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General

Process equipment (e.g. Washer-disinfectors and Sterilisers) must be subjected to periodic testing and validation in accordance with a recognised standard/reference document e.g. ISO 15883, CFPP01-01.

Process equipment must be operated in accordance with the manufacturer’s instructions.

Ensure appropriate Personnel Protective Equipment (PPE) is worn at all times when carrying out decontamination activities.

Cleaning

The device can be cleaned either by using an automated process or manually cleaned by hand.

A validated automated washer-disinfector is preferable to manual cleaning as it provides thermal disinfection and a reproducible process that should give consistently reliable results. However, the instructions below provide details of how the device can be processed using either method.

Detergents should be CE marked and specifically intended for cleaning medical devices.

1. Automated cleaning

  • Ensure any movable parts of the device are opened where possible in order to facilitate the cleaning process. To do so, lock the InSafe syringe sleeve in the forward position. Unscrew the plunger retaining nut and separate the plunger assembly from the body of the device (as shown in image below). The plunger should remain detached from the body assembly during the cleaning process as this assists the cleaning process.
  • Both the handle and body assembly can be processed in an automated washer-disinfector.
  • Do not overload the washer disinfector as this may compromise the effectiveness of the process.
  • Process using a standard instrument cycle.
  • After processing the device must be visually inspected to ensure it is clean and dry. If there is any evidence that the device is not clean it must be reprocessed.

These instructions have been validated using the following washer-disinfector programmes:

Programme 1:

Cold pre-wash
Wash stage: 5 minutes using an alkaline detergent with a pH 13-14.
Rinse stage: 1 minute
Disinfection stage: 90°C for a minimum 1 minute / Ao Value 600
Drying

Programme 2:

Cold pre-wash: 2 minutes
Wash stage: 2 minutes using a neutral detergent
Rinse stage: 2 minutes
Disinfection stage: 80°C for a minimum 10 minute / Ao Value 600
Drying: 90°C

Ultrasonic Bath

If a suitable automated washer-disinfector is not available the device can be cleaned in an ultrasonic bath but it should be manually cleaned, in accordance with the instructions (right), prior to being placed in the bath. When removed from the bath the device must be rinsed thoroughly in clean (preferably purified) water.

2. Manual cleaning

Fully immerse the device in a solution of detergent and water.  The ratio of detergent:water should be consistent with that recommended by the detergent manufacturer*.

Fully immerse the device throughout the cleaning process to prevent splashing and the creation of aerosols.

Ensure the temperature of the water used for the initial immersion of the device does not exceed 45°C.

Using a low-linting disposable cloth wipe all the accessible surfaces of the device.  If necessary, a soft nylon brush may also be used. Agitate and irrigate the device as appropriate to help dislodge any contamination.

Rinse in clean (preferably purified) water.

Dry the device using a lint free single-use cloth.

Visually inspect the device to ensure it is thoroughly clean.  Repeat the cleaning process if necessary.

*This process was validated using an enzymatic detergent.

Sterilisation

  • Sterilise using moist heat (steam).
  • Ensure the InSafe Syringe sleeve is locked in the forward position and that the plunger assembly is detached from the body assembly during sterilization.
  • If the autoclave is a vacuum steriliser, the plunger and body assembly can be placed together in an autoclavable bag and sealed prior to processing. If the autoclave is a Type N benchtop (gravity displacement) steriliser the device must not be wrapped prior to the sterilization process as this will inhibit steam penetration.
  • These instructions have been validated using a porous load steam steriliser (Autoclave) operating on a 134°C to 137°C cycle for a minimum 3 minutes.
astek innovations

Astek Innovations Ltd
Astek House | Atlantic Street | Altrincham | Cheshire | WA14 5DH | United Kingdom
Telephone +44 (0)161 942 3900 | Fax +44 (0)161 942 3901 | Email info@astekinnovations.co.uk