20.safety devices
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Safety Instruments/Devicesuntukuntuk
Keselamatan Pasien
Dr. A. Samhari Baswedan MPAWorkshop Workshop KeselamatanKeselamatan PasienPasien dandan ManajemenManajemen RisikoRisiko KlinisKlinis didi RumahRumah SakitSakit
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Dr. Ahmad Samhari Baswedan MPADr. Ahmad Samhari Baswedan MPA
•• MulaiMulai di Yogyakarta, 7 Pebruari 1954; Sekarang Sekarang di Taman Rasuna Apartment, Tower 18N, Unit 20I, Jln HR Rasuna Said, Kuningan Jakarta, 12930; HandPhoneHandPhone : 0811 80 70 30; ee--mailmail : [email protected]
•• MenerimaMenerima Masters in Public Administration, Harvard University, USA, 1998. LulusLulus Medical Doctor, Gadjahmada University, Yogyakarta, 1981
• Sekarang,Sekarang, Anggota Komite Keselamatan Pasien PERSI dandan Program Manager PR-TB Global Fund ‘Asiyiyah dan Konsultan Manajemen Rumah Sakit & Kinerja Organisasi
• Sebelumnya,ebelumnya, Management Consultant (Organisasi & SDM) & Guest Lecture Program Magister Kesehatan FK-UGM. 2001 – 2006; Health Coordinator, UNICEF East Timor 2000-2001; Health & Nutrition Coordinator, UNICEF Indonesia 1988-2000; Nutrition & Health Officer, UNICEF Indonesia 1983-1988 ; Teaching Staff, Medical School Gadjahmada University 1981-1983 2
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HARUS SAFETY DEVICE
Empiris – Teoritis - Praktis
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Safety Devices dalam Pelayanan Kesehatan
CONTINUUM of CAREORANG ORANG
Fisik Specimen Data &Images
DIAGNOSTIK
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CONTINUUM of CAREORANGsakit
ORANGSEHAT
Medikasi(MedicineDelivery)
Farmasi NursingTindakan
(Inter-vention)
TERAPI
Adapted from Safety Framework, RS Persahabatan Jakarta, November 2007
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Safety Device dan Multi-Causal Theory“Swiss Cheese” Diagram (Reason, 1991)
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KTDKNC
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MENGAPA HARUS SAFETY?
TEKNIS STRATEGIS
HAI / BSI / CRBSINSI
“Tuntutan”Image
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NSIMis-Diagnosis
ImageSustainability
Rp TURUN
“Total Cost of Care” NAIKTotal Value TURUN
“Total Business Cost”TINGGI
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HAIs: Masalah Pelayanan Kesehatan Dunia
MORBIDITAS• 32 % = Urinary Tract Infections• 22 % = Surgical Site Infections • 15 % = Pneumonia/Lung Infections • 14 % = Blood-Stream Infections
MORTALITAS• 11,1 % • 8,2 % • 36,3 %• 30,9 %
HAI : “Hospital Acquired Infection” / BSI : Blood stream Infection / CRBSI : Catheter-Related BSI
• 14 % = Blood-Stream Infections • 30,9 %
DIMANA?• 1,96 % = High Risk Nurseries (PICU/NICU)• 1,12 % = Well-Baby Nurseries • 24,55 % = ICU (semua pasien) • 74,55 % = Di luar ICU (semua pasien)
USA : Klevens, Edwards, Richards, et al. Pub Health Rep 2007;122:160-6
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Global Distribution of HIV Infections, 1984-1997
Global Distribution of HIV/AIDS, 1999Source: UNAIDS/WHO Source: Ippolito, et.al.
North America/ Western Europe
Others Sub-Saharan
KTD Luka Tusuk/NSI & ANCAMAN AIDS
Sub-Saharan Africa
Others
North America/ Western Europe
Others Sub-Saharan Africa 90%
70%26%
6%
4%
4%
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INDONESIA? # 1 TER-“CEPAT” DI ASIA
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Hasil Klinis Terbaik Yang Dapat Dicapai
+Kepuasan Pelanggan (Pasien & Keluarga)
Total VALUE = Hasil Pelayanan
Kepuasan Pelanggan (Pasien & Keluarga)
+Keuangan RS tetap “Sehat”
VALUE : Kriteria UTAMA Safety Device
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Contoh Analisa “Total Cost of Care”
Penggunaan IV Cath Convensional:• Rp 4,500 (3 kali dalam 2 hari) = 13,500• Thrombophob Rp. 13,500 (3 tube) = 55,500• Dressing Rp 4,750 (3 kali) = 14,250• Cost/Biaya pasang IV Cath (3 kali) = 3X• Cost/Biaya Keluhan pasien = 3Y
TOTAL Cost of Care = ( 83,250 + 3X + 3Y )
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TOTAL Cost of Care = ( 83,250 + 3X + 3Y )
Penggunaan IV Cath “Biomaterial” (Setengah Safety)• Rp 4,500 (1 kali, pada hari 1) = 4,500• Rp. 14,500 (1 kali dalam 2 hari) = 14,500• Thrombophob Rp.13,500 (1 tube) = 13,500• Dressing Rp 4,750 (2 kali) = 9,500• Cost/Biaya pasang IV Cath (2 kali) = 2X• Cost keluhan pasien = 2Y
TOTAL Cost of Care = ( 52,000 + 2X + 2Y)
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ASBASB--270208270208
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SAFETY DEVICE
ALAT KESEHATAN dengan RISIKO TERKECIL berakibatKTD (“Adverse Events”/“Unintended Negative Outcomes”)
Error Margin : 3% - 5%
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TaxonomiSafety Devices
MedicationDelivery
Diagnostic
Medical
Syringes
NonSyringes
Specimen Capture
ADS
RUPS
IVCatheter
Non-IVCatheter
Blood
Non-Blood
Therapy
Intervention Safety Tools
VacuumTUBEs
“CLOSED
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Data/Image Capture
Non-Blood“CLOSEDSystem”
Other TUBEsor Devices
Care Related
Non-Care Related
Non-Medical
Waste Mngmnt.
Food, Linen, Gas, Ambulance etc.
Building
Others
Medical/BioWaste
“Sharps”Waste
Safety Devices
ECG, USG, MRI, CT-ScanICU Monitor
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ALAT yang BANYAK dipakai DI RSAlcohol Swab
Alat SuntikSarung Tangan
IV Catheter“Dressing”
Botol Infus / Infusion SetCatheter / NGT
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Catheter / NGTTempat TidurTermometer Tensimeter
ECGAmbulans
USG / Rontgen / CT-Scan / MRI dll…
SUDAHKAH Mereka MEMENUHI Kriteria SAFETY?
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Refraktometer, Non Contact Tonometer, Biometri, Ultrasonografi Mata, Topografi Korne, Nd.Yag
Laser, Argon laser, LASIK, Foto Fundus, Optical , Optical Coherence Tomography/OCT, Coherence Tomography/OCT, FundusFundus FluoresceinFluoresceinAngiography/FFA, Non Contact Angiography/FFA, Non Contact TonometriTonometri/ NCT, / NCT, ElectroretinographyElectroretinography/ERG, Perimeter Humphrey, /ERG, Perimeter Humphrey, Octopus, Goldman Laser Octopus, Goldman Laser NdNd--YagYag, Laser Argon, , Laser Argon,
HEPA FilterHEPA Filter, Mikroskop Operasi dengan CCTV, Alatbedah katarak Fakoemilsifikasi, Bedah Vitreretina,
Glaukoma, Okuloplasti, Strabismus dll.
ASBASB--2610201026102010
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Situasi RS di Indonesia?
Absence of Equipment Maintenance :India : Moderate
Nepal : HighNepal : High
Bangladesh : Moderate
Srilangka : Moderate –Low
Indonesia : High(IAPB Workshop Report, 2008)
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PRINSIP SAFETY DEVICE1
• The RIGHT DEVICE for
• The RIGHT PROCEDURE for• The RIGHT PROCEDURE for
• The RIGHT PATIENT
2
Safety in
• Procuring, Using, Maintainingasb0108
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KRITERIA SAFETY DEVICE
SAFETY BAHAN TEKNOLOGI
PROSES
Untuk PASIEN
Untuk PETUGASTEKNIS
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Untuk PETUGAS
UntukANGGARAN
KONSEPTUAL / Strategis
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KRITERIA KONSEPTUAL
Safety
untuk
Pasien
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SafetyAMAN
untuk
Petugasuntuk
Kelangsungan
Bisnis
Beyond Quality…Safety
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#1:AMAN untuk PASIENRISIKO TERKECIL untuk KTD & KNC
(HAI/BSI, Drug Reactions, and
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Safety
(HAI/BSI, Drug Reactions, and
IATROGENIC DAMAGE dan terutama,
MIS-DIAGNOSIS )
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#2: AMAN untuk PETUGAS
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Beyond QualitySafety
RISIKO TERKECIL
untuk NSI & Blood Splatter,TIDAK memudahkan ERROR saat DIPAKAI
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#3: AMAN untuk ANGGARAN(Kelangsungan Bisnis)
Memberi TOTAL VALUE yang TINGGI,
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Beyond QualitySafety
Memberi TOTAL VALUE yang TINGGI,Menurunkan TOTAL COST of CARE
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Beban Biaya Akibat KTD
Akibat fokus pada harga : Biaya pemeriksaan suhu pasien 2.5x (RS X, Tangerang, 2009)
Akibat Misdiagnosa : Tuntutan 2,3 M & public apologia, dlm proses (RS X, JaBar, 2009)public apologia, dlm proses (RS X, JaBar, 2009)
Akibat Perawatan Pasca-bedah tidak terkontrol: Nenek jadi Buta setelah operasi Katarak (Medan, 2007) – Penyelesaian secara “kekeluargaan”…..
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• BAHAN• TEKNOLOGI
KRITERIA TEKNISSAFETY DEVICES
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• TEKNOLOGI• PROSES
BAHAN : Medical / Surgical GradeTEKNOLOGI : Mutakhir dg Error Margin 3% - 5%PROSES : Fokus pada Fungsi BUKAN Penampilan
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Basics for Hypodermic Syringe
Tapered Plunger
Marka Jelas
Positive Stop “retaining ring”
Barrel BENING
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“Serrated Thumb Press” Sayap
lebar “Flanges”
Luer TipLatex - Free Stopper
Kriteria Standar
BAHAN Polyprophylene Medical Grade
MINIMUM “Reflux” dan“Sticktion”
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Kriteria ALAT SUNTIK yang baik:
Bahan polyprophylene medical grade
Jarum stainless steel surgical grade & double bevel
Barrel bening (transparan)
Marka jelas (“bold scale marking”)
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Marka jelas (“bold scale marking”)
Plunger sulit lepas saat aspirasi (“positive stop”)
Plunger ada lekukan (“tapered plunger rod”)
Pangkal Barrel “bersayap lebar” (“wide flange”)
Pangkal Plunger “kasar” (“serrated thumb press”)
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Bebas “lateks/karet alam” (“Latex free”)
Bebas “reflux” (“aliran balik darah”)
Bebas “sticktion” (“aliran obat tersendat-sendat”)
Kriteria ALAT SUNTIK yang baik:
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Bebas “sticktion” (“aliran obat tersendat-sendat”)
Jarum Aman dari risiko Luka Tusuk
Barrel rusak sesudah dipakai.
Limbah Metal dan plastik dapat dipisah
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Bahan kateter : “Biomaterial”
Bahan bagian yang lain : polypropylene medical grade dan stainless steel
“Mandrin” aman dari luka tusuk dan Blood Splatter
Basics for IV Catheter
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“Mandrin” aman dari luka tusuk dan Blood Splatter
• Phlebitis = Komplikasi IV Catheter yg paling sering
• Bahan kateter merupakan penyebab utama thrombophlebitis
• Bahan “Biomaterial” mengurangi phlebitis s/d 46%
• Bahan Biomaterial mengurangi kerusakan ujung kateter s/d 50%
SOURCE : Gaukroger, P.B. et al, Infusion Thrombophlebitis: A prospective comparison, Anaesth Intens care (1988), 16, 265-271
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Basics Of…?
asb26102010
Do We know?
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asb0108asb26102010
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Bahan : “Full Cotton”
Packing : “Full aluminum foil” dg “heat-resistant lining” di bagian luar dan diproses secara vakum
Bahan aktif : Isopropyl alcohol / Acohol + Iodine / Alcohol + Chlorhexidine
Basics for Alcohol Swabs
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Basics for “Electronic Diagnostics” Industrial Component NOT General OR Household
Micro-voltage & “Full Insulation”
Clear direction for maintenance & calibrations
50,000 hours LCD
Margin of Error maximum 3%
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RISIKO TINGGI(1) Infeksi , (2) Image,
(3) Tuntutan
DIMANA & KAPAN?
DVA HARUS mendahulukan Safety Pasien & Petugas
TINGGI dalam(1) Pemakaian Alat,
(2) Beban Kerja, (3) Capital Investment.
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DIMANA & KAPAN Safety Device?
HARUS (“Segera”) :1. UGD 2. ICU 3. OK
4. Laboratorium (Klinik/Mikro/Rad.) 5. Poliklinik6. Bangsal Bedah 7. Bangsal Paediatri6. Bangsal Bedah 7. Bangsal Paediatri
Sebaiknya juga segera…1. VIP Unit* 2. Bagian Gizi
Baru kemudian….Semua Bangsal/Unit Pelayanan
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MEMILAH dan MEMILIH?Tindak Lanjut?
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LAKUKAN DVA : Device Value Audit!
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Langkah Langkah Device Value Audit
ApakahKTD Terkaitdg Peralatan?
(RCA)
PeralatanSUDAH Safety?
YA!
TIDAK
MONITOR(HAI/BSI/NSI)
andREVIEW
YA!
BELUM FOKUS PADA Unit:HIGH RISKS for
KTD krn Alat?
KTD krn Cara Pakai?
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Teruskan RCAutk mencari PenyebabMendasar
KTD!
SEGERALAKUKAN
DVA!
HIGH RISKS forInfections,
Image, LegalHIGH in
Usage/Consumables, Production Pressure, Capital Investment.
LAKUKAN Laporan KTD/NSI, RCA, FMEA, Risk Grading dll
Pemakaian Safety Device mencegah KTD dan mengurangi biaya total RS denganmencegah risiko pemborosan biaya pelayanan/pengobatan dan biaya akibat KTD!
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Medical Device Recalls List
Source:Source:www.fda.gov/MedicalDevices/Safety/
RecallsCorrectionsRemovals/default.htm
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‘CLS’ /‘‘CLS’ /‘Checkheck List forist for Safety’afety’
Device Value Audit PLUS Maintenance Plan?
Procurement Plan
Contractual Strategy Contractual Strategy
Training Strategy
Technology Updates (Plan & Strategy)
ROI Strategy?
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