Step-by-step guide: simple first validation

Step-by-step guide: simple first validation

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.

Glossary note: ‘qualification’ means checking.

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 10A.1. Validation certificate template).

Table 10A.1. Validation certificate template Download the validation certificate template

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 The ‘challenge pack’ must be defined for the individual practice. Among all the types of packs and steriliser load configurations that are processed within the practice, the practice needs to identify those that are most difficult for steam to penetrate and required temperature to be reached and maintained. The challenge pack is the most difficult-to-sterilise pack. The contents of the challenge pack and the loading configuration must be recorded so that the same conditions can be replicated at each validation.

□ 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 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 10A.2. Penetration and drying time)

□ packs containing hollowware (eg kidney dishes, bowls) 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 10A.2. Example of penetration and drying time

Mechanical/physical monitoring of sterilisation cycle parameters, biological indicators

□  Review the documentation in the practice policy and procedure manual for each steriliser used, including:

□ manufacturer’s instructions

□ heat distribution studies (Figure 10A.1. Example of heat-distribution study)

□ description of the challenge pack and load (Table 10A.2. Example of penetration and drying time)

□ diagram of chamber loading (Figure 10A.2. Diagram of chamber loading)

□ penetration times (Tables Table 10A.2. Example of penetration and drying time, Table 10A.3. Example of processing time).

□ The service technician should:

□ perform a heat-distribution study  (if needed) to check for cold spots in the chamber and record (Figure 10A.1. Example of heat-distribution study ). 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 (Table 10A.3. Example of processing time)

□ check the drying time (establish that the recommended time is adequate and increase if needed; see Table 10A.2. Example of penetration and drying time, Table 10A.3. Example of processing 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 with a thermocouple throughout the total processing time (ie ‘time at temperature’ testing) at least once. This check should continue to check the drying time. The penetration time can also be checked while this is being performed.

□ The staff member with designated responsibility for sterilisation should perform microbiological qualification (checking) using appropriate indicators in three successive cycles (Table 10A.4. Results of physical and microbiological qualification).

Figure 10A.1.

Example of heat-distribution study

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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.

Figure 10A.2.

Diagram of chamber loading

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Table 10A.3. Example of processing time

Table 10A.4. Results of physical and microbiological qualification

*Attach temperature records from service technician supporting this qualification

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 before starting according to:

• the cycle number (1 for the first, 2 for the second or 3 for the third)
• 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), for example:
  • Cycle 1 label one indicator 1/M (1st cycle in the middle of the challenge pack) and the other 1/C (1^st cycle on the tray nearest the cold spot)
  • Cycle 2 label one indicator 2/M (2nd cycle in the middle of the challenge pack) and the other 2/C (2^nd cycle on the tray nearest the cold spot)
  • Cycle 3 label one indicator 3/M (3rd cycle in the middle of the challenge pack) and the other 3/C (3^rd cycle on the tray nearest the cold spot)
• the control (7th) 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.

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.

Indicator processing

All indicators are to be incubated according to the manufacturer’s instructions and results recorded (Table 10A.4. Example of results of physical and microbiological qualification).

Interpretation of the results of the indicators

□ If the process has been performed correctly, all the ‘M’ and ‘C’ indicators will show colour change, indicating no bacterial growth or equivalent. Colour change indicates a process failure and must be investigated. Some incubators or readers will provide an automated final pass or fail result within a specified amount of time. Record the results.

□ If the process has been performed correctly, the single unsterilised control ‘Z’ indicator will show growth. If not, the batch of indicators or the incubator is faulty (the service technician needs to check the incubator 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

□ the microbiological qualification with appropriate indicators placed 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 in each of the three cycles.

Unloading of 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 the 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.