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CSSD Expert Visits South Africa

SteriView interview with René Vis

René Vis, who is the Sterilization Quality Manager for Sterile Medical Devices at the VU University Medical Centre in Amsterdam, the Netherlands, recently visited the country to give a series of presentations. SteriView interviewed him while he was here and asked him the following questions:

SV
The title of your presentation was "The CSSD of the Future" and as far as South Africa is concerned, the current state of the art in the Netherlands is way in the future. Presumably, your hospital sterilization practice was not always so advanced, so what spurred to on to achieve such excellence?

Rene
It all started over 20 years ago, when a number of patients died as a result of being giving contaminated medications that had been prepared in a hospital pharmacy. This resulted in a Government investigation, not only into hospital pharmacies, but also into other areas of the hospital that sterilized medical devices.

When the Government inspectors went into my hospital's CSSD they informed me that the way we were operating was not good practice. They told me that they understood my problem of not having funds available, but that they would have to take up the matter with the Director of the Hospital. They told him that there were major problems in the CSSD; in that your sterilizers are not functioning properly, and you do not have a washer disinfector. They told him that he must rectify the matter within a year or two, or at the very least have a plan of how he was going to upgrade the CSSD to the required specification. They also told him that the Government inspectors would visit his CSSD again and if he did not comply with these instructions, the CSSD will be shut down. This obviously concerned the hospital's Board of Directors, as they were afraid that if the CSSD was shut down, they could not operate.

SV
So nothing would have really changed if it were not for these Healthcare inspectors?

Rene
The technicians and managers in the CSSD were willing to change, but they did not have the authority, that was the main problem. There should be standards and guidelines in place, but also that they should be enforced. It is no use having a road sign that says that the speed limit is 80Km per hour, if there are no police to enforce the law. The Department of Health should enforce the law and insist that the hospitals install and operate proper sterilization departments.

SV
After your brief visit to South Africa, you will be aware that there are many challenges facing sterilization practitioners here, what do you think is the most pressing need that should be tackled first?

Rene
A good place to start would be to empower yourselves through education. In our country for example, sterilizers are bought by the user and not by the hospital management. You need education because if you do not know what specifications are required, you might not get what you want. The buyer should know what the required performance specifications are and whether the sterilizer meets these specifications. The first thing you should do is to train and educate your CSSD managers, so that they know what they should buy. If they draw up a wrong specification for their hospital and then put out a tender, it would cause a problem, as you would end up with unsuitable offers. They also need to be trained to evaluate all the offers received in order to make an informed buying decision.

I visited one of your CSSD's and there was a reading on the sterilizer and nobody knew what it meant. That is a lack of education. If you are in doubt, you are in a very dangerous situation. It is no use only being trained to do certain functions, if you are not trained to think! You cannot expect these people to draw up specifications for a sterilizer. I have been told that the majority of your sterilizers do not even have chart recorders. How can the operator be sure that sterilization process was correct? The EN standard says that if you are using a machine to re-process a device, then that machine must give you sufficient information to confirm that the process has been done correctly.

If there are no guidelines and no standards, companies will tend to supply products with the lowest possible specifications, especially if the hospitals do not know what they need. Hospitals need to be aware of what is going on in the rest of the world. There are European standards for the design and validation of sterilizers and washer disinfectors. South Africa may not be ready to adopt and implement these standards at the moment, because it would cost a lot of money. They should however, at least be planning to do so.

SV
It seems that CSSD Forums are a useful way of developing and sharing knowledge among practitioners. How do we go about setting up such forums and do you think we need National or Regional Forums?

Rene
Setting up regional forums or associations is a good way to start. The hospitals in an area should combine forces and exchange information. It works best if only CSSD practitioners attend such meetings in order to keep them focussed on relevant issues. A representative from a company can also be invited to do a presentation and help to build self-esteem, which is very important.

You can set up a National Association by combining regional forums. A Board must be appointed from the regional forums, which meets once a year. The National Association should be the forum to liase with Government. That is how it works in the Netherlands. I meet with the Chief Healthcare Inspector once a year and we talk about developments and difficulties in the work place. He also informs me of their goals are for the next year. So we know what to anticipate. Start locally and build the National Association.

SV
What do you discuss in such forums?

Rene
Daily problems - they should talk about what kind of sterilizers they use. Do they run a Bowie Dick, should they run a Bowie-Dick? Should they do an air-leak test? What do we all think about the Helix test? Is there place for Calivac? They should think of things such as these and build self-esteem. First of all they should get managers organised, and then the technicians. They are the most important people as they do the work.

SV
There is no formally recognised CSSD training in South Africa. Do you think that someone should approach a university and interest them in running a course in order to raise the status of practitioners?

Rene
You could do so, but we did not, so it can be done in other ways. If an educational programme has been developed in the workplace and adopted as a standard, then the Government in our country will also adopt it. They will first check out such a field standard, and will in most cases say that if this is your normal procedure or training programme, then for the time being this will be your standard.

There are several educational programs in the world. The American association, IAHCSMM has a programme, which is also a correspondence course. You could adopt the Dutch program, but it is in Dutch and the language may be a problem. Maybe if there were enough trainees in South Africa, the publishing company would consider translating it into English. It is something to discuss at CSSD forums.

SV
Why are you against of "Point-of-Use" reprocessing of medical devices?

Rene
In most cases "Just in-Time" or "Flash" sterilization is not done in the CSSD - it is done in a working place like in the Theatre. I do not trust the technicians there, to be quite frank, not because they are not trustworthy, but because they are so pressed for time. If you give them the opportunity to bypass the system, they are forced to do it. So what we did was, we took everything out and now there is no way back. If they give a device to me, it is gone for half a day. They tell the surgeon it is in process, you cannot use the device. But if it is there, you can just rinse it under the tap and flush it a bit and place it in glutaraldehyde.

We saw glutaraldehyde in the tray in one of your hospitals and the instructions said 20 minutes for disinfection and 10 hours for sterilization. Let us say that it was properly cleaned, and they soaked a device in it for 20 min. You can use this product, in a non-critical application. If you are going to do a knee surgery or an abdominal surgery operation, I would want a sterile product, and I would not want a disinfected one. I don't want the viruses from anybody else and I would be very surprised if anyone disagrees with me, but still they take the risks.

SV
It is common practice in South Africa for a surgeon to have a list of patients requiring scopes and to perform such procedures, using the same instruments again and again without proper re-processing. How do you get over this problem in the Holland?

Rene
The surgeon does not have the instruments under his control, so he cannot do two procedures with the same scope. What happens is that he does a procedure and the scope will be taken away to re-process it, then he gets it back. He is therefore forced to follow the protocol; there must be some form of law enforcement on this in the hospitals. You want to take good care of your patients.

Of course, this was not always the case in Holland either. Up until about 8 years ago, if you needed to have your stomach examined and you worked in the hospital, you made sure that you were the first patient on the list, as you would get the cleanest instrument. If you were the last, you were in big trouble. It is maybe, not such a problem if the instrument being used is purely for visualisation and it has no lumen or biopsy channel. But if they are taking biopsies and the surgeon wants to know if you have stomach cancer and you are negative, but the patient before you was positive and there was still tissue in the biopsy channel, you can be treated for something you do not have. It is very, very dangerous and while this may be hard to accept if you do not have enough instruments, I really think that you should not treat patients with unsafe instruments. Someone should tell the surgeons what the dangers are because they are not necessarily aware of them.

SV
There is certainly a conflict of interest here, because both the surgeon and the hospital would like to operate on as many patients, as quickly as possible.

Rene
Yes, but they know what the risks are. We visited a hospital where they had a special Operating Theatre with a lock on the door. It was only used by one neurosurgeon who wanted a very clean environment to work in, because he knows what the dangers of infection are. They are however, using the same sterile packaging material over and over again at this hospital, so while this surgeon is focussing on doing a good job in the area under his control, all his good work is possibly being undone because of poor practice in the CSSD and he does not know it. This doctor should be taken through the CSSD and shown what is happening, but he would probably not want to get involved, because he will have to make changes. I think that this is one of the main principles of management, we call it "Meten is weten" - "To measure is to know" and if you know, you have to act. Most people would rather not to measure, so they don't have to act!

SV
So measurement and control is very important in the CSSD?

Rene
I think that a CSSD is very comparable to a Hospital Pharmacy that manufactures certain products. Hospital Pharmacies are very strictly controlled by legislation and are regularly inspected to ensure that they comply with the rules and regulations. The raw materials that Hospital Pharmacies receive from a vendor are first checked to confirm that they are of the correct specification and are safe to use. They are then weighed and formulated into a new pharmaceutical product.

The CSSD's raw materials are dirty instruments, and in most cases they are cleaned by hand in an un-controlled way. If you compare the two processes you will see that pharmaceutical manufacture is strictly controlled, whereas re-processing dirty instruments is a big "black hole". The reason for this is that the eyes of the world are focused on pharmaceutical manufacturing, - it is a big issue, whereas nobody seems to care how dirty instruments are being re-processed. We do it by hand and hope that we are doing a good job. I firmly believe that we need stricter control in this area.