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Transcript of 02/09 11h30 Plenária - sobecc.org.br 11h30 Plenária... · 6 Instrument circulation in a hospital...
•Preparation at the point of use•Preparation, cleaning, disinfection•Drying•Inspection, maintenance and testing•Packaging•Sterilisation•Storage
ISO 17664 (2004)
6
Instrument circulation in a hospital
Storage/transport
Cleaning/disinfection
Service and maintenance
Functional testing
Sterilisation
Storage
Available for use
Use
3.5 Cleaning
A validated method of cleaning shall be specified. At least one validated automated method using a washer-disinfector shall a lso be specified unless the medical device cannot withstand any such proces s, in which case a warning should be issued.
Where appropriate, at least the following informati on shall be included:
.accessories required for cleaning process;
.identification and concentration of chemicals requi red for cleaning;
.identification of water quality,
.limits and monitoring of chemical residues
.limits on temperature, concentration of solution(s) , exposure time,
.process temperature(s);
.techniques to be used including rinsing;
ISO 17664 (2004)
Chapter 5 allows the building of groups of instrume nts:
„Where the manufacturer supplies a number of differe nt medical devices which share common features and attributes, the validation specified may be performed with respect to these me dical devices as a group of family, provided that the manufacture r can demonstrate the commonality of the medical devices and that the tests and assessments address the worst case featur e or attribute of the group of family“
________________________________________________________Standard EN/ISO 17664:
ISO 17664 (new)
Scope
1.1 InclusionsThis International Standard specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device.
The provisions of this standard are applicable for medical devices that are intended for invasive or other direct patient contact.
Processing instructions are not defined in this standard. Rather, this International Standard specifies requirements to assist manufacturers of medical devices in providing detailed instructions for processing that consists of the following activities where applicable:
ISO 17664 (new)1.1 Inclusions
a) Pre-treatment at the point of use before processing;b) Preparation before cleaning,c) Cleaning,d) Disinfection;e) Drying;f) Inspection, maintenance and testing;g) Packaging;h) Sterilization;i) Storagej) Transportation.
1.2 This standard excludes:• noncritical medical devices not intended for direct patient contact;• Textile devices used in patient draping systems or surgical clothing;• processing of medical devices specified by the manufacturer for
single-use only and supplied sterile.
6.7.1.2 If the medical device is intended to be disinfected a validated method of manual disinfectionShall be specified if automated disinfection is not possible
ISO 17664 (new)
Categories of instruments and specific requirements for use:
>Instruments, to be used outside the body.
>Instruments, to be usedinside the body withoutpenetration of the mucosaor skin.
>Instruments, penetratingthe skin or mucosa.
Clean / Disinfected
High Level Disinfected
Sterile
Spaulding Classification by the CDC
Classification of the instruments groups
Group 1: Critical Instruments,like hooks; no hidden surfaces and lumens
Group 2: Critical InstrumentsScissors, Clamps
Group 3: Shift shaft instrumentsRongeur etc.
Group 4: Shaft instruments for MISneed validation, as the result of the cleaning can not be inspected
Group 5: Micro surgical Instrumentsneed validation, as the result of the cleaning can not be inspected
Group 6: Complex Deviceshas to be tested, as no analogical conclusions can be made
Group 7: Flexible Instrumentsneed validation, as the result of the cleaning can not be inspected
1. Messungnach Kontamination
2. Messungnach Vorreinigung + 10 min 40°C Einweichen
4. Messungnach Reinigung
1. Messungnach Kontamination
2. Messungnach Vorreinigung + Ultraschall 10 min 40°C
3. Messungnach Reinigung
Nr.87/26 Zr Zr Zr Zr Zr Zr
Crile clamp 1 98 4 4 122 3 3Crile clamp 2 66 3 3 97 3 3Crile clamp 3 121 2 2 145 3 3
Crile Clamp,
Comparison of Group 2 Instruments
Group 2 (Instruments with hidden surfaces): Side cutter
1. Messungnach Kontamination
2. Messungnach Vorreinigung + 10 min 40°C Einweichen
3. Messungnach Reinigung
1. Messungnach Kontamination
2. Messungnach Vorreinigung + Ultraschall 10 min 40°C
3. Messungnach Reinigung
Nr.87/26 Zr Zr Zr Zr Zr Zr
Wire cutter 1 69 10 10 95 4 4Wire cutter 2 79 9 7 57 4 4Wire cutter 3 59 9 8 65 3 4
Tischler-Morgan(Not dismountable)
Step 1
Yes 1 Yes 2 Yes 3
NoStep
2
Yes 1 Yes 2 Yes 3
No Step 3
Yes 1 Yes 2 Yes 3
NoValidation notsuccessfull
Group 3: Shift shaft instruments
Group 3 (Shift shaft instruments):Rongeur,Arthroskopiezangen etc.
1. Messungnach Kontamination
2. Messungnach Vorreinigung + 10 min 40°C Einweichen
4. Messungnach Reinigung
1. Messungnach Kontamination
2. Messungnach Vorreinigung + Ultraschall 10 min 40°C
3. Messungnach Reinigung
Nr.87/26 Zr Zr Zr Zr Zr Zr
Rongeur 1 85 14 16 249 13 7Rongeur 2 121 11 10 311 12 7Rongeur 3 88 17 17 245 30 17
BronchoscopyForceps
(Dismountable)Step 1
Yes 1 Yes 2 Yes 3
NoStep
2
Yes 1 Yes 2 Yes 3
No Step 3
Yes 1 Yes 2 Yes 3
NoValidation not
successfull
Group 3: Shift shaft instruments (dismantable)
Mechanics: Amount of WaterPressureUltrasound
Temperature
Interacting Time
Chemical AgentWater Quality
Parameters of the Cleaning Cycle
Results: Remaining contamination in the shaft
MIS Instruments dismountable
100%
0%
100%
0%
73%
27%
27%
73%
0%10%20%30%40%50%60%70%80%90%
100%
Hunderte
Miele 7836 Oxivario GesamtAnteill der Ins. 11
Miele 7836 Tw/Tb GesamtAnzahl der Ins. 11
Miele 7735 AlkalischGesamt Anteil der Ins.11
Miele 7735 EnzymatischGesamt Anteil der Ins.11
Anzahl der Instrumrnte unter 5 Counts/secAnzahl der Instrumrnte über 5 Counts/secManual pre-cleaning required
100%
0%
95%
5%
84%
16%
48% 52%
42%
58%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Hunderte
Niagara EnzymatischGesammt Anteil der
Ins.19
Miele 7836 OxivarioGesamt Anteill der Ins.
19
Miele 7836 Tw /TbGesamt Anzahl der
Ins. 19
Miele 7735 AlkalischGesamt Anteil der
Ins.19
Miele 7735 Enzymatisch Gesamt
Anteil der Ins.19
Anzahl der Instrumrnte unter 5 Counts/secAnzahl der Instrumrnte über 5 Counts/sec
MIS Instruments, not dismountable with Luer adapterResults: Remaining contamination in the shaft
Manual pre-cleaning required
Tab. 58: Zusammengefasste Ergebnisse Gruppe 2 „Alkalisch maschinell und ggf. manuellen Vorreinigung“
Step 3
Step 2
Step 12 A Titan 2 A Ceramic 2 B 2 C 2 D 2 E 2 F
Group 2: AlkalineE
ffort
for
clea
ning
Instruments sorted by category
Tab. 59: Zusammengefasste Ergebnisse Gruppe 2 „Enzymatisch maschinell und ggf. manuelle Vorreinigung“
Step 3
Step 2
Step 12 A Titan 2 A Ceramic 2 B 2 C 2 D 2 E 2 F
Group 2: Enzymatic automated and manual if necessar y
Effo
rt fo
r cl
eani
ng
Instruments sorted by category
Val
idat
ion
not
suc
cess
full
Val
idat
ion
not
suc
cess
full
Influence of the detergent
Power of cleaning processes
Enzymatic process
Alcaline process
Multicomponent Enzymatic process
Oxivario Process
First results of the year 2005
In order to implement the up and coming EN ISO 1588 3 in practice, we worked out the “Guidelines of the DGKH, DGSV and AKI for validating and routinely monitoring automatic washing and disi nfecting processes for thermo-stable medical devices, and principles f or selecting a washer-disinfector (WD)”Part 1**.
In an inter-hospital trial conducted with 18 hospit als, the practicability and meaningfulness of the test method was investiga ted.
5 of 18 WD involved in the trial were over threshol d.
Although the sensitivity of the semi-quantitative B iuret / BCA method used in the tests is fairly low, it can be presumed that the evaluation framework is sufficient for the moment to identify WDs with poor cleaning quality, and to monitor the quality of the measures carried out here.
Inter-hospital trials to determine minimal cleaning performance according to the Guidelines from DGKH, DGSV and AKI; Zentr Steril 2005; 13
Foaming in the cleaning process
Logger data in a washer/disinfector loaded with hea vily soiled instruments
Dosing of the cleaning agent:
Pressure decrease from 0.2 bar to 0.1 bar
Protein detection methods
• Bradford-Method• Modified OPA-Method• Biuret-Reaction• BCA-Protein Assay Kit • Ninhydrin-Reaction• TOC (Total organic Carbon)• ATP• Combur 3Test • HemoCheck-S
44
HemoCheck-S
46
• Test Kit for a qualitative determination blood on surgical
instruments
100µg 1µg 0µg
Combur 3 Test
50
• Hemoglobin katalysed the Oxidation of the indicator by
organic H2O2
• Very sensitive
• Detection limit at 0,3 µg/ml
• Extraction of the protein from the instrument can be
performed with SDS
Method Sensitivity
Recovery
Training Costs Results
Bradford
+ ++ 0 - 3
OPA + ++ - -- 0
Biuret + ++ - -- 0
BCA + ++ - - 1
Ninhydrin
+ - + + 2
TOC - + - -- -3
ATP - - + 0 -1
Hemocheck
++ - + + 3
Comburtest
++ ++ + ++ 7
Criteria for selection of the test method
Classification of the instruments groups
Group 1: Critical Instruments,like hooks; no hidden surfaces and lumens
Group 2: Critical InstrumentsScissors, Clamps
Group 3: Shift shaft instrumentsRongeur etc.
Group 4: Shaft instruments for MISneed validation, as the result of the cleaning can not be inspected
Group 5: Micro surgical Instrumentsneed validation, as the result of the cleaning can not be inspected
Group 6: Complex Deviceshas to be tested, as no analogical conclusions can be made
Group 7: Flexible Instrumentsneed validation, as the result of the cleaning can not be inspected
Products: Endoscopic Take-Apart Instrument / Company:…...
ADVICE:
Reprocessing procedures have only limited implications to a surgical instrument. The limitation of the numbers of reprocessing procedures is therefore determined by the function / wear of the device. In case of damage the device should be reprocessed before sending back to the manufacturer for repair.
Reprocessing Instructions
Preparation at the Point of Use:
Remove gross soiling by submerge the instrument into cold water (<40°C) immediately after use. Don’t use a fixating detergent or hot water (>40°C) as this can cause the fixation of residua which may influence the result of the reprocessing process.
Transportation: Safe storage and transportation to the reprocessing area to avoid any damage and contamination to the environment.
Preparation for Decontamination:
The devices must be reprocessed in a disassembled state.
Pre-Cleaning: Warning: Do not allow the instruments to rest on th e bottom of an ultrasonic cleaner unit during cleaning, as damage or incomplete cleaning could re sult. 10 minutes at 40°C in an ultrasonic bath with 0,5% detergent. Brushing the instrument under running tap water until all visible residues are removed Flushing the inner lumens of all parts with a water jet pistol (pressure min. 3 bar) with cold tap water for at least 10 seconds.
Cleaning:
Manual Cleaning Process: 1. Rinsing under running tap water (<40°C) until all visible soil has been removed. If needed a soft bristle brush should be used to remove visible soil; 2. Submerge instruments in an detergent (if ultrasonic bath is used, ultrasonic process of 3 minutes and ultrasonic frequency of 35 kHz have been shown to be effective). Follow the instructions of the manufacturer of the detergent; 3. Rinse the instrument under running tap water to remove the detergent.
Automated Cleaning: Connect the instrument to a rack for MIS-instruments and start the program
• 4 min pre-washing with cold water (<40°C); • 6 min washing with 0,5% detergent at 55°C; • 3 min neutralising with warm water (>40°C); • 2 min intermediate rinsing with warm water
(>40°C). Special instructions of the manufacturer of the automated washing machine have to be followed.
Disinfection:
Manual Disinfection: 1. Submerge instruments in an disinfection detergent according to the instructions of the manufacturer of the detergent; 2. Rinse the instrument with sterile water to remove the detergent.
Automated Disinfection: Automated Thermal Disinfection in washer/disinfector under consideration of national requirements in regards to A0-Value (see EN 15883)
Drying: Manual Drying: Dry the instrument with a lint free towel. The instrument may never be heated up >140°C. To avoid water residues we recommend using sterile compressed air to insufflate cavities.
Automated Drying: Drying of outside of instrument through drying cycle of washer/disinfector. If needed, additional manual drying can be performed through lint free towel. Insufflate cavities of instruments by using sterile compressed air.
Functional Testing, Maintenance:
Functional testing, if available according to instructions of use and visual inspection for cleanliness. If necessary perform reprocessing process again until instrument is visibly clean.
Packaging: Appropriate packaging for sterilization.
Sterilization: Sterilization of instruments by applying a fractionated pre-vacuum process (according DIN EN 554 / ISO 11134) under consideration of the respective country requirements. Parameters for the pre-vacuum cycle: 3 prevacuum phases with at least 60 milli bar Heat up to a minimum sterilization temperature of 132°-134°C Minimum Holding time: 3,5 min Drying time: minimum 10 min Flash sterilization is not allowed on lumen instrum ents!
Storage: Storage of sterilized instruments in a dry, clean and dust free environment at modest temperatures of 5°C to 40°C.
Reprocessing validation study information
The following testing test devices, materials & machines have been used in this valdition study; Detergent: deconnex 28 Alka One, (Borer, Zuchwil, Switzerland) deconnex 23 Neutrazym, (Borer, Zuchwil, Switzerland) Washer / Disinfector: Miele 7735 CD Instrument Rack: Miele E450-1 Details: See report SMP 05506011407-1
Conclusion
• ISO 17664 is demanding more information from the manufacturer for the user
• ISO 17664 is requiring qualified equipement accordin g to the standard and validated processes
• Methods for the evaluation and quality control of c leaning processes has already been developed and establish in some countries.
• They have led to an improvement of the outcome of t he cleaning process
• Sensitive test methods have to be validated when ap plied in the daily routine