Regional Hospital Klagenfurt
Sterilisation of medical instruments
When the surgeon calls for scissors in the operating theatre, he gets a sterile instrument. That seems to be a matter of course. However, there are different levels of sterility. At the Klagenfurt Regional Hospital, the sterility of medical instruments has dramatically improved in recent years because a committed team integrated tests into routine processes based on standards and — almost as a by-product — raised the level of a related equipment standard.
- Credit: Regional Hospital Klagenfurt
[2007-10-31] “Standards have become my hobby,” explains Horst Taferner with a smile. The former head of the Central Sterilisation Supply Department (CSSD) at the Klagenfurt Regional Hospital achieved an accomplishment within five years that would have been impossible without standards:
Building an internationally renowned management structure for instrument cleaning, raising the quality of sterilisation and integrating tests into routine work. “Again and again, teams of visitors come to us to learn more about our operations and to get new ideas for their own work,” Mr. Taferner explains proudly.
A decisive resolution
It all started several years ago. In 2000, the hospital’s management decided to centralise sterilisation operations. Up to that time, there was a workroom for preparing surgical instruments next to each of the 26 operating theatres.
Because of this decision, a centralised unit was established and construction work started. Parts of the basement of one building were adapted and new instrument washers according to ÖNORM EN 15883 as well as additional surgical instruments — for logistical reasons — were purchased.
Moreover, the sterilisation equipment was also brought in line with ÖNORM EN 285. Thus, the CSSD lives up to the state of the art. Horst Taferner was the ideal man for implementing the new standards.
After starting as an intensive-care nurse in 1982, he moved to the operating theatres and then on to sterilisation where he had worked as a team member for eight years before taking the helm — and responsibility for the big restructuring.
- Credit: Regional Hospital Klagenfurt
Clear structures
The new centralised unit needed a new management. Mr. Taferner prepared the ground for certification according to ISO 9001:2000. That required clear instruction flows, development of guidelines, traceable paths and processes, error monitoring and continuous staff training. Five years later, the certificate was obtained.
Why did it take so long? With 35,000 surgical interventions per year, certification was a large-scale project. Moreover, by creating the infrastructure, Mr. Taferner brought about a crisis for the equipment manufacturers that eventually resulted in products of a higher quality benefitting all other sterilisation units as well. However, let us start from the beginning.
Perfecting equipment tests
Medical instruments are first washed and then sterilised. For decades, this has been done — to draw a comparison with everyday life — in a dishwasher and then in a pressure cooker. The level of cleanliness is defined in ÖNORM EN 15883.
The efficacy of cleaning was verified — to put it simply — by soiling the instruments with test soiling made up of mashed potatoes, egg and food colouring agents, cleaning them and checking the result. A new test method using sheep blood developed by the Institute of Applied Hygiene in Graz was optimised in co-operation with the team of the sterilisation unit in Klagenfurt. “Sheep blood is closest to human blood,” says Taferner and goes on with a little bit of pride: “All over Europe, the equipment market collapsed.”
- Credit: Regional Hospital Klagenfurt
Complex surgical equipment
The new standard was followed by another challenge from Klagenfurt. After all, not all the instruments are as simple as tweezers or surgical knives. Out of the 35,000 surgeries performed in Klagenfurt, almost 3,000 are complicated interventions requiring complex equipment.
Heart surgery, laparoscopy and lower abdomen interventions increasingly rely on minimally invasive techniques. This means that the patients do not have any long incisions but only two or three “holes” near the surgical field. The surgeon manipulates handles that are connected to the instruments by a long tube.
These instruments are made of complex materials — mixtures of metal and plastics —, have many angles and bends and have to be disassembled before cleaning.
- Credit: Regional Hospital Klagenfurt
Improving the equipment
To clean complicated instruments — screwed links, tubes and sleeves — in accordance with the new standard, the interior of the cleaning equipment had to be re-designed and built anew.
Metal pipes with holes for cleaning tubes, washing processes going in both directions and, in some cases, clamps for bringing small parts into the right position were needed and also developed over the years.
“The suppliers were upset when we told them that their previously good equipment was not in line with the standard demanded in the call for tenders.” The equipment manufacturers have learnt. And so did Taferner and his team.
Audits creating added value
Therefore, it took five years up to the first validation according to the standards ÖNORM EN 554, EN ISO 15883 1-2 and the ON Rule ONR 112069. In 2005, the time had come. The staff was trained, the system was in place.
“Each audit took us one step further,” explains Taferner. After 2005, training was improved. An error management system was introduced, which raised the satisfaction of surgeons and nurses. In concrete terms, this means that the surgeons can file complaints. By means of a new bar code, it is possible to track the method and time of cleaning and the person in charge for each instrument.
Further structural and technical changes were a matter of course. Then an auditor raised a new challenge for Mr. Taferner by asking a simple question: “How can you prove that the instruments are as clean as you think they are?” The next project was born.
- Dipl.-Ing. Dr. Sandra Eder, MBA, and Horst Taferner, Head of the Central Sterilisation Supply Department of the Klagenfurt Regional Hospital
Research follows development
In 2006, the re-positioned sterilisation unit launched a research project. The main issue was how is it possible to prove that the instruments are clean in everyday operation?
Since October 2005, the chemist Dipl.-Ing. Dr. Sandra Eder has been working at the Klagenfurt Regional Hospital. Mr. Taferner contacted her — with success. Within eight months, they implemented a research project during full operation. Three tests — a wipe test, a washing test and a laboratory test — were examined.
With the help of the chemist and the hospital’s Institute of Laboratory Diagnostics, the tests were prepared for the users in a practice-oriented way. The team developed a test set that can be easily applied by the staff — no university graduates — and that is both effective and inexpensive.
The next major audit will take place for certification in 2008, and Mr. Taferner — now responsible for improving the nursing care system within the hospital management — is looking forward to it.
International attention
The Central Sterilisation Supply Department became a model for many because of its standards-compliant organisation. After its presentation at the World Forum for Hospital Sterile Supply, international companies came to see how the system really worked in practice.
And there was only one way to achieve success according to Sandra Eder: “I cannot ‘sell’ a standard alone, but only within the overall package of practical application. Thereby, the standard is filled with life and improved.”
