BBraun
Validated Instrument Reprocessing Procedures Guide
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Aesculap® Validated Reprocessing Procedures
AVA-V6
Validated Reprocessing Procedures Preface
Premium quality instruments are a valuable commodity that deserve to be treated with care and respect. The surgical instrumentation of a hospital represents a considerable proportion of its fixed assets. In view of this, it is essential that the functionality and value of reusable medical devices, particularly surgical instruments, are preserved for the long term through professional reprocessing. The measures recommended here should be implemented in accordance with the manufacturer's instructions, hygiene requirements, and health and safety regulations. Instrument reprocessing is becoming increasingly regulated by the German Medical Devices Act, a global harmonization of standards, and specific national laws and regulations (such as the MPBetreibVO (Medical Devices Operator Ordinance) as part of the MPG (Medical Devices Act) within Germany), which explicitly demand validation measures for reprocessing. The best way to comply with such requirements, and demonstrate compliance, is to implement a dedicated quality management system incorporating these measures. This brochure provides details of the validated reprocessing procedures used for Aesculap AG products.
2
Contents
1.
About these instructions for use
4
2.
Product-specific characteristics
4
3.
Validated instrument reprocessing procedure
5
3.1
General safety instructions
5
3.2
General information
5
3.3
Validated cleaning and disinfecting procedure
6
3.4
Preparations at the place of use
6
3.5
Preparations before cleaning
6
3.6
Cleaning/Disinfection
6
3.7
Wipe disinfection for electrical devices without sterilization
7
3.8
Manual cleaning/disinfection
7
3.8.1
Manual cleaning and wipe disinfecting
8
3.8.2
Manual cleaning with immersion disinfection
9
3.8.3
Manual cleaning with ultrasound and immersion disinfection
11
3.9
Mechanical cleaning/disinfection
13
3.9.1
Mechanical alkaline cleaning and thermal disinfecting
13
3.9.2
Mechanical neutral or mild alkaline cleaning and thermal disinfecting
14
3.10
Mechanical cleaning/disinfection with manual pre-cleaning
15
3.10.1
Manual pre-cleaning with a brush
15
3.10.2
Manual pre-cleaning with ultrasound and brush
16
3.10.3
Mechanical alkaline cleaning and thermal disinfecting
17
3.10.4
Mechanical neutral or mild alkaline cleaning and thermal disinfecting
18
3.11
Steam sterilization
19
3.12
Sterilization for the US market
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3
Validated Reprocessing Procedures
1.
About these instructions for use
These instructions for use: ■ contain information about the various validated reprocessing procedures and notes on sterilization for all Aesculap products. ■ do not replace the instructions for use of the product being reprocessed. Note Before reprocessing, take note of the product-specific characteristics.
2.
Product-specific characteristics
► Before each clean, take note of any restrictions on
handling the product. If product-specific instructions for use are available, the following proscriptions/restrictions may have to be observed: ■ Reprocessing ■ Oxidizing chemicals ■ Immersion/insertion ■ Disassembling ■ Chemicals and temperature ■ Ultrasonic cleaning ■ Positioning aids ■ Cleaning ■ Cleaning brush and other accessories ■ Medical compressed air ■ Sterilization
4
3.
Validated instrument reprocessing procedure
3.1
General safety instructions
Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
3.2
General information
Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore, the time interval between application and reprocessing should not exceed 6 hours; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/ alcohols) should be used. Excessive dosages of neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking on stainless steel becoming unreadable either visually or by machine. Residues containing chlorine or chlorides, e.g., in surgical residues, medicines, saline solutions, and in the service water used for cleaning, disinfection, and sterilization, will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Perform additional drying, if necessary. Only process chemicals that have been tested and approved (e.g., VAH/DGHM or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturer's recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes in materials, e.g., fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion ► For further detailed advice on hygienically safe and material-/value-preserving reprocessing, see www.a-k-i.org Publications, Red Brochure – Proper maintenance of instruments 5
Validated Reprocessing Procedures
3.3
Validated cleaning and disinfecting procedure
3.5
Preparations before cleaning
► Carry out non-fixating/NaCl-free pre-cleaning
Note See the instructions for use pertaining to the instrument in question for product-specific information about appropriate equipment.
3.4
Preparations at the place of use
immediately after use. ► During disassembly, take note of the product-spe-
cific characteristics described in the corresponding instructions for use.
3.6
Cleaning/Disinfection
► If applicable, rinse non-visible surfaces (preferably
► Observe the product-specific safety notes relating
with deionized water), using a disposable syringe, for example. ► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.
to the reprocessing procedure contained in the corresponding instructions for use.
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3.7
Wipe disinfection for electrical devices without sterilization
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Wipe disinfection
RT
≥1
-
-
Meliseptol HBV wipes 50 % Propan-1-ol
RT:
Room temperature
Phase I ► Remove any visible residues with a disposable dis-
infectant wipe. ► Wipe all surfaces of the optically clean product
with a fresh, disposable disinfectant wipe. ► Observe the specified application time (1 min min-
imum).
3.8
Manual cleaning/disinfection
► Prior to manual disinfection, allow water to drip off
for a sufficient length of time to prevent dilution of the disinfecting solution. ► After manual cleaning/disinfection, visually check visible surfaces for residues. ► Repeat the cleaning/disinfection process if necessary.
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Validated Reprocessing Procedures
3.8.1
Manual cleaning and wipe disinfecting
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Cleaning
RT (cold)
-
-
D–W
-
II
Drying
RT
-
-
-
-
III
Wipe disinfection
-
>1
-
-
Meliseptol HBV wipes 50 % Propan-1-ol
IV
Final rinse
RT (cold)
0.5
-
FD-W
-
V
Drying
RT
-
-
-
-
D–W: FD–W: RT:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature
Phase I
Phase IV
► Clean the product under running faucet water,
► After the specified exposure time (at least 1 min),
using a suitable cleaning brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
rinse the disinfected surfaces under running FD water. ► Drain any remaining water fully.
Phase II ► Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Validated cleaning and disinfecting procedure. Phase III ► Wipe all surfaces of the product with a single-use
disinfectant wipe.
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Phase V ► Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Validated cleaning and disinfecting procedure.
3.8.2
Manual cleaning with immersion disinfection
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Disinfecting cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
III
Disinfection
RT (cold)
15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended:BBraun Stabimed ► Note the information on appropriate cleaning
► Mobilize non-rigid components, such as set screws,
brushes and disposable syringes, see Validated cleaning and disinfecting procedure.
► Thoroughly rinse through these components with
Phase I ► Fully immerse the product in the cleaning/disinfec-
tant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.
links, etc. during cleaning. the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible
surfaces) under running water. ► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing. ► Drain any remaining water fully.
9
Validated Reprocessing Procedures
Phase III ► Fully immerse the product in the disinfectant solu-
tion. ► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of
the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible
surfaces). ► Mobilize non-rigid components, such as set screws,
joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable
syringe at least five times. ► Drain any remaining water fully.
Phase V ► Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Validated cleaning and disinfecting procedure.
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3.8.3
Manual cleaning with ultrasound and immersion disinfection
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Ultrasonic cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
III
Disinfection
RT (cold)
15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning
brushes and disposable syringes, see Validated cleaning and disinfecting procedure. Phase I ► Clean the product in an ultrasonic cleaning bath
(frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe.
Phase II ► Rinse/flush the product thoroughly (all accessible
surfaces) under running water. ► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing. ► Drain any remaining water fully.
Phase III ► Fully immerse the product in the disinfectant solu-
tion. ► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing. ► Rinse lumens at least five times at the beginning of
the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened.
11
Validated Reprocessing Procedures
Phase IV ► Rinse/flush the product thoroughly (all accessible
surfaces) under running water. ► Mobilize non-rigid components, such as set screws,
joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable
syringe at least five times. ► Drain any remaining water fully.
Phase V ► Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Validated cleaning and disinfecting procedure.
12
3.9
Mechanical cleaning/disinfection
Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
3.9.1
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
Step
T [°C/°F]
t [min]
Water quality
Chemical/Note
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant
■ 0.5 % working solution – pH = 11* III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning and disinfection device
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended:BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechani-
cal cleaning/disinfecting.
13
Validated Reprocessing Procedures
3.9.2
Mechanical neutral or mild alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
Step
T [°C/°F]
t [min]
Water quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
Neutral: ■ Concentrate: – pH neutral – <5 % anionic surfactant
■ 0.5 %* working solution Mildly alkaline: ■ Concentrate: – pH = 9.5 – <5 % anionic surfactant ■ 0.5 % solution III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning and disinfection device
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended:BBraun Helimatic Cleaner neutral ► Check visible surfaces for residues after mechani-
cal cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if neces-
sary.
14
3.10
Mechanical cleaning/disinfection with manual pre-cleaning
Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
3.10.1 Manual pre-cleaning with a brush
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Disinfectant cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Rinsing
RT (cold)
1
-
D–W
-
D–W: Drinking water RT: Room temperature *Recommended:BBraun Stabimed ► Note the information on appropriate cleaning
► Thoroughly rinse through these components with
brushes and disposable syringes, see Validated cleaning and disinfecting procedure.
the cleaning disinfectant solution (at least five times), using a disposable syringe.
Phase I
Phase II
► Fully immerse the product in the cleaning/disinfec-
► Rinse/flush the product thoroughly (all accessible
tant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
surfaces) under running water. ► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
15
Validated Reprocessing Procedures
3.10.2 Manual pre-cleaning with ultrasound and brush
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Ultrasonic cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Rinsing
RT (cold)
1
-
D–W
-
D–W: Drinking water RT: Room temperature *Recommended:BBraun Stabimed ► Note the information on appropriate cleaning
brushes and disposable syringes, see Validated cleaning and disinfecting procedure. Phase I ► Clean the product in an ultrasonic cleaning bath
(frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible
surfaces) under running water. ► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
16
3.10.3 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
Step
T [°C/°F]
t [min]
Water quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant
■ 0.5 % working solution – pH = 11* III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning and disinfection device
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended:BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechani-
cal cleaning/disinfecting.
17
Validated Reprocessing Procedures
3.10.4 Mechanical neutral or mild alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
Step
T [°C/°F]
t [min]
Water quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
Neutral: ■ Concentrate: – pH neutral – <5 % anionic surfactant
■ 0.5 %* working solution Mildly alkaline: ■ Concentrate: – pH = 9.5 – <5 % anionic surfactant ■ 0.5 % solution III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning and disinfection device
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended:BBraun Helimatic Cleaner neutral ► Check visible surfaces for residues after mechani-
cal cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if neces-
sary.
18
3.11
Steam sterilization
► Take note of the product-specific characteristics
relating to sterilization described in the corresponding instructions for use, such as whether or not the product needs to be disassembled. ► To prevent breakage due to stress corrosion, sterilize the instruments with the locking mechanism open, or locked on the first ratchet tooth. ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g., by opening any valves and faucets). ► Validated sterilization process – Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.
3.12
Sterilization for the US market
■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization.
■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method
Temp.
Time
Minimum drying time
Prevacuum
270 °F/ 275 °F
4 min
20 min
*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc.
19
Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com
Technical alterations reserved
Aesculap – a B. Braun company
Brochure No. C63402
11/11
V6