Quality control

Who is responsible for the quality of the medical gases delivered in bulk and in the hospital?

IJsfabriek Strombeek is responsible for the quality of the medical gases up to and including the delivery. The quality of the distribution of these medical gases in the hospital is the exclusive legal responsibility of the hospital pharmacist. He forms his opinion on the quality of the distribution in its hospital on the basis of:

1. The established quality of the network.
2. The established quality of the gases such as they come out of the pipe network.

How to check the quality of the pipe network?

Pipeline systems for medical gases must comply with the European Standard EN-ISO 7396-1:2007. The installer of the pipe network in the hospital should submit the evidence that this standard was followed in the design, installation, operation, performance, documentation, testing and commissioning of the pipeline systems for compressed medical gases, gases for the propulsion of surgical instruments and vacuum.

This part of ISO 7396 shall also apply to extensions of and changes to existing pipeline distribution systems, and any modification or replacement of distribution systems or sources.

How to check the quality of the medical gases such as they come out of the pipe network?

IJsfabriek Strombeek provides in that connection the following services: making a qualified person and of all materials available required to carry out analyses on invitation, under orders, under the supervision, under the responsibility and instead of the hospital pharmacist. Thereby, the analysis methods which are reserved to the hospital pharmacy must be used, namely those that are stated in the monographs of the Ph. Eur. under the heading Essai (Fr.) / Tests (Eng) (test tubes).

Analyses are carried out on the spot, in the branch locations indicated by the pharmacist. This is very important because the hospital pharmacist then gets an exact picture of the medical gases such as his patients inhales them. This is not the case when samples are taken for later analysis outside the hospital. By inevitable changes in temperature during transport water and oil can for example accumulate on the wall of the sample cylinders, allowing later too low a result for these impurities when measured.

Analysis can be done on the medical gases O₂, N₂O, air and CO₂.

How long are the results of the analyses valid?

Once a distribution network has been checked and found to be correct (the first time at the delivery), its quality does not change, unless there are fundamental changes made to that network (conversions). In principle, the results of the analysis remain valid as long as nothing is changed to the pipeline network.

Of course, you can make an agreement with the hospital pharmacist to deviate from this principle. With this must be taken into account that the implementation of the analyses, including the travel there and back, and discussion with the pharmacist and the Technical Director before and after, takes in a full working day. Analyses of more than 5 branches or analyses on several campuses can take up more than one working day.