
KTD L"*a T"$"*NSI.
SI'5' % 1or"an :
5eraat (; Dokter (?@=) : 5etugas 8a" (A=)
1'5'N :Saat menyuntik % pasang I-at! % am"il Dara!>
DIM'N' :
di Dalam%Dekat 1amar 5asien (B;=) > 61 (CB=) >5oli (?B=) > +D (=) > (I (E=)>
(.S #$ C ?H= M!s
5rt)
asb#%#&
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/o4a/ Di$ri4"ion
o+ HIV In+,!ion$#6789-677
/o4a/
Di$ri4"ion o+HIVAIDS# 6777So0r(e= NAIDS3 So0r(e= Ippo)ito, et.a).
North Ameri'a!
Western Europe
Su3%Saharan
A,ri'a
thers
North Ameri'a! Western Europe
thers Su3%Saharan
A,ri'a 876976
5656
:6
:6
asb#%#&IND6N,SI'3 ? T,.-;CEPAT
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#(: AMAN untukINSTITUSI KESEHATAN
TI$AK %ud RUSAK)TI$AK BER*UNGSI
TI$AK %ud +d, l'n PENUNTUTAN
%!%-ut PELAANAN l!-, E*ISIEN
Beyond Quality
Safety
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Beban "ia)a Aki3at @/D
A*i4a HAI : =>% (ari oa/),n,ri2aan RS 0i/ang# pada!al pasien
dg 0'I !anya H= dari total pasien (?B
0ospital StudyJ MedMinedJ S'J C
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#/: AMAN untuk LINGKUNGAN.
$", BAHAN RAMAH l,n0kun0n
TI$AK 'ul,t d,1MUSNAHkn
TI$AK %ud REAKSI d!n0n OBAT
Beyond Quality
Safety
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#3: AMAN untuk ANGGARAN.
%!%-!", TOTAL 4ALUE 5n0 TINGGI%!nu"unkn TOTAL COST o6 CARE
Beyond Quality
Safety
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Ha$i/ K/ini$ T,r4ai* Yang Da)aDi!a)ai
BK,)"a$an P,/anggan Pa$i,n
K,/"arga
BK,"angan RS ,a) ;S,0a<
VALUE : 1riteria T'M' Safety
'8, 0asil
5elayanan
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#ontoh Analisa -Total #ost o, #are/
5enggunaan I at! onvensional:
• .p @JH
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#ontoh Kasus Aki3at Non Sa,et)F
Progra2 Ti(a* EG$i,n : 'ia&a r"in !,* $"0"2,na(i 3 *a/i /i)a 'ia&a oa/ IV T0,ra)&
2,na(i 6#5 - >#5 *a/i /i)a (data .S di KakartaJ
C
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• "AHAN• TEKN.GI•
PRSES
KRITERIA TEKNIS
SAFETY DEVICES
'AHAN : M,(i!a/ S"rgi!a/ ra(,TEKNOLOI : M"a*0ir (g Error Margin 3% - 5%
PROSES : Fo*"$ )a(a F"ng$i 'UKAN P,na2)i/an
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*asics for 0ypodermic Syringe
Ta),r,(P/"ng,r
;S,rra,( T0"24Pr,$$< Sa&a)
/,4ar;F/ang,$
<
Mar*a ,/a$
L",r Ti)La, -
Fr,,So)),r
Po$ii, So);r,aining ring<
'arr,/'ENIN
1riteria Standar
'AHANPo/&)ro)0&/,n, M,(i!a/
ra(,MINIMUM;R,"< (an
;Si!*ion<asb0108
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1riteria '8'T SNTI1 yang "aik:
*a!an polyprophylene medical grade
Karum stainless steel surgical grade & dou"le "evel
*arrel "ening (transparan) Marka Pelas (“bold scale marking”)
5lunger sulit lepas saat aspirasi (“positive stop”)
5lunger ada lekukan (“tapered plunger rod”)5angkal *arrel #"ersayap le"ar$ (#ide Qange$)
5angkal 5lunger #kasar$ (#serrated t!um" press$)
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*e"as #lateks%karet alam$ (#8ate free$)
*e"as #reQu$ (#aliran "alik dara!$)
*e"as #sticktion$ (#aliran o"at tersendat-sendat$)
Karum 'man dari risiko 8uka Tusuk
*arrel rusak sesuda! dipakaiG
8im"a! Metal dan plastik dapat dipisa!
1riteriaALAT SUNTIK
yang "aik:
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'a0an *a,,r : ;'io2a,ria/<
'a0an 4agian &ang /ain : )o/&)ro)&/,n,
2,(i!a/ gra(, (an $ain/,$$ $,,/
;Man(rin< a2an (ari /"*a "$"* (an '/oo(S)/a,r
• Phlebitis= Komplikasi IV Catheter yg paling sering
• Bahan kateter merupakan penyebab utama thrombophlebitis
• Bahan “Biomaterial” mengurangi phlebitis sd !"#
• Bahan Biomaterial mengurangi kerusakan u$ung kateter sd
%'*C+ , -aukroger. P/B/ et al. In0usion 1hrombophlebitis, 2 prospective comparison. 2naesthIntens care
(3455). 3". 6"%7683
'a$i!$ +or IV Ca0,,r
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SAFE/ DEI:E
b0kanCSAFER De!i(e
b0kan
CAffordab)e Safety
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M,(i!a/ D,i!, R,!a//$
' FD' classiRes medical device recalls into t!ree categoriesJrepresenting t!e potential risk to pu"lic !ealt! lass I--!ig! risk a reasona"le c!ance t!e product ill cause serious
!ealt! pro"lems 6. deat!G
lass II--less-serious risk a possi"ility t!e device ill causetemporary%reversi"le !ealt! pro"lemsJ 6. a remote c!ance t!e device
ill cause serious !ealt! pro"lemsG lass III--lo risk little c!ance t!at using or "eing eposed to t!e
device ill cause !ealt! pro"lemsG *TJ t!e product violates FD' laJ sot!ere is still a need to take an action to address t!e pro"lemG
' FD'Os classiRcation determines t!e num"er of c!ecks t!e
company !as to make and t!e num"er of audits FD' illconduct to ensure eectiveness of t!e recall actionG It isintended to ensure t!e company folloed t!roug! on itsdecision to implement t!e recall action
So"r!,: GfdaGgov%MedicalDevices%Safety%.ecallsorrections.emovals%defaultG!tm
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D+A HAR&S mendahulukan Sa,et) Pasien Petu*as
RISI@> /INI9%; Infeksi , 9"; Ima1e,
9+; 4e1a)
/INI da)am9%; Pemakaian A)at,
9"; Beban @erGa,9+; :apita) In!estment.
DIMANA?
DIMANA PERLU Safety
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DIMANA PERLU SafetyDevice3
HARUS ;S,g,ra ICU3 OK
9 La4oraori"2 (1linik%Mikro%.adG) 5
Po/i*/ini* = 'ang$a/ ',(a0 'ang$a/Pa,(iari
S,4ai*n&a "ga $,g,ra6 VIP Uni > 'agian ii
'ar" *,2"(ian
Semua *angsal%nit 5elayanan
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BAGAIMANA?TINDAK LANUT.
Segera LAKUKAN Device Va/",
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