Loan instruments

Neither a borrower nor a lender be
For loan oft loses both itself and friend

William Shakespeare
Hamlet 1600

Sharing information

• Problem Definition
• National standard
  • Published December 1997
• Layout and implementation of the standard
• Present status of the standard
• Conclusion

Problem definition

• Validation of the reprocessing within the CSSD quality system
• Risk of CJD contamination
• Surprise attack
  • Reprocessing within an hour
  • Unknown instruments
• No reprocessing information provided
  • Preparation, cleaning, disinfection
  • Inspection, maintenance and testing
  • Packaging and sterilization
• Mostly in CSSD unfriendly trays

Trays

problem

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National standard

• When?

National standard

• Why???
• • Every hospital has the same problems
  • Every supplier has the same problems
  • Use versus reprocessing
  • Responsibilities of hospital and supplier must be clear

National standard

• Who?
• • Operating theatre staff
  • Hospital purchase department
  • Manufacturer/supplier
  • CSSD
• Dutch Orthopaedic Trade Society (DOTS)
• Dutch Central Sterilization Club

Normative reverences

• Besluit gesteriliseerde medische hulpmiddelen in ziekenhuizen (1983)
  • Dutch legislation on sterilization in hospitals
• Medical Device Directive
  • Essential requirements §13.6h
• EN 285 and EN 554
• prEN ISO 15883 part 1
  • 8 tests of cleaning efficacy
• prEN ISO 17664
• • Information to be provided by the manufacturer for reprocessing of resterilizable medical devices

Responsibilities

• Supplier is responsible for the instruments and the provided information
• Hospital is responsible for the reprocessing
• • Manager CSSD and Sterilization Quality Manager
  • Based on the information provided by the supplier and the interpretation of that data
• After reprocessing the hospital must provide the supplier with a declaration of decontamination

Layout of the standard

• Published December 1997
• Supplier informs the CSSD
• • Completed registration form
  • Declaration of decontamination
  • Tray list
  • Cleaning, disinfecting and sterilization protocol
  • Maintenance instructions
• In case of new instruments the CSSD needs
  2 workdays to process the data and to instruct the staff

Layout of the standard

• Delivering the instruments at the CSSD
• • Transportation in closed transport box
  • Supplier issues a declaration of decontamination
    • Prions/CJD protocol
    • Cleaning, disinfection and sterilized (not sterile)
• CSSD needs 1 workday for reprocessing before the procedure
• CSSD needs 1 workday for after the procedure

Declaration of decontamination