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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Just for fun!

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

Record keeping

• The hospital must keep a dossier with all relevant data of the loan instruments
• Registration form
• Declaration of decontamination
• Reprocessing data
• The supplier must keep a dossier of every loan instrument tray
• Where and when the tray was used
• All declarations of decontamination
• Maintenance file