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Recommendations by the Quality Task Group
[17] Quality Assurance on the Unclean Side of a CSSD (Part 2)

Procurement of reusable instruments

Checking criteria

• Define participants: hygiene commission, purchasing department, CSSD management
• Queries catalogue (example: minimally invasive instrument(s)):
  • Is reprocessing possible?
  • Can automated cleaning and disinfection be performed?
  • Can automated cleaning and disinfection be performed with the existing procedure (e.g. Vario programme with thermal disinfection at 93 °C and 10 min hold time), cleaning agents and inserts?
  • Are the instruments to be sterilised?
  • Can the existing sterilisation procedures (e.g. steam sterilisation at 134 °C) be used?
  • What changes and additional purchases are needed?
  • Are revalidation procedures necessary?
• Review manufacturers and suppliers in respect of service, consultation, repairs
• Costs
• Competencies and procurement

Records

• Instructions from the manufacturers of the instrument(s), washer-disinfectors, cleaning agents and disinfectants
• Capacities
• Disposal regulations
• Internal logistics, e.g. collection and delivery service.

Documentation

• Minutes showing adoption of resolutions, additional measures required, competencies as well as justification of purchase or rejection
• Schedule for implementation and, if applicable, for training, briefing, inclusion in the cleaning and disinfection plans and working instructions

Requirements for CSSD personnel

• Are extra working hours required?
• Is the personnel complement sufficient?
• Plan for additional training and briefing measures

Stainless Steel Surgical Instruments Straight from the Factory

Checking criteria

• Packing and storage
  • Remove as directed protective covers, protective foils
  • Check for damage during transport or storage
  • Dry storage, protect against medicament vapours
• Introduction into the instrument circuit
  • Carry out prescribed preliminary measures before placing in circulation, e.g. run once or repeatedly through the cleaning, disinfection, drying, control, packing and sterilisation cycle.

Records

• Manufacturers instructions
• Existing internal working instructions that have already demonstrated their value
• Brochure "Proper Maintenance of Instruments"

Documentation

• Updated working instructions
• Confirm implementation of defined measures:
• what, how, how often checked by whom?

Requirements for CSSD personnel

• Train personnel in repetitive defined procedures
• Brief in special procedures

Disposal and Transport

Checking criteria

• Consult with OR, the wards, as applicable, the external collection and delivery services and/or contractor - define participants
• Define subject catalogue
  • Open hinged instruments
  • Place in suitable trays - quantity/container and close the disposal container
  • Do not place disposable items in the trays, but in the waste
  • Do not pour residues of skin disinfectants, Ringer’s solution and drugs into the disposal container
  • Define how modular instruments are to be handed in (dismantled or not)
  • Secure sensitive special instruments e.g. microsurgical instruments or rigid endoscopes for transportation
  • Define dry or wet transportation, preliminary treatment e.g. wipe off, rinse etc. (if necessary, different instructions for running operation and weekend/emergency)
• Define competencies
• Check the working instructions

Records

• Information on the manufacturers
  • Handling, handing in, dismantling as applicable, supports
  • Disinfectants for wet transportation, cleaning and disinfectant effect, e.g. effective against hepatitis B viruses as per certificate
  • Information on risk of corrosion during longer exposure times
• German Society for Hygiene and Microbiology (DGHM) list
• Guideline of the Robert Koch Institute (RKI) on requirements for processing instruments
• Accident Prevention Regulations for the healthcare sector

Documentation

• Working instructions
• Organisation of collection and delivery service
• Cleaning and disinfection plan
• Training schedules for the CSSD, surgical and ward staff

Requirements for personnel

• Appropriate protective clothing and measures for taking in non-disinfected instruments and utensils
• Working instructions for taking in items, preliminary treatment and other final working steps.