Reprocessing procedures

Classification of medical devices

For reprocessing, the medical devices and their components are classified according to their type of application and the resulting risks:

  • Non-critical medical devices: surfaces accessible to the user and patient, e.g., device surfaces, cables
  • Semi-critical medical devices: parts conducting breathing gas, e.g., breathing hoses, masks.

Non-critical medical devices

Disinfectants based on aldehydes or quaternary ammonium compounds are recommended for manual disinfection. Observe the applicable country-specific listings for the disinfectants. The list of the German Association for Applied Hygiene (Verbund für Angewandte Hygiene VAH) applies in German-speaking countries.The composition of the disinfectant is the responsibility of the manufacturer and can change over time. Strictly observe the manufacturer's information on the disinfectants.

Procedure:

  1. Remove soiling immediately with a cloth soaked in disinfectant. WARNING Risk of electric shock or device malfunction Penetrating liquid may cause device malfunction or damage to the device, which may endanger the patient. Only wipe-disinfect the device surface and cables, making sure that no liquids penetrate into the device.
  2. Perform surface disinfection by scrubbing and wiping.
  3. Remove disinfectant residues after the contact time has elapsed.

Semi-critical medical devices

Manual cleaning

Running water and typical cleaning agents based on mildly alkaline compounds are recommended for manual cleaning.

Procedure:

  1. Wash off soiling on surface under running water.
  2. Use cleaning agents in accordance with manufacturer’s specifications. Make sure that all surfaces and interior spaces to be cleaned can be reached effectively. Use suitable brushes if necessary.
  3. Rinse components under running water until cleaning agent residues are no longer discernible.
  4. Inspect components for visible soiling and damage. Repeat manual cleaning if necessary.

Manual disinfection

Disinfectants based on aldehydes or quaternary ammonium compounds are recommended for manual disinfection. Observe the applicable country-specific listings for the disinfectants. The list of the German Association for Applied Hygiene (Verbund für Angewandte Hygiene VAH) applies in German-speaking countries.The composition of the disinfectant is the responsibility of the manufacturer and can change over time. Strictly observe the manufacturer's information on the disinfectants.

Procedure:

  1. Disinfect components by immersing.
  2. After the contact time has elapsed, rinse the components under running water until disinfectant residue is no longer discernible.
  3. Inspect components for visible soiling and damage. Repeat manual disinfection if necessary.
  4. Shake off all excess water. Allow components to dry thoroughly.

Machine cleaning and disinfection

For machine cleaning and disinfection of components that conduct breathing-gas, use a washer-disinfector in accordance with ISO 15883, preferably with a cart for anesthesia and ventilation accessories.

Procedure:

  1. Strictly, observe the instructions for use of the washer-disinfector.
  2. Position components so that all interior spaces and surfaces are completely flushed and water can drain off freely.
  3. Use a suitable cleaning agent.
  4. Select a suitable program (preferably anesthesia program).
  • Cleaning must be performed at 40 °C to 60 °C (104 °F to 140 °F) for at least 5 minutes.
  • Thermal disinfection must be performed at 80 °C to 95 °C (176 °F to 203 °F) and with corresponding contact time.
  1. Carry out final rinsing with deionized water.
  2. Immediately remove the components from washer-disinfector.
  3. Inspect components for visible soiling and damage. If necessary, repeat the program or perform manual cleaning and disinfection.
  4. Allow components to dry thoroughly.

Visual inspection

Inspect all components for damage and wear such as cracking, embrittlement or pronounced hardening, and residual soiling.

WARNING Risk due to defective components Reusable accessory parts (e.g., when reprocessed) and removable device components also have a limited life span. Due to a number of factors associated with handling and reprocessing, (e.g. corrosive effects of disinfectant residues are greatly increased by autoclaving), wear can increase to distinctly reduce life span. Exchange any components exhibiting signs of external wear (e.g. cracks, deformation, discoloration, delamination).

WARNING Risk due to flow measurement failure Deposits which are not removed during reprocessing can damage the measuring wires in the flow sensor or cause fire.

  • Perform regular visual inspections for dried mucus residues, drug aerosols and lint.
  • Prevent contamination of the flow sensor due to particles in the disinfectant.
  • If deposits remain after reprocessing, or if the flow sensor is damaged, replace the flow sensor.

Sterilization

During sterilization, living microorganisms are removed from semi-critical medical devices. Residual water in the interior spaces of the components is also dried out.

  • Sterilize only components that have been cleaned or disinfected. For sterilization, use a vacuum steam sterilizer (in accordance with EN 285), preferably with fractional vacuum.