Workshop Report

On 27 April 2000 the spring meeting of the society ‘Sterilisation in hospitals’ took place at the University Hospital of Antwerp. 109 participants attended the workshop.

In the first paper on Custom Procedure Trays (CPT) Marc Corthals of Maxxim Medical first sketched the history of CPT’s. The CPT is the result of the search for the optimalisation of surgical and logistical procedures. He defined CPT as a completely sterile set which also includes the disposables needed before and after surgery. Furthermore he described the different CPT concepts and ended by discussing the advantages of CPT. The most important ones are:

• simplification of the logistical procedures;
• restrictions of the number of suppliers;
• easy calculation of the cost per procedure;
• possibility to use products one has chosen oneself;
• on time delivery;
• reduction of the stocks;
• billing at the right time;
• an increased efficiency in the operating theatre;
• a uniform way of operating;
• constant quality;
• a lowered risk of infection;
• waste reduction;
• lower personnel costs.

In the USA in 80% of the surgical procedures CPT is used. Mr Corthals expects a breakthrough in Europe and described the best way of tackling such a project.

He also looked towards the future and indicated that the Encompass principle will undoubtedly further simplify the logistics. This means that not only the implements needed for surgery are collected, but also the disposable aids which will be needed by the patient during the pre- and the post-treatment in other words during his total hospital stay.

Engineer Joost van Doornmalen (KW2) discussed in his paper the statement: "Sterile medical aids: a quality product".

He gave an overview of all the steps in the production process in the CSSD It has as its goal the delivery, in a reproducable fashion, of a safe sterile medical aid to the user.

He started with the routing of the aids and continued with the treatment, desinfecting and the packaging. Joost paid ample attention to the sterilising process and pointed out that when producing and purchasing medical aids the possibility of sterilising the product in question should be taken into account and not the other way round. Furthermore he focused on the why of the chosen sterilisation method. Steam sterilisation got his special attention because this technique is according to him considered as all too obvious. It has become all too easy to ignore potential problems. Attention should be paid to the difficult mixing of steam and air, and the penetration of steam into the narrow lumina. It should also not be forgotten that steam is a surface steriliser.

He also analysed the differences in the processes of B, N and S autoclaves and made it very graphical. Finally he stated that all the links are interlocked and have to lead to the above mentioned goal.

Dr. Licoppe (3M) offered an integrated solution with ETS (Electronic Test System) for monitoring steam sterilisation.

She pointed out that ETS could be an answer to the challenges facing the CSA in a continuously evolving sterilisation landscape such as:

• Budgetary restrictions;
• Minimisation of the risk by the application of risk assessment techniques;
• And the fact that the CSSD as a result of the appearance of the M.D.D. is more and more considered as a production unit which has to meet the same norms as the ones applicable to the industry.

Moreover the controlling of physical parameters is gaining more and more importance vis à vis the chemical and biological controls. ETS provides physical data allowing the head of the CSSD to ascertain whether a load is sterile.

Dr. Licoppe sketched the structure and the way of working of the system and enumerated the different possibilities. The most important ones are:

• The Bowie-Dick test. ETS can replace the classic BD-testpack. It meets the EN 285. An early warning is emitted when air is detected in the room in quantities insufficient to cause BD failure. In this way preventative measures can be taken.
• Data logging. By transferring the collected data to a personal computer with ETS software interesting information can be obtained such as: Fo integration, calibration check and an error analysis. Moreover the theoretical temperature curve can be calculated and a leak test carried out. The data can also be stored.

Dr. Johan De Neve provided additional information and discussed a number of graphs registered with the help of ETS.

After the break pharmacist Marc Borgmans and the head of the CSA, Walter Mertens, both from the AZ Middelheim, gave a detailed account of how their sterilisation unit, as the first in Belgium, succeeded in obtaining the ISO 9002 certificate.

They first defined the concept of quality to then arriving at the ISO 9002 and the CSA. Marc pointed out that the ISO-quality system is based on the assessment of a process. It does not guarantee a perfect process but ensures that errors are detected and what is even more important that it is followed up with corrective measures. In this way a circular system is put into place in which the processes are continuously refined in a circle of plan - do - check - act - plan - do - ...

When implementing Borgmans found the help of the consultant invaluable, especially with the translating (interpretation) of the norm to the CSA. The quality guide is the ultimate result. It describes:

• the declaration of issue;
• the management of the quality system;
• the internal organisation with the goals, the organisation of the quality system, the responsibilities and the competences;
• the description of the quality system;
• in appendices the structure of the covering procedures and the work procedures, the organogram.

Marc advised when describing the work procedures not to go into too much detail but to see to it that the procedure is clear and brief.

Finally there is the audit. The auditor does not judge the value of the process but mainly checks the internal coherence of the quality system.

Marc ended by pointing out that the added value of a quality system consists of the fact that one tries to avoid errors and this both on ethical and on financial grounds. The training op personnel is a lot more streamlined as written procedures are available. If the organisation succeeds in avoiding bureaucratic derailments then it will engage itself in a process of permanent improvement which should be the true goal of a quality system.

Walter Mertens then discussed how this could be realised in their CSA. The framework he outlined was:

• to make use of already existing documents;
• to take the legislation into account.

Remarkable in his account is the fact that all members of staff are involved in the project especially in the description of the work procedures. He concluded that it was more interesting to work on getting the ISO-certification than to have one.

Marc also presented a CD-rom on which all procedures are discussed.

Undoubtedly their pioneering work will thus be repeated much more quickly.

The traditional statutory meeting ended a successful seminar.

Wim Renders