IDI - Irish Decontamination Institute...

IDI - Irish Decontamination Institute

NOTE: These WFHSS web archive pages are not maintained anymore. Please visit wfhss.com for current WFHSS affairs.
/ IDI - Irish Decontamination Institute / Education / Lectures / EFHSS Conference 2002 / Loan Instruments

EFHSS Conference 2002 - Lectures
Loan Instruments

PDF Version (210 KB; updated 09 May 2015)

The following slide show was presented by René Vis (CSC - The Netherlands) at the EFHSS Conference 2002 in Dublin.


1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

Loan instruments

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

William Shakespeare
Hamlet 1600

13 September 2002René Vis1

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

Sharing information

  • Problem Definition
  • National standard
    • Published December 1997
  • Layout and implementation of the standard
  • Present status of the standard
  • Conclusion
13 September 2002René Vis2

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

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
13 September 2002René Vis3

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

Trays

problem

Loan Instruments - Trays
Much better

Loan Instruments - Trays

13 September 2002René Vis4

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

Just for fun!


Loan Instruments Loan Instruments
13 September 2002René Vis5

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

National standard

  • When? Loan Instruments - National Standard
13 September 2002René Vis6

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

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
13 September 2002René Vis7

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

National standard

  • Who?
    • Operating theatre staff
    • Hospital purchase department
    • Manufacturer/supplier
    • CSSD
  • Dutch Orthopaedic Trade Society (DOTS)
  • Dutch Central Sterilization Club
13 September 2002René Vis8

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

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
13 September 2002René Vis9

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

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
13 September 2002René Vis10

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

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
13 September 2002René Vis11

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

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

13 September 2002René Vis12

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 
Loan Instruments
13 September 2002René Vis13

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

Declaration of decontamination

Loan Instruments - Declaration of decontamination
13 September 2002René Vis14

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

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
13 September 2002René Vis15

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

Implementation of the standard within the hospital

  • All parties involved must be informed
    • Operating theatre
      • Must inform CSSD about the surgical procedure
      • All trays to CSSD
    • Purchase department
      • While ordering out they must also ask for the reprocessing information
    • Suppliers
      • Must comply with MDD
    • CSSD
      • Building database and record keeping loan instruments
  • General purchase conditions
13 September 2002René Vis16

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

Present status of the standard

  • Mostly all of the hospitals and suppliers use the standard
  • Having the standard makes it easier to discuss the issue of loan instruments
13 September 2002René Vis17

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

All problems solved?

  • Still having problems with:
    • exotic trays
    • the reprocessing time
    • the provided information
  • But we must have ongoing communication with all parties involved to make sure everyone understands the difficulties with the reprocessing of loan instruments and dangers for the patient.
13 September 2002René Vis18

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

Conclusion

  • The national standard has proven to be a useful tool for organising the loan instruments
  • All national associations must be involved in the “making off” the standard
  • We are now planning an evaluation of this standard
  • The declaration of decontamination can also be used for instruments that are out for repair and replaced by another instrument (e.g. flexible endoscopes)
13 September 2002René Vis19

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
 VU medisch centrum
 

To be, or not to be: that is the question
 

To loan, or not to loan:

that is the question of knowing the
limitations and restrictions on
reprocessing and taking responsibility

13 September 2002René Vis20