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Issues relating to orthopaedic containers
and the IDSc survey
Institute of Decontamination Sciences
Presentation Overview
• The presentation of orthopaedic equipment
• Issues with wrapping
• Background to IDSc questionnaire
• Results from the IDSc questionnaire
Presentation of orthopaedic equipment
Institute of Decontamination Sciences
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Containers with feet and insert brackets
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Heavy Layered Orthopaedic Tray
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Wet Loads
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Steps to achieve a dry undamaged load
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Equipment containment
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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
Design – boxes within boxes
Institute of Decontamination Sciences
Evidence suggests
Institute of Decontamination Sciences
• 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??
Back ground to questionnaire
Institute of Decontamination Sciences
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.
Aim of the questionnaire
Institute of Decontamination Sciences
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.
The Questionnaire
Institute of Decontamination Sciences
• 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
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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
Results from the questionnaire
Part A - Implants
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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.
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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
Implants
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Are these devices available from the manufacturer as individual packaged
sterile items?
Individually single packed items
5%
23%
Not investigated
Yes
No
47%
Some but not all
15%
Reasons for single use not being
purchased
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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
Tracking systems
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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
Part B - Instrument manufacturers
containers
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• 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.
Part C - Processing problems
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• 74% of units have issues with the design of the
instrument containers.
• 56% of units have complained to the manufacturer
• Main issues listed are:
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Feet
Sharp corners
Handles
Insufficient holes for steam penetration
• Manufacturers this has been mentioned to:
Stryker, Zimmer, Smith and Nephew, Synthes, Biomet, Depuy, Finnsbury
Part D - Damage wraps
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• 68% of units have experience damaged wraps with
these types of containers.
• Most common points of damage
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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.
Types of wrapping materials
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Point damage identified
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• 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%
Part E - Wet loads
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• 55% of units have issues with wet loads
• Reasons stated are:
– Weight
– Different thermal capacities of the set components
– Size of sets
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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
Actions to prevent wet loads
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• 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
Part F – Frequency of unusable sets
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• 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.
Part G Loan instrument management
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• 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
Next steps
Institute of Decontamination Sciences
• 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.
Conclusion
Institute of Decontamination Sciences
No matter what the company tells you
You are not alone!