Issues relating to orthopaedic containers and the IDSc survey

1. Issues relating to orthopaedic containers and the IDSc survey Presentation Overview • The presentation of orthopaedic equipment • Issues with wrapping • Background to IDSc questionnaire • Results from the IDSc questionnaire

2. Presentation of orthopaedic equipment

3. Containers with feet and insert brackets

4. Heavy Layered Orthopaedic Tray

5. Wet Loads

6. Steps to achieve a dry undamaged load

7. Equipment containment Ideal containment should: • Give a sensibly dry load • Prevent damage to packaging by either weight or poor design of trays • Not require extended drying on sterilisers

8. Design – boxes within boxes

9. Evidence suggests • Issues are historic and universal • Tray design needs to support decontamination and sterilisation with regard to materials, weight and shape “But you are the only Trust having these issues!” or are you??

10. Back ground to questionnaire The questionnaire was generated by a collaboration comprising of: • IDSc technical group • AfPP • ABHI The purpose of the questionnaire was to gain information on issues relating to the provision, presentation, decontamination and use of orthopaedic instruments and implants.

11. Aim of the questionnaire Gather evidence from all those involved in the decontamination of orthopaedic sets to support discussions with manufacturers to affect beneficial changes in practice ensuring re usable medical devices, instruments and implants are available “fit for purpose” first time every time.

12. The Questionnaire • The questionnaire was sent out to all IDSc members to get an overview on their issues with instruments, implants and containers. • The questionnaire had 53 questions in 7 parts • A – related to implants • B - instrument containers provided by the manufacturers • C – reprocessing problems • D - damaged wrap issues • E – wet set issues • F – unusable set • G – loan instrument management • There was a 33.5% response from different trusts

13. Results from the questionnairePart A - Implants Do you process trays which contain plates and screw? 89% of responders' process trays which contain plates and screws. 3% didn’t and there was one blank What range of devices do you process? 86% process screws and plates, under other manufacturers were listed as Illazarov, Mini fragment, Ex Fix kits, Spinal implants, drills, nails, wires, pins, wirers. The commonly listed metals were titanium and stainless steel.

14. Following use how are these devices cleaned? 34% of units remove the devices from the manufacturers containers for washing and place in din baskets 52% leave them in situ in the manufacturers containers 2.6% used both methods. How are these devices inspected following cleaning and disinfection? 34% visually by the naked eye 52% visually under magnification

15. Implants Are these devices available from the manufacturer as individual packaged sterile items?

16. Reasons for single use not being purchased • Mainly use loan trays • Only limited number of plate sizes • Cost • Lack of storage • Always done it this way • Surgeons don’t like single use • Theatre staff refuse to purchase • Too much work for theatres • Theatres don’t like to change practise

17. Tracking systems Do you have a system for tracking the whole tray through each stage of the decontamination process? 84.2% YES 5.2% NO 4 blank Are you able to individually track these devices to patients on whom they will be used? 39.5% YES 50% NO 7.8% blank

18. Part B - Instrument manufacturers containers • 87% of units who responded use the manufacturers instrument containers for reprocessing. • 68% of the equipment containers contain trays, of which only 45% are made of the same materials as the container itself. • 40% of units have had problems with plastics within the containers cracking and flaking away from the metal container. Only 3 units have lodged formal complaints, in one trust the flaking caused a cancelled procedure with a loan set.

19. Part C - Processing problems • 74% of units have issues with the design of the instrument containers. • 56% of units have complained to the manufacturer • Main issues listed are: • Feet • Sharp corners • Handles • Insufficient holes for steam penetration • Manufacturers this has been mentioned to: Stryker, Zimmer, Smith and Nephew, Synthes, Biomet, Depuy, Finnsbury

20. Part D - Damage wraps • 68% of units have experience damaged wraps with these types of containers. • Most common points of damage • Feet 21% • Edges 2.6% • Corners 8% • Pressure points with stacking 5.2% • Theatres 2.6% • 5.5% of units have containerised as many sets as possible to prevent damage.

21. Types of wrapping materials

22. Point damage identified • Post sterilisation prior to despatch 57.89% • At the point of delivery to theatres 42.10% • After delivery but prior to use 63.15% • At the table in theatre 34.21% Approximately how long after sterilisation and delivery is the damage identified? Immediately 10.5% Within an hour 2.6% Within a couple of hours 10.5% Over a day 23.68% On receipt at theatre 10.5% Point of use 5.2% Blanks 18.5%

23. Part E - Wet loads • 55% of units have issues with wet loads • Reasons stated are: • Weight • Different thermal capacities of the set components • Size of sets • 65% of units have extended their drying times, most common 21% to 20 minutes but it varies between 10 to 45 minutes. • 58% of units thought the extended drying time prevented wet loads

24. Actions to prevent wet loads • Solid aluminium sheet under the trays to create a heat sink to flash off the water • Addition of an additional negative pulse to autoclave cycle • Re pack sets into din baskets and rigid containers • Use soaker sheets and a pre warming load so the thermal shock is less • Soaker sheets • Re test autoclave having a maximum weight of containers • Autoclave no more than 4 large sets Policy • 60% of trusts no visible moisture, 8% would use with a small amount

25. Part F – Frequency of unusable sets • 53% report regular delays or cancellations due to unusable sets • 18.5% of units report that this is a weekly occurrence, 2.6% report it happening daily, 10.5% happening monthly, 10.5% never • 42% reported specific sets which affected surgery while 44.7% said it was general to all orthopaedic sets. • 68.5% have removed equipment from problem sets to reprocessing in din baskets wrapped. • 26.3% discussed with the manufacturer the implications regarding validation due to the change to presentation, 50% haven’t.

26. Part G Loan instrument management • 58% of units aware of the Loan Tray Management guidelines • 74% aware of the MHRA guidance on loan devices • 66% apply the above recommendations • In addition 40% have their own policies and procedures • 37% of units find the set contents vary between use • 87% follow the manufacturers reprocessing instructions • 2.6% have to request compatibility statements, 2.6% follow BS EN 15883 and HTM 2030 / 2010 guidance

27. Next steps • IDSC technical group to review the information to see if it needs to go out to a wider audience. • Present the information to ABHI group to engage discussion. • Pull a working party together to review containment and manufacturers validation data.

28. Conclusion No matter what the company tells you You are not alone!