EFHSS Questions and Answers - Question Q00001

Is it really necessary in a traceability system to trace to the patient or is this concept commercially driven?

In a total quality concept you must know who your suppliers and customers are. In case of a recall you must be able to find the patient on whom the instruments were used. CSSD's can provide the instruments and trays with two barcodelabels so that one can go into the patients file. Not many hospital CSSD's, and OR's. do have a total quality system. But they should!

Vis, R.

While I think we will all agree that a computerised tracing system is the ideal option in a CSSD which makes it simple to trace to the patient we have to realise that many European countries do not have these systems widely used and depend on a simple labelling system, at least for the present. If we must trace these to the patient should we not also trace all the commercially sterilized products also, and how do we store the mountains of paperwork? Surely a quality system can be shown in the sterilization records of a CSSD department.

Mary Deane

The main purpose of a Quality Management System in the Sterile Supply is to make sure, that no "non sterile" item is able to be released. This includes the need of validated processes for decontamination, cleaning and sterilization as well as an exact documentation. Under this point of view I cannot see the need for a traceability up to the patient for every single medical device or set.

In case of juridical problems due to an infection, in general the concerned hygiene-expert will check the documentation of the reprocessing steps. If the items have been reprocessed under conditions, which meet the state of art (i.e. the appliance of national and international standerds) and there is an adequate documentation for this, I think there is no difference wether the patient had been treated with item A or item B.

T. Miorini, Austria

I agree with Mr. Miorini regarding this matter as a concept to say "Prevention is better than cure", during the sequence of steps after receving instruments from OR for decontamination. FDA evaluation and documentation of equipments involved in sterilization are constantly upgrade and evaluated to proof this process. Hovever, certain instruments/Implants are monitored by several monitoring parameters to ensure sterility assurance. There are several steps involved in quality assurance during a process ensuring sterility after sterilization. However, a good processing technician/s would eliminate the problem by following the required protocols and ensuring quality by basic step by step inspection during reprocessing through sterilization assurance of the instrument/equipment involved with proper monitoring, of all the monitoring systems involved in sterility assurance. Items involved with presterilized objects from different corporations have to be constantly managed with visual inspection to eliminate the problem at the early point of despensing. There are several techniques to retrace by the architecture of documentaion within an organization.

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