Step-by-step guide: complex validation
Complex validation is performed when simple first validation has previously been performed. Some steps are performed by staff and some (such as installations, technician assistance, maintenance and repairs) must be done by a trained technician from an organisation authorised by the Therapeutic Goods Administration sponsor of the equipment.
Responsibility
The staff member with designated responsibility for reprocessing reusable medical devices to perform the following:
1. Review the documented procedures covering all parts of the reprocessing procedure to ensure reproducibility:
- workflow issues: dirty through to clean and environmental cleaning
- precleaning and cleaning of instruments, including drying and visual inspection
- packing of contents in a sterile barrier system, including sealing and labelling
- loading of the steriliser
- mechanical/physical monitoring (chemical indicators and recording of exposure time and temperature) of the sterilisation cycle parameters
- unloading of the steriliser and checking the packs are dry and intact and checking monitoring results and correct chemical indicator change
- storage of sterile items
- maintenance of steriliser as required by the manufacturer (including water changes and cleaning).
2. Perform or supervise the documented procedures.
3. Check that the procedures were performed correctly.
4. Record correct completion of each procedure (Table 10B.1. Sample complex validation certificate).
Table 10B.1. Sample validation certificate Download the sample validation certificate
Clinic name:
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Steriliser identification:
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Process
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Process documented in policy and procedure manual
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Process performance, effectiveness and reliability checked (ie validated)
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Sign and date
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Cleaning of the reprocessing area
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Workflow (dirty to clean)
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Precleaning and cleaning of instruments
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Drying and visual inspection
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Content, packing and sterile barrier system of challenge pack
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Loading of challenge load
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Monitoring of cycle parameters
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Unloading of the steriliser (steriliser log)
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Storage of sterile items
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Cleaning and maintenance of steriliser (maintenance log)
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Cleaning and maintenance of ultrasonic cleaner
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Cleaning and maintenance of washer-disinfector
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Cleaning and maintenance of drying cabinet
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Cleaning and maintenance of incubator
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Name of service company:
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Steriliser technician:
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Date:
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Name of staff member with responsibility for practice sterilisation:
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Signature:
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Date:
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Procedure
Review the following steps and record findings.
Workflow issues: dirty through to clean
□ Review documentation in practice policy and procedure manual or other documentation (such as signage in reprocessing area).
□ Observe performance of the tasks from pre-treatment at point of use, through precleaning, cleaning and sterilisation to storage, including environmental cleaning relevant to instrument reprocessing.
□ Check that workflow from dirty to clean is not compromised and that environmental cleaning is adequate.
Precleaning, cleaning and drying of instruments
□ Review documentation in practice policy and procedure manual or other documentation.
□ Perform or supervise precleaning, cleaning and drying.
□ Check that the instruments are clean, under good lighting using magnification (pay special attention to serrations).
Pack contents, packing and sterile barrier system
□ Review documentation in practice policy and procedure manual or other documentation.
□ Perform or supervise pack preparation with correct contents, packing and sterile barrier system.
□ Check packs:
□ have the correct contents
□ are packed correctly in the correct sterile barrier system and do not exceed those of the documented challenge packs
□ have seals that are intact
□ have a Class 1 chemical indicator on the outside of each pack
□ have been labelled with the date, steriliser number (if applicable), load (batch) number and staff identification of cleaner and packer (if applicable)
□ have instruments loosely open, not tightly closed
□ that contain hollowware (eg kidney dishes, bowls), if packed in laminate pouches, are packed with the opening against the paper, not the laminate plastic side
□ have not had ballpoint pens used on pack surfaces.
Loading of the steriliser
□ Review documentation in practice policy and procedure manual.
□ Perform or supervise loading of the steriliser.
□ Check that:
□ the total contents of the steriliser do not exceed those of the documented ‘challenge load’ (Table 10B.2. Examples of challenge loads: contents and loading configuration, Table 10B.3. Example of penetration and drying time)
□ packs loaded with hollow items are on their sides
□ the paper side of any laminated pack is adjacent to the laminate side of another
□ individual instrument packs are separated on racks
□ trays of unwrapped instruments are not overloaded
□ there is a Class 1 chemical indicator in the tray with unwrapped instruments.
Table 10B.2. Example of challenge load: contents and loading details
Challenge load
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Loading details
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2 excision sets and 1 minor surgery set
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3 packs in the chamber
Minor surgery set in middle
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Sample only; actual challenge loads and loading configuration will depend on the practice’s reprocessing requirements.
Table 10B.3. Example of penetration and drying time
Challenge pack description
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Challenge pack/load loading
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Penetration time
Steriliser 1 (minutes)
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Penetration time
Steriliser 2 (minutes)
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Drying time
Steriliser 1 (minutes)
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Drying time
Steriliser 2 (minutes)
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2 excision sets and 1 minor surgery set
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3 packs in the chamber
Minor surgery set in the middle
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2
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0
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12
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12
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Mechanical/physical monitoring of sterilisation cycle parameters
□ Review the documentation in the practice policy and procedure manual for each steriliser used, including:
□ manufacturer’s instructions
□ heat distribution studies
□ description of the challenge pack and load (Table 10B.2. Examples of challenge loads: contents and loading details, Table 10B.3. Example of penetration and drying time)
□ diagram of chamber loading (Figure 10B.1. Diagram of chamber loading)
□ penetration times (Table 10B.3. Example of penetration and drying time).
□ The service technician should:
□ perform a heat-distribution study (if needed) to check for cold spots in the chamber and record. Note: This study is only required once and may be available either from the manufacturer or a previous validation. If not, it can be determined by the service technician.
□ establish the penetration time for the ‘challenge pack’ within the ‘challenge load’ and record (this combination reflects the greatest challenge to the sterilisation process of any load)
□ set the processing time on the steriliser for all loads (ie holding time plus penetration time) and document it (Table 10B.3. Example of penetration and drying time)
□ check the drying time (establish that the recommended time is adequate and increase if needed; see (Table 10B.3. Example of penetration and drying time)
□ perform additional function checks for validation of the sterilisation cycle (ie during the processing and drying time)
□ perform physical qualification (checking) of the temperature within the challenge pack within a challenge load throughout the total processing time (ie ‘time at temperature’ testing) at least once (eg by placing temperature sensors and a biological indicator within the most challenging pack and at other sites within the steriliser, including the coldest area to find the chamber reference temperature). Steam penetration can be measured during the sterilisation cycle by calculating the difference between the pack and other temperature sensors, and the chamber reference temperature. The physical qualification should continue to check the drying time. Temperature and pressure qualifications are performed on a minimum of three consecutive cycles.
□ check the temperature of the incubator (if onsite) and calibrate if necessary.
□ The staff member with designated responsibility for sterilisation should:
□ perform microbiological qualification (checking) using appropriate indicators in three successive cycles (Table 10B.5. Sample results of physical and microbiological checking).
A heat-distribution study is only required once and may be available either from the manufacturer, a previous validation, or can be determined by the service technician.
The indicators
□ Biological or enzymatic indicators:
- have a spore count equivalent to 105
- are from the same batch.
□ A minimum of two indicators are required for each load to be validated plus one control indicator.
□ Indicators need to be suitable for the type of steriliser and temperature selected (enzymatic indicators on the Australian market are not suitable for gravity displacement bench top sterilisers operating at 134°C and cannot be used for either additional monitoring or validation).
Labelling indicators
□ Label indicators (Table 10B.4. Examples of indicator labelling) before starting according to the:
- steriliser (if more than one steriliser)
- cycle number (eg 1 for the first, 2 for the second or 3 for the third)
- challenge load (eg E for excision set) and the position it is to be placed in the steriliser (eg M for middle of challenge pack or C for cold spot if determined or placed anywhere on tray if none).
□ The control indicator can be labelled Z; this is left outside the steriliser and never sterilised. This indicator, which is treated with the others, will be used to substantiate that the batch of indicators was active.
□ The procedure is then repeated for the excision set for both sterilisers, the V being replaced by an ‘E’.
Table 10B.4. Examples of indicator labelling
Steriliser 1
Cycle 1 label 1 indicator 1/1/E/M (steriliser 1,1st cycle, excision set in the middle of the challenge pack) and the other 1/1/E/C (steriliser 1, 1st cycle, excision set, on the tray nearest the cold spot)
Cycle 2 label 1 indicator 1/2/E/M (steriliser 1, 2nd cycle, excision set in the middle of the challenge pack) and the other 1/2/E/C (steriliser 1, 2nd cycle, excision set, on the tray nearest the cold spot)
Cycle 3 label 1 indicator 1/3/E/M (steriliser 1, 3rd cycle, excision set in the middle of the challenge pack) and the other 1/3/E/C (steriliser 1, 3rd cycle, excision set, on the tray nearest the cold spot)
Steriliser 2
Cycle 1 label one indicator 2/1/E/M (steriliser 2,1st cycle, excision set in the middle of the challenge pack) and the other 2/1/E/C (steriliser 2, 1st cycle, excision set, on the tray nearest the cold spot)
Cycle 2 label 1 indicator 2/2/E/M (steriliser 2, 2nd cycle, excision set in the middle of the challenge pack) and the other 2/2/E/C (steriliser 2, 2nd cycle, excision set, on the tray nearest the cold spot)
Cycle label 1 indicator 2/3/E/M (steriliser 2, 3rd cycle, excision set in the middle of the challenge pack) and the other 2/3/E/C (steriliser 2, 3rd cycle, excision set, on the tray nearest the cold spot).
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Repackaging between cycles
The packs will be reused pack(s) from the previous cycle; the contents of the pack(s) must return to room temperature before repackaging and the next cycle run. To save time, the instruments from the pack(s) will be cooled quickly after unpacking and removing the indicator by placing the instruments in cool water. The instruments will be then dried and repacked with the next indicator and the next cycle run.
Interpretation of the results of the indicators
□ If the process has been performed correctly, all the ‘M’ and ‘C’ indicators should show no growth or its equivalent; otherwise, it indicates a process failure and must be investigated. Record results.
□ If the process has been performed correctly, the single unsterilised control ‘Z’ indicator should show growth. If not, the batch of indicators or the incubator is faulty (the service technician needs to check it with the thermocouple as part of annual servicing).
□ A pass result is 100%: all six processed biological indicators (minimum of two in each load over three cycles) should not have changed colour and the control biological indicator should have changed colour after incubation. Any failures must be fully investigated as to cause and corrective action documented and the entire procedure repeated.
Check the steriliser settings and results of steriliser monitoring
□ Ensure:
□ time and temperature were correctly set
□ routine monitoring of each cycle’s time at temperature (either by printout, download of data logger, manual recording of time at temperature, or by the use of a Class 4, 5 or 6 chemical indicator) occurred at the correct frequency, was reviewed for adequacy, was signed off and is recorded in a log
□ the physical qualification of temperature (‘time at temperature’ testing) inside the challenge pack/load showed that the centre of the pack reached the correct sterilising temperature and that was maintained for the required time. Similarly, that the temperature during drying was also maintained for the correct time
□ the microbiological qualification with appropriate indicators inside the challenge pack/load showed that the centre of the pack and outside the pack inside the chamber was effective in sterilising these indicators on each of the three cycles (this will take 2 days to verify, as the indicators used require incubation)
□ all points are checked for each total processing time used for different pack/load types (the sterilisation temperature is not changed for different pack/load types). The use of multiple processing times and multiple sterilisers increases complexity and care must be taken to avoid errors when different cycles are selected.
Unloading the steriliser
□ Review documentation in the practice policy and procedure manual or other documentation.
□ Perform or supervise unloading.
□ Check that cooled are dry, undamaged, seals are intact, and the Class 1 chemical indicator on the outside of each pack or in the tray with unwrapped items has changed colour.
Storage of sterile items
□ Review documentation.
□ Perform the task of storage.
□ Check that stored items are kept dry, dust free and undisturbed, and packs have been processed, marked with the date and load number and stored in a manner to allow stock rotation. Check cleaning of the storage area does not compromise sterility.
Cleaning and maintenance of reprocessing equipment
□ For each piece of equipment used in the practice (ultrasonic cleaner, washer-disinfector, drying cabinet, steriliser, incubator), review documentation in the practice policy and procedure manual, manufacturer’s instructions and maintenance log.
□ Perform or supervise routine maintenance procedures as documented.
□ Check that maintenance tasks have been performed and are in accordance with the manufacturer’s requirements.
□ Visually inspect cleanliness and check that the documented cleaning schedule has been completed.