Tracking and Traceability of Surgical Instruments and sets

1. Tracking and Traceability of Surgical Instruments and sets SATS – May 2013 Roger Sheard

2. Introduction What do we mean by Tracking and Traceability Why should we do these things Where What choices do we have How A few thoughts to ponder

3. Tracking Marking items processed in CSSD by some sort of labeling or writing on the outer pack – a description and expiry date? Recording how these items are processed in CSSD (autoclave/cycle numbers)

4. Traceability Keeping a record of each item used on a patient Being able to trace back to see that the item(s) were processed in CSSD

5. Why do we need to do this? So that we can be sure that all items used on a patient were correctly decontaminated and  recorded as being re-processed successfully Because we need to do so to meet local audit/accreditation requirements

6. Legislation - International UK -Health Services Circular 2000/032 Traceability – it is important that systems are in place to allow sets of surgical instruments to be tracked through decontamination processes in order to ensure that the processes have been carried out effectively. Systems should also be implemented to enable the identification of patients on whom instrument sets have been used. This is important so that relevant patients can be identified in the event of exposure to a potential risk, and is relevant to both primary and secondary care sectors.

7. South African National Core Standards Audit Document 3.5 SterilisationServices - The health establishment has an effective decontamination process in place Section 9: Tracking system for product sterilization, identification, recording and recalls – SOP/Policy/Records

8. What do we need to do? • We need to have SOP’s. • What records do we need to keep? • Patient – how much detail? • For how long? • Sterilization Cycle? • For how long? • Washing and disinfection cycle? • For how long?

9. Where? Where do we keep the records? Can we find the details when we really need them? When did you last look? Are we moving with the times and looking for systems to help us?

10. What choices do we have? Do we want to be able to track all items used on a customer all the way through the complete decontamination cycle? Is tracking back to sterilization enough? Or should you track back to washing/disinfection? Should we be tracking individual instruments or just sets and packs? How can you track individual instruments What about loan sets?

11. Sterile Stores PackingArea Autoclave Area PassFail Decontamination Area Dispatch Non-Conformance processing Received Service Repair User Sterile Store Quarantine Customer / User Patient Record Return / Used Items

12. Manual or automated? Manual Systems: Systems using envelopes, labels and label guns. Simple, cheap and can provide certain information and records: Washing/Disinfection records, Sterilizer Cycle, Bowie Dick and Biological results. Labels that tie back to the Sterilizer Cycle can be put on Patient Records. Can tie back to washer/disinfector cycle. Doesn’t record movement of the set/instrument from Theatre back to CSSD – or whether it was complete. Can’t track individual instruments. Few problems with technology but lots of paper required.

14. Automated Systems

15. Automated Systems? Using Bar Codes, scanners, computers and dedicated software what can be done? Is it worth the effort and expense? What benefits do the hospital achieve? How do you weigh clinical benefits versus financial benefits?

16. Clinical Benefits • An automated system can help ensure that the proper procedures are followed aiding patient outcomes • To ensure patient safety, and as warranty against litigation, automated systems can provide a clear link between individual patients and the instrument, item or set of instruments used in any procedure, enabling the identification of every process, location and person involved. • Can assist locating sets urgently required • Can assist analysis of non-conformances: • Sharps returned to CSSD or sent to laundry

17. Financial benefits Inventory Control of sets and/or individual instruments How many sets do you have? How often do you use them? How often do individual instruments require repair or maintenance Do you have sets/instruments that aren’t used? Can you do without any? Do you known when the peak processing times are? Can you re-allocate staff at quiet times? Do you have sets ready when you need them? Can you avoid delays in theatre?

18. More benefits – courtesy of Sue Meredith • Know where your products are • Know who is using them • Stock rotation • Identify any losses

19. Even more benefits – courtesy of Sue Meredith • Who works hardest? • Who is hiding? • Training needs

21. How can you identify sets? Tags Sets or instruments Numbers or bar codes Labels Patient record

22. Bar Coding Sets on a tag:

23. Bar Coding Instruments

24. Adhesive 2D Matrix Dots Pre-printed adhesive dots with 2D Barcodes Advantages: • High contrast mark Disadvantages? • Durability issues • Adhesion issues

25. Bar coding on a label:

26. Thanks for staying awake Enjoy the rest of the conference Roger Sheard rogers@safmed.co.za 021 763 3280