Consulting Solutions "Insights for Excellence"
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Every hospital faces similar challenges, but individual pathways are necessary to find customized solutions. We offer a wide range of service solutions to meet the exact and individual needs of a customer. We provide sales supporting services, starting with the analysis over optimisation and implementation up to a partnership. Thus, we can act as a solution provider towards the customer.
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Instrument reprocessing has multiple challenges
We already thought about several of them and some might sound familiar to you. Have a look at the following sterile cycle, choose your topic and find answers to your demands. Please send us your questions if there are open points.
"Insights for Excellence" written by our expert Dr. Gerhard Kirmse
Cleaning and sterilizing implants
Germany currently sees a users discussion whether all implants including bone screws should be supplied sterile
The main background is a lack of proper standards how such implants should be reprocessed.
Manufacturers instructions vary and an official guideline similar to instruments does not exist. It can be imagined that an implant with a long term contact would impose a higher risk than an instrument and the question is asked how this risk can be reduced.
- Processing only in special trays
- No cleaning in a washer disinfector together with contaminated instruments
- Control of bioburden
- Control of endotoxin
- Limited number of reprocessing cycles
It again comes back to the question, what is clean enough. Supplying sterile improves traceability but will certainly change processes in the OR completely.
Cleaning and sterilization
I recently found an article about Seattle Childrens Hospital warning patients about potential infections risks due to improper reprocessing
"Debris" was discovered. The article goes on with "This is the second time ...has alerted patients about problems with sterilizing surgical equipment" and an expert is cited that ". It seems we still have to continue the discussion about the importance of proper cleaning."
Luckily the CJD discussion has triggered more attention to cleaning but it still is not in everbodies mind.
Source: Seattle Times
One challenge – various solutions
For thorough cleaning trays have to be split in the washer disinfector
Identifying trays belonging together on the packing side is a challenge, especially on loaner sets. An article in "Outpaient Surgery" showed the solution with color wrapped paper clips and container locks.
However there are also more durable solutions like numbered clips.
No matter what the solution is, most important is:
- Identify the challenge
- Find a solution
- Test it
- If not satisfactory, find a better one
Many times we find ourselves caught in old habits having stopped searching for improvements.
Quality – the black hole?
Three reasons hospitals resist investing in quality
I read the article on the Healthmark Newsletter. It was well explained by the cost structure of hospitals, reimbursement and return on investment.
However it is strange that in the industry strong quality management is regarded as an activity to reduce cost. You would expect a pressure on quality in hospitals simply for ethical reasons. Potentially it is just a lack of understanding.
This set is urgent! Push or Pull?
I spent one hour in an SPD managers office
During that time she received four calls about sets, which should be processed quickly as they were needed by the OR. Every time more phone calls, searching for the set, disruption of the process.
However this is production of what the user needs (called pull production) which is what modern industry productions are looking for. Today SPDs are "push" productions, whatever comes in goes out as quickly as possible, first-in-first-out, which looks like a much more organized process (no searching etc) but frequently means late hours.
For the future we have to think how we can combine benefits of both processes.
What makes our goods dry in in steam sterilization (or not)
Obviously the sterilizer and its cycle is a main influencing factor but it may be worth looking into other directions too
In a recent case, drying problems were mostly limited to very heavy sets and plastic moulded trays. It might be much easier to retrofit a few sets than to extend a sterilizing cycle, which would cost more time for each set processed.
However each situation has to be looked onto individually.
We keep talking about validation...
On the one hand several countries validate their processes, on the other hand we still expect them to fail and ask for process controls. Besides daily Bowie Dick tests it seems to be very unclear how many controls we need. In the industrial interpretation, the meaning of a validated process you can only get good parts out of it as long as it is kept within the validation parameters.
If you get failures you need to re-validate potentially with more parameters. This is clearly not how reprocessing should work. Maybe we should start talking about process testing instead of validation.
Some instruments sent for repair are in the description marked as "corroded"
In fact they all have brown stains; however this is not necessarily corrosion.
Besides electron microscopy we use a fairly simple test: Immersion in ultrasound for 10 min. at 55° C with a highly concentrated aggressive alkaline cleaner.
With many instruments at least parts of the stains are removed which proves that this is a residue and not corrosion. This should be also performed in a hospital on routine basis to post-clean an instrument first before taking further action.